cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Web-based, Computer-tailored, Pedometer-based Physical Activity Intervention for Adults: a Cluster-randomized Controlled Trial

The present study used a cluster-randomized controlled trial to evaluate the effects of a computer-tailored, pedometer-based Physical Activity (PA) intervention delivered through the Internet. An invitation e-mail with study information was sent to managers of 18 white-collar workplaces. Eight workplaces consented to participate. All employees of a single workplace were allocated at random to either the intervention or a waiting list control group, in order to avoid contamination between employees receiving the intervention and those who were not receiving the intervention. Subsequently, employees of the participating workplaces were recruited by e-mail. Only Dutch speaking employees between 18 and 65 years old, who had access to the Internet at work or at home, were eligible. Interested employees could sign up by returning a confirmation e-mail to the researchers. On receiving this information, a meeting was organized in each of the eight worksites to deliver all documents for baseline measurement (T0) to the participants, including an informed consent form, a blinded pedometer, an activity log and a self-administered questionnaire. During this meeting, information was provided on how to use the pedometer, how to log PA activities and how to answer the questionnaire. Moreover, the participants were asked to adhere to their usual PA pattern throughout the baseline measurement. After one week, all measurement tools were collected, and average daily step counts were calculated. At this point, participants in the intervention condition received (1) a booklet with information on how to increase steps, (2) a non-blinded pedometer, which they could use for three months, and (3) a username, a password and the amount of average daily steps, calculated by the researchers, so that participants could use this number when requesting the online computer-tailored step advice. Participants in the control condition did not receive any of the above mentioned intervention components. One and three months later, all participants again received a blinded pedometer, which was worn for one week. When wearing the blinded-pedometer one month (T1) and three months (T2) post baseline, intervention participants were allowed to also were the non-blinded pedometer. Furthermore, the same self-reported questionnaire was used to measure PA level at T1 and T2 in order to test the effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking
* Age range: 18 - 65 years old
* Access to the Internet at work or at home
Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)

Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men will be enrolled in the study. Qualifying patients will receive one of three possible doses of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month, 3-months, and 6-months following treatment.


Eligibility Criteria:
Eligible patients are 50 to 80-year-old men who have experienced some or all of the following urinary symptoms for at least 6 months:

* frequent or urgent need to urinate
* difficulty starting their urinary stream
* interruption of their urinary stream
* feeling of incomplete emptying of bladder after urinating
* interruption of sleep due to the urge to urinate

Patients should have tried oral medication for their condition in the past, and be willing to discontinue any current BPH medications for a period of time before undergoing study treatment. They should be in good general health and have no previous surgery, or other procedure(s) intended to reduce prostate size.
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

* To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c
* To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo
* To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Eligibility Criteria:
Inclusion criteria :

* Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and \<30 milliliter per minute (mL/min)/1.73 per meter square (m\^2).
* Signed written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

* At the time of screening, age \<18 years.
* Hemoglobin A1c (HbA1c) \<7% or \>11%.
* Type 1 diabetes.
* Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
* Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
* Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
* Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

The primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder.

This study involves a brief phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 12 sessions of CBT treatment and will be randomly assigned to an ICT or ICT sham condition which will consist of completing ICT computer tasks on a daily basis during the first four weeks of treatment and booster sessions following treatment. Participants will also complete research assessments at mid-treatment, post-treatment, and 3-month follow-up intervals. Research assessments include a battery of questionnaires, computerized tasks, interviews, and behavioral tasks.

Eligibility Criteria:
Inclusion Criteria:

* age 18-55
* meet DSM-5 criteria for Bulimia Nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or Binge Eating Disorder (i.e., at least one episode of binge eating per week on average for the past 3 months).
* be stable on psychiatric medications for at least 3 months

Exclusion Criteria:

* have a diagnosis of anorexia nervosa or a BMI \< 18.5
* have extreme malnutrition or other medical complications that require acute hospitalization
* are at acute suicide risk
* are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder)
* have previously completed a trial of CBT for Bulimia Nervosa or Binge Eating Disorder
* have a diagnosis of an intellectual disability or autism spectrum disorder
* currently taking stimulant medications
* score of 95% or higher on 550ms block of Go/No-Go assessment task, indicating high inhibitory control at Baseline
Real-life-persistence to Antifibrotic Treatments

This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.

Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.


Eligibility Criteria:
Inclusion criteria:

All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.

Exclusion criteria:

No exclusion criteria will be applied.
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Subject is pre-menopausal female 18 to 51 years of age at Screening.
* Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
* Subject has heavy uterine bleeding associated with uterine fibroids.

Exclusion Criteria:

* Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
* Subject has a history of osteoporosis or other metabolic bone disease.
* Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
* Subject has a history of clinically significant condition(s) including but not limited to: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Mindfulness, Mental Fatigue, Inhibitory Control and Endurance Performance in Athletes

This study investigated the mediating effect of dispositional mindfulness on the impact of mental fatigue on neurocognitive functions and endurance performance in athletes.

Recent research suggests that mental fatigue by prolonged cognitive tasks would impair neurocognitive functions (e.g., executive functions, brain activity) and sports performance, especially inhibitory control and endurance performance. On the other hand, individuals with higher dispositional mindfulness have been linked to greater athletic performance and cognitive functions. Still, there is little known whether higher dispositional mindfulness counteracts the detrimental effects of mental fatigue on endurance performance and inhibitory control in athletes. Therefore, this study is conducted to investigate whether dispositional mindfulness mediates the effects of mental fatigue on neurocognitive functions and endurance performance in athletes.

The qualified participants will visit the lab on two counterbalanced order occasions to complete either a modified incongruent Stroop task (mental fatigue condition, MF) or a modified congruent Stroop task (control condition, CON) for 30 minutes. Before and after each cognitive task, participants will be measured for their subjective mental fatigue by a visual analog scale (VAS). After each cognitive task, inhibitory control and endurance performance will be evaluated by a Flanker task and a graded exercise test (GXT), respectively. Furthermore, the general and athletic dispositional mindfulness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ) and Athlete Mindfulness Questionnaire (AMQ), respectively.

Specifically, the targeted primary outcomes are neurocognitive functions (i.e., reaction time, accuracy and ERPs in Flanker task) and endurance performance (i.e., VO2max \& time to exhaustion in GXT); The secondary outcomes are subjective (i.e., VAS score)/objective (i.e., reaction time, accuracy in Stroop task) mental fatigue, motivation in tasks, mood (i.e., BRUMS-C).

Eligibility Criteria:
Inclusion Criteria:

1. Regular sports training at least 4 hours weekly
2. Normal or corrected-to-normal vision
3. Right-handed

Exclusion Criteria:

1. Physical limitation or injury in lower limbs before and during the study
2. Diagnosed or self-reported neurological disorders (e.g., epilepsy)
3. Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
How do Attitude About Pay for Performance Differ Among Different Anesthesia Care Provider and Over Time

The investigators hypothesize that common objections to P4P relate to potential loss of autonomy or concerns about adverse effects on patient care.

We seek to establish baseline attitudes about Pay for Performance (P4P) in the OUHSC Dept of Anesthesiology and determine what differences exist between faculty, CRNAs and residents. We plan to resurvey annually to determine if attitudes change as the department implements a P4P program. We hope that by understanding the attitudes of anesthesia care providers, we can alleviate their concerns. We hope to account for their concerns as we develop and modify our P4P program. We believe that acceptance of the general idea of P4P is important if individuals are to maintain job satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* All anesthesia care providers in the department

Exclusion Criteria:

* locum faculty members and CRNAs
Olive Leaf Extracts in the Control of Diabet

This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

Patients over 18 years of age with:

-Diabets

This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

All the population will benifit of a biological assessment which include:

* Complete lipid profile, blood sugar, creatinine
* HbA1c (if the patient is diabetic).
* Inflammatory assessment: reactive protein C One population will be rendomized:The population with diabetes. In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.

Continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with:
* diabetes.

Exclusion Criteria:

* Exclusion criteria: None.
Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs).

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥18 years) with at least two ICD-9 codes for a particular cancer (ICD-9 code 140-208.9) within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code
* At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and
* Continuous enrolment in the LabRx database during follow-up.

Exclusion Criteria:

* Less than 18 years old
* Less than one month (30 days) of enrolment prior to index date or three months (91 days) of follow-up post index date; and
* Not continuously enrolled in the LabRx database during follow-up.
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.

1. Investigate the timing and dose of FTC-TDF and FTC-TAF as oral PrEP and in vitro PEP (applied directly to removed foreskin tissue) required to prevent ex vivo HIV infection in foreskin tissue and blood using the explant model
2. Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
3. Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP
4. Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against ex vivo HIV infection using the explant model
5. To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention trials implementation

Eligibility Criteria:
Inclusion Criteria:

Participants must satisfy all the following criteria within 21 days prior to their circumcision visit:

1. Clinically eligible for either forceps guided, or dorsal slit circumcision
2. The ability to understand and sign a written informed consent form by participant (and participant's legal guardian if younger than 18 years) prior to participation in any study procedures and to comply with all trial requirements
3. Male sex at birth
4. Age 13- 24 years
5. Haemoglobin \>9g/dL
6. Weight \>35Kg
7. Two negative rapid HIV antibody tests results (manufactured by different companies), dating from 21 days or less prior to VMMC
8. Two locator information details (including physical address, telephone contacts, email) for contacting of either patient or their parent

Exclusion Criteria:

1. Any significant acute or chronic medical illness and current therapy that in the opinion of the site investigator would preclude receipt either of investigational products, or VMMC
2. Any evidence that participant is not suitable for VMMC
CO2 as a Stress Agent for Perfusion Imaging

Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow to the muscles of the heart when the heart is at rest and when it is under stress. The stress test in MPI can be done using medications, such as persantine, that dilate coronary arteries and increase blood flow. Similarly, elevated carbon dioxide (CO2) levels in the blood, or hypercapnia, also dilates arteries and increases blood flow. Thornhill Research Inc. has developed the RA-MR™ sequential gas delivery system used to control CO2 levels in the blood. The RA-MR™ can deliver precise amounts of CO2 through a mouthpiece for inhalation to increase CO2 levels in the blood and thereby increasing blood flow like during stress.

The objective of this study is to compare the differences in blood flow through the arteries of the heart during stress with hypercapnia and adenosine MPI. The imaging will be done using positron emission tomography (PET) with the radioisotope, or tracer, called Rubidium (Rb-82). The Rb-82 is given through a pump, or elution system.

The investigators hypothesize that hypercapnia will induce a stress-to-rest increase in myocardial blood flow by a factor of 2 or more in myocardial regions supplied by non-stenotic arteries in normal volunteers and participants with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

For all participants

* Age ≥ 18 years old
* BMI ≤ 40 kg/m2
* Able and willing to comply with the study procedures
* Written informed consent
* Participants with documented coronary artery disease
* Stable coronary artery disease on a stable medication regime.
* Healthy volunteers without known heart disease
* Low risk of coronary artery disease (CAD)

Exclusion Criteria:

* History or risk of severe bradycardia (heart rate \< 50 beats per minute) not related to chronotropic drugs
* Known second- or third-degree Atrio-ventricular block without pacemaker
* Atrial flutter or atrial fibrillation
* Dyspnea (NYHA III/IV), wheezing asthma or Chronic Obstructive Pulmonary Disease (COPD)
* Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or at any time after consent
* Percutaneous coronary intervention (PCI) within 30 days prior to screening or at any time following consent
* Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent
* Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
* Known hypersensitivity to adenosine
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent
LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)

The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female adults, 18 years or over
* Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean DBP (diastolic blood pressure) ≥ 90 mm Hg\* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).

If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)

* Patient who is willing to, and is able to sign the informed consent form

Exclusion Criteria:

* Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected Duration Of The Study
* Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
* Patient has history of malignant hypertension
* Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
* Patient takes antihypertensive drugs