cyrilzakka/clinical-trials huggingface dataset:
A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:

  * abdominal (central) obesity as defined by the waist circumference in men of \> 102 cm and women of \> 88 cm or a BMI equal or greater than 30 kg/m2

and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp \< 180/110 mm Hg

or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:

* bp equal or greater than 140/90 mm Hg but equal or less than 160/100 mm Hg

or a patient whose hypertension is controlled (\< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:

* Fasting plasma glucose equal or greater than 5.6 mmol/L and \< 7.0 mmol/L
* Triglycerides \> 1.7 mmol/L or specific treatment for this lipid abnormality
* HDL-c in men \< 0.9 mmol/L and in women \< 1.1 mmol/L or specific treatment for this lipid abnormality

Exclusion Criteria:

* A Patient With A Diagnosis Of Type II Diabetes Defined As Fasting Blood Glucose Level Equal Or Greater Than 7.0 Mmol/L Or A 2hpg In A 75-G OGTT Equal Or Greater Than 11.1 Mol/L Or Using Any Anti-Hyperglycemic Agents
* Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Or Hypertensive Encephalopathy)
* Patient Intolerant To Any Component Of Losartan 50 Mg / Losartan 100 Mg / Losartan 100 Mg + Hctz 12.5 Mg / Losartan 100 Mg + Hctz 25 Mg Or With A Documented History Of Angioedema
* Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance On The Basis Of The Case History Or A Recent Laboratory Test (Serum Creatinine \> 130 Mmol/L Or Creatinine Clearance \< 45 Ml/Min, Ast \> 2 Times Above The Normal Range, Alt \> 2 Times Above The Normal Range, Serum Potassium \< 3.5 Or \> 5.5 Meq/L)
* Patient With Symptomatic Heart Failure (Classes 3 And 4)
* Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
* Patient Who Has Undergone Percutaneous Coronary Angioplasty Or Coronary Artery Bypass Within The Last 3 Months
* Pregnant Woman Or A Woman Of Childbearing Potential
Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System

The purpose of this study is to determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the three interventions under study will increase FMC while causing a blunting in FMD.

Further, the investigators plan to study the circadian variability of FMC and FMD. The investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the early hours.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ECG.

Exclusion Criteria:

* any active disease
A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
* Subject has provided written and verbal informed consent/assent.
* Subject has facial acne vulgaris (including the nose).
* Subject is willing to comply with study instructions and return to the clinic for required visits.
* Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
* Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial
* Subject has used any of the following topical anti-acne preparations or procedures on the face:

  * Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
  * Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
  * Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.
* Subject has used the following systemic anti-acne medications:

  * Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
  * Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
  * Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
  * Retinoid therapy within six months of the initiation of treatment.
The PrEliMS Feasibility Trial

The PrEliMS study is a mixed-methods feasibility randomised controlled trial of a point of diagnosis intervention programme which aims to provide emotional support for newly diagnosed people with Multiple Sclerosis (MS). This feasibility study will enable us to plan for a definitive trial to evaluate the clinical and cost-effectiveness of this point of diagnosis intervention programme. The aim is to assess the feasibility of the trial procedures and intervention, and to evaluate the key feasibility parameters before proceeding to a definitive trial. Participants (N=60) will be randomised into three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support).

Potential participants will be people who have been recently diagnosed with MS (or currently going through diagnosis process), and who are aged 18 years or over, recruited through MS clinics. Participants, after consent, will complete baseline measures before being randomised into to one of three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support). Group 1 (20 patients) will not receive any intervention. Group 2 (20 patients) will receive Support 1 which will include one face-to-face support session delivered by an MS Nurse. Group 3 (20 patients) will receive Support 2 which includes MS Nurse Support (i.e., Support 1) plus Peer Support. Peer Support will include a minimum of two peer support session delivered by Peer Support Workers (i.e. patients with lived experiences). All groups will receive usual care. The outcome measures will be collected at 3 and 6 months after randomisation by all participants. Feedback interviews with up to 21 participants (7 from each group) and up to 10 service providers (5 MS Nurses who delivered the MS Nurse Support and 5 Peer Support Workers who delivered the Peer Support) will be conducted to assess what parts of the intervention were helpful or unhelpful, the acceptability of randomisation and trial procedures, and the appropriateness of the measures used.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible to join the trial if they:

* are 18 years or over
* have recently received a diagnosis of MS (any type of MS) or currently going through MS diagnosis process)
* can communicate in English
* able and willing to give consent
* not receiving psychological intervention

Exclusion Criteria:

Patients will be excluded if they:

* have a severe co-morbid psychiatric condition (e.g. dementia), as reported by patients or their carers or confirmed by the clinical team making the initial approach
* are currently receiving psychological interventions or received this within the last three months (we will not exclude those on medication for their mood problems but will record this information).
* do not have mental capacity to consent to take part in the trial
* are unable to communicate in English
the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children

Cognitive behavioral therapy sessions can effectively reduce distress in mothers of children with autism. here we emphasize on the role of problem solving appraisal in CBT sessions to improve problem solving skills ability and minimize psychological distress . pre- intervention assessment (T1) for all participants , then designed 8 sessions for study group will apply .

post intervention assessment (T2) will conduct immediately after CBT sessions

mothers of children with autistic spectrum disorders have a lots of burdens due to child symptoms its, lack of availability of services and limited resources , thus in turn lead them to become unable to face problems/stressors and to be psychological distress. CBT is an effective therapy to minimize stress, anxiety and depression. Mothers who participated in the study recruited from three governmental hospitals that has an out patients clinics specialized in autism and other developmental disorders for children at ElBehairah governate , Egypt . Based on inclusion and exclusion criteria for mothers and their children, mothers informed about the nature of the study and their benefits for participations. assessment tools will use ; depression ,anxiety and stress scale (DAS) and problem solving inventory (PSI). First assessment will occur , then randomly the participants divide into either study ( intervention) group or control group .CBT sessions will provide for study group to enhance their problem solving ability and psychological state. Second assessment (T2) will occur after finishing program sessions for all participants

Eligibility Criteria:
Inclusion Criteria:

Mothers caregivers who have:

* A child with autism spectrum disorders diagnosed science at least 6 months , and her/ his diagnosis done by a psychiatrist
* Just one child with autistic disorder
* Their ages between 20-50 years old
* Did not expose to previous interventional / rehabilitation programs for his/her child.

Exclusion Criteria for mothers:

* have a diagnosis of any of psychiatric disorders
* Being absent more than three sessions in study group

Exclusion criteria for children: if they have:

* Intelligence level below 70
* Have severe deterioration
* Receive psychiatric medication
* Have multiple disorders
A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma

Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which psychotherapy is widely practiced. Depression is one of the most common co morbid disorders when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and depression have been related to a reduced specificity in autobiographical memory.

Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET) in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will also attempt to develop protocols to implement this new technology into clinical practice and collect data to develop a treatment progress prediction model.

Study design: A randomized controlled intervention study.

Study population: 144 individuals with memories of CSA or war related trauma and symptoms of PTSD and/or depression.

Intervention: VRET or TAU.


Eligibility Criteria:
Inclusion Criteria:

* principal diagnosis meeting DSM-IV criteria for PTSD and/or major depression following CSA or war related trauma
* between the ages of 18 and 70-years-old
* having sufficient fluency in Dutch to complete treatment and research protocol

Exclusion Criteria:

* current bipolar disorder
* current psychotic disorders
* current suicidality
* high dissociation level (Dissociative Experiences Scale (DES) cut-off score ≥ 40)
Fitness and Well-being of Caregivers in the Hauts-de-France Region

The ageing of the population is accompanied by an increase in the frequency of chronic illnesses, leading to a rise in the number of caregivers. These caregivers do not have the time to look after their own health, and they are very often in a deteriorated mental state with no knowledge of their level of fitness. A deterioration in their fitness can be a source of the development of diseases induced by a sedentary lifestyle. On the other hand, patients with chronic respiratory disease can benefit from respiratory rehabilitation (RR), which includes outpatient or home-based physical activity. The literature has demonstrated an improvement in the mental state of caregivers following a RR carried out by their loved ones without taking an interest in their fitness. The aim of the study will be to establish 1. a representation of the level of fitness and mental state of caregivers; 2. to assess the presence/absence of benefits on fitness and mental state of caregivers depending on the form of RR: home versus outpatient where the caregiver is not integrated in this last form.

The literature reports more anxiety and depressive symptoms , a greater psychological and social burden and a poorer quality of life in caregivers than in their non-caregivers peers. Knowing the fitness of caregivers, by means of an assessment of their abilities, would make it possible to define their profile, which should reflect an altered fitness linked to a state of ill-being. The results of these assessments would make it possible to establish a prevention policy, and following a rehabilitation programme for their patients, their health should improve. For caregivers who agree to take part in the study, their physical, mental and social health will be assessed. The total duration of the visit, including all the assessments, is estimated at 1h30. We expect the fitness and mental and social state of all the caregivers to deteriorate in line with the indicators available in the literature for people of the same age who are not carers. Following care of the patients, we expect an improvement in fitness and mental state of the carers.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age;
* Have a sick relative taking part in a RR program, either as an outpatient at the Clinique de la Mitterie or at home with FormAction Santé;
* Have the cognitive ability to understand the instructions for carrying out the physical tests and the questions for answering the questionnaires;
* Be able to read;
* Have no disability preventing them from carrying out the physical tests;
* Have given their written consent to take part in the research;
* Be willing to comply with all the research procedures and duration.

Exclusion Criteria:

* Refusal to sign consent;
* Operation less than one month old;
* Presence of psychological or psychiatric disorders;
* Impossibility of receiving informed information;
* Impossibility of participating in the entire study;
* Contraindication to physical activity.
Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing

The purpose of this study is to develop an empirically validated, scientifically-based HIV and STI prevention program that can be delivered online to young men who have sex with men (YMSM) who were recently tested for HIV.

Presently, there are a limited number of proven HIV interventions culturally tailored to young men who have sex with men (YMSM). This is alarming because Men who have sex with men comprise 68% of HIV/AIDS diagnoses in men, despite representing a much smaller proportion of the population. In addition, MSM are reporting more sexual risk behavior than in previous years and there is significant concern that HIV infection rates may once again be on the rise after more than a decade of remaining relatively stable.

The Internet is a viable intervention avenue because of it's high percentage of accessibility and usage, especially among young adults. Moreover, it might hold a strong appeal for YMSM, since its anonymity confers a sense of perceived safety against stigma surrounding HIV prevention information.

The purpose of this study is to compare two different versions of an online HIV/STI intervention for YMSM. This study is part of an overall program of research designed to understand and prevent HIV infection among high-risk youth. Participation in this study will help us to determine the usefulness of an tailored and interactive HIV Internet-assisted intervention.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 24 years of age
* Self-identify as a biological male
* Understand and read English
* Have tested HIV negative at an approved clinic within 6 weeks
* Report at least one (male) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.

Exclusion Criteria:

* Have been diagnosed with HIV within the past three months
* Participation in another HIV prevention program
* No access to the Internet or an email address
Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions

As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.

This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

* Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
* Age ≥ 18
* Written informed consent after participant's information

Exclusion Criteria:

* Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
* Pure GGO lesion
* Patients at increased risk of bleeding

  1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy
  2. Coagulopathy: Thrombocytopenia (\< 100,000/mm3) or prolonged PT (INR \> 1.5)
* Patient with existing or risk of pulmonary and cardiovascular decompensation
* Intolerance to sedation
* Vulnerable groups such as pregnant woman, breast feeding, etc.
* Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility
Muscle Architecture and Muscle Strength in Fibromyalgia

The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:

* Is there a significant difference in muscle morphology between FMS and controls?
* Is there a significant difference in muscle strength between FMS and controls?
* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?
* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality?

Fibromyalgia syndrome (FMS) was named by Smythe and Moldofsky when they defined tender points in 1970s. It is defined as chronic, generalized musculoskeletal pain accompanying with fatigue, sleep disturbance , cognitive and somatic disturbance. FMS has variable prevalence as %0,7-11 and usually affects middle aged women. It is second most common rheumatologic disease after osteoarthritis and thought to be the most common reason for musculoskeletal pain in middle aged women.

Recent studies have reported that both sarcopenia and decreased muscle strength occur in patients with chronic inflammatory diseases such as rheumatoid arthritis. There are concerns that sarcopenia may affect exercise tolerance, activities of daily living, and ultimately have a negative impact on cardiovascular fitness and physical and emotional well-being. On the other hand there is researches that support inflammation-driven pathways in the pathogenesis of fibromyalgia. Given the risk of pain related reduction in physical activity, patients are expected to have accelerated muscle wasting , decreased muscle strength and endurance and functionality.

However, there is no study that focused on muscle architecture and strength in FMS. This led us to design our study which will evaluate patients lower extremity muscles' thickness and pennation angles by ultrasound , most daily used muscles' strength by dynamometer, functionality by timed-up test and try to find whether there is a correlation between these parameters and patients' disease activity which will be determined with FMS specific scales.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the 2016 ACR (American College of Rheumatology) diagnostic criteria.
* Diagnosed at least 1 year ago.

Exclusion Criteria:

* Patients diagnosed with other rheumatological diseases, muscle diseases, or neuropathies.
* Patients with a history of trauma affecting muscle morphology.
* Patients engaging in regular exercise (at least 3-4 times a week for a minimum of 40 minutes).
* Patients with uncontrolled comorbid diseases