louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04087876: Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations
Official title: Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: intrahepatic cholangiocarcinoma
iCCA
Metastatic cholangiocarcinoma
FGFR genomic alteration
biliary cancer
bile duct cancer
liver cancer
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2019-09-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Basilea provided expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib was ongoing.


Eligibility criteria: The following inclusion criteria were applied:

* all other treatment options had been exhausted
* patient was ineligible for any ongoing trials or was geographically inaccessible to trials including a trial with derazantinib
* there was a reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
* patient was willing and able to provide written informed consent
* if applicable, regulatory approval by the appropriate jurisdiction was obtained

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Basilea Pharmaceutica International Ltd
name: Manuel Häckl, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03062176: Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease
Official title: Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heart Failure, Systolic
Renal Disease, End Stage
Chronic Kidney Diseases
Keywords: Heart failure
End-stage renal disease
Interleukin-1
Interleukin-1 receptor antagonist
Metabolomics
Lipidomics
Chronic kidney disease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* 18 years or older
* Chronic heart failure
* Left ventricular ejection fraction less than 50%
* C-reactive protein greater than or equal to 2 mg/L
* Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V \> 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate \<30 mL/min/1.73m2)

Exclusion Criteria:

* Inability to complete maximal cardiopulmonary exercise testing
* Need for urgent or emergent care
* Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease
* Allergy to rubber, latex, Escherichia coli or anakinra

Primary outcomes:
measure: Peak oxygen consumption (PVO2)
timeFrame: 6 months
Secondary outcomes:
measure: Heart Failure Hospitalization
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Benjamin W Van Tassell, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292576: Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits
Official title: Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa

Detailed description: Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* BMI between 18.5 and 30 kg/m2
* Sedentary to moderate physical activity habits

Exclusion Criteria:

* Consumption of dietary supplements, antioxidants or anti-inflammatory medication, such as aspirin, ibuprofen, naproxen, or any medication that can affect the study outcomes
* Actively smoking
* Suspected abuse of alcohol or illicit drugs
* Significant illness within two weeks prior to study start or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study
* Subject who cannot be expected to comply with study procedures
* Currently participating or having participated in another clinical trial during last 4 weeks prior to the beginning of this study
* Consumption of chocolate or its derivates 24 hours before the blood sample taken

Primary outcomes:
measure: Measurement of changes in SOD2 gene expression
timeFrame: after acute dose and 4 weeks of chronic dose
Secondary outcomes:
measure: Determination of DNA methylation pattern in the chronic phase of the study
timeFrame: After 4 weeks of chronic dose
measure: Evaluation of (-)epicatechin bioavailability in plasma
timeFrame: After 4 weeks of chronic dose
measure: Determination of plasma antioxidant capacity as a marker of oxidative stress
timeFrame: After 4 weeks of chronic dose
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Medicina Genomica
name: Maria Elizabeth Tejero Barrera, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00373776: Miltefosine for Mucosal Leishmaniasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leishmaniasis
Keywords: mucosal
leishmaniasis
miltefosine
Lead sponsor: AB Foundation
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Detailed description: Treat bolivian mucosal leishmaniasis with miltefosine.

Eligibility criteria: Inclusion Criteria:

* Mucosal leishmaniasis

Exclusion Criteria:

* Abnormal liver function tests (LFT)
* Abnormal kidney function test
* Concomitant diseases

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: toxicity
Other outcomes:
Locations:
city: Palos Blancos
country: Bolivia
Study officials:
affiliation: CIBIC
name: Jaime soto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164876: Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
Official title: A Randomised, Double-blind, Placebo-controlled Study of the Safety, Pharmacokinetics and Exploratory Pharmacodynamics of AUT00206 for 28 Days as Adjunctive Therapy in Patients With Recently Diagnosed Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Autifony Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: King's College London
First posted: 2017-05-24
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.


Eligibility criteria: Key inclusion Criteria:

* Male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening);
* Positive and negative symptoms assessed by PANSS;
* Medically and psychiatrically stable;
* On a stable dose of antipsychotic drugs;
* Able to give fully informed written consent and likely to comply with the requirements of the trial.

Key exclusion Criteria:

* clinically relevant, as assessed by a physician, abnormal findings at the screening assessment;
* sensitivity to excipients of the trial medication;
* current use of contraindicated drugs;
* participation in another clinical trial of unlicensed medicines within the previous 30 days;
* loss of more than 400 mL blood, within the previous 3 months; history of drug or alcohol dependence in the last year;
* significant acute or chronic illness;
* significant medical history or concurrent medical condition that warrants exclusion;
* objection by subject's physician

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
timeFrame: 28 days
measure: Plasma concentrations of AUT00206
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
Study officials:
References:
Clinical trial NCT01376076: Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
Official title: Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: schizophrenia
QTc
cardiac repolarization
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Men or women, age 18 to 50, inclusive
* Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening
* Negative pregnancy test
* Normal physical examination results, vital signs, and clinical lab test results

Exclusion Criteria:

* Axis II disorder severe enough to interfere with the study
* Smoking more than 20 cigarettes a day
* History or presence of cardiovascular disorder
* Pregnant/breast-feeding and/or planning to become pregnant/breast-feed
* Imminent risk of injuring self or others or causing significant property damage

Primary outcomes:
measure: Heart rate-corrected QT interval (QTc)
timeFrame: 35 days of double-blind treatment, up to 56 days total.
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Forest Investigative Site 001
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 004
state: California
city: Willingboro
country: United States
facility: Forest Investigative Site 002
state: New Jersey
city: Houston
country: United States
facility: Forest Investigative Site 003
state: Texas
Study officials:
affiliation: Forest Laboratories
name: Suneeta Ahuja, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05607576: Dexcom G6 for Total Pancreatectomy With Islet Autotransplantation (TPIAT) Patients
Official title: Accuracy of Dexcom G6 After Radiation Exposure-A Cross Sectional and Longitudinal Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Dexcom G6
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-11-07
Enrollment: 18
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A single-center prospective trial on the effects of standard of care radiation exposure on the Dexcom G6 continuous glucose monitoring (CGM) device.

Detailed description: To determine if standard of care radiation exposure longitudinally effects the accuracy and precision of the G6 transmitter in the post TPIAT in-patient population.

Reduce burden for patients to remove and waste a functional and expensive Dexcom G6 CGM for radiologic procedures.

Eligibility criteria: Inclusion Criteria:

* Planned TPIAT at CCHMC
* Staying in-patient at CCHMC post TPIAT
* Planned to receive a Dexcom G6 CGM

Exclusion Criteria:

• Hemo- or peritoneal dialysis

Primary outcomes:
measure: Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %)
timeFrame: 3 months
measure: Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Deb Elder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tellez S, Hornung L, Smith E, Trout A, Brady S, Lowe C, Courter J, Abu-El-Haija M, Elder D. Real-World Accuracy of a Continuous Glucose Monitoring System after Radiologic Exposure. Pediatr Diabetes. 2024 Aug 7;2024:2210509. doi: 10.1155/2024/2210509. eCollection 2024.
Clinical trial NCT02430376: dbGaP Protocol: Genetic Variants Associated With Pentalogy of Cantrell
Official title: dbGaP Protocol: Genetic Variants Associated With Pentalogy of Cantrell
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pentalogy of Cantrell
Keywords: Non-Muscle Myosin
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-04-30
Enrollment: 3280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE

Brief summary: Background:

Pentalogy of Cantrell (POC) is a syndrome that involves many heart abnormalities as well as large defects in the chest and abdominal wall. This often results in the heart and other organs being present outside the body at birth. Surgeons have learned to replace them and repair the heart. Researchers want to find possible gene changes that cause POC. To do this, they want to study data from the Pediatric Cardiovascular Genetics Consortium (PCGC) Cohort. The PCGC collects data and DNA samples from people with heart diseases and their families

Objectives:

- To find gene mutations in people with Pentalogy of Cantrell (POC) or other related syndromes.

Eligibility:

- PCGC data and DNA samples that are open to study by the public.

Design:

* Researchers will study the data from the PCGC.
* The gene testing being done in this study was consented to in the original studies. No new consent or waiver request is required.
* The study will last 1 year.

Detailed description: The purpose of this protocol is to identify genetic mutations in patients with the diagnosis of Pentalogy of Cantrell (POC) or other related syndromes. We will be looking for any exomic/genomic mutations that could be associated with this syndrome. We have produced a mouse model with a mutation in the gene encoding nonmuscle myosin IIB which exhibit problems with ventral wall closure, including extrathoracic location of the heart (ectopia cordis) and defects in the abdominal wall with protrusion of the guts and liver. These mice have severe defects in both the heart and brain, and resemble humans born with POC, who manifest these same abnormalities, and so we take a special interest in mutations in nonmuscle myosin proteins.

Eligibility criteria: * We will analyze data from subjects from congenital cardiovascular disease databases.

Primary outcomes:
measure: To identify novel genetic mutations associated with the disease Pentalogy of Cantrell
timeFrame: Ongoing
Secondary outcomes:
measure: To identify the molecular mechanisms underlying the congenital disease Pentalogy of Cantrell, to aid in the development of novel therapeutic strategies.
timeFrame: Ongoing
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Robert S Adelstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02438176: Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 105
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.


Eligibility criteria: Inclusion Criteria:

1. Patients agreement of consent
2. Patients who age more than 19
3. patients who undergoing catheter ablation of atrial fibrillation
4. Patients who are not vascular disease

Exclusion Criteria:

1. patients who do not agree with study inclusion
2. persistent AF
3. Patients with vascular disease or venous anomaly
4. Patients with structural abnormality of the heart

Primary outcomes:
measure: Patient's subjective discomfort
timeFrame: 6month after procedure
Secondary outcomes:
measure: Procedure time
timeFrame: 1day
measure: Procedure related complication rate
timeFrame: 1 month after procedure
measure: Long-term AF recurrence rate
timeFrame: 12 month after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT03541876: French Pediatric Helicobacter Pylori Observatory
Official title: Data Collection for the Creation of the French Pediatric Helicobacter Pylori Observatory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Keywords: children
treatment
observatory
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 1201
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with confirmed diagnosis of H. pylori infection

Brief summary: Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.

No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.


Eligibility criteria: Inclusion Criteria:

* Child with confirmed H. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies
* Age \< 18
* No opposition of at least one of the 2 parents to the use of health data for research purposes

Exclusion Criteria:

* Child with confirmed H. pylori infection by indirect diagnostic methods

Primary outcomes:
measure: Diagnosis of H. pylori infection
timeFrame: at inclusion
measure: Age
timeFrame: at inclusion
measure: Sex
timeFrame: at inclusion
measure: Country of birth
timeFrame: at inclusion
measure: Clinical symptoms
timeFrame: at inclusion, 3 and 6 months
measure: Microbiological diagnosis
timeFrame: at inclusion, 3 and 6 months
measure: Endoscopic diagnosis
timeFrame: at inclusion, 3 and 6 months
measure: Rates of bacterial resistance profiles
timeFrame: at inclusion, at 3 and 6 months
measure: antibiotic therapy
timeFrame: at inclusion, 3 and 6 months
measure: Bacterial eradication rates
timeFrame: 3 and 6 months
measure: Side effects and tolerance of first and second line treatments
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille Catholic University
Study officials:
affiliation: Lille Catholic University
name: Nicolas Kalach, PR
role: PRINCIPAL_INVESTIGATOR
References: