cyrilzakka/clinical-trials huggingface dataset:
A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants

The purpose of this study is to assess the rate and extent of absorption of macitentan following administration of a single oral dose of macitentan formulated as final market image (FMI) (test), compared to macitentan as the clinical service formulation (CSF) under fasted conditions in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical and surgical history collected at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Systolic blood pressure (SBP) between 100 and 145 millimeters of mercury (mmHg) (inclusive) and diastolic blood pressure (DBP) between 50 and 90 mmHg (inclusive) at screening, preferably measured on the right arm, supine after 5 minutes of rest and standing after 3 minutes
* Twelve-lead electrocardiogram (ECG) with heart rate between 45 and 90 beats per minute (bpm) and without clinically relevant abnormalities, at the discretion of the investigator, measured after the participant is supine for at least 5 minutes, at screening
* Body weight not less than 50.0 kilograms (kg) and body mass index (BMI) between 18.5 and 30.0 kilograms per meter square (kg/m\^2) (inclusive)
* All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta- hCG\]) pregnancy test at screening and must have a negative urine pregnancy test on Day -1 of each intervention period

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to macitentan or drugs of the same class, or any excipients of the drug formulations
* Taken any disallowed therapies, concomitant therapy within 14 days (or longer, based on elimination half-life) before administration of study intervention in the first intervention period
* Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 10 half-lives (whichever is longer) before study intervention intake in the first intervention period, or received a biological product within 3 months or 10 half-lives (whichever is longer) before study intervention intake in the first intervention period, or is currently enrolled in an investigational study
* Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) greater than (\>) 1.5 \* upper limit of normal at screening
* Positive results from the human immunodeficiency virus (HIV) (type 1 and 2) serology at screening
Effects of Water-Based Exercise on Lipid Profile and Lipoprotein Lipase of Dyslipidemic Premenopausal Women

The aim of this study was to investigate the effects of water-based exercises on lipid profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women.

It was hypothesized that a water-based aerobic interval-training period would decrease plasma concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL levels, as well as maximal oxygen uptake (VO2max) values.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Sedentary
* Dyslipidemic
* Aged between 40 and 50 years old

Exclusion Criteria:

* Smokers
* Hypolipemic drugs users
The Framingham Study: Examining DNA Markers and Links to Diseases

Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research.

The purpose of this study is to support this national resource by aiding in its research capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine DNA and its relationship to risk of developing these disease and health conditions.

Approximately 330 families have participated in the Framingham Study. Participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. During the exam, the Framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. Participants will also be asked to complete a questionnaire at home regarding dietary and health habits.

Many studies have shown that hematocrit (HCT) levels are associated with cerebrovascular disease, cardiovascular disease (CVD), peripheral vascular disease, as well as all-cause mortality. Twin studies have shown that HCT variation is largely determined by genetic factors with heritability estimated as 40% - 65%. So far, no linkage analysis in humans between HCT and DNA markers have been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in controlling HCT levels. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in 330 families. HCT was measured in the original cohort and Framingham offspring. These data provide us the opportunity to undertake linkage analyses using variance component method to map quantitative trait loci (QTL) of HCT.

Eligibility Criteria:
* INCLUSION /EXCLUSION CRITERIA

The study population will include the members of the 330 Framingham Study families with genome scan.
Behavioural Insights to Improve Take up of SRH Services (Uganda)

This is a randomised controlled trial to test the impact of a modified e-coupon service, delivered through SMS, on uptake of sexual and reproductive health services among women calling a free hotline in Uganda.

The overall goal of the proposed research project is to increase uptake of sexual and reproductive health (SRH) services among clients who call into Marie Stopes Uganda's free hotline. The study seeks to achieve this goal by using behavioural economics to design interventions to increase redemptions of e-coupons distributed to hotline clients. The intervention will include modifying the text message sent to e-coupon recipients as well as sending follow-up texts reminding clients to use their coupons. The impact of the intervention will be evaluated using a randomized controlled trial (RCT). The intervention will be implemented and data will be collected regularly over a period of approximately 12 months. Strict confidentiality procedures in line with Marie Stopes International's best practices will be put into place to ensure that information made public or otherwise distributed outside the principle investigators and other key personnel cannot be linked to any individual respondents. Results from the study will be published in a report, among other outputs, and the outcomes will be shared within MSI as well as with the wider SRH community.

Eligibility Criteria:
Inclusion Criteria:

* Callers to the call centre who are over the age of 18, receive an e-coupon, and consent to participate in the research.

Exclusion Criteria:

* Callers who are below the age of 18, non-recipients of e-coupons, and those who receive e-coupons but do not consent to participate in the study.
Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be involved in pain alteration in PD.

To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with PD.

36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. This increase would be the same than those observed with L-Dopa.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
* Parkinson's disease patients with a score ≤ 3 on the Hoehn and Yahr scale
* Patients treated with dopaminergic antiparkinsonian drugs (L-Dopa, dopamine agonists, ICOMT...)
* Patients affiliated to a social protection program
* Women with efficacy contraception

Exclusion Criteria:

* Patients suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies...)
* Parkinson's disease patients with a score \> 3 on the Hoehn and Yahr scale
* Depressed patients (MADRS score \< 16)
* Patients suffering from a cancer
* Patients under tutelage, curatella or law protection
* Patients with a complete contraindication against apomorphine injections or duloxetine administration (selective serotonin reuptake inhibitor and monoamine oxydase inhibitors)
* Patients without any control of their arterial hypertension
* Patients with a neuroleptic treatment
* Pregnant women
Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers

In recent years ketamine abuse becomes prevalent in youth in some Asian countries. Chronic ketamine abuse may lead to uropathology and cognitive impairments. No pharmacological interventions have been identified as effective for treating ketamine abuse or helpful in achieving or maintaining abstinence from ketamine. Cognitive-behavioral treatment is currently an important psychosocial intervention for addictive problems. This study aimed to test whether a brief cognitive-behavioral training program has a positive influence on stage transitions among ketamine abusers.

409 ketamine abusers were recruited in this study, with 285 ketamine abusers participated in a 6-hour brief cognitive-behavioral intervention and 124 ketamine abusers attended educational lectures on ketamine abuse. A brief cognitive-behavioral intervention was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention. Stage of Change and knowledge about ketamine were assessed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* ketamine use in 30 days
* more than 18 years old

Exclusion Criteria:

* no brain damage
18790 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurnace Portability and Accountability Act) Form
* An unbmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been dianoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
4. The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear).
5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
6. The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye.
7. The subject's refractive cylinder must be ≤0.75D in each eye, if present
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator)
3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
10. Suspicion of or recent history of alcohol or substance abuse.
11. History of serious mental illness.
12. History of seizures.
13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.
Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen

This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study

Exclusion Criteria:

* Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study.
* Receipt of additional doses of rabies vaccine after completion of initial vaccine series.
* For additional entry criteria please refer to protocol.
Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning

The investigators aimed to assess the ability of a modified version of Behavioral Activation for occupational and social improvement to produce change in: 1. social adjustment, 2. work functioning, 3. avoidance behavior and 4. behavioral activation.

Psychosocial functioning was assessed before and after BA treatment in medication responsive depressed individuals who continued to have impaired social functioning. The primary goal was to demonstrate feasibility of recruitment and retention, and obtain an open pilot sense as to whether there are benefits from this brief psychotherapy approach in this population. The investigators also planned to refine measures and estimate the effect size of any treatment response to estimate power and sample size with the goal of completing a future controlled study.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 20-75 years
* a primary diagnosis of Dysthymic Disorder, Chronic major depressive disorder or double depression
* a \>50% decrease in 17 item Hamilton Rating Scale for Depression (HRSD-17) score and a final HRSD-17 score ≤ 10 with an adequate antidepressant medication (ADM) trial (\> 4 weeks on at least 50% Physician's Desk Reference maximum ADM dose)
* a rating of 1 ("very much improved") or 2 ("much improved") on the Clinical Global Impressions-Improvement scale (CGI-I)
* continued functional impairment, defined by scores \>1.9 on the Social Adjustment Scale (SAS)
* unemployment (jobless, looking for work) according to the Bureau of Labor Statistics: jobless and looking and available for work, or underemployed.

Exclusion Criteria:

* Structured Clinical Interview for Diagnostic and Statistical Manual, fourth edition (DSM-IV) Axis I disorders-diagnosed cognitive or psychotic disorders
* bipolar disorder
* active eating disorders
* severe borderline personality disorder
* alcohol or drug dependence (except nicotine) in the last 6 months
* current suicide risk
* unstable medical conditions
* use of psychotropic medications other than antidepressants
The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies

The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters

Surgery is considered one of the most stressful events in human life. Research indicates that patients show high levels of stress from at least six days before surgery and up to a week post the operation. Stress levels return to normalcy only after several weeks. Research shows that psychological interventions given to women suffering from cancer can improve their coping abilities and overall function, decreases stress levels, enhances adherence to treatments,and increases quality of life and even life expectancy.

Women enrolled in this study will be divided into two groups: an experimental group and a control group. Both groups will receive standard care. The control group will interact with a nurse for one hour. The experimental group will receive one of two forms of psychological intervention: either a cognitive intervention, or a psychophysiological intervention (tailored to each woman).

Measurements and Instruments include: 1) Self-report questionnaires, such as:Profile of Mood States (POMS-SF),Coping Inventory (COPE), Life Orientation Test Revised (LOT- R),Stress Level Report, 2) Demographics, 3) Global assessment by the head nurse. 4)Physiological and behavioral measures, such as: vital signs and use of medicine. 5)Hormonal and immunological measures: levels of cortisol in saliva and plasma, levels of catecholamines in plasma, salivary levels of IgA1, and peripheral blood NK cells and lymphocyte phenotyping.6)levels of cytokines including IL-1,2,4,6,10,12, TNF-alpha, Interferon-gamma.

Time intervals for the collection of blood and saliva and the administration of the questionnaires:

During the first week after being given the diagnosis and prior to the intervention:Blood \& saliva, Stress Level Report, POMS-SF, COPE, LOT-R

A day prior to surgery:Blood \& saliva, Stress Level Report

On discharge from hospital:Blood \& saliva, Stress Level Report

30 days after surgery:Stress Level Report,POMS-SF,COPE,LOT-R.

Eligibility Criteria:
Inclusion Criteria:

* Woman with ovarian, cervical or endometrial cancer/tumor
* Women who speak Hebrew
* Women who sign the consent form

Exclusion Criteria:

* Women who have received neoadjuvant treatment
* Women suffering from any form of depression, anxiety or schizophrenia
* Women suffering from autoimmune or infectious diseases
* Women taking medications which have immunological effects (steroids ,beta-blockers)
* Women suffering from dementia or concentration problems
Oral Photographs of Patients on Oral Hygiene Motivation

Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.

Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.

Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters.

Maintaining oral health requires a motivated patient. The adherence to a lifelong oral hygiene regimen is significantly influenced by an individual's motivation and manual dexterity. The physician's responsibility in this context is to provide guidance to the patient regarding the appropriate and efficient oral hygiene routine, as well as to motivate their adherence to it. The definition of motivation is to stimulate action or effort towards a particular goal or objective. Motivation is a condition that can be altered in response to external influences and time, rather than being a characteristic. The primary objective of motivation is to enhance persons' knowledge of this matter by highlighting oral health, introducing oral hygiene, and offering information on efficacious mechanical cleaning procedures for eliminating factors that contribute to the deterioration of oral hygiene.

Participants were divided into 2 groups using https://www.randomizer.org/ website:

Control group (CG) (n=28): Conventional oral hygiene education (COHE) \[22\]

Intervention group (IG) (n=28): In addition to COHE, the following steps were followed:

* Session 1: A photograph was taken before (F1) and after (F2) full-mouth scaling root planing (fmSRP). Then the patient was shown the difference.
* 2nd session: A photograph was taken (F3) and the patient is shown the difference between F1 and F3.
* 3rd session: A photograph was taken (F4) and the patient is shown the difference between F1 - F3 - F4.

Eligibility Criteria:
Inclusion Criteria:

* age ranging from 18-60 years;
* a minimum of 12 teeth;
* and being available for the follow-up assessment
* participants were wanted to be right-handers when toothbrushing to standardization.

Exclusion Criteria:

* Patients with systemic illnesses or conditions,
* smokers and individuals taking any medication that may affect periodontal health were not included in the study.
* Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.