louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05146544: Characteristic and Real Intensity of Exercise in a Hospital-based Physical Activity Protocol for Patients With Chronic Disease
Official title: Characteristic and Real Intensity of Exercise in a Hospital-based Physical Activity Protocol for Patients With Chronic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Inactivity
Keywords: Adapted Physical activity
Chronic disease
exercise
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a cross-sectional monocentric study performed at the Nancy University Center of Sports Medicine and APA, France, between February 2020 and July 2021, in patients requiring implementation of APA.

Brief summary: The objective is to better characterize an adapted physical activity (APA) program within of the management of chronic diseases.

In France, since 2016, medical doctors have been able to prescribe APA to their patients with chronic diseases but while there are indeed prescription recommendations, there is no clear characterization of the practical reality of APA programs.

The interest of this work is to benefit from the experience of the Center of Sports Medicine and Adapted Physical Activities in Nancy (France) specifically dedicated to the prescription and the initiation of an APA program for of patients with a chronic disease.

Thus, this work aims to determine the real intensity of the APA, the effectiveness of the assessment necessary for the dispensation of the APA and other parameters likely to modify the result of the treatment.


Eligibility criteria: Inclusion Criteria:

- age greater than 18 years old, with the ability to perform a cardiopulmonary exercise test

Exclusion Criteria:

* beta-blocker treatment.

Primary outcomes:
measure: evaluate the real intensity level of adapted physical activity (APA).
timeFrame: Heart rate mean during 1 hour in the first APA Session (cross-sectional monocentric study)
Secondary outcomes:
measure: Evaluate Six-Minute Walk Test (6-MWT) efficacity to determine physical activity capacities
timeFrame: 6 minutes in the first APA Session (cross-sectional monocentric study)
measure: Evaluate sit-to-stand test (1 minute)) efficacity to determine physical activity capacities
timeFrame: 1 minute in the first APA Session (cross-sectional monocentric study)
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy.
Study officials:
References:
Clinical trial NCT03496844: Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma
Official title: A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
name: Banner University Medical Center
First posted: 2018-04-12
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.


Eligibility criteria: Inclusion Criteria:

1. Male
2. Be ≥ 18 years of age
3. Diagnosed with prostate cancer
4. Be willing and able to provide informed consent
5. Be informed of the investigational nature of this study

Exclusion Criteria:

1. Having a history of severe claustrophobia
2. Weight exceeding 400lbs

Primary outcomes:
measure: True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Phillip H Kuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Hani Babiker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073644: Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
Official title: Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: imatinib resistant or intolerant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be selected by primary care clinic.

Brief summary: The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.

Detailed description: Open label

Eligibility criteria: Inclusion Criteria:

* Age 18 years and above
* Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor after imatinib treatment failure or intolerance

Exclusion Criteria:

* Subjects with conditions that are contraindicated with sunitinib malate

Primary outcomes:
measure: Safety and tolerability of sunitinib malate as measured by the incidence, severity, seriousness and relatedness to treatment adverse events (AEs), laboratory abnormalities, vital signs (blood pressure) and the use of concomitant medications.
timeFrame: 36 weeks
Secondary outcomes:
measure: Effectiveness of sunitinib malate will be measured by the overall response as determined by the objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST).
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
city: Manila
country: Philippines
facility: Private Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00266344: MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)
Official title: MK0928 Phase IIb Dose-range Finding Study -Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-12-16
Enrollment: 520
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of primary insomnia

Exclusion Criteria:

* Patients with an active psychiatric disorder other than primary insomnia

Primary outcomes:
measure: Patient-reported total sleep time.
Secondary outcomes:
measure: Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05579444: Systems Biology of Gastrointestinal and Related Diseases
Official title: Systems Biology of Gastrointestinal and Related Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ulcerative Colitis
Crohn Disease
Obesity
Colon Polyp
Eosinophilic Esophagitis
GERD
Gastro Esophageal Reflux
Barrett Esophagus
Esophageal Cancer
Gastritis
Gastric Ulcer
Duodenal Ulcer
Intestinal Metaplasia
Gastric Cancer
Lymphocytic Colitis
Microscopic Colitis
Celiac Sprue
IBS
Irritable Bowel Syndrome
SIBO
NAFLD
Gallstone Disease
Keywords: gastrointestinal disease
gastric upset
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years old or older who visit WAGI for the following reasons:

* Colonoscopy
* Screening
* Surveillance
* Diagnostic Esophagogastroduodenoscopy (EGD) Screening Surveillance Diagnostic Initial consultation: differential diagnosis (including suspected and definitive diagnosis), disease management plan, diagnostic plan (laboratories, imaging, medical therapy, non-medical therapy)
* Follow-up visits: same as the initial visit
* Biologic infusions (can collect disease activity levels at the time)
* Diagnosis of any gastrointestinal disease

Brief summary: This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

Detailed description: This is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. Molecular and metadata will be collected from a large study population at multiple time points. Machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.

Eligibility criteria: Inclusion criteria

* Any patient 18 years old or older that schedules a visit to WAGI clinics or endoscopy center
* Able to use electronic communications
* Able to communicate in English
* Consent to participate in the study

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of human determinants of gastrointestinal diseases.
timeFrame: Up to 10 years
measure: Identification of microbial determinants of gastrointestinal diseases.
timeFrame: Up to 10 years
Secondary outcomes:
measure: Prediction of efficacy of biologics in treating IBD.
timeFrame: Up to 10 years.
measure: Development of a molecular test for C. difficile infection (CDI)
timeFrame: Up to 10 years.
measure: Quantify change in microbial species over time post colonoscopy
timeFrame: Up to 10 years.
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118844: Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions
Official title: Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bariatric Surgery
Laparoscopic Bariatric Surgery
Robotic Bariatric Surgery
Gastric Bypass
Morbid Obesity
Keywords: bariatric surgery
surgical conditions
deep neuromuscular blockade
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* patient between 18 and 64 years
* indication for bariatric surgery accordingly to HAS
* patient undergoing laparoscopic or robotic gastric bypass surgery
* written informed consent
* affiliation to social security

Non-inclusion Criteria:

* known hypersensibility to any of the drugs used during this study
* absence of written informed consent

Primary outcomes:
measure: Improvement of surgical conditions
timeFrame: 15 minutes
Secondary outcomes:
measure: Pneumoperitoneum generated pressure
timeFrame: 15 minutes
Other outcomes:
measure: time needed to perform gastrojejunal anastomosis
timeFrame: 90 minutes
measure: 10 point-VAS to evaluate surgical conditions
timeFrame: 2 x 15 minutes
Locations:
city: Vandoeuvre-Les-Nancy
country: France
facility: CHU Nancy/Brabois
Study officials:
affiliation: CHU Nancy, Department of Anaesthesia & Critical Care
name: Thomas Fuchs-Buder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.
Clinical trial NCT01494844: Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
Official title: Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Respiratory Device Comfort
Keywords: Patient Monitoring
Capnography
Human Engineering
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Oridion
First posted: 2011-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This research study will test the comfort of two noninvasive respiratory monitoring sensors (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting. People who enter into the study will wear the two interfaces, one after the other, for 20 minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and rate the comfort of each with a seven question survey. A total of 30 participants will be recruited.


Eligibility criteria: Inclusion Criteria:

* Normal body temperature
* Between the ages of 19-65 years
* Self-report as feeling to be in typical health
* No skin irritation face or neck where a sensor would be placed.
* School of Health Professions student

Exclusion Criteria:

* Any injury or condition that would affect assessment of comfort.

Primary outcomes:
measure: Comfort Rating Self-Report Instrument
timeFrame: 5 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jonathan B Waugh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waugh JB, Epps CA. Comfort evaluation of noninvasive respiratory monitoring interfaces. Respir Care 2011; 56(10): 1722.
Clinical trial NCT00036244: Synthetic Human Secretin in Children With Autism
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism
Lead sponsor: Repligen Corporation
Sponsor class: INDUSTRY
First posted: 2002-05-09
Sex: ALL
Minimum age (years): 32
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.


Eligibility criteria: Autism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Pediatric Neurology
state: California
city: Oakland
country: United States
facility: Children's Hospital and Research Center at Oakland
state: California
city: Centennial
country: United States
facility: 1st Allergy & Clinical Research Center
state: Colorado
city: Gainesville
country: United States
facility: Alachua Family Psychiatry
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Metairie
country: United States
facility: The Clinical Trials Center:A Division of Children's Hospital
state: Louisiana
city: Hingham
country: United States
facility: Hardy Healthcare Associates
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Sandy
country: United States
facility: Children's Biomedical Center of Utah
state: Utah
city: Edmonds
country: United States
facility: Puget Sound Neurology
state: Washington
Study officials:
References:
Clinical trial NCT04917744: Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors
Official title: Longitudinal Metabolite Levels in Patients Receiving Maintenance PARP Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 5
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with melanoma scheduled to receive immunotherapy for their ovarian cancer.

Brief summary: This study evaluates blood samples and compares levels of metabolites (levels of vitamins, carbohydrates, proteins, etc., that are in the blood), before and after the plasma exchange in patients scheduled to receive immunotherapy for their ovarian cancer. The information gained from this study may help researchers better understand the side effects from each treatment and possibly lessen those side effects for future treatments.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.

OUTLINE:

Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition.

Eligibility criteria: Inclusion Criteria:

* Adults
* Patients with ovarian cancer starting PARP inhibitor treatment

Exclusion Criteria:

* Patients unwilling to return for blood draws, patients unwilling to continue PARP inhibitor treatment for at least one month

Primary outcomes:
measure: Change of mesenchymal stem cell (MSC)-derived cancer support factors
timeFrame: At four weeks post PARP inhibitor treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Jacob J. Orme, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02633644: Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
Official title: The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Heart Failure
Cardiovascular Diseases
Heart Diseases
Lead sponsor: Enopace Biomedical
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure


Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed as chronic heart failure NYHA class II-III
* Subject should be receiving optimal medical treatment
* Subject signed and dated informed consent

Exclusion Criteria:

* Subject has severe aortic sclerosis or calcification
* Subject diagnosed with severe aortic valve disease
* Subject has severe mitral stenosis
* Subject involved in any concurrent clinical investigation
* Subject with cerebral vascular accident or transient ischemic attack prior to enrollment
* Subject diagnosed with Marfan Syndrome
* Subject with moderate or severe chronic obstructive lung disease
* Subject is allergic to iodine or contrast media
* Subject with prior cardiac transplant or heart transplant candidate
* Subject with a life expectancy of less than 12 months

Primary outcomes:
measure: The occurrence of all system and/or procedure related serious adverse events
timeFrame: 6 months
Secondary outcomes:
measure: The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)
timeFrame: 6 months
measure: The change in the exercise capacity as defined in a 6-minute walk test
timeFrame: 6 months
measure: The change in heart failure symptoms, as measured by quality of life, defined as an improvement from baseline on the Minnesota Living with Heart Failure® Questionnaire (MLWHFQ)
timeFrame: 6 months
measure: The change in echocardiographic assessment of LV ejection fraction
timeFrame: 6 months
measure: The change in echocardiographic assessment of LV end systolic volume
timeFrame: 6 months
measure: The change in echocardiographic assessment of LV end diastolic volume
timeFrame: 6 months
measure: The change in echocardiographic assessment of left atrium volume index
timeFrame: 6 months
measure: The change in echocardiographic assessment of LV mass index
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Athens
country: Greece
facility: Hippokration General Hospital
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
city: Tiberias
country: Israel
facility: Baruch Padeh Medical Center (Poriya)
Study officials:
affiliation: Enopace Biomedical
name: Daniel Weiss, MD
role: STUDY_DIRECTOR
References: