louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03550573: 3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Official title: 3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic cardiomyopathy
sudden death
3D mapping
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 30
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: Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats. Today, there are no reliable means to identify HCM patients at risk of sudden death. The CardioInsight™ has recently been developed by Medtronic for non-invasive advanced cardiac mapping system. The CardioInsight™ Noninvasive 3D Mapping System is a non-invasive mapping system that collects chest ECG signals and combines these signals with CT scan data to produce and display simultaneous, bi-atrial and biventricular, 3-D cardiac maps.

It is a monocentric, prospective, comparative and analytical study. 20 HCM patients will be recruited in the National Reference Center for inherited cardiac diseases of Lyon. The 3D-propagation maps of 10 well phenotyped and genotyped HCM patients with previous VF (ventricular fibrillation) will be compared to 10 HCM patients without previous VF.

After consent signed, Holter ECG, scanner and CardioInsightTM 3D_ECG mapping will be planned in the month following the inclusion. 12-lead ECG, 24h holter ECG, cardiac scanner will be performed as standard procedure of each center in the current health care of the patient.

The widespread screening of HCM patients with 3D high-density noninvasive mapping should improve the risk-benefit ratio of implantable defibrillator therapy. It is expected that more patients at risk will benefit from this device.


Eligibility criteria: Inclusion criteria :

* HCM patient confirmed by echocardiogram.
* Patient who signed the consent.
* Patient benefiting from a social insurance system or a similar system

Exclusion Criteria:

* pregnant women,
* left ventricular dilation (diastolic \>60 mm diameter) and/or left ventricular systolic dysfunction (LVEF \<55%),
* prior cardiac surgery,
* atrial fibrillation,
* renal disease (serum creatinine \>2.0 mg/dl),
* primary cardiac valve disease
* coronary artery disease
* Previous recent cardiac scan

Primary outcomes:
measure: Identification of specific markers of risk of sudden death in HCM patients from the maps created by the combination of CT and signal data.
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
References:
Clinical trial NCT02104973: Obesity Prevention in Schoolchildren
Official title: Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Secretaria de Salud, Mexico
name: Secretaría de Educación Pública, México
name: Universidad Iberoamericana
First posted: 2014-04-07
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city.

Detailed description: In Mexico, obesity is becoming the most public health problem. The increase in body mass is associated with the changes in the alimentary environment, resources for physical activity in a context of poor health literacy of the population and low efficacy of the health system. Schools, as social settings, are a opportunity for obesity prevention.

The study includes three phases: 1) evaluation of training, in which the psychological context in which obesity is generated is evaluated. The evaluation will be performed by collection of qualitative and quantitative information, 2) design a strategy from the information obtained. The intervention will include working sessions with teachers, parents and children, establishment of schools in window counseling in nutrition and physical activity and the secretion of a website to not communicate with the public and Provide information, 3) evaluation of the strategy in a community trial with two groups of schools, one intervention and one control.

Eligibility criteria: Inclusion Criteria:

* Children students in selected schools
* Anthropometric diagnostic of normality or overweight
* Informed consent of parents

Exclusion Criteria:

* Children with special diet or children with limited motor functioning

Primary outcomes:
measure: Body mass index
timeFrame: 0, 12 months
Secondary outcomes:
measure: Change in vegetal and fruit consumption
timeFrame: 0, 12 months
Other outcomes:
measure: Adiposity
timeFrame: 0, 12 months
measure: Physical activity
timeFrame: 0, 12 months
Locations:
city: Mexico
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Distrito Federal
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Marco A González, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03817073: Assessing Fatiguability of Tongue Muscles in MS
Official title: Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Weakness
Fatigue
Multiple Sclerosis
Deglutition Disorders
Exertion; Excess
Lead sponsor: Thomas More Kempen
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
First posted: 2019-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP \<50% of the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.

Detailed description: Eligibility is Mini-Mental State Exam-score (MMSE) \> 23, a Eating Assessment Tool-score (EAT-10) \> 3, or a Functional Oral Intake Scale-score (FOIS) \< 7, or failing the Yale Swallow Protocol.

Eligibility criteria: Inclusion Criteria:

* proven MS
* subjective dysphagia

Exclusion Criteria:

* MMSE \< 23
* major head and neck surgery
* history of cancer

Primary outcomes:
measure: Number of successful repetitions
timeFrame: 30 minutes
measure: Evolution of MIP during subsequent repetitions
timeFrame: 30 minutes
Secondary outcomes:
measure: Baseline MIP as predictor for number of repetitions
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Thomas More University College of Applied Sciences
state: Antwerpen
Study officials:
affiliation: Thomas More University College
name: Jan Vanderwegen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03971773: PSYCHOLOGICAL CARE AND HYPNOSIS IN PATIENTS WITH CANCER
Official title: PSYCHOLOGICAL CARE AND HYPNOSIS IN PATIENTS WITH CANCER
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypnosis and Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The general aim of the research that we propose to implement is to study the potential benefits of hypnosis in the psycho-social care of patients with cancer. The main goal of this study is to measure the effects of hypnosis sessions on quality of life, anxiety and patient adjustment strategies. The effects of these interventions will be the subject of quantitative measurement via standardized scales in pre- and post-intervention situations of the potential effects of hypno-therapeutic intervention in cancer patients and


Eligibility criteria: Inclusion Criteria:

* Patient with any kind of cancer and followed by a psychologist

Exclusion Criteria:

* Patient with neurological trouble
* Patient with psychiatric decompassation

Primary outcomes:
measure: quality of life scale
timeFrame: 36 months
Secondary outcomes:
measure: anxiety scales
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance publique hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Emilie Garrido
role: STUDY_DIRECTOR
References:
Clinical trial NCT05703373: Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana
Official title: Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.


Eligibility criteria: Inclusion Criteria:

* Pregnant women attending interventional antenatal clinics during the 6-month study

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion with first supplement filled by MMS
timeFrame: 6-month intervention period
Secondary outcomes:
measure: Implementation: Proportion for which MMS is filled
timeFrame: 6-month intervention period
measure: Implementation: Proportion for which first and second supplement filled by MMS
timeFrame: 6-month intervention period
measure: Implementation: Feasibility
timeFrame: 8 months
measure: Clinical: Number of Pregnant Women with an Adverse Birth Outcome
timeFrame: 6-months
measure: Clinical: Weight Gain in Pregnancy
timeFrame: 6-months
measure: Clinical: Number of mothers diagnosed with Maternal Anemia
timeFrame: 6-months
Other outcomes:
Locations:
city: Block 8
country: Botswana
facility: Kgatelopele (Block 8)
state: Gaborone
city: Kopong
country: Botswana
facility: Kopong Clinic
state: Molepolole
city: Gaborone
country: Botswana
facility: Gabarone West Clinic
city: Gaborone
country: Botswana
facility: Lesirane Clinic
city: Gaborone
country: Botswana
facility: Mahlaku Lekganyane (Mmopane Block 1)
city: Gaborone
country: Botswana
facility: Nkoyaphiri Clinic
city: Gaborone
country: Botswana
facility: Tlokweng Main Clinic
city: Molepolole
country: Botswana
facility: Borakalalo
city: Molepolole
country: Botswana
facility: Boribamo Clinic
city: Molepolole
country: Botswana
facility: Boswelakoko-Borakalalo New Clinic
city: Molepolole
country: Botswana
facility: Phuthadikobo Clinic
city: Palapye
country: Botswana
facility: Kediretswe Clinic
city: Palapye
country: Botswana
facility: Palapye Primary Hospital
Study officials:
References:
Clinical trial NCT02280473: A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Current use of an artificial tear product
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
* Current eye infection or inflammation

Primary outcomes:
measure: Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
timeFrame: Baseline, Day 30
Secondary outcomes:
measure: Change From Baseline in the OSDI© Score
timeFrame: Baseline, Day 7
measure: Change From Baseline in Tear Break-up Time (TBUT)
timeFrame: Baseline, Day 30
measure: Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
timeFrame: Baseline, Day 30
measure: Change From Baseline in the Schirmer Test
timeFrame: Baseline, Day 30
Other outcomes:
Locations:
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: San Diego
country: United States
facility: Eric M. White, OD, Inc.
state: California
city: Bangor
country: United States
facility: Eye Center Northeast
state: Maine
city: Kansas City
country: United States
facility: Moyes Eye Center, PC
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Warwick
country: United States
facility: David W. Ferris & Associates, Inc.
state: Rhode Island
city: Brentwood
country: United States
facility: Primary Eyecare Group, PC
state: Tennessee
city: Memphis
country: United States
facility: The Eye Center at Southern College of Optometry
state: Tennessee
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, Carlisle-Wilcox C, Vehige J, Haque S. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study. Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17.
Clinical trial NCT01317173: Factors Related to the Progression of Chronic Kidney Disease
Official title: The Impact of FGF23 and Klotho on Progression of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease progression
FGF 23
Klotho
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2011-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-diabetic chronic kidney disease between the ages of 18 and 65 years old.

Brief summary: Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Non-diabetic chronic kidney disease

Exclusion Criteria:

* Presence of DM
* Actively using calcium based phosphorus binder of vitamin D

Primary outcomes:
measure: Progression of kidney disease
timeFrame: continuous measurement of kidney functions 3 monthly for two years or until the outcome reached
Secondary outcomes:
measure: Evaluation of Ca P metabolism
timeFrame: 3 monthly for two years or until the outcome reached
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Education and Research Hospital
Study officials:
References:
Clinical trial NCT04990973: Evaluation of Diet and Sleep in Vascular Health: A Pilot Study
Official title: Influence of Diet on Sleep and Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Keywords: Mediterranean diet
cardiovascular health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-08-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.

Detailed description: Poor sleep quality is highly prevalent in adults in the U.S. and worldwide. Recent work suggests that dietary intakes may influence sleep. This mechanistic study will test whether consuming a healthy, Mediterranean diet will improve sleep quality in U.S. adults with poor sleep and lead to better cardiovascular disease risk profile. Given the relationship between sleep and cardiovascular health, improving sleep quality through dietary measures could contribute to improving health in adults.

Eligibility criteria: Inclusion Criteria:

* Sleep \>6 hours/night
* Sleep complaints

Exclusion Criteria:

* Smoking
* Allergies to foods
* Inability to comply with study procedures
* Gastrointestinal disorders

Primary outcomes:
measure: Score on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
measure: Sleep Fragmentation Index
timeFrame: 4 weeks
measure: Average Sleep Duration Per Night
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Urinary 6-sulfatoxymelatonin Level
timeFrame: Change from baseline to 4 weeks
measure: Change in Tryptophan
timeFrame: Change from baseline to 4 weeks
measure: Change in Kynurenine
timeFrame: Change from baseline to 4 weeks
measure: Change in Serotonin
timeFrame: Change from baseline to 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Marie-Pierre St-Onge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200473: A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients
Official title: A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Effects of Nebivolol on Safety and Efficacy in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Nebivolol
Hypertension
Beta-Blockers
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

Detailed description: This study was a multi-center, multi-national, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

Eligibility criteria: Inclusion Criteria:

* An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Secondary hypertension
* Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents
* Pregnancy, nursing or women of childbearing age not using appropriate contraception

Primary outcomes:
measure: The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline
Secondary outcomes:
measure: - The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline
measure: - Response rate
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00635973: Open-Label Extension of Other SZ1839 (Iressa) Trials
Official title: Multi-Centre, Open-Label Extension Trial of Treatment With ZD1839 (Iressa) in Patients Who Have Been Treated in Other ZD1839 Clinical Trials and May Benefit From Continued Monotherapy ZD 1839.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Iressa
Gefitinib
Cancer
Patients diagnosed with cancer who have previously received Iressa in an Iressa clinical trial
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 100
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: A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.


Eligibility criteria: Inclusion Criteria:

* Received treatment in a previous Iressa clinical trial
* Provided Informed Consent to participate in the trial
* 30 days or less since completing the previous Iressa trial.

Exclusion Criteria:

* Radiotherapy completed more than 14 days before starting treatment in this trial
* Incomplete healing from prior surgery
* Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs

Primary outcomes:
measure: Adverse Events
timeFrame: Every 28 days
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Every 28 days
measure: Survival
timeFrame: Every 28 days
Other outcomes:
Locations:
Study officials:
References: