louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01421823: A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Idiopathic Fecal Incontinence
Keywords: Fecal Incontinence
Alpha agonist
Lead sponsor: RDD Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.

Detailed description: This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:

* patients previously treated with alpha agonist will be treated with placebo.
* patients previously treated with placebo will be treated with alpha agonist.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent.
* Male or female subjects 18 to 65 years of age.
* Fecal incontinence score over 8.
* The patient is able to understand the treatment and is willing to comply with the prescribed regimen.

Exclusion Criteria:

- Has a clinically significant history or presence of any of the following conditions:

* Known allergy to the API.
* Porphyria.
* Glaucoma.
* Pregnancy or lactation.
* Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
* Type 1 diabetes mellitus;
* Insulin treated type 2 diabetes mellitus.
* Renal insufficiency.
* Liver insufficiency.
* Malignant disease within 5 years of screening;
* Has hypertension (sitting blood pressure over 140/90 mmHg at screening)
* History of rectal surgery.
* History of HIV, hepatitis B, hepatitis.
* Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
* Use of tricyclic or monoamine-oxidase inhibitors.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
* Unable to understand the use instruction for the ointment, as judged by the investigator.

Primary outcomes:
measure: Fecal Incontinence
timeFrame: After 2 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Proctology Clinic, Asaf Harofe Medical Center
Study officials:
affiliation: RDD Pharma Ltd
name: Yehiel Ziv, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02672423: A Study of Abemaciclib in Healthy Participants
Official title: A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-02-03
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.

This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility criteria: Inclusion Criteria:

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have known allergies to abemaciclib, related compounds, or any components of the formulation
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
timeFrame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose
measure: PK: Maximum Observed Drug Concentration (Cmax)
timeFrame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Daytona Beach Clinical Research Unit
state: Florida
city: Evansville
country: United States
facility: Evansville Clinical Research Unit
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01957423: Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.
Official title: Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
whey protein
soy protein
nutritional status
activity of disease
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-10-08
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease patients.

Detailed description: The patients were split into two groups: one group was supplemented with whey protein and the other, with soy protein. Participants were assessed at three moments: before starting the intervention and after 8 and 16 weeks. The nutritional status and body composition were measured using bioimpedance analysis, anthropometry and albumin and pre-albumin dosages. Dietary intake was determined by 24-h dietary recalls. The disease activity was evaluated by Crohn's Disease Activity Index, serum cytokines and C-reactive protein dosages.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha

Exclusion Criteria:

* smokers
* who were using other medication or nutritional supplements.

Primary outcomes:
measure: Body mass index
timeFrame: 16 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 16 weeks
measure: Body lean percentage
timeFrame: 16 weeks
measure: Mid-arm circumference
timeFrame: 16 weeks
measure: Mid-arm muscle circumference
timeFrame: 16 weeks
measure: Corrected arm muscle area
timeFrame: 16 weeks
measure: Crohn's Disease Activity Index
timeFrame: 16 weeks
measure: C-reactive protein
timeFrame: 16 weeks
measure: Serum albumin
timeFrame: 16 weeks
measure: Pre-albumin
timeFrame: 16 weeks
measure: Triceps skin fold thickness
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: Sao Paulo
Study officials:
affiliation: University of Campinas
name: Maria MS Vilela, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03837223: RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER
Official title: RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER AFTER TRIGGER WITH ANALOGS OF GNRH: THE HUMANITAS PROTOCOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GnRH Trigger and Rescue Protocol
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 271
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In HR patients (AMH\> 3.5 ng / ml, AFC\> 15 follicles and if more than 18 follicles with diam. 12mm to induction) the trigger was obtained with triptorelin 0.2 mg / sc. In patients considered to be at intermediate risk of OHSS a rescue protocol has been implemented (HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily) and fresh embryo transfer.

Brief summary: Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To reduce this occurrence several studies have focused on the importance of support of the luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of OHSS (\<18 recovered oocytes) which performed GnRH trigger and rescue protocol.


Eligibility criteria: Inclusion Criteria:

AMH ( antimullerian hormone) \> 3.5 ng / ml, AFC (antral follicles count) \> 15 follicles and if more than 18 follicles with diam. 12mm to induction

Exclusion Criteria:

high risk of OHSS ( ovarian hyperstimulation syndrome)

Primary outcomes:
measure: ongoing pregnancy rate (OPR)
timeFrame: 2013-2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.
citation: Humaidan P, Kol S, Papanikolaou EG; Copenhagen GnRH Agonist Triggering Workshop Group. GnRH agonist for triggering of final oocyte maturation: time for a change of practice? Hum Reprod Update. 2011 Jul-Aug;17(4):510-24. doi: 10.1093/humupd/dmr008. Epub 2011 Mar 30.
citation: Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.
Clinical trial NCT01781923: Cognitive Remediation in 22q11DS
Official title: A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 22q11.2 Deletion Syndrome
Velo-Cardio-Facial Syndrome
Keywords: Cognitive remediation
Social Cognition
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Harvard University
name: University of Pittsburgh
First posted: 2013-02-01
Enrollment: 38
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a Social Cognitive Training (SCT) program. The computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. A preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.


Eligibility criteria: Inclusion Criteria:

* molecular/cytogenetic confirmation of 22q11DS

Exclusion Criteria:

* Intelligence Quotient \<60
* diagnosis of psychosis
* pregnancy
* home location does not permit participation in small groups

Primary outcomes:
measure: Change in sustained attention
timeFrame: Baseline and 12 weeks
measure: Change in executive function.
timeFrame: Baseline and 12 weeks
measure: Change in verbal memory.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Social skills
timeFrame: 40 weeks
measure: Change in brain function and white matter structure.
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
Study officials:
affiliation: Duke University
name: Vandana Shashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01455623: Development and Validation of a Disability Severity Index for CMT
Official title: Development and Validation of a Disability Severity Index for Charcot Marie Tooth Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Charcot Marie Tooth Disease
Keywords: CMT
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Muscular Dystrophy Association
First posted: 2011-10-20
Enrollment: 291
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two cohorts:

1. Patients self identified as having CMT and have chosen to be a part of the Inherited Neuropathies Consortium Contact Registry, housed by the Rare Disease Clinical Research Network.
2. Healthcare Providers working in the field of CMT.

Brief summary: It is necessary for outcome measures to accurately reflect the state of health of a person in order for clinical trials to show benefit. The most commonly used outcome measure for Charcot Marie Tooth Disease (CMT) is the CMT Neuropathy Score, which uses cutoffs of points designated as mild (0-10 points), moderate (11-20) or severe (21-36). These terms are arbitrary. This study is looking to base mild, moderate, and severe on what both people affected with CMT and those who provide for people with CMT consider appropriate.


Eligibility criteria: Inclusion Criteria:

* patients with CMT ages 8-100,
* health care professionals who take care of patients with CMT.

  * Eligible patients will be patients that have joined the INC RDCRN Contact Registry. These will be patients or guardians with known or probable inherited neuropathies.
  * Eligible health care professionals who participate in the care of patients with inherited neuropathies (physicians, genetic counselors, physical and occupational therapists etc.) attending the 4th International CMT Consortium to be held in Potomac Maryland June 29-July 1, 2011.

Exclusion Criteria:

* Does not read or speak English.

Primary outcomes:
measure: Compare Patient and Healthcare Provider impressions of what constitutes mild, moderate and severe impairment in CMT
timeFrame: 1 year
Secondary outcomes:
measure: Develop a Disability Severity Index including items with high patient-physician concordance
timeFrame: 1 year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Wayne State University
name: Sindhu Ramchandren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315223: Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Congestive Heart Failure
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.

Patients recruited by year:

2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5


Eligibility criteria: Inclusion Criteria:

* Patients suffering from CHF, NYHA II-IV class
* LV lower than 35% to LV lower than 45%

Exclusion Criteria:

* Patients with additional disease with life-expectancy of less than 2 years

Primary outcomes:
measure: Reduction of hospitalization for acute heart failure
timeFrame: Five years
Secondary outcomes:
measure: Improved clinical outcome for CHF patients
timeFrame: Five years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
citation: Kleiner Shochat M, Fudim M, Kapustin D, Kazatsker M, Kleiner I, Weinstein JM, Panjrath G, Rozen G, Roguin A, Meisel SR. Early Impedance-Guided Intervention Improves Long-Term Outcome in Patients With Heart Failure. J Am Coll Cardiol. 2021 Oct 26;78(17):1751-1752. doi: 10.1016/j.jacc.2021.08.036. No abstract available.
citation: Shochat MK, Shotan A, Blondheim DS, Kazatsker M, Dahan I, Asif A, Rozenman Y, Kleiner I, Weinstein JM, Frimerman A, Vasilenko L, Meisel SR. Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: A Randomized Controlled Trial (IMPEDANCE-HF Trial). J Card Fail. 2016 Sep;22(9):713-22. doi: 10.1016/j.cardfail.2016.03.015. Epub 2016 Apr 4.
Clinical trial NCT03890523: Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
Official title: Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Disease
Fistula Bronchial
Fistula, Gastric
Keywords: 3D printed
airway stent
carina
distal bronchi
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
name: Shanghai Tong Ren Hospital
name: Ruijin Hospital Luwan Branch
First posted: 2019-03-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi and aimed to determine the feasibility, efficacy and safety of this technique.


Eligibility criteria: Inclusion Criteria:

* Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT.
* The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment.

Exclusion Criteria:

* Severe infection
* coagulation disorders

Primary outcomes:
measure: Relief of symptoms
timeFrame: 1 month
measure: Heal of fistula
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with adverse events that are related to stent implantation
timeFrame: 6 months
measure: Stent patency time
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Luwan Branch
Study officials:
affiliation: Ruijin Hospital
name: Zhongmin Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: