louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03382314: HDDO-1614 Bio Equivalence Study
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Hyundai Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2017-12-22
Enrollment: 38
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A randomized, open-label, single-dose, crossover study

Detailed description: This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).

Eligibility criteria: Inclusion Criteria:

* Body weight 50kg ≤ / BMI=18\~29kg/㎡
* A person who is determined to be eligible for the test through a physical examination or an interview
* Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, and serology test

Exclusion Criteria:

* Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
* Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
* Any person who shows any of the following results in the screening test

  1. AST or ALT \> 2 times upper limit of normal range
  2. Total Bilirubin \> 2.0mg/dL
  3. Glomerular filtration Rate(eGFR) \< 60mL/min/1.7㎡
* Those who show signs of hypotension (systolic blood pressure ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
* Those who have a history of drug or who have a positive urine drug test

Primary outcomes:
measure: Bio-Equivalence between test drug and comparators
timeFrame: Day 1 ~ Day 27
Secondary outcomes:
measure: Bazedoxifene Pharmacokinetic Assessment
timeFrame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
measure: Cholecalciferol Pharmacokinetic Assessment
timeFrame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
Other outcomes:
Locations:
city: Junggu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
Study officials:
References:
Clinical trial NCT02246114: Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women
Official title: Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Smoking
Smoking Cessation
Keywords: Pregnancy
Smoking
Smoking cessation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2014-09-22
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant women. Investigators hypothesize that more regular self-monitoring, text messages and feedback as provided by home carbon monoxide monitoring device combined with medical feedback on results will reduce smoking during pregnancy compared to only receiving text message and no self-monitoring by home monitoring device and no feedback by home carbon monoxide monitoring device . The periconceptual period is a life period, where given the immediacy of the fetus and future child, a pregnant woman is willing to try and modify potentially harmful behaviors.

Detailed description: Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease and cancer risk, has proven remarkably difficult in traditional medical practice settings, and successful medical trials have been costly and labor intensive. This proposal aims to utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation among pregnant women who smoke. Investigators hypothesize that women who have access to a self-monitoring device more frequently (i.e., at home) and receive feedback about their carbon monoxide level will have greater reductions in smoking as determined by declining serum cotinine levels over the course of the study compared to women who do not have access to a self-monitoring device and do not receive feedback about their carbon monoxide level, but only receive text messages.

Eligibility criteria: Inclusion Criteria:

* Pregnant women 18-40 years old
* Participants will be pregnant women estimated to be between 6 and 20 weeks into their pregnancy
* Pregnant women have smoked at least at least one cigarette in the prior 7 days
* Own a smartphone capable of delivering and receiving text messages

Exclusion Criteria:

* Project materials and text messages are in English, potential participants will be excluded if they cannot read English and if there are concerns about the ability to comprehend or comply with study procedures

Primary outcomes:
measure: Primary Outcome of Serum Cotinine Levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: MS Hershey Medical Center, Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Richard S Legro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847314: Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
Official title: Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Keywords: Hypogonadism
Abdominal obesity
Physical exercise
Testosterone
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients in medical practices \> 35yrs fulfilling all criteria for documentation.

Brief summary: With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.


Eligibility criteria: Inclusion Criteria:

* Male patients \> 35yrs
* Waist Circumference \> 102cm
* Clinically and biochemically confirmed hypogonadism (testosterone group)
* Willingness to attempt weight optimization

Exclusion Criteria:

* Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours
* hypersensitivity towards the active pharmaceutical ingredient or other ingredients.

Primary outcomes:
measure: Waist Circumference
timeFrame: At each visit
Secondary outcomes:
Other outcomes:
Locations:
city: Many locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02252614: Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain
Official title: Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain, PCA Contramal Consumption
Keywords: naproxen sodium+codein, paracetamol+codein,lumbar disc surgery
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-09-30
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.

Detailed description: Patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo).

The primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia

Exclusion Criteria:

* Patients, known allergies to any of the drugs used in this study
* eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)

Primary outcomes:
measure: Pain intensity, contramal consumption
timeFrame: Postoperative 24 hour
Secondary outcomes:
measure: side effects, nausa, vomiting
timeFrame: postoperative 24 hour
Other outcomes:
Locations:
Study officials:
affiliation: Diskapi YBERH
name: Reyhan Polat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857114: Measuring the Effects of Touch Relaxation Painful Patients in Oncologie Nursing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Measure the impact of touch relaxation on pain communicative patients suffering from chronic pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety welfare and consumption of analgesics


Eligibility criteria: Inclusion Criteria:

hospitalized in the oncology department at least 3 days

* presenting the cancerous type of pain caused by their disease or treatment
* numerical scale pain score = 4/10
* receiving weak and strong opioids
* platelet count\> 100
* can receive anxiolytic
* adult
* Patient of both sexes
* no other relaxation approaches

Exclusion Criteria:

* against indication to touch: wound, bruises, circulatory disorders, diseases psychiatiques
* risk of hematoma
* numerical scale pain score \< 4/10
* understanding of the difficulties of the French language
* no receiving weak and strong opioids

Primary outcomes:
measure: Pain
timeFrame: 3 days
Secondary outcomes:
measure: anxiety
timeFrame: 3 days
measure: consumption of analgesics
timeFrame: 3 days
measure: wellness
timeFrame: 3 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT02056314: Developing and Evaluating Effectiveness of a Reinstatement Tutorial
Official title: Developing and Evaluating Effectiveness of a Reinstatement Tutorial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Gambling
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Lottery and Gaming
First posted: 2014-02-05
Enrollment: 260
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare a computerized tutorial to a brochure in terms of their education impact of people who wish to end voluntary self-exclusion. Voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. The Centre for Addiction and Mental Health (CAMH), in cooperation with Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. The goal of this study is to determine if this new computerized tutorial decreases the harm of gambling experienced by gamblers who are reinstated. For example, are they less likely to relapsing to problematic levels of gambling.

Detailed description: Voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. Currently there are over 10000 people in the program. Although some self-exclusion programs place a permanent ban on the individual, others offer the possibility of reinstatement after a period of time. Many problem gamblers actually do change their minds about self-exclusion and wish to return to gambling. Centre for Addiction and Mental Health (CAMH), in cooperation with Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. The goal of this study is to evaluate an the intervention to determine its impact on problem gamblers who is reinstated from relapsing to problematic levels of gambling. The content for the tutorial will be informed by CAMH, will be developed for land based gambling, and also adapted for online gambling as well.

Eligibility criteria: Inclusion Criteria:

* people currently in the voluntary self-exclusion program who wish to be reinstated (allowed back into the casino to gamble).

Exclusion Criteria:

* people who are not currently in the voluntary self-exclusion program

Primary outcomes:
measure: Gambling frequency
timeFrame: 6 months
Secondary outcomes:
measure: Gambling cravings
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Nigel E. Turner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04640155: Treating Chronic Pouchitis With a Low FODMAP Diet
Official title: Treating Chronic Pouchitis With a Low FODMAP Diet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pouchitis
Keywords: Low FODMAP Diet
Pouchitis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.

Detailed description: Following recruitment for entry into the study, subjects be asked to complete symptom surveys and provide a fecal sample for calprotectin measurement. Shortly after their screening visit, patients will be randomized 1:1 to either the low FODMAP diet (experimental) or regular diet (control) group. Patients in the experimental group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counseled regarding FODMAP containing foods. They will be asked to adhere to this diet over the next 6 weeks. At the end of the 6 week period, subjects will complete a 3-day food diary. Those in the regular diet group will be contacted by the dietician and given an educational handout at the beginning of the study period regarding best dietary practices. At the end of the 6 week study period, both groups will again be asked to complete another set of symptom surveys and provide a fecal sample for calprotectin measurement.

Eligibility criteria: Inclusion Criteria

* Patients aged 18-65 with a diagnosis of ulcerative colitis that have undergone ileal pouch-anal anastomosis following proctocolectomy for medication-refractory disease
* Either ≥4 episodes of pouchitis per year (antibiotic-dependent) OR persistent symptoms despite 4 weeks of antibiotic therapy (antibiotic-resistant)

Exclusion Criteria

* Diagnosis of indeterminate colitis or Crohn's disease
* Celiac disease
* Current use of low FODMAP diet
* Known dietary allergies
* Current use of antibiotics for reasons other than treatment of pouchitis
* Clostridium difficile infection
* Complication following ileal pouch-anal anastomosis requiring reoperation

Primary outcomes:
measure: Mean Difference in Fecal Calprotectin
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean Difference in Composite Symptom Scores
timeFrame: 6 weeks
measure: Mean Difference in Cleveland Global Quality of Life Score
timeFrame: 6 weeks
measure: Rate of Normalization of Fecal Calprotectin
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Digestive Health Center
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Stephen B Hanauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05663255: Effectiveness of CFTR Modulators According to Co-therapy
Official title: Is Effectiveness of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators Impacted by Co-therapy? A Population-based Comparative Effectiveness Study Using Data From French Cystic Fibrosis Registry Linked to French National Healthcare Insurance Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
CFTR modulators
co-therapy
SNDS
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 1990
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exhaustive on the recruitment of the all french CF patients meeting with eligibility criteria.

Brief summary: Unless CFTR modulators are highly effective, the introduction of CFTR (Cystic fibrosis transmembrane conductance regulator) modulators could lead to concomitant reduction or discontinuation of respiratory co-therapies in real-life. Such reduction/discontinuation of respiratory co-therapies could lead to an overall decrease of the effectiveness of CF care.

MODUCO study aims: 1) to compare the clinical effectiveness on lung function and pulmonary exacerbation of CFTR modulator during the year of initiation, according to level of co-therapy among CF patients; 2) to describe the nature and level of respiratory co-therapies (azithromycin, RhDNase, inhaled antibiotics) in the year before the initiation of CFTR modulator; 3) to describe the changes in respiratory co-therapies during the first and the second year following the initiation of CFTR modulator and compare between the two CFTR modulators; 4) to describe adherence to CFTR modulator during the first and the second year following its initiation; 5) to study the association between the nature of respiratory co-therapies and adherence to CFTR modulator during the first and the second year following its initiation.

A national population-based comparative effectiveness study will be conducted, based on retrospective analysis of clinical and prescription data of the French CF registry linked with the French national health data system (SNDS).


Eligibility criteria: Inclusion Criteria:

* - CF patients aged 6 years and more,
* Treated at least 6 months by ivacaftor or lumacaftor/ivacaftor or elexacaftor/tezacaftor/ivacaftor,
* Included in the French CF registry,
* For whom probabilistic matching with the SNDS database has succeeded.

Exclusion Criteria:

* none

Primary outcomes:
measure: Lung function
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01135355: Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients
Official title: Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients at Risk for Respiratory Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Blood Stem Cell Transplant Failure
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 26
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematopoietic stem cell transplantation (HSCT) for any indication.

Brief summary: The aim of our study is to determine whether a clinically relevant laboratory measurement (of seven specific immunologic biochemicals in the blood) can identify which bone marrow transplant recipients are likely to progress to respiratory failure. Our ultimate goal is to devise a comprehensive and inclusive laboratory test that is effective at determining who is likely to go on to respiratory failure, in order to facilitate early medical intervention.


Eligibility criteria: Inclusion Criteria:- Hematopoietic stem cell transplantation (HSCT) for any indication.

* Patients will range from age 0 to age 21. There is no gender restriction. We expect the male to female ratio to end up being about 50/50
* Ability to understand and the willingness to sign a written informed consent document.

Primary outcomes:
measure: Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine.
timeFrame: weekly during hospitalization for transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Rajni Agarwal-Hashmi
role: PRINCIPAL_INVESTIGATOR
References: