cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

The purpose of this study is to determine whether it is better to start an anti-HIV regimen containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment regimen is best as a first treatment for HIV infection.

Highly active antiretroviral therapy (HAART) regimens containing PIs, NNRTIs, or nucleoside reverse transcriptase inhibitors (NRTIs) have been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future anti-HIV treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens.

Patients will be randomized to one of three HAART treatment arms:

* Arm 1 participants will receive one or two PIs plus two NRTIs.
* Arm 2 participants will receive one NNRTI plus two NRTIs.
* Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs.

Before randomization to a treatment arm, patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs. The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice. The study-specified NNRTIs will be nevirapine (NVP) or efavirenz (EFV). The study-specified NRTIs will be abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T).

The study sites will provide ABC, 3TC, ddI, or d4T to all patients who are assigned to take these medications. All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription. At Months 1 and 4 and then every 4 months thereafter, patients will receive a medical history update, physical exam, and questionnaire. Blood samples will also be drawn to measure CD4 cell count, viral load, and genotypic antiretroviral resistance. Changes in treatment regimens may occur at any time.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Agree to practice abstinence or to use barrier methods of birth control during the study
* Are at least 13 years old or have signed informed consent from legal guardian for patients between the ages of 13 and 18

Exclusion Criteria:

* Have ever taken any anti-HIV drugs
* Are unable to complete the study for any reason
* Pregnancy
* Breastfeeding
* Any condition that, in the investigator's opinion, may interfere with the study
Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial

The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.

Eligibility Criteria:

1. Patients with long-term maintenance hemodialysis with AVF as the vascular access;
2. Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur.
3. Doppler ultrasound /DSA/magnetic resonance angiography show the diameter of AVF fistula is \>50% narrow than the adjacent segment of the fistula lumen.
4. Blood flow of the AVF is \<500ml/min or monthly declines of the blood flow\>25%.
5. Patient signed the informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with long-term maintenance hemodialysis with AVF as the vascular access;
2. Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur;
3. Doppler ultrasound /DSA/MRA show the diameter of AVF fistula is \>50% narrow than the adjacent segment of the fistula lumen;
4. Blood flow of the AVF is \<500ml/min or monthly declines of the blood flow\>25%;
5. Patient signed the informed consent.

Exclusion Criteria:

1. allergic to the iodine contrast or gadolinium contrast agent;
2. local infection;
3. the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine);
4. the presence of severe artery steal syndrome;
5. stenosis of immature fistula or fistula \<2 month after vascular anastomosis;
6. severe central venous stenosis;
7. discontinue hemodialysis treatment (such as to transfer to peritoneal dialysis or kidney transplant);
8. severe cardiac dysfunction (New York Heart Association cardiac functional classification III or worse), unstable angina pectoris, myocardial infarction, severe left ventricular hypertrophy, or severe vascular embolic disease;
9. participated in other clinical trials within 12 weeks;
10. alcohol and/or drug abusers, mental disorders;
11. patients not suitable as the subjects of this trial under the consideration of researchers.
Safety Assessment of Angioplasty Procedures

Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries. To evaluate the safety of angioplasty performed in patients operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be determined and compared with data from the literature.

The use of active stents for the treatment of coronary stenosis is currently the standard treatment in almost all types of coronary lesions. In percutaneous transluminal treatment of coronary lesions, balloon angioplasty and bare stents have not shown satisfactory results in the past. The so-called active drug-eluting balloon could represent a new therapeutic option for the treatment of de novo lesions.

Eligibility Criteria:
Inclusion Criteria:

* Interventional revascularization of a coronary lesion,
* Member or beneficiary of a social security system,
* Informed of the study.

Exclusion Criteria:

* Language barrier,
* Minor,
* Pregnant woman,
* Person under guardianship,
* Person deprived of his/her liberty,
* Refusal to participate.
nTMS for Motor Mapping of Rolandic Lesions

To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control.

Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon

Experimental intervention:

presurgical motor mapping by navigated transcranial magnetic stimulation and fusion with intraoperative neuronavigation

Control intervention:

presurgical motor mapping by navigated transcranial magnetic stimulation without access of the surgeon to this data Follow-up per patient: 6 months Duration of intervention per patient: 45 minutes

Eligibility Criteria:
Key inclusion criteria:

* indication for resection of a supratentorial tumor within or adjacent to the primary motor cortex
* preoperative nTMS mapping of the ipsilateral hemisphere
* implementation of the mapping data into preoperative planning
* continuous MEP monitoring - informed consent

Key exclusion criteria:

* no motor eloquent tumor
* infratentorial tumor
* no postoperative imaging
* prognosis lower than 3 months of survival - age \<18 years
Postoperative Complications Following Total Knee Arthroplasty

The aim of this study is to investigate the effect of combined spinoepidural and general anesthesia on the incidence of postoperative complications following total knee arthroplasty

Total knee arthroplasty is known to cause complications (pulmonary thromboembolism, acute kidney injury, arryhthmias and infection). The investigators aimed to study the effects of two different anesthesia techniques, i.e. combined spinoepidural anesthesia and general anesthesia on the incidence of postoperative complications such as arrhythmia, pulmonary thrombeoembolism, infection, acute kidney injury and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective unilateral total knee arthroplasty

Exclusion Criteria:

* Patient refusal
* Scheduled for bilateral or unilateral unicondylar knee arthroplasty
* Known history of allergy to drugs used in the study
* Severe systemic disease
* Morbid obesity (BMI\>30)
* History of renal dysfunction
Pathophysiological Mechanisms of Fibromuscular Dysplasia

Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery, arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order to progress into identifying possible causative mechanisms of the disease, we design a pathophysiology study destined to assess endothelial function in patients with fibromuscular dysplasia and to identify possible plasmatic biomarkers of the disease.


Eligibility Criteria:
Inclusion Criteria for patients with multifocal fibromuscular dysplasia:

* confirmed multifocal fibromuscular dysplasia
* diagnosed for less than 10 years
* without significant atherosclerotic disease or recent cardiovascular event
* Statins and antiplatelet drugs are forbidden
* hypertensive patients
Study to Assess Potential Different Properties of Telmisartan Compared to Candesartan in Healthy Volunteers

Study to assess potential different properties of telmisartan, which due to its Vd, should result in stronger "beneficial" effects of AT1 blockade in tissues (e.g. aldosterone suppression and renin increase) plus stronger AT2 stimulation compared to candesartan


Eligibility Criteria:
Inclusion Criteria:

1. Males, aged 18 to 45 years.
2. Absence of any relevant disease as determined by no clinically deviation from normal in medical history, clinical laboratory determination, ECGs and physical examinations
3. Systolic blood pressure (SBP) between 100 and 140 mmHg systolic and below 85 mmHg diastolic (both left and right arm) and a heart rate of ≥50 bpm
4. Signed informed consent form
5. No intake of drugs inbetween a waiting time of ten times of half-life

Exclusion Criteria:

1. Contraindications to Ang II antagonists, known hypersensitivity, history of angioedema, serious allergy, asthma, allergic skin rash, significant allergic rhinitis or sensitivity to any drug
2. History of cardiovascular diseases: any clinically significant cardio-vascular disease, a supine diastolic blood pressure \>86 mmHg and systolic \>141 mmHg measured by a standard sphygmomanometer or a heart rate ≤49 bpm
3. Cerebrovascular diseases: history of stroke or transitory ischemic attacks (TIAs) or history of any cerebral bleeding
4. Renal diseases: serum creatinine \>1.5 mg/dL
5. Gastrointestinal/Hepatic diseases: Aspartate aminotransferase (ASAT) \>40 U/l or Alanine aminotransferase (ALAT) \>40 U/L, serum bilirubin \>2x upper limit of normal, history of malabsorption or inability to tolerate oral medication, history of gastric or duodenal ulcers, history of significant gastrointestinal bleeding, history of hepatitis within the past years
6. Any history of alcohol or drug abuse
7. Use of any of the following drugs within 4 weeks of study enrolment (e.g. agents known to induce drug metabolizing enzymes): anabolic steroids and corticoids, antiarrhythmics (amiodarone, mexiletine, quinidine, propafenone), antibiotics (chloramphenicol, tetracyclines, sulfonamides, macrolides, cephalosporins, rifampicin, nalidixic acid), antiepileptics (phenytoin, carbamazepine), antifungals (e.g. griseofulvin), barbiturates, cimetidine, ethacrynic acid, fibrates, furosemide, haloperidol, lipid lowering agents (cholestyramine, hydroxymethylglutaryl, coenzyme A (HMG CoA) reductase inhibitors, dextrothyroxin), thyroid replacement therapy hormones or thyrostatics (thioureylene-type). The use of nonsteroidal antiinflammatory drugs (NSAIDs) should be discontinued 2 weeks prior to study enrolment, the one exception of aspirin should be one (1) week prior to study enrolment
8. Participation in any other investigational study, within the 30 days prior to enrolment
9. Blood donation within the previous 3 months
10. The investigator might disqualify a subject for a sound medical or psychiatric reason
Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.

Group A: patients receiving single dose of IV cefazolin 10-60 minutes before incision.

Group B: patients receiving a single dose of IV cefazolin 10-60 minutes before incision + a single dose of intra-articular vancomycin powder before articulation (hip or knee) closure.

Eligibility Criteria:
Inclusion Criteria:

* Standard criteria for the implantation of primary total hip or knee replacement
* Revision of an aseptic THA or TKA.
* Adults \>18 years of age
* Diagnosis of Osteoarthrosis (OA), Osteonecrosis (ON), Arthritis; or aseptic loosening of THA/TKA.
* Subject is willing to consent to participate in the study
* Subject is available for follow-up through at least 2 years
* Subject has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk.
* Subject who are fluent in English and / or French and able to understand their role in the study

Exclusion Criteria:

* Active, local infection or systemic infection.
* Participation in any other pharmaceutical, biologic or medical device clinical investigation
* Subjects with known allergy to vancomycin
* Subjects unable to consent
* Patient with skin pathology
Silent Hypoxia and Awake Proning in COVID-19 Patients

The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.


Eligibility Criteria:
Inclusion Criteria:

* Non dyspneic (NRS =/\< 1) patients with positive SARS-CoV-2 test
* Age 18 - 80 years
* Patients managed at home
* Inclusion within 72 hours from positive test

Exclusion Criteria:

* Chronic hypoxia (SpO2 \< 93 %) and/or first measured SpO2 \< 93 %
* Admitted to hospital for COVID-19 prior to inclusion
* Unable to perform pulse oximetry
* Unable to perform physiotherapy
Data Acquisition to Model Glycemic Response

To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. The investigators will collect real-time glucose data from a continuous glucose monitor (CGM) system; accelerometer, aggregated activity, and sleep data from a wrist-worn activity tracker; mood and experiential data; and food information. Non-sensor data will be collected using a paper log, or via a study app when available.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Be able to read, speak, and understand English
* Have a primary care provider

Exclusion Criteria:

* Not receive or require kidney dialysis
* Not be pregnant
* Not have type 1 diabetes
* Not have type 2 diabetes and be prescribed three or more daily injections of insulin
Effects of Proprioceptive Neuromuscular Training on Sensory and Motor Function in Guillain Barre Syndrome

This study aims to determine the effects of Proprioceptive Neuromuscular Training on Sensory versus Motor Function in patients presenting with Guillain Barre Syndrome.

This study will be a randomized controlled trial and will be conducted to determine the effects of proprioceptive neuro-muscular training on sensory and motor function of lower limb,In this study data will be collected from multiple Hospitals of Lahore via Berg Balance Scale, Timed Up and Go test One Leg Stance test before and after intervention. Non- probability convenient sampling technique will be used to enroll 26 patients in total. The patients will be randomly allocated into two groups through lottery method, to either the proprioceptive training group or control group.Both groups will be assessed for proprioception via lower extremity position test as a baseline. Proprioception training programme will be implemented in experimental group and will be carried out for eight weeks, with three (60-minute) sessions per week. It will start with 10 minutes of Warm-up. This will be followed by 30 minutes of proprioceptive exercises targeting lower extremities. Proprioceptive exercises will be divided into three components, standing on Foam with eyes open and eyes closed and passing any object from one subject to the other for 10 minutes, throwing and catching a ball will be performed while standing on foam for additional 10 minutes, throwing and catching a ball, will be performed on trampoline to further challenge the balance system. After each set of 10-minute exercise, the subjects will be given two-minute resting periods. In the end, 10 minutes will be given for cool down exercises to bring the heart rate back to resting level. All participants in both groups will be evaluated before and after the treatment programs. Data will be analyzed by using Statistical Package of Social Sciences Version 26.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Guillain Barre Syndrome already taking treatments
2. Inflammatory Demyelinating Guillain Barre Syndrome patients
3. Acute motor sensory axonal neuropathy
4. Guillain Barre Syndrome patients in the subacute phase
5. Guillain Barre Syndrome patients with impaired proprioception
6. Patients with Glasgow Coma Scale above 12

Exclusion Criteria:

1. Other Guillain Barre Syndrome types
2. Spinal cord injury
3. Traumatic neuritis
4. Not Fulfilling Above Criteria Of Age
A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants

The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.

Primary Outcome: Change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F

Secondary endpoints: Comparative evaluation of any post-operative variation between subjects receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged between 45 and 75 years inclusive.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
* Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet.
* Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.

Exclusion Criteria:

* Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
* Female subjects who are pregnant or lactating.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).
* Subjects who are currently involved in any injury litigation claims.
* Subjects with a known history of poor compliance to medical treatment.
* Subjects who have previously had an osteotomy or significant surgery in the affected knee.
What is the Effect of Prolapse Surgery on Voiding?

The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is the very first one to combine several innovative low-invasive and low-cost methods to analyse the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* Dutch, French or English- speaking women
* symptoms of pelvic organ prolapse
* preoperatively pelvic floor surgery.

Exclusion Criteria:

- history of neurological disease