louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04452994: Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma
Official title: Individual Patient IND Expanded Access Program JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Patient J.M. With Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-07-01
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this individual-patient investigational new drug (IND) single patient request (SPR) is to provide participants treatment with JNJ-68284528, an investigational product prior to its marketing authorization. Such access may be considered for participants with serious/life-threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03214094: Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Official title: Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric or Duodenal Ulcers
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 1119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The survey population will consist of participants with a diagnosis of gastric or duodenal ulcers and during low-dose aspirin administration in the routine medical care.

Brief summary: The purpose of this survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

Detailed description: The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.

This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

The survey will enroll approximately 1,000 participants.

- Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

* Participants with a history of gastric or duodenal ulcer

Exclusion Criteria:

* Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
* Participants with active upper gastrointestinal hemorrhage at initiation vonoprazan therapy
* Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
* Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Drug Reactions
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets
timeFrame: Up to 12 months
measure: Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets
timeFrame: Up to 12 months
measure: Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets
timeFrame: Up to 12 months
measure: Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06783894: Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome
Official title: Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: psychological disturbances resulting from irritable bowel syndrome causes sexual dysfunction in men such as weak erection of penis. The different exercise forms are important in improving symptoms of this syndrome and exercise also may improve sexual dysfunction in men

Detailed description: Forty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will divided into Group I or Group II . The group will contain twenty subjects. Group I will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly. the duration of physical activity will be 12 weeks. Group II will not perform any physical activity.

Eligibility criteria: Inclusion Criteria:

* men with irritable bowel syndrome
* men with erectile dysfunction
* married men

Exclusion Criteria:

* obese men
* chest/renal disease men
* cardiac/metabolic disease men
* systemic disease men

Primary outcomes:
measure: international index of erectile fucntion
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: Irritable Bowel Syndrome Severity Scoring System
timeFrame: it will be assessed after 12 weeks
measure: Irritable Bowel Syndrome Quality of Life Questionnaire
timeFrame: it will be assessed after 12 weeks
measure: State Anxiety Inventory
timeFrame: it will be assessed after 12 weeks
measure: Beck depression inventory
timeFrame: it will be assessed after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali MA Ismail
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03636594: Feasibility of Dance in People With COPD
Official title: "Let's Boogie": Feasibility of a Dance Intervention in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Dance
COPD
Maintenance program
Pulmonary rehabilitation
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: Canadian Lung Association
First posted: 2018-08-17
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite the benefits associated with individuals with chronic obstructive pulmonary disease (COPD) engaging in pulmonary rehabilitation (PR) programs, the benefits diminish by 6 months. A new innovative approach is needed to increase motivation to exercise and to minimize diminution of effect. Dance is a fun and interactive activity, which has shown benefits in other populations, such as Parkinson's disease and stroke. The aim of this study was to investigate the feasibility of dance in individuals with COPD following PR.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD confirmed by spirometry (FEV1/FVC \< 0.7)
* Adequate communication with or without corrective hearing aids
* No intensive PR for at least 6 months before recruitment
* An ability to provide informed consent.

Exclusion Criteria:

* Presence of comorbidities that could have prevented communication or safe exercise

Primary outcomes:
measure: Enrollment rate
timeFrame: 8 weeks
measure: Attendance rate
timeFrame: 8 weeks
measure: Participant satisfaction and perceived benefits (Participant satisfaction questionnaire) questionnaire
timeFrame: 8 weeks
measure: Occurrence of adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in functional capacity (6-minute walk test)
timeFrame: Change from baseline to end of 8-week dance program
measure: Change in Balance Evaluation Systems Test (BESTest) score
timeFrame: Change from baseline to end of 8-week dance program
measure: Change in Berg Balance Scale score
timeFrame: Change from baseline to end of 8-week dance program
measure: Change in balance confidence (activities specific balance scale)
timeFrame: Change from baseline to end of 8-week dance program
measure: Change in anxiety and depression (hospital anxiety and depression scale)
timeFrame: Change from baseline to end of 8-week dance program
measure: Change in health related quality of life (chronic respiratory disease questionnaire)
timeFrame: Change from baseline to end of 8-week dance program
measure: Change in step count
timeFrame: Change from baseline to end of 8-week dance program
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Dina Brooks, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04922294: Implementation of a Cardiometabolic Disease Staging System in Primary Care
Official title: Cardiometabolic Disease Staging System to Improve Medical Management of Obesity and Diabetes in Primary Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Obesity
Overweight
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care physicians employed at the University of Alabama at Birmingham within the Primary Care or Family Medicine departments

Brief summary: The aim of this study is to develop a clinical decision support system (CDSS) that incorporates obesity management guidelines and treatment options for use by physicians and, potentially, patients based on a cardiometabolic disease staging system. This CDSS will be designed using primary care provider input through a qualitative approach to explore physician preferences for the appearance, electronic location, treatment options, referrals, accessibility and other user requirements of the CDSS.

Detailed description: To provide appropriate medical management of obesity and facilitate the diabetes risk assessments of people with excess adiposity, a comprehensive staging system that establishes five stages of cardiometabolic disease risk-the cardiometabolic disease staging system (CMDS) has been developed. This staging is based on Adult Treatment Panel III metabolic syndrome risk factors to guide decision making for selection of treatment modality and intensity in the management of obesity. Hence, the study hypothesis is that providing CMDS to PCPs through a CDSS for medical management of obesity can aid in reducing the barriers of obesity and diabetes treatment at the PCP-level and improve the quality of obesity and diabetes care. In this pilot and feasibility study, investigators will implement an early-phase CDSS in a pragmatic PCP setting to assess the uptake and acceptability of CDSS delivered to PCPs implementing CMDS at the point of care, and collect pilot data to assess change in patient engagement and satisfaction.

Investigators will conduct initial focus groups with PCPs and a series of iterative design steps targeting PCP and patient needs. These qualitative interviews would be used to determine the initial set of requirements and prototypes of the user interfaces and notifications.

Eligibility criteria: Inclusion Criteria:

* Primary care physicians employed at the University of Alabama at Birmingham

Exclusion Criteria:

* Physicians ≥19

Primary outcomes:
measure: Implementation preferences
timeFrame: Over one hour interviews or focus groups
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Associate Professor
name: Tapan S Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05084794: The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed
Official title: Does Fixation of Medium-sized Posterior Malleolus Fractures Provide Better Outcome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Posterior Malleolus Fractures
Keywords: ankle
fracture
posterior
malleolus
fixation
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims prospective randomized comparison of mid-term clinical outcomes of middle-sized posterior malleolus fractures with and without internal fixation.

Detailed description: Although it has traditionally been accepted that posterior malleolar fractures involving less than 25 percent of the tibial plafond do not require operative fixation, this belief is now questioned. A number of studies have shown that the posterior malleolus contributes significantly to ankle stability. Many studies have also demonstrated that postoperative outcomes are better in patients who underwent posterior malleolar reduction and fixation.

The aim of this prospective study is to show how internal fixation of the posterior malleolus, including middle-sized posterior malleolar fractures (10-25%), affects clinical outcomes and to discuss the factors that may lead to arthritis of the ankle joint. The groups will be randomized. The clinical and functional results of 40 patients who will be operated between 2015-2019 due to ankle fracture will be evaluated at short to mid-term (2-5 years). According to our hypothesis, internally fixed posterior malleolar fractures give better clinical and functional scores.

Eligibility criteria: Inclusion Criteria:

Patients who were operated for ankle fractures, including posterior malleolar fracture between 10-25% of the joint surface. Two to five years of follow-up with functional and radiological outcome.

Exclusion Criteria:

Posterior malleolar fractures accompanied by severe soft tissue damage after high-energy injury will not be included in the study. Written consent will be obtained from all participants, patients who do not give consent or refuse to participate will not be included in the study. Patients who left the study voluntarily will not be included in the statistics. Patients with additional joint disorders, previous surgery or previous history of ankle complaint will not be included.

Primary outcomes:
measure: Short Musculoskeletal Function Assessment (SMFA) Questionnaire
timeFrame: 2 year
measure: Kellgren-Lawrence grading system for osteoarthritis
timeFrame: 2 year
measure: American Orhopaedic Foot and Ankle Score (AOFAS) Score
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02346760: Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
Official title: A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of UB-621 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Simplex Virus Infection
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2015-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.

Detailed description: This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.

Eligibility criteria: Inclusion Criteria:

* With age between 20 and 55 years.
* With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
* Body weight: \<85 kg.
* Subject has signed the written informed consent form.

Exclusion Criteria:

* With significant active infection (acute or chronic) within 28 days prior to the screening visit.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
* Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
* Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
* The clinical investigator considers that the subject is not in the condition to participate in this study.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 70 or 112 days
Secondary outcomes:
measure: Peak concentration of UB-621
timeFrame: Up to 70 or 112 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hoapital
name: Wing Wai Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05262894: Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow
Official title: Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accident Caused by Snow Avalanche
Keywords: snow
avalanche
hypercapnia
diffusion
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is aimed at investigation of respiratory gases propagation in snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow.

Detailed description: The study is aimed at investigation of respiratory gases (oxygen and carbon dioxide) propagation in the simulated avalanche snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow. A special apparatus was created for sampling and measurement of gas concentrations and to assure stable geometry of the experiment required for data evaluation.

Eligibility criteria: Inclusion Criteria:

* healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
* without a smoking history

Exclusion Criteria:

* Tiffeneau Index less than 0.70
* any cardiovascular or respiratory condition

Primary outcomes:
measure: The length of breathing
timeFrame: Continuously within up to 20 minute interval from the beginning of the breathing experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University, Faculty of Biomedical Engineering
Study officials:
affiliation: Czech Technical University in Prague, Fac. of Biomedical Engineering
name: Karel Roubik, prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roubik K, Sieger L, Sykora K. Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover Study. PLoS One. 2015 Dec 14;10(12):e0144332. doi: 10.1371/journal.pone.0144332. eCollection 2015.
citation: Roubik K, Sykora K, Sieger L, Ort V, Horakova L, Walzel S. Perlite is a suitable model material for experiments investigating breathing in high density snow. Sci Rep. 2022 Feb 8;12(1):2070. doi: 10.1038/s41598-022-06015-y.
Clinical trial NCT04585360: Psychiatric Manifestations Associated With Behcet's Disease
Official title: Psychiatric Manifestations Associated With Behcet's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Behçet's Disease, neuroBehcet, Anxiety, Depression, Tiredness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient regularly monitored in the internal medicine department of Bicêtre

Brief summary: The psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study.

Detailed description: Patients will be evaluated during a day-care facility for Behçet's disease activity together with evaluation of anxiety and depression symptoms (SCL90-R and MINI assessments), fatigue (MFI) and quality of life (SF36).

Eligibility criteria: Inclusion Criteria:

* Adult male or female
* Regular follow-up in the internal medicine department of Bicetre hospital
* Diagnosed with Behçet's disease

Exclusion Criteria:

* Refusal to participate in the study
* Poor command of the French language
* Patients under legal protection
* Pregnant woman

Primary outcomes:
measure: SCL90-R questionnaire
timeFrame: Inclusion visit
Secondary outcomes:
measure: MINI questionnaire
timeFrame: Inclusion visit
measure: MFI questionnaire
timeFrame: Inclusion visit
measure: SF36 questionnaire
timeFrame: Inclusion visit
measure: BSAS/BDCAF evaluation
timeFrame: Inclusion visit
Other outcomes:
Locations:
city: Le Kremlin-Bicetre
country: France
facility: Internal medecine department
state: Val De Marne
Study officials:
affiliation: APHP, Hôpital Bicetre
name: NOEL NN Nicolas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: