louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06476262: Occupational Gaps After Mild Stroke: a Single-Center Observational Study
Official title: Investigating Occupational Gaps After Mild Stroke: Prevalence, Explanatory Factors, and Impact on Quality of Life in a Single-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Occupational Problems
Lead sponsor: Clinique Les Trois Soleils
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Sud Francilien
First posted: 2024-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was selected from the active file of stroke patients undergoing post-stroke consultation at the Centre Hospitalier Sud Francilien.

Brief summary: The goal of this observational study is to investigate participation restrictions and their determinants in people after a mild stroke. The main questions it aims to answer are:

Do mRS score, time since stroke onset, cognitive disorders, mood disorders and fatigue negatively impact occupations after mild stroke?

Does an increased prevalence of occupational gaps correlate with a diminished quality of life following mild stroke?


Eligibility criteria: Inclusion Criteria:

* over 18 years old,
* a diagnosis of stroke confirmed by cerebral imaging,
* an mRS score \<3 at the post-stroke consultation,
* informed about the study
* not opposed to participation

Exclusion Criteria:

* cognitive dysfunction making participation in the study impossible,
* phasic disorders preventing comprehension of the questionnaires,
* neurological deficits prior to the stroke, a history of psychiatric disorders
* being under legal protection.

Primary outcomes:
measure: Occupational Gaps Questionnaire
timeFrame: the OGQ was administred at the inclusion
Secondary outcomes:
measure: Hospital Anxiety and Depression scale
timeFrame: HADS was asministred at the inclusion
measure: Montreal Cognitive Assessment
timeFrame: MoCA was administred at the inclusion
measure: Stroke Impact Scale
timeFrame: The SIS was administred at the inclusion
measure: modified Ranking Scale
timeFrame: The mRS was administred at the inclusion
measure: Fatigue Severity Scale
timeFrame: The FSS was administred at the inclusion
Other outcomes:
Locations:
city: Boissise-le-Roi
country: France
facility: Clinique Les Trois Soleils
Study officials:
affiliation: Clinique Les Trois Soleils
name: Christophe T Duret, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084562: Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT
Official title: Descriptive Study Comparing Regadenoson Versus Dipyridamole in Use as Pharmacological Stress Agent Before a Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (SPECT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Perfusion Imaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 300
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: Patients reffered for an indication of myocardial perfusion scintigraphy in the nuclear medicine unit

Brief summary: Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. A pharmacological stress is proposed when stress test is not possible or contraindicated, Several drugs have a marketing authorization in this indication (adenosine, dipyridamole, regadenoson, dobutamine).

Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it would allow a reduction of undesirable effects compared to other agents, especially adenosine. It is simple and quick to use thanks to a single dose administration. However, its cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for a limited number of doses, the indication of which must be justified (asthmatic patient or with severe COPD). Few studies in the literature specifically compare these two pharmacological agents (examination time, cost, tolerance) and the opinion on the use of regadenoson in the service is limited.


Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years
* Myocardial scintigraphy by pharmacological stress agent
* Used molecules = Dipyridamole or Regadenoson

Exclusion Criteria:

* Physical stress test by single or mixed effort (associating pharmacological stress)
* Pharmacological agent used = Adenosine
* Inclusion in the ERCAD protocol
* Double isotope protocol
* Patient refusal due to study information

Primary outcomes:
measure: Duration of the test
timeFrame: 24 hours (Visit 1: During the examen)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service
Study officials:
affiliation: Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service
name: Christian SCHEIBER, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448962: Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 in Patients With Primary Hypercholesterolemia and Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension, Essential
Primary Hypercholesterolemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 109
Sex: ALL
Minimum age (years): 19
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 Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

Detailed description: Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

* Patient with known or suspected secondary hypertension
* Other exclusions applied

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 8
measure: Mean sitting systolic blood pressure (MSSBP)
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cardiovascular Hospital
Study officials:
affiliation: Yonsei Cardiovascular Hospital
name: Seok Min Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00676962: Facilitating Implementation of Cognitive Behavioral Therapy in Primary Care and Community Clinics
Official title: Facilitating Implementation of Cognitive Behavioral Therapy in Primary Care and Community Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Implementation
facilitation
psychotherapy
training
Lead sponsor: South Central VA Mental Illness Research, Education & Clinical Center
Sponsor class: FED
First posted: 2008-05-13
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators propose to test the effect of external facilitation on the extent that brief cognitive behavioral therapy (CBT) for depression is incorporated into routine practice in primary care and community based clinics in the VA. The investigators will provide training in brief CBT to mental health providers in participating clinics. To the investigators' knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

Detailed description: We will test the effect of external facilitation on the extent that brief CBT for depression is incorporated into routine practice in primary care and community based clinics in the VA. We will provide training in brief CBT to mental health providers in participating clinics. To our knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

Eligibility criteria: Inclusion Criteria:

* mental health clinicians in selected clinics who do or are willing to do psychotherapy.

Exclusion Criteria:

* clinicians who do not do psychotherapy in eligible clinics.

Primary outcomes:
measure: CBT progress notes
timeFrame: Monthly post-training for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: South Central MIRECC
name: Michael R Kauth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663491: Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis
Official title: Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety
Keywords: Gastroscopy
Transnasal Endoscopy
Sedation
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of patients safety and comfort in nasal endoscopy.

Detailed description: Introduction: Numerous indications require regular outpatient upper gastrointestinal endoscopy (EGD). In most cases, peroral gastroscopy is performed. The aim of this study was to evaluate the necessity and outpatients' demand for transnasal gastroscopy (nEGD).

Methods: A questionnaire was used to assess patients' choice of method, previous experience, psychological and sociodemographic data. Furthermore, the patients' satisfaction with and potentially perceived discomfort during the examination as well as their preference for a method with regard to future examinations was evaluated.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Adequate knowledge of oral and written german

Exclusion Criteria:

* Inpatient Treatment
* For medical reasons (narrow nasal cavity, band ligation of esophageal varices, Placement of a percutaneous endoscopic gastrostomy, planned colonoscopy under sedation the same day, abnormal coagulation, emergency procedures)

Primary outcomes:
measure: Patients satisfaction (pain, discomfort, experience)
timeFrame: During Endoscopy procedure
Secondary outcomes:
measure: Pain during the procedure
timeFrame: During Endoscopy procedure
measure: Previous experience with endoscopy
timeFrame: Before Endoscopy procedure
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
affiliation: University of Leipzig
name: Albrecht Hoffmeister, Prof Dr
role: STUDY_CHAIR
References:
citation: Schuldt AL, Kirsten H, Tuennemann J, Heindl M, van Bommel F, Feisthammel J, Hollenbach M, Hoffmeister A. Necessity of transnasal gastroscopy in routine diagnostics: a patient-centred requirement analysis. BMJ Open Gastroenterol. 2019 Apr 14;6(1):e000264. doi: 10.1136/bmjgast-2018-000264. eCollection 2019.
Clinical trial NCT05248191: FMT for Postop Crohn's Disease
Official title: Fecal Microbiota Transplant for Postoperative Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Crohn Disease
Keywords: Crohn's disease
Ileocecal resection
Fecal microbiota transplant
Intestinal microbiota transplant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.

This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.

Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.


Eligibility criteria: Inclusion Criteria:

* Able and willing to sign informed consent form
* Age 18 or older
* English speaking
* Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
* Prior ileocecal resection for CD
* Stable medications for 30 days
* Women of reproductive age: Agree to remain abstinent or use effective birth control
* Able and willing to comply with all study procedures

Exclusion Criteria:

* Antibiotic therapy within 15 days
* Probiotic therapy within 15 days
* Adenomatous polyps that have not been removed
* Anticipated antibiotic use over the study period
* Subtotal or total colectomy
* Current ostomy (ileostomy or colonoscopy)
* Anticipated surgical procedure over study period
* Pregnancy
* Severe food allergy
* Diagnosis of end stage liver disease or cirrhosis
* Absolute neutrophil count \< 500 cell / uL
* Life expectancy \< 6 months

Primary outcomes:
measure: Ileal-associated microbiota engraftment
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
name: Byron Vaughn, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04569162: Rhizomelic Chondrodysplasia Punctata Registry
Official title: Rhizomelic Chondrodysplasia Punctata Registry At Nemours Children&#39;s Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: RCDP - Rhizomelic Chondrodysplasia Punctata
RCDP1
RCDP2
RCDP3
RCDP4
RCDP5
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: RhizoKids International
First posted: 2020-09-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual at any age with rhizomelic chondrodysplasia punctata or a closely related condition

Brief summary: The goal of this registry is to collect medical information on individuals with rhizomelic chondrodysplasia punctata and closely related conditions. The study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

Detailed description: The goal of this registry is to collect information on individuals with rhizomelic chondrodysplasia punctata (also called RCDP). This registry will enable detailed natural history studies of RCDP, with the hopes that identification of risk factors will allow for preventative treatments and thus a better quality of life for individuals with these diagnoses.

This study is limited to chart review, after signed informed consent obtained. There will be no additional visits or time in clinic because of participation in this registry. This study involves only the collection and storage of data extracted from the medical record. Records that may be requested and reviewed as a part of this study include but may not be limited to: specialist evaluations, surgical reports, results of blood and urine tests, genetic testing, x-rays, CT/MRI imaging. There are no special procedures, visits, or expectations of the individual as a result of participation in this registry. No one will be asked to have any specific testing for the sole purposes of this research.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with RCDP or closely related conditions by metabolic and/or genetic testing

Exclusion Criteria:

* Not meeting diagnosis of RCDP or closely related conditions by study team physician review of prior metabolic and/or genetic testing

Primary outcomes:
measure: Characterizations of the natural history of rhizomelic chondrodysplasia punctata
timeFrame: 5 years
measure: Identification of clinical features that are predictive of poor outcomes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours
state: Delaware
Study officials:
affiliation: Nemours
name: Michael Bober, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454791: Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Official title: Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
diclofenac
subcutaneous injection
glatiramer acetate
Copaxone
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
Collaborators: name: Teva Neuroscience, Inc.
First posted: 2011-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on injection site reaction following self-administer glatiramer acetate in people with Multiple Sclerosis.

Detailed description: A 4 week study with active or placebo medication at randomization and switch treatment at 2-week crossover visit (2 weeks on each arm). There will be a total of 3 visits to the clinic. Subjects will receive instruction on how to apply the DSTG/placebo at the injection site and keep a daily injection site reaction diary.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple Sclerosis (MS) made at least 3 months prior based on McDonald or Poser criteria.
* Age 18 or more
* Ongoing treatment with glatiramer acetate (Copaxone) for three months or more.
* No MS exacerbation for 60 days prior to screening.
* Mean score of greater than or equal to 1.0 on screening Local Injection Site Reaction scale of last 3 days.
* Written informed consent.

Exclusion Criteria:

* Regular use of any non-steroidal anti-inflammatory drug (NDAID), except Asprin (\<325 mg daily), between screening and end of study.
* Any contraindication to Diclofenac Sodium Topical Gel (DSTG)

  * allergy to DSTG or any NSAID.
  * history of asthma, urticaria, or other allergic reaction after taking any NSAID.
* Females who are breast feeding, pregnant or have potential to become pregnant during the course of the study(fertile and unwilling/unable to use effective contraceptive measures).
* Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing.
* Any other serious and/or unstable medical condition.

Primary outcomes:
measure: Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
timeFrame: 2 weeks
measure: Pain Scale at 2 Weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Subject Global Impression at 2 Weeks
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: MS Center at Evergreen Healthcare
state: Washington
Study officials:
affiliation: MS Center at Evergreen Healthcare
name: Ted R Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540891: The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score
Official title: The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 372
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day form).

Determine onset of urinary peak flow improvement after 7 days Secondary: Determine improvement in Bother Score after 7 \& 28 days; improvement in sexual function after 28 days; assess one-month efficacy and safety


Eligibility criteria: Inclusion Criteria:

- Men aged greater than or equal to 50 years with a history of lower urinary tract symptoms (LUTS) related to BPH for greater than or equal to 6 months, an International Prostate Symptom Score (I-PSS) (0 to 35 points scale) of at least 13 points, a maximum urinary flow rate (Qmax) between 5 and 12 mL/sec (with a voided volume of greater than or equal to 150 mL), a residual urine volume of less than or equal to 350 mL, and a bothersomeness score (0 to 6 points scale) of at least 3 points. All patients will undergo prostate size assessment by transrectal ultrasonography (TRUS) if not done within past 12 months.

Exclusion Criteria:

- Include, but are not limited to: concomitant lower urinary tract disease; previous prostatic surgery; history of postural hypotension or syncope; concomitant use of medications that may alter the voiding pattern; and clinically relevant biochemical abnormalities. Patients with a serum prostate-specific antigen (PSA) \>10 ng/mL will be excluded, and those with an elevated serum PSA between 4 and 10 ng/mL must have prostate cancer excluded to the satisfaction of the investigator.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluate the safety and onset of symptom relief using an acute I-PSS form(7 day form).
timeFrame: 7 day
measure: Determine onset of urinary peak flow improvement
timeFrame: after 7 days
Secondary outcomes:
measure: Determine improvement in Bother Score
timeFrame: after 7 & 28 days
measure: To determine the improvement in sexual function
timeFrame: after 28 days
measure: Assess one-month efficacy and safety
timeFrame: one month
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Yasir Nagarwala, M.D.
role: STUDY_DIRECTOR
References: