Clinical trials: Malformations
Malformations
Varenicline Pregnancy Cohort Study
A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.
- Trial name
- NCT01290445
- Testing
- varenicline, cigarette smoke from maternal smoking, Non-Exposure
- Volunteers
- 885,185 people
- Sponsor
- Pfizer
Lymphatic Malformation
Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and…
- Trial name
- STARBORN-1 (NCT05871970)
- Testing
- TARA-002
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Protara Therapeutics
Tuberous Sclerosis Complex, Seizures
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P.
- Trial name
- NCT02544750
- Testing
- GWP42003-P
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Depressive Disorder, Pregnancy
Bupropion and Specific Cardiovascular Malformations
The study is an extension of earlier work based on a retrospective epidemiologic study of infants born to women who were exposed to bupropion in their estimated first trimester of pregnancy using data from a large US health plan…
- Conditions
- Depressive Disorder, Pregnancy, Smoking Cessation
- Trial name
- NCT01165255
- Testing
- 3. Exposure to other antidepressants during the first trimester comparison cohort, 2. Exposure to bupropion outside the first trimester comparison cohort, 1. Exposure to bupropion during the first trimester
- Volunteers
- 7,005 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease
Novel Endovascular Access Trial (NEAT)
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require…
- Trial name
- NEAT (NCT02036671)
- Testing
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Where
- 9 sites in Australia, Canada and 1 more
- Volunteers
- 80 people
- Sponsor
- C. R. Bard
Pregnancy, Neonates
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693…
- Trial name
- Care (NCT00702338)
- Testing
- corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH), human Chorion Gonadotropin (hCG)
- Volunteers
- 1 people
- Sponsor
- Organon and Co
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive…
- Trial name
- BYLieve (NCT03056755)
- Testing
- Alpelisib, Fulvestrant, Letrozole
- Where
- 94 sites in United States, Argentina and 17 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
Visceral Artery Aneurysms, Arteriovenous Malformations
Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations.
- Trial name
- NCT02079818
- Testing
- Penumbra Ruby Coil System
- Where
- United States
- Sponsor
- Penumbra Inc.
Endometriosis
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
- Trial name
- NCT00784693
- Testing
- Tanezumab
- Where
- 30 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pfizer
Fistulas Arteriovenous
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses.
- Trial name
- DissolveAVF (NCT04226599)
- Testing
- Dissolve AVF, Armada 35
- Where
- 10 sites in China
- Volunteers
- 220 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Hemodialysis Access
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.
- Trial name
- NCT00479180
- Testing
- Vascugel
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Pervasis Therapeutics, Inc
Chronic Kidney Diseases, Diabetes
KidneYou - Innovative Digital Therapy
The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness…
- Conditions
- Chronic Kidney Diseases, Diabetes, Arterial Hypertension, Chronic Glomerulonephritis
- Trial name
- NCT05286632
- Testing
- KidneYou APP
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Advice Pharma Group srl
Solid Tumor, Renal Cell Carcinoma (Kidney Cancer)
A Study of NDI 1150-101 in Patients With Solid Tumors
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as…
- Conditions
- Solid Tumor, Renal Cell Carcinoma (Kidney Cancer), Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Non-Small Cell Lung Cancer
- Trial name
- NCT05128487
- Testing
- NDI-101150, Pembrolizumab
- Where
- 19 sites in United States
- Volunteers
- 106 people
- Sponsor
- Nimbus Saturn, Inc.
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Pregnancy, Neonates
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or…
- Trial name
- NCT00703014
- Testing
- Corifollitropin Alfa 150 μg, 200 IU RecFSH/Follitropin beta (Days 1 to 7), 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
- Volunteers
- 541 people
- Sponsor
- Organon and Co
Intracranial Aneurysms, Cavernous Carotid Fistula
Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency
- Conditions
- Intracranial Aneurysms, Cavernous Carotid Fistula, Vertebrobasilar Fistula
- Trial name
- NCT01054391
- Testing
- NEC - Neurovascular Embolization Cover
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Nfocus Neuromedical
Arteriovenous Malformation, Gastrointestinal Bleed
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess…
- Conditions
- Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid
- Trial name
- NCT07639853
- Testing
- Concerto Versa™ Detachable Coils
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Medtronic Endovascular
Endometrial Cancer
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.
- Trial name
- NCT06463028
- Testing
- Sapanisertib, Serabelisib, Paclitaxel
- Where
- 18 sites in United States
- Volunteers
- 40 people
- Sponsor
- Faeth Therapeutics
Recurrent Glioblastoma Multiforme, Primary Glioblastoma Multiforme
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients.
- Conditions
- Recurrent Glioblastoma Multiforme, Primary Glioblastoma Multiforme, Brain Neoplasms, Malignant, Leptomeningeal Disease (LMD)
- Trial name
- NCT03423628
- Testing
- Radiation Therapy, AZD1390
- Where
- 11 sites in United States, Japan and 1 more
- Volunteers
- 159 people
- Sponsor
- AstraZeneca
Post-thrombotic Syndrome, Iliac Vein Compression Syndrome
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study
Primary objective: To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different…
- Trial name
- NCT02942394
- Testing
- sinus-Obliquus Stent System
- Where
- 7 sites in Austria, Germany and 2 more
- Volunteers
- 60 people
- Sponsor
- Optimed Medizinische Instrumente GmbH