louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02851134: Search for New Genetic Mutations Major Effect in Crohn's Disease
Official title: Search for New Genetic Mutations Major Effect in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: genetic
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Crohn disease subject

Brief summary: This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.

Detailed description: The EPIMAD Registry covers a large area of Northern France (9 millions inhabitants) and collects all incident CD cases and data from CD multiplex families (families with 3 or more CD affected patients) in the Nord the Pas de Calais the Somme and the Seine Maritime. If the investigators could demonstrate that most CD cases from multiplex families were related to high frequency of NOD2 gene mutations, the investigators found some CD multiplex families without any NOD2 gene involvement. Thus in these families high prevalence of CD cases may rely on other major genetic susceptibility variant(s) that remain to be determined.

this clinical research Whole Exome Sequencing protocol, aiming to highlight genetics mutations with major effect in CD has been initiated.

This study is a familial genetic study with intra-familial controls. The genetics analyses are:

* Ascertain of no significant NOD2 mutation in the family members by Sanger DNA sequencing
* WES (CD patients and family controls unaffected subjects)
* Genotyping of all mutations found, case control and segregation analyses to validate their implication in CD.

Eligibility criteria: Inclusion Criteria:

* Crohn disease subject
* EPIMAD family with, at least, 3 Crohn disease subjects

Exclusion Criteria:

* Pregnant or lactating women

Primary outcomes:
measure: NOD2 gene status
timeFrame: 8 months after recruiting
Secondary outcomes:
measure: Whole Exome Sequencing
timeFrame: 10 months after recruiting
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Corinne Gower, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frade-Proud'Hon-Clerc S, Smol T, Frenois F, Sand O, Vaillant E, Dhennin V, Bonnefond A, Froguel P, Fumery M, Guillon-Dellac N, Gower-Rousseau C, Vasseur F. A Novel Rare Missense Variation of the NOD2 Gene: Evidencesof Implication in Crohn's Disease. Int J Mol Sci. 2019 Feb 15;20(4):835. doi: 10.3390/ijms20040835.
Clinical trial NCT02166034: Effects of School Gardens on Children's Diet, Nutritional Knowledge, Etc.
Official title: Healthy Gardens, Healthy Youth (HGHY): A People's Garden School Pilot Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Keywords: children
fruit
vegetable
diet
school
garden
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Washington State University
name: University of Arkansas
name: Iowa State University
First posted: 2014-06-18
Enrollment: 3531
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether school gardens influence children's dietary intake, nutritional knowledge, and other outcomes.

Detailed description: Schools in New York, Washington State, Iowa, and Arkansas were randomly assigned to receive school gardens and associated curriculum or to serve on the wait list control group that received gardens and curriculum at the end of the 2-year study. Baseline data were collected in Fall 2011. Garden interventions began in Spring 2012. Follow-up data were collected at 6, 12, 18 months following baseline data collection.

Eligibility criteria: Inclusion Criteria:

* Schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
* Schools did not already have a school garden.

Exclusion Criteria:

none.

Primary outcomes:
measure: change in fruit + vegetable intake at school
timeFrame: change from baseline to follow-up at 6, 12, 18 months
Secondary outcomes:
measure: Garden Intervention Fidelity
timeFrame: At 3 garden intervention time points -- 6, 12, 18 months after baseline
measure: change fruit & vegetable consumption at home
timeFrame: change from baseline (Fall 2011) to follow-up at 6 months, 12 months, 18 months.
measure: change in Nutritional Knowledge
timeFrame: change from baseline to follow-up at 6, 12, 18 months
measure: change in Science Technology Engineering Math (STEM) self efficacy
timeFrame: change from baseline (Fall 2011) to follow-up at 6, 12, 18 months.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Schools in Arkansas
state: Arkansas
city: Osceola
country: United States
facility: Schools in Iowa
state: Iowa
city: Ithaca
country: United States
facility: Schools in New York State
state: New York
city: Tacoma
country: United States
facility: Schools in Washington State
state: Washington
Study officials:
affiliation: Cornell University
name: Nancy M Wells, PhD
role: STUDY_DIRECTOR
References:
citation: Wells NM, Meyers BM, Todd LE, Henderson CR Jr, Barale K, Gaolach B, Ferenz G, Aitken M, Tse CC, Pattison KO, Hendrix L, Carson JB, Taylor C, Franz NK. The carry-over effects of school gardens on fruit and vegetable availability at home: A randomized controlled trial with low-income elementary schools. Prev Med. 2018 Jul;112:152-159. doi: 10.1016/j.ypmed.2018.03.022. Epub 2018 Apr 5.
Clinical trial NCT01408134: Viability Imaging in Volumetric Angiography (VIVA 1)
Official title: Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Scarring
Keywords: Inter-reader variability of myocardial viability imaging
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is twofold:

1. To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging
2. To evaluate DE CT image quality using a consensus DECT protocol

Detailed description: The presence of myocardial scar using radionuclide or magnetic resonance imaging techniques indicates myocardial segments with a reduced likelihood of functional recovery following myocardial revascularization. Preliminary evidence suggests that multi-detector CT (MDCT) angiography also can detect irreversible myocardial scarring through the detection of regions of delayed hyperenhancement (DE) of the myocardium.1-4 However, existing studies have been performed in single centers, and the reproducibility, and impact of this modality on recovery of myocardial function is unknown. In this study, the investigators propose a single-center trial using a standardized MDCT DE protocol among patients scheduled for clinical cardiac CT with planned reoperative surgical. The primary endpoint will be characteristics of DE imaging of the myocardium including its inter-reader variability and factors associated with image quality. These findings will further our understanding of the role of DE MDCT for the detection of myocardial viability.

Eligibility criteria: Inclusion Criteria:

* Eligible patients will be adults, ages 18 and above with:

  1. Known CAD with prior MI based upon clinical history or electrocardiographic criteria
  2. Planned redo-surgical myocardial revascularization
  3. Referred for CT (and eligible) for pre-op substernal mapping/coronary artery evaluation

Exclusion Criteria:

1. Inability to provide informed consent
2. Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis)
3. Chronic kidney disease manifested by a serum creatinine \>1.5 mg/dL, an estimated creatinine clearance \<50 ml/kg/min or on dialysis
4. Currently reporting or evaluated in NYHA class IV heart failure

Primary outcomes:
measure: Inter-reader variability of myocardial viability
timeFrame: day One
measure: DE CT image quality
timeFrame: day One
Secondary outcomes:
measure: Scan and patient factors related to the image quality
timeFrame: day One
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT03902834: Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
Official title: Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preconditioning
Lung Cancer, Nonsmall Cell
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Wearable technology is increasingly being used to promote healthy behaviour. In this study, the investigators propose the development and evaluation of Move for Surgery, which utilizes a wearable activity bracelet (Fitbit) and proven behavioural change techniques, for preconditioning of patients prior to lung cancer surgery. The primary outcome of this study will be compliance with Move for Surgery, as a surrogate measure for feasibility. Secondary outcomes, including accrual rates, perioperative pulmonary complications, cost per patient, and patient satisfaction, will also be collected. The investigators have partnered with the Canadian Partnership Against Cancer (CPAC) and Lung Cancer Canada (LCC) to develop Move for Surgery. The ultimate goal of this preliminary study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Move for Surgery on postoperative complications in the thoracic surgery population.


Eligibility criteria: Inclusion Criteria:

* Eligible participants include patients with NSCLC set to undergo pulmonary resection.

Exclusion Criteria:

* There will be no exclusion based on functional status in this feasibility study; rather, a subsequent analysis of participant demographics will be performed to inform future phases of this study.

Primary outcomes:
measure: The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion.
timeFrame: 12 months
Secondary outcomes:
measure: Rate of accrual
timeFrame: 12 months
measure: Perioperative patient complications
timeFrame: 12 months
measure: Cost per patient
timeFrame: 12 months
measure: Patient-reported health-related quality of life
timeFrame: 12 months
measure: Patient-reported health-related physical activity
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References:
Clinical trial NCT06154434: Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets
Official title: An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Whanin Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.


Eligibility criteria: Main Inclusion Criteria:

1. Healthy subjects, over the age of 19 years old
2. Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.
3. All subjects should be judged normal and healthy during a pre-study medical evaluation

   * Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.
4. Subject is willing to participate and to Sign written informed consent form
5. Female subjects of childbearing age who use contraception other than hormonal contraception.
6. Subjects who has no history of psychical disorder within the last five years

Main Exclusion Criteria:

1. Subjects who have a medical history specified in protocol
2. Subjects who are expected to have the prohibited medication and activity etc. during the study period
3. Subjects who can not comply with requirements as per protocol
4. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
5. Subjects who are not suitable for the clinical trial

Primary outcomes:
measure: AUClast
timeFrame: Up to 72 hours
measure: Cmax
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Whan In Pharm.
Study officials:
affiliation: Chungbuk National University Hospital
name: MINGYU PARK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06593834: A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation
Official title: A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease (aGVHD) After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Graft-versus-host Disease
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation

Detailed description: The study is conducted on patients after hematopoietic stem cell transplantation and the intervention is Bacillus coagulans, aiming to investigate the preventive effect of Bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.

Eligibility criteria: Inclusion Criteria:

1. Patients are fully aware of the study, voluntarily participate and sign informed consent;
2. Age: ≥18 years old;
3. Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC).

Exclusion Criteria:

1. Refused to participate in this clinical study;
2. Unable to take the drug orally;
3. Allergic to Bacillus coagulans;
4. People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients.

Primary outcomes:
measure: Rate of acute graft-versus-host disease
timeFrame: 100th day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00117234: Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia
Official title: A Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Anemia
Keywords: chronic heart failure
congestive heart failure
low hemoglobin
anemia
CHF
Symptomatic Congestive Heart Failure (CHF)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-06
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.


Eligibility criteria: Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Peak VO2 less than or equal to 16 ml/kg/min - Hemoglobin concentration between 9.0 and 12.0 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Unable to do cardiopulmonary exercise testing - Major organ transplant (e.g., lung, liver, heart) or renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion

Primary outcomes:
measure: Exercise tolerance, measured as peak VO(subscript)2
Secondary outcomes:
measure: Exercise duration; *NYHA classification; *Patient-reported outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ponikowski P, Anker SD, Szachniewicz J, Okonko D, Ledwidge M, Zymlinski R, Ryan E, Wasserman SM, Baker N, Rosser D, Rosen SD, Poole-Wilson PA, Banasiak W, Coats AJ, McDonald K. Effect of darbepoetin alfa on exercise tolerance in anemic patients with symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2007 Feb 20;49(7):753-62. doi: 10.1016/j.jacc.2006.11.024. Epub 2007 Feb 5.
Clinical trial NCT03537534: Intraurethral Lidocaine After Endourology Procedures
Official title: Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dysuria
Lead sponsor: San Antonio Uniformed Services Health Education Consortium
Sponsor class: FED
First posted: 2018-05-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many urological conditions are diagnosed and treated with the use of endourology procedures. Unfortunately, dysuria is a common patient complaint following these procedures. Intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. Many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. There is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. We have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.


Eligibility criteria: Inclusion Criteria: Adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia.

-

Exclusion Criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation

-

Primary outcomes:
measure: Subjective patient symptom score
timeFrame: 1 day (immediately before and after procedure)
Secondary outcomes:
measure: Patient complications
timeFrame: within 30 days
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: BAMC
state: Texas
Study officials:
affiliation: San Antonio Uniformed Services Health Education Consortium
name: Christopher Allam, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03629834: Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.
Official title: Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients more than 18 years treated by CPAP for Obstructive Sleep Apnea Syndrome diagnosed at the Sleep Medicine Unity of the Amiens Hospital having a MWT between the 01/01/15 and 31/12/16 were included. Patients were excluded if they had an Central Apnea Syndrome, Central Hypersomnia, no driving license or if they refused.

Brief summary: Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.


Eligibility criteria: Inclusion Criteria:

* patients treated by CPAP for Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

* Central Apnea Syndrome
* Central Hypersomnia

Primary outcomes:
measure: Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment
timeFrame: one day
measure: Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
citation: Basille D, Baud ME, Andrejak C, Basille-Fantinato A, Jounieaux V. Correlation between the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test in Obstructive Sleep Apnea Patients Treated with Positive Airway Pressure. Respir Med Res. 2020 Nov;78:100787. doi: 10.1016/j.resmer.2020.100787. Epub 2020 Aug 28.