louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02297646: Influencing Factors on Training Efficacy in Healthy Adults
Official title: The Influence of Carbohydrates on Training Efficacy and Health Status in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Health Status
Maximal and Submaximal Parameters of Physical Performance
Keywords: Prevention
Exercise
Health
Endurance
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of carbohydrate intake on training efficacy and health parameters of an endurance training program in healthy adults.

Detailed description: Carbohydrate availability in endurance exercise seems to attenuate exercise-induced perturbations of cellular homeostasis and consequently diminishes the stimulus for training adaptation. Therefore, a negative relationship with exercise efficacy seems plausible. However, experimental evidence is rare and far from conclusive. Therefore, the present study aims to test the influence of carbohydrate intake on the efficacy of a typical preventive training program.

Eligibility criteria: Inclusion Criteria:

* no diseases
* nonsmoker
* BMI 25-30 kg/m²
* blood pressure \<160/100 mm/Hg
* unmedicated
* untrained status
* V̇O2max \< 50 mL/kg/min

Primary outcomes:
measure: Maximum oxygen consumption (VO2max)
timeFrame: 24 weeks
Secondary outcomes:
measure: Numerous serum parameters from venous blood (LDL, HDL, Cholesterol, Triglycerides)
timeFrame: 24 weeks
measure: Resting heart rate
timeFrame: 24 weeks
measure: Resting blood pressure
timeFrame: 24 weeks
measure: Body fat (Skinfold thickness)
timeFrame: 24 weeks
measure: Ventilatory anaerobic threshold (VT)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Institute of Sports and Preventive Medicine, Saarland University
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Tim Meyer, M.D. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04143646: New Technologies for Intensive Prevention Programs - NET-IPP
Official title: New Technologies for Intensive Prevention Programs - NET-IPP
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Herzzentrum Bremen
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In a randomized trial patients hospitalized for myocardial infarction are prospectively enrolled and assigned to either a web-based intensive prevention program or usual care (1 : 1 randomization). The web-based program includes telemetric transmission of data on cardiocascular risk factors (physical activity, blood pressure, body weight) by patients to the study center, e-learning modules by the study center and repetitive electronic contacts by e-mails and apps between a prevention assistant and the patient.

In addition, genetic risk on cardiovascular events will be assessed in all patients of the intervention group by a polygenetic risk score (PRS). Patients of the intervention group are randomly assigned to disclosure of genetic risk vs. no disclosure. The study hypothesis is that disclosure of genetic risk improves cardiovascular risk factor control by increased patient motivation.


Eligibility criteria: Inclusion Criteria:

1. Hospitalization due to acute myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction) defined according to valid international guidelines
2. Access to internet and consent to participate in a web-based prevention program
3. Consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization

Exclusion Criteria:

1. Patient refusal or inability to give informed consent
2. Hemodynamically significant valvular heart disease
3. Exercise limitations due to clinical conditions not related to CAD (such as severe orthopedic disorders,..)
4. Any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis \< 2 years,..)
5. Inability to cooperate with the protocol, including longterm follow-up
6. Chronic drug and alcohol abuse

Primary outcomes:
measure: Rate of participants with serious adverse cardiovascular events
timeFrame: 24 months
Secondary outcomes:
measure: LDL cholesterol
timeFrame: 24 months
measure: Smoking status
timeFrame: 24 months
measure: Physical inactivity
timeFrame: 24 months
measure: Blood pressure
timeFrame: 24 months
measure: Body mass index
timeFrame: 24 months
measure: HbA1c
timeFrame: 24 months
Other outcomes:
measure: Adherence to preventive medication
timeFrame: 24 months
measure: Assessment of quality of life
timeFrame: 24 months
Locations:
city: Bremen
country: Germany
facility: Herzzentrum Bremen
Study officials:
References:
Clinical trial NCT06340646: Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
Official title: Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholangiocarcinoma
Multiple Myeloma
Colon Cancer
Rectal Cancer
Keywords: Participant engagement
Genetic testing
Cholangiocarcinoma
Multiple Myeloma
Colorectal cancer
Underrepresented populations
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The Foundation for Barnes-Jewish Hospital
First posted: 2024-04-01
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.


Eligibility criteria: Eligibility Criteria:

* Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.

  * If diagnosed with multiple myeloma, must be African-American.
  * If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 65 years old at the time of diagnosis.
  * At least 18 years old
  * Able to understand and willing to sign an IRB-approved written informed consent document

Primary outcomes:
measure: Participant knowledge of clinical genetic testing
timeFrame: 6-8 weeks after results have been received and one year after disclosure of results
measure: Participant expectations of benefit
timeFrame: 6-8 weeks after results have been received and one year after disclosure of results
measure: Participant personal utility
timeFrame: 6-8 weeks after results have been received and one year after disclosure of results
Secondary outcomes:
measure: Participant anxiety
timeFrame: Baseline, 6-8 weeks after results have been received, and one year after disclosure of results
measure: Participant satisfaction
timeFrame: Baseline, 6-8 weeks after results have been received, and one year after disclosure of results
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Graham Colditz, M.D., DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05495269: Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Official title: Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sturge-Weber Syndrome
Glaucoma
Ocular Hypertension
Lead sponsor: Qlaris Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single treatment
Primary purpose: TREATMENT

Brief summary: Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.


Eligibility criteria: Inclusion Criteria:

* Between 12 and 19 years of age at Screening.
* Diagnosed with SWS
* Elevated IOP
* Willing to continue current dosing regimen of IOP-lowering medications
* Able to provide informed consent and follow study instructions

Exclusion Criteria:

* Expected to undergo IOP-lowering surgery
* Incisional or laser surgery of any type 4 months prior to study
* Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye
* History of or active clinically significant ocular disease
* Use of topical ocular corticosteroids in the 6 weeks prior to study
* Patient cannot be applanated or tolerate IOP measurements
* Patient is pregnant or lactating
* Uncontrolled systemic disease that can interfere with study participation
* Inability to self-dose or identify a caregiver for all study eye drop administration

Primary outcomes:
measure: Ocular safety
timeFrame: Over 28 days
measure: Systemic safety
timeFrame: Over 28 days
Secondary outcomes:
measure: Ocular hypotensive effectiveness
timeFrame: 28 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke Eye Center
name: Sharon Freedman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02085369: Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
Official title: Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Cognitive function
Gene expression
Metabolomics
Obesity
Overweight
Lifestyle
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2014-03-12
Enrollment: 100
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: Obese patients with bariatric surgery

Brief summary: Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.


Eligibility criteria: Inclusion Criteria:

* First bariatric surgery

Exclusion Criteria:

* More than one surgery

Primary outcomes:
measure: Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery)
timeFrame: 1 year
Secondary outcomes:
measure: The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention)
timeFrame: Measures 1 y, 2 y, and 5 y after surgery.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Academic Hospital Uppsala
name: Magnus Sundbom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Helgi Schiöth, Prof
role: STUDY_DIRECTOR
affiliation: Uppsala University
name: Olga Titova, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06284369: Video Messages for Smoking Cessation Campaign
Official title: Developing, Evaluating and Testing Video Messages for a Smoking Cessation Campaign Among Mongolian Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 240 adult smokers will be recruited. Subjects will be asked to view video messages that encourage smoking cessation. The effect of these videos will be assessed.

Detailed description: This study will use a parallel, two-arm randomized control trial design. After consenting to participate in the study, Participants will be invited to fill out the online questionnaire form which will include one randomly selected ad exposure. The participation in the study will contain three parts: pre-test, video-ad stimuli, and post-test. Pretest will contain questions on the demographic information and readiness to quit smoking. Video ad stimuli segment will contain the selected video ad. The posttest will contain the manipulation check, readiness to quit smoking, message engagement, and PME questions. A randomization table will be generated using Research Randomizer software (ResearchRandomizer.org; Social Psychology Network) and subjects will be randomized to video ad 1 or video ad 2 in permuted blocks of 2.

The video ads are a part of the "Victory" media campaign designed for the tobacco cessation clinical project in Mongolia. Each video ad ends with the slogan "Every attempt is a victory".

Video Ad 1. This video ad was designed using a loss-framed message and emphasized the costs of continuing to smoke (losses) demonstrating the severe negative health consequences of smoking (e.g., complicated COVID-19, ICU hospitalization). The main actor in the ad is a famous young male Mongolian singer.

Video Ad 2. The video emphasized the benefits of quitting (gains) using a female actor.

After the viewing of the video ad participants will be asked to report reaction by completing an online posttest survey.

Eligibility criteria: Inclusion Criteria:

* Eighteen years and older
* Current smoker every day or some days
* Has smoked a minimum of 100 cigarettes in a lifetime

Exclusion Criteria:

* Non Smokers
* Must have internet access to complete questionnaires

Primary outcomes:
measure: Message Engagement
timeFrame: Immediately post-video message view.
Secondary outcomes:
measure: Readiness to Quit Smoking
timeFrame: Change between pre-exposure and post-exposure to video message, an average of 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00507169: SVT-40776 in Patients Suffering From Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder (OAB)
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2007-07-26
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: TREATMENT

Brief summary: The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine


Eligibility criteria: Inclusion Criteria:

* Patients suffering from OAB for at least 6 months prior to inclusion

Exclusion Criteria:

* Pregnant and breastfeeding women
* Any medical condition or need for co-medication which interferes with the drug under investigation (SVT-40776) or the comparator (tolterodine)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00095069: Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)
Official title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2004-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of insomnia

Primary outcomes:
measure: Patient-reported amount of sleep and time to fall sleep at night after three months
Secondary outcomes:
measure: Patient-reported awakenings at night
measure: Sleep quality
measure: Functioning after 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.
Clinical trial NCT02146469: Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Official title: Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Varicella
Keywords: varicella vaccination
Lead sponsor: Shanghai Municipal Center for Disease Control and Prevention
Sponsor class: OTHER
Collaborators: name: Shanghai Institute Of Biological Products
First posted: 2014-05-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is as follows:

1. To know the antibody level during different interval after received 1 dose varicella vaccine.
2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.

To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.

All blood specimens will be tested by a third-party detection institution.


Eligibility criteria: Inclusion Criteria:

* Aged 1 to 7
* Without a previous history of varicella
* With an axillary temperature ≤37.5℃ at the time of vaccination
* Appropriate varicella vaccination history
* With guardian signing the informed consent and available for clinical observation

Exclusion Criteria:

* Hypersensitive to any active substance of the vaccine including excipients and antibiotics
* With acute illness, severe or acute attack of chronic illness or fever
* With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
* Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
* With a family or personal history of seizure, chronic illness, epilepsy or allergy
* With unknown immunization history or unable to follow the immunization schedule of EPI
* Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month
* With hemorrhagic tendency or prolonged period of bleeding
* Received whole blood, plasma or immunoglobulin within 5 months
* Received systemic antibiotics or antiviral treatment for acute illness within 7 days
* With an axillary temperature ≥38℃ within 3 days
* Participating in another clinical trial
* Any situation that might influence the consequence of the clinical trial

Primary outcomes:
measure: Seroconversion rate and GMCs after varicella vaccination
timeFrame: 35-42 days after each dose vaccination
Secondary outcomes:
measure: The incidence of Adverse Events Following Immunization
timeFrame: 30 days after each dose vaccination
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai municipal center for disease control and prevention
state: Shanghai
Study officials:
affiliation: Shanghai Municipal Center for Disease Control and Prevention
name: Xiaodong Sun
role: STUDY_DIRECTOR
References:
Clinical trial NCT05323669: Molecular Profile of Thyroid Nodules
Official title: Study of Molecular-genetic Profile of Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Thyroid Nodule
Keywords: thyroid cancer
thyroid nodule
miRNA
molecular testing
Lead sponsor: Belarusian State Medical University
Sponsor class: OTHER
Collaborators: name: The Institute of Genetics and Cytology National Academy of Sciences of Belarus
name: Minsk City Clinical Oncologic Centre
First posted: 2022-04-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of the Republic of Belarus

Brief summary: Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.

Detailed description: This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population.

Part B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.

Eligibility criteria: Inclusion Criteria:

Patients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old.

Exclusion Criteria:

no

Primary outcomes:
measure: Molecular profile of thyroid nodules
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Belarusian State Medical University
name: Gennadij G Kondratenko, MD PhD Prof
role: STUDY_DIRECTOR
References: