cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets

The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be male or female between 12 to 17 years of age, inclusive
* Participant must have a body weight of at least 40 kilogram (kg)
* Informed consent must be obtained (from participant and/or his/her parent(s)/legal guardian, as applicable) and an age-appropriate Assent Form, as applicable, indicating that the purpose of, and procedures required for, the study are understood and that the participant is willing to participate in the study
* Participant must be able to comply with the protocol requirements, and adhere to prohibitions and restrictions specified in the protocol
* Participant has documented chronic human immunodeficiency virus (HIV) -1 infection, and is aware of his/her HIV-1 diagnosis
* Participant must be on a stable antiretroviral (ARV) regimen for at least 3 months and has documented plasma HIV-1 ribonucleic acid (RNA) less than (\<) 50 copies/ milliLitre (mL) within 3 months prior to screening
* Participant must be willing to assess swallowability of the placebo tablets and be able to do so (as demonstrated by the intake of a reference placebo tablet)

Exclusion Criteria:

* Participant has any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant, or prevent the participant from meeting or performing study requirements
* Participant has any condition that, in the opinion of the Investigator, could prevent, limit, or confound the protocol-specified assessments
* Participant has any active clinically significant physical or psychological disease or findings during screening that, in the Investigator's opinion, would compromise the participant's safety, ability to swallow (eg, candidiasis), or outcome of the study
* Participant has history of difficulty with oral intake of ARV therapy or other medications
* Participant is taking disallowed concomitant medications or over-the-counter products
* Participant is a family member of an employee or Investigator of the study site or Participant is a family member of an employee of Johnson \& Johnson
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS).
* RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months.
* PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs.

Exclusion Criteria:

* Secondary RLS.
* Daytime RLS symptoms requiring treatment.
* Primary sleep disorder.
* Sleep apnea.
* Night or shift work.
* Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern.
* Pregnant or lactating women.
* Women of child-bearing potential not using acceptable method of birth control.
* Use of prohibited medication.
Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico

This study evaluates the effectiveness of community health workers when added to routine care for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It does so by recording information on adherence to therapy, blood pressure and hemoglobin A1c while a non-governmental organization working in Mexico trains and introduces a community health worker program.

Compañeros en Salud (CES), an affiliate project of Partners in Health, has been working in the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the local Ministry of Health to rehabilitate and staff existing government primary care clinics. Each community's clinic is staffed by one CES project physician year-round. CES activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and hypertension. CES currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and consists of monthly in-clinic visits by primary care physicians.

Over 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health worker program called "Acompañantes" to its project communities to augment care of patients with NCDs. Acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of NCDs, their treatments, and adherence to therapy. The introduction of Acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The investigators' project will document their experience over this time, and for one year after introduction of the Acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.

Eligibility Criteria:
Inclusion Criteria:

* Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both
* Daily medications required for patient's condition
* Residence and receipt of therapy within the study catchment area
* Age greater than or equal to 18 years.

Exclusion Criteria:

* Known or suspected secondary hypertension
* Known or suspected Type 1 diabetes
* Pregnancy
* Chronic use of glucocorticoids.
Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations

Neuromuscular block improves operation conditions during laparoscopic surgery. In this study, a new measurement tool is assessed: the degree of abdominal distension during the time course of the neuromuscular block is measured and compared with a standardized score (surgical rating score).


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic gynecologic surgery
* American Society of Anesthesiologists Physical Status ASA 1-2

Exclusion Criteria:

* anticipated difficult airway
* increased risk for pulmonary aspiration
* acute infection
* pregnancy
* impaired liver- oder kidney function
* neuromuscular disease
* chronic intake of drugs known to influence neuromuscular blockade
Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers

Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2

Exclusion Criteria:

* History of clinically significant disease or disorder as judged by the investigator
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug.
* History of haemophilia, von Willebrand´s disease, lupus anticoagulant or other diseases/syndromes that may alter or increase bleeding.
* History of previous or ongoing psychiatric disease
Factors Influencing Selective Mutism

The study's goal is to check and verify basic assumptions of a new selective mutism developmental model from Melfsen and Walitza through standardized and routinely used patient questionnaires. The primary emphasis is the question of a connection between selective mutism and high sensitivity, dissociation, emotional regulation, family structure, social anxiety and self-esteem.


Eligibility Criteria:
Inclusion Criteria:

* Children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (ICD-10) for selective mutism
* Adults who suffered selective mutism when they were children or adolescents
* All study participants or their legal representative have given written permission for their experiences to be documented in the study.

Exclusion Criteria:

* Temporary mutism, e.g. from emotional disturbances or separation anxiety (F93.0), or depression
* Profound developmental disturbances (F84.2) like early childhood autism (F84.0), atypical autism (F84.1), Rett Syndrome (F84.2), alternative disintegrative childhood disturbances (F84.3), hyperactivity disturbance with decrease of intelligence and movement stereotypes (F84.5), or Asperger's Syndrome.
* Schizophrenia (F20)
* Profound mental retardation
* Delineated development disturbances of speech and language (F80)
* Organic brain disease with loss of language or disturbance of speech development
Radiation Therapy in Treating Patients With Head and Neck Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.

OBJECTIVES:

* Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy, in terms of preventing disease recurrence, in patients with head and neck cancer.
* Compare the early and late toxic effects of these treatments in this patient population.
* Compare disease-free and overall survival of patients receiving these treatments.
* Assess quality of life in patients receiving these treatments.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

* Arm I: Patients undergo radiotherapy 3 times daily, with an interval of at least 6 hours between any 2 treatments, 5 days a week, for just over 2 weeks, for a total of 13-14 treatment days.
* Arm II: Patients undergo radiotherapy daily, 5 days a week, for 6-6.5 weeks. Quality of life is assessed at baseline and then annually for 5 years.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 460 patients (230 per arm) will be accrued for this study within 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following:

  * Oral cavity
  * Oropharynx
  * Hypopharynx
  * Larynx
  * Nasal sinuses
  * Skin
* Undergone curative surgery within the past 70 days

  * All macroscopic disease removed
* At high or intermediate risk of recurrence

  * No low risk of recurrence
* No evidence of distant metastases
* Considered treatable by radiotherapy

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other prior or concurrent malignancy that would preclude study participation
* No other uncontrolled medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* See Disease Characteristics
The Effect of Muscular Strength Training in Patients With Drug Addiction

Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. There are few studies today that provide information about SUD patient's physical health, and especially there is little information about their muscular strength. One of the project's aims is to measure muscular strength in SUD patients who are being treated for their addiction, and see if they have decreased neuromuscular function. If so, we will investigate the effect of maximal strength training on neuromuscular function in these patients.


Eligibility Criteria:
Inclusion Criteria:

* being treated for drug abuse
* not using drugs during intervention period

Exclusion Criteria:

* participated in strength training in previous 6 months
* cardiovascular disease
* any other disease that impedes to finish tests
* not showing up for testing sessions
* carried out less than 85% of planned exercise sessions
Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1)

The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20).

The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma.

Translated with www.DeepL.com/Translator (free version)

I

Methods :

* Multicentric retrospective observational epidemiological study based on the collection of data from patient records.
* Selection of voluntary hospital sites in regions with excess mortality during the epidemic phase.
* Systematic identification of Covid-19 cases from coding data (PMSI) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the PMSI.
* Establishment of an ad hoc CRF for cases only with collection of clinical data concerning lymphoma and Covid-19 and routine biological data: Cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers.
* Estimated total number of sites: 10-15 and number of cases to be collected: 50-60.

Translated with www.DeepL.com/Translator (free version)

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age with lymphoma and a diagnosis of Covid-19 requiring hospitalization.
* In order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients.

Exclusion Criteria:

Patients who refused to participate

-
A Study of Apatinib in Recurrent or Recurrent High-grade Glioma

The purpose of this study is to determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old, male or female;
* 2. The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma;
* 3. ECOG score: 0-2 points;
* 4. The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST \<2\*ULN;c. TBIL≤1.5\*ULN; d. Plasma Cr≤1.5 \*ULN;
* 5. No history of mental illness in patients;
* 6. Thyroid function is normal;
* 7. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria:

* 1. Pregnant or lactating women;
* 2. Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure\> 150 mmHg and diastolic blood pressure\> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0;
* 3. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
* 4. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
* 5. Have mental illness, or history of substance abuse;
* 6. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an International Normalized Ratio (INR) ≤1.5 Farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 U daily for adults), or low dose aspirin (80 to 100 mg daily);
* 7. Researchers think it is not suitable for inclusion. All patients underwent CT or MRI of the head one week prior to the start of the protocol, with intracranial hemorrhage.
Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?

Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical capacity, accelerating return to activities and reinsertion and reducing mortality. It associates reconditioning to effort and therapeutic education for the optimal control of " risk factors ". It corresponds to a global approach to patients, thus counterbalancing the tendency to hyperspecialise in medicine. However, because of the lack of specialised centres, only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in e-health, the deployment of the Internet and certain " connected " devices may provide alternatives outside hospital, by enabling the follow-up of patients and their physiological parameters (heart rate, blood pressure, weigh, physical activity...), and the adaptation - using an interactive web platform - of the physical activity programme, nutrition, compliance with medication and weaning from smoking. This project proposes to evaluate the effects of a so-called " connected " CVR programme, and to show its non-inferiority compared with a conventional CVR.


Eligibility Criteria:
Inclusion Criteria:

* men or women,
* aged between 30 and 75 years,
* presenting coronary artery disease without heart failure (Left ventricular ejection fraction on echocardiography (Simpson method) \> 45 %).
* Patients who have provided written consent.

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Pregnant or breastfeeding women
* Inability to use connected numeric devices even simple operations (tablette, cardiofrequency meter, BP monitor...)
* Heart failure, with a low or preserved left ventricular ejection fraction
* Contra-indication for cardiovascular rehabilitation :

  * Severe obstructive heart disease (severe and asymptomatic obstacle to left ventricular ejection)
  * Acute unstable coronary syndrome
  * Tight aortic valve stenosis
  * Severe progressive cardiac rhythm or conduction disorders without pacing and discovered during the initial stress test
  * Intracavitary thrombus
  * Presence of moderate to severe pericardial effusion
  * Severe pulmonary artery hypertension (systolic PAP \>70mmHg)
  * Recent history of venous thromboembolism (previous 3 months)
  * Progressive inflammatory or infectious disease
  * Inability to engage in physical exercise
* Impaired executive functions making it impossible to understand and comply with the CVR programme (Mini Mental Test \< 24)
* Heart transplant
* Associated medical condition likely to impair functional capacities (examples: non-stabilised metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilised disorder such as neoplasm, systemic diseases...)
* Physical disability in the lower limbs that could hamper reconditioning, whether neurological (central or peripheral), arterial (in particular, peripheral artery disease with a systolic index \< 0.6) or orthopaedic (degenerative or inflammatory rheumatism)
On-Eye Evaluation of Contact Lens Axis Location

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark \[TEST1 (T1), TEST3 (T3), TEST5 (T5)\], worn on the right eye, and 1 lens without embossed mark \[TEST2 (T2), TEST4 (T4), and TEST6 (T6)\] worn on the left eye.


Eligibility Criteria:
Inclusion Criteria:

* Sign written Informed Consent.
* Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
* Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
* History of herpetic keratitis.
* Slit-lamp findings at baseline as specified in the protocol.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
* Clinically significant dry eye not responding to treatment.
* History of refractive surgery.
* Other protocol-defined exclusion criteria may apply.
Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

Haemorrhoidal artery ligation operation (HALO) is an operation that ties off vessels to piles. This study examines whether the ultrasound (doppler) is necessary to guide this tying off or not.

HALO (haemorrhoidal artery ligation operation) has proved to be a popular and effective treatment for bleeding piles. Currently the HALO is a Doppler guided procedure though when the Doppler mechanism does not function it has been noted that the results are similar. This prompts the question does the Doppler guide the operation to tie off the important vessels to shrink he piles, or can the vessels that underlie the visible piles be treated without Doppler. Professor Phillips from St.Marks has reviewed the protocol and agrees that it is well designed and worthwhile.

Eligibility Criteria:
Inclusion Criteria:

* For consenting adults (18-90 years) with grade one and two piles listed for HALO at Poole hospital by three consultants trained in the HALO technique, the patients will be offered to be involved in the study.

Exclusion Criteria:

* Other grades of piles, age outside 18-90 or other anal condition