louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005478: Precursors of CVD Risk Factors--Project Heartbeat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: To elucidate the changes in body size, composition, and configuration occurring in adolescence, because these are important precursors of change in blood pressure and blood lipids.

Detailed description: BACKGROUND:

Project HeartBeat! was uniquely designed to investigate the course of change in cardiovascular disease risk factors and several categories of covariates, including the anthropometric indicators addressed in this study. The data pertained to the 678 participants who entered the Project in 1991-93 at ages 8, 11 or 14 years of age, of whom 49.1 percent were female and 20.1 percent were black. Of the 395 participants who became eligible for 10 or more 4-monthly examinations, 349 (88.4 percent) completed at least 10 occasions; 538 participants of 556 who were eligible for seven or more examinations (96.8 percent) completed at least seven. Multi-level (MLn) analytic methods previously tested with other data were utilized for this analysis.

DESIGN NARRATIVE:

Data from Project Heartbeat were analyzed. Hypotheses tested included: (1) the time patterns of change in several indicators of body size, composition and configuration over the period of observation; (2) the relations between the time patterns of change in these indicators and the corresponding patterns for change in selected endocrine factors; and (3) the explanatory contributions of energy intake and expenditure to variation between individuals in their observed time patterns of change in these indicators. The anthropometric indicators addressed were: weight (total mass), height, body mass index (BMI, wt/ht2), fat-free mass, fat mass, per cent body fat, and fat distribution (waist/hip ratio). Each of these indicators were examined first separately and then in relation to selected endocrinologic measures (testosterone, estradiol, and DHEAS) and to energy intake and expenditure (from interview histories of diet and physical activity). Existing data from up to twelve 4-monthly examinations over the age range from 8-17 years conducted in Project HeartBeat! were analyzed.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Darwin Labarthe
References:
Clinical trial NCT00886678: A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)
Official title: A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
pemetrexed
radiation
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).


Eligibility criteria: Inclusion Criteria:

* Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
* Presence of measurable disease by RECIST
* Inoperable stage IIIA or IIIB
* ECOG performance status 0-1
* No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

* Carcinoid tumor, small cell carcinoma of lung
* Patients with any distant metastasis
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
* Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
* Women and men of childbearing potential who have no willing of employing adequate contraception

Primary outcomes:
measure: tumor response rate
timeFrame: Tumor assessments after completion of chemoradiotherapy and every 2 months
Secondary outcomes:
measure: overall survival
timeFrame: baseline to date of death from any cause
measure: time to progressive disease
timeFrame: baseline to measured progressive disease
measure: the safety profile
timeFrame: every cycle
measure: site of first failure in patients who develop progressive disease
timeFrame: baseline to measured progressive disease
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ma Sheng lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893178: Impact of Polymorphism on Pulmonary Pressure in Subjects With Pulmonary Hypertension of Different Cause
Official title: Impact of Different Genetic Polymorphism on the Pulmonary Pressure in Patients With Pulmonary Hypertension of Different Cause With Special Focus on Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Pulmonary Hypertension
Keywords: eNOS Polymorphism
TNF alpha polymorphism
pulmonary pressure
polymorphism of vasoactive substances
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2009-05-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHF elevated pulmonary hypertension

Brief summary: Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected.

Especially patients with chronic heart failure can develope PH. The reasons therefore are lacking.

The researchers investigate different polymorphism and the influence of these on pulmonary artery pressure (measured invasively) in patients with congestive heart failure (CHF) and patients with primary pulmonary hypertension.

Detailed description: The study consists of 3 arms-patients with CHF and PH, patients with CHF without PH and patients without CHF and PH.

The PH measurement is due to routine catheterization, thereafter we measure different vasoactive polymorphism.

Eligibility criteria: Inclusion Criteria:

* CHF with or without pulmonary hypertension or
* patients with normal LVEF and pulmonary hypertension
* right heart catheterization due to routine
* informed consent

Exclusion Criteria:

* no right heart catheterization
* no informed consent
* elevated pulmonary pressure due to valve diseases or congenital heart disease

Primary outcomes:
measure: Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure
timeFrame: Dec. 2010
Secondary outcomes:
measure: Rate of G308A TNF alpha polymorphism within the different groups
timeFrame: Dec. 2010
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig- University Leipzig
Study officials:
affiliation: University Leipzig-Heart Center
name: Sven Möbius-Winkler, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05413278: Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Services
Official title: Fit for Transfer: Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transition
Inborn Errors of Metabolism
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Main aims of this project are

* To assess the baseline status-quo of transition and "fitness for transfer" in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related quality of life (HrQoL), and self-efficacy in adolescnets with inborn errors of metabolism. Biochemical or physical parameters as appropriate for the respective diseases from 12 months before are documented.
* To provide targeted, structured intervention modules (using available and, if necessary, adapted materials).
* To measure the effects of these interventions on information about adult services short-term (within a month) and to re-assess all other baseline status-quo parameters long-term (6 and 12 months later). Psychological assessments will be complemented by biochemical or physical parameters as appropriate for the respective diseases and indicative for transition success.


Eligibility criteria: Inclusion Criteria:Patients

* with an inborn error of metabolism in the care of a specialized metabolic care unit
* requiring specialized adult metabolic care
* at least 14 years old
* with a disease for which at least one biochemical and / or physical parameter disease marker is well established .

Exclusion Criteria:

Patients -

* with insufficient knowledge of the German
* with cognitive impairment to a degree that consent, and participation would be impossible
* in an end-of-life situation
* with a disease for which no biochemical and / or physical parameter disease marker is well established

Primary outcomes:
measure: Disease knowledge
timeFrame: change from baseline to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Childrens Hospital Vienna
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Basel
country: Switzerland
facility: University Childrens Hospital Basel
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Childrens Hospital Bern
city: Bern
country: Switzerland
facility: University Hospial Bern
city: Zürich
country: Switzerland
facility: University Childrens Hospital Zürich
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT04508478: Exercise Training to Atrial Fibrillation
Official title: The Impact of Exercise Training to Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
weight training
aerobic training
cardio-pulmonary function
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the impacts of different exercise training programs to the cardiopulmonary function, muscle metabolism, and body mass composition

Detailed description: Atrial fibrillation (AF) has been a global threat due to its increasing incidence and prevalence, and also its potential complications of embolic stroke and heart failure, and therefore has a great impact on life expectancy and quality of life. AF with preserved ventricular function is associated with exercise intolerance, and the effect of physical training had shown to improve life quality and heart function in the population. However, the optimal physical training modalities and intensities are not well studies.

Here we conduct a prospective, randomized, and interventional trial to investigate the effects of different exercise training programs to the burden of AF. We also exploit advanced imaging modalities, including dual x-ray absorptiometry and muscle magnetic resonance, to explore the change of body mass compositions. With this project, we will be able to explore the effects of different physical exercise modalities to the burden of AF and heart function, and also build up a best exercise training program, specific for this population.

Eligibility criteria: Inclusion Criteria:

1. Paroxysmal or persistent atrial fibrillation
2. Daily activity below moderate intensity \< 300 minutes or high intensity \< 150 minutes per week.

Exclusion Criteria:

1. Active infection.
2. Implant cardiac pacemaker.
3. Uncontrolled hypertension.
4. Cardiopulmonary contraindication to exercise training, such as decompensated heart failure, acute pulmonary edema, unstable angina, uncontrolled arrhythmia causing hemodynamic compromise, symptomatic severe aortic stenosis, suspected dissecting aortic aneurysm, severe pulmonary hypertension, acute myocarditis, endocarditis or pericarditis, uncontrolled asthma and SpO2 \< 90% at rest on room air.
5. Inability to follow verbal command or to walk on treadmill or use stationary bike.

Primary outcomes:
measure: AF burden
timeFrame: 5 months
measure: CPET/6 minute walking test
timeFrame: 5 months
measure: DEXA/muscle MRI
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Chieh Yu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03032978: Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment
Official title: Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial


Eligibility criteria: Inclusion Criteria:

* 18-50 years.
* Males or females.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Patients younger than 19 years old or older than 50 years old.
* Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.

Primary outcomes:
measure: Pain: VAS
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ehsan Hossam
state: Giza Governorate
Study officials:
References:
Clinical trial NCT04340778: Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion
Official title: Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 210
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial


Eligibility criteria: Inclusion Criteria:

* nulliparous women requesting copper IUD insertion

Exclusion Criteria:

* multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.

Primary outcomes:
measure: pain during IUD insertion: visual analog scale
timeFrame: 5 minutes
Secondary outcomes:
measure: duration of insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04465578: Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
Official title: Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Urinary Retention Postoperative
Urinary Retention After Procedure
Keywords: Stress urinary incontinence
Pubovaginal sling
Urinary retention
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.

Detailed description: A randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. The incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue \> 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "No" to the question 3 of the Urogenital Distress Inventory questionnaire).

Eligibility criteria: Inclusion Criteria:

* 18 years old and no improvement with conservative management

Exclusion Criteria:

* Prior anti incontinence surgery

Primary outcomes:
measure: To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
timeFrame: 1 month
Secondary outcomes:
measure: To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.
timeFrame: 1 month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Tiago Rosito, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439878: Effect of Galactose Ingestion on Postprandial Lipemia
Official title: The Acute Effects of Galactose Ingestion on Oral Fat Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lipemia
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, blinded crossover design.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose.


Eligibility criteria: Inclusion Criteria:

* Male
* 18 to 35 years old
* Body mass index \<30 kg/m2

Exclusion Criteria:

* Female
* Body mass index \>29.9 kg/m2
* Any history of metabolic disease
* Allergies or intolerances to milk and/or cream

Primary outcomes:
measure: Postprandial increase plasma triglyceride concentrations
timeFrame: 5 hours
Secondary outcomes:
measure: Postprandial plasma insulin concentrations
timeFrame: 5 hours
measure: Postprandial plasma glucose concentrations
timeFrame: 5 hours
measure: Postprandial plasma non-esterified fatty acid concentrations
timeFrame: 5 hours
measure: Postprandial plasma lactate concentrations
timeFrame: 5 hours
measure: Postprandial subjective hunger ratings
timeFrame: 5 hours
measure: Postprandial subjective fullness ratings
timeFrame: 5 hours
measure: Postprandial subjective satisfaction ratings
timeFrame: 5 hours
measure: Postprandial prospective food consumption ratings
timeFrame: 5 hours
measure: Postprandial overall appetite ratings
timeFrame: 5 hours
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
citation: Watkins J, Simpson A, Betts JA, Thompson D, Holliday A, Deighton K, Gonzalez JT. Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men. J Nutr. 2020 Jul 1;150(7):1765-1772. doi: 10.1093/jn/nxaa105.
Clinical trial NCT03118778: Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population
Official title: Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population: A Descriptive Retrospective Observational Study Using Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Disease
Keywords: Stress Ulcer Prevention
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 90895
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were prescribed PPIs during Jan. 2015 to Dec. 2015 will be identified and then all their inpatient and outpatient information will be extracted.

Brief summary: This is a descriptive retrospective database analysis study in using database. All patients with a physician PPI prescription will be selected to estimate the PPI inappropriate use.

Detailed description: Study primary objective is to identify the inappropriate use of PPI (overall, outpatient \& inpatient).

Eligibility criteria: Inclusion Criteria:

* All patients in 2015 China Health Insurance Research Association (CHIRA) database.
* Patients had PPI prescription during Jan. 2015 to Dec. 2015 will be selected to estimate the PPI inappropriate use.

Exclusion Criteria:

• Patients without data of treatment information.

Primary outcomes:
measure: Overall proportion of patient inappropriate use of PPI
timeFrame: 2015.01-2015.12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
Study officials:
References: