cyrilzakka/clinical-trials huggingface dataset:
Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.

Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patients
* Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
* At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
* Naiive from darunavir
* Free from any opportunistic infection
* Creatinin \< 3N
* ASAT \& ALAT \< 5N
* Haemoglobin \> 7 g/dl
* Platelets \> 50 000/mm3
* Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
* Signed informed consent

Exclusion Criteria:

* HIV-2 infected patients
* Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
* Patients with a documented problem of treatment compliance within the last 12 months
* Ongoing active treatment against any opportunistic infection or tuberculosis
* Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
* Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
* Patient already treated with darunavir
* Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers

The objectives of the study are 1) to determine the influence of daily consumption of well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine inflammatory marker changes consistent with decreased cancer risk.

Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients, but the unique characteristic of Brassicas (Broccoli in particular) is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by an enzyme in the plant called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes, and apoptosis.

The aim of this study is to investigate how daily consumption of broccoli with myrosinase inactivated by cooking influences glucosinolate metabolism and absorption, and consequent regulation of inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Non tobacco user
* Cancer Free
* Not currently taking glucosinolate/isothiocyanate containing supplements

Exclusion Criteria:

* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisinidione)
* History of bariatric surgery or nutrient malabsorption disease
* Pregnant, lactating, or intending to become pregnant during the study period
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Prospective Single Center Open Label Study of Shoulder OA Pain

Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients

Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glenohumeral osteoarthritis
* SPOM score greater than or equal to 50 in study shoulder
* Willing to discontinue oral and topical analgesia other than rescue acetaminophen
* abstinence from any other IA or per-articular injections for the shoulder during the course of the trial
* patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month
* pain at least 50% of the days during previous month
* patients who have failed conventional therapy of NSAIDs or steroid injections
* patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder
* cooperative and able to communicate effectively
* agree not to participate in any other studies during trial

Exclusion Criteria:

* significant pain from other joints requiring chronic analgesic therapy
* presence of one or more conditions besides OA that could confound pain and functional assessments
* clinically apparent tense effusion, malalignment or instability in study shoulder
* shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity
* inability to abstain from analgesic use other than rescue acetaminophen
* IA injections of steroids to the study shoulder within 3 months or any other joint within the prior month
* IA injection of hyaluronic acid in the study shoulder within 9 months of baseline
* allergic reaction to HA
* any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder
* uncontrolled hypothyroidism
* pregnant or breastfeeding women
* planned surgical procedure
* history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site
* treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline
Trans Nasal Insufflation for the Treatment of Snoring

This research is being done to examine if a nasal cannula can be used to keep the throat open during sleep, thereby treating sleep apnea.

People with sleep apnea and people who snore without sleep apnea may take part in this study. Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the throat. The most common form of treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For this reason, patients often have difficulty sticking to therapy.

Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights, the investigators will monitor your sleep and your breathing throughout the night. The investigators will apply several electrodes (sensors) to your scalp and face to monitor your sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor your breathing and oxygen level.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adults over the age of 21
* Diagnosed obstructive sleep apnea

Exclusion Criteria:

* Unstable cardiovascular disease
* Uncontrolled hypertension (BP \> 190/110)
* Severe intrinsic lung diseases (supplemental O2 \> 2 L/min during the day)
* History of chronic renal insufficiency
* History of hepatic insufficiency
* Pregnancy
* Bleeding disorders or Coumadin use
* Sleep Disorders other than Obstructive Sleep Apnea (OSA)
* Tracheostomy
* Allergy to lidocaine
Mediterranean Diet and Postprandial Lipemia

The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study was to clarify the role of adipose tissue in modulating the postprandial lipid response induced by the two dietary approaches by evaluating the activities of lipoprotein lipase (LPL) and hormone-sensitive lipase (HSL).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Stable metabolic control (HbA1c\<8.0%) on diet or diet alone or diet+metformin
* BMI\<30 kg/m2 and body weight stable during the last six months.
* Both sexes; only post-menopausal women.
* Normal fasting lipid levels
* No use of hypolipidemic drugs

Exclusion Criteria:

* Patient with renal (serum creatinine \>1.5 mg/dl) or hepatic (serum transaminases \>three times upper normal values) impairment.
* Patients with history of cardiovascular disease.
* Pre-menopausal women.
* Any other acute or chronic degenerative disease.
* Anemia (Hb\<12 g/dl).
* Uncontrolled blood pressure.
* Use of any drugs able to interfere with the study medications
Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders

The research project aims to analyze the implementation of a new health care system - "alternative device to hospitalization and crisis home for people without home" - whose objective is to provide the homeless and suffering from severe psychiatric disorders adequate care to prevent situations from seeking care or complication of their disease. This device, if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is based on the original concept of "Soteria House." This will build tools for evaluating the performance of care device by a process evaluation describing and analyzing what activity involves the device, This research seeks to analyze the experimental device in the early stages of its implementation. The observation and analysis of the program period will adjust the management arrangements of the device. The data and conclusions from this research will identify the contributions and benefits of such a device and analyze the difficulties encountered in its implementation.


Eligibility Criteria:
Inclusion Criteria:

Adults without home with severe psychiatric disorders utilizing the structure, adults who master the French language

Exclusion Criteria:

adults not mastered the French language
Safety and Efficacy of Topical Cream for Post-inflammatory Hyperpigmentation Skin Among Malaysians

This study was conducted to determine safety and efficacy of topically applied cream containing combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract for its skin brightening effect on post-inflammatory hyperpigmentation among the Malaysian population. The study duration is 20 weeks and the skin assessment will be carried out at baseline, week 4, week 8, week 12, week 16 and week 20.The main questions this study aims to answer are:

1. To determine the efficacy of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
2. To investigate the safety of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
3. To assess the participants satisfaction of using topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.


Eligibility Criteria:
Inclusion Criteria:

* Malaysia citizen
* Healthy adult, aged between 18 to 40 years old.
* Participants who have post-inflammatory hyperpigmentation on skin

Exclusion Criteria:

* Participants with skin disorders such as skin infection or skin inflammation.
* Participants who have undergone any skin and cosmetic treatments such as dermal fillers, botox, laser, chemical peels within the last 3 months.
* Participant who is taking isotretinoin for the past 6 or 12 months and immunocompromised patients.
* Pregnant, breastfeeding women or planned for pregnancy during the study period.
Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains

The goal of this study is to determine safety and tolerability of Losartan when used for treatment of an acute grade II or III hamstring strain and determining the effect of losartan on recovery of hamstring muscle function. Subjects will be adults age 18 and older with grade 2 or 3 hamstring injury who participate in greater than 100 hours per year in Level 1 or Level 2 athletics or have a similar activities or physical work load (e.g. military personnel). Subjects will undergo examination, MRI, and functional assessment before, during, and after 4 weeks of losartan (50mg QD) or placebo.


Eligibility Criteria:
Inclusion Criteria

1. 18 years of age and older;
2. Have had grade II or III hamstring injury within the 7 days prior to enrollment;
3. Greater than 100 hours per year in Level I (football, basketball, or soccer) or Level II (racquet sports, skiing, manual labor occupations/heavy physical work) and activities that require running and sprinting;
4. Agree to take study medications as prescribed

Exclusion Criteria:

1. Have had previous hamstring injury on the same side or chronic symptoms;
2. Have an injury that requires surgical intervention (e.g. avulsion with associated bony involvement, grade III complete tears);
3. Have concurrent lower back symptoms;
4. Pregnant or breast feeding;
5. Is a smoker;
6. Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic involvement);
7. Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II receptor blocker (ARB);
8. Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure or greater than or equal to 90 mmHg diastolic pressure);
9. Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or less than or equal to 60 mmHg diastolic pressure);
10. Have orthostatic hypotension defined as a drop in systolic pressure greater than or equal to 2 0mmHg or a drop in diastolic blood pressure greater than or equal to 10 mmHg or reports of lightheadedness or dizziness upon standing;
11. Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities;
12. Sickle cell anemia/trait;
13. Have contraindications for MRI - including:

    * Prior surgery for an aneurysm;
    * Have cardiac pacemaker;
    * Have metal fragments in the eyes, brain, or spinal cord from shrapnel, metal work, or welding;
    * Have surgical implants, such as ear implant or neurostimulator;
    * Have a history of claustrophobia;
    * Have a history of not tolerating previous MRI scans without medication
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients

The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations


Eligibility Criteria:
Inclusion Criteria:

* Morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause

Exclusion Criteria:

* candidates not meeting the inclusion criteria
Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

The "pulsed dose" RF treatment in various painful disorders may provides better pain relief with longer duration compared to previous Pulsed Radiofrequency (PRF) treatment in similar clinical settings. Also, there would has not been any worrisome complications from the procedures.

Pain scores on visual analog scale (VAS) of 0_10 before and two hours immediately after radiofrequency lesioning and at 30 , 60, 90 day after procedure. Along with Oxford shoulder score (OSS) is a 12-item patient-reported specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. . The reduction in medications and the number of complications associated with the technique will be assessed.

Diagnostic suprascapular nerve block will done by 1.0 ml of 0.5% bupivacaine under fluoroscopic guidance using non-ionized dye (iohexol). Pain reduction more than 50% based on mean VAS assessment for at least three hours consider diagnostic.

Machine used is,(NeuroTherm 1100) RF lesion generator. The standard radiofrequency technique used, patient in sitting position , non-invasive blood pressure and peripheral oxygen saturation will monitored with non invasive pulse oxymetry. Vascular peripheral intravenous routes will opened shoulder region exposed and under complete aseptic technique skin will be anesthetized with 2.0 ml of 2% lidocaine at puncture site, suprascapular notch was identified. The landmark to guide the initial entry point was a line drawn along the length of the scapular spine, bisected with a vertical line from the angle of the scapula. A radiofrequency needle was introduced through the skin, 2.5 cm along the line of the spine in the upper outer quadrant, and then guided to the edge of the suprascapular notch by use of C_arm guide fluoroscopy with the image intensifier (22-gauge, 50-mm needle; 5-mm active tip) The nerve was located accurately by stimulating at 2 Hz (threshold \< 0.5 V). PRF was applied for 120 seconds 2 or 3 times (NeuroTherm radiofrequency lesion generator) creating a tingling and paresthesia felt in the dermatomal distribution of the nerve in question. Motor stimulation (2 HZ). Impedances were checked to ensure a complete electrical circuit and range from 200 to 400 Ohms, if impedance is \> 400 1 ml of 1% lidocaine will be injected.

Eligibility Criteria:
Inclusion Criteria:

* aged at least 18 years old
* both male and female
* had unilateral or bilateral chronic shoulder pain longer than one month
* rotator cuff tear arthropathy
* adhesive capsulitis shoulder instability
* post-traumatic pain
* post-surgical pain

Exclusion Criteria:

* Duration of shoulder pain \< 1 month
* Patients had any previous surgical intervention or nerve blocks to the shoulder.
* patient refused or declined treatment
* Allergy to local anesthetics or steroid or contrast material.
* Severe psychiatric illness disorder,
* infection at site of injection
* Patients with a pacemaker or neurostimulator.
* Pregnancy.
Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock

This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

All patients with a diagnosis of septic shock will be considered for study participation. All potential study patients will receive standard of care for the treatment of septic shock.

After screening for eligibility, patients meeting all inclusion and no exclusion criterion will be randomized. Patients will be randomized to one of three treatment arms.

Treatment with study drug must be initiated as early as possible, but no later than 24 hours after the onset of septic shock, defined by the start of vasopressor therapy.

Patients will be treated for at least 3 days with study drug. After the first 3 days of treatment, patients still requiring vasopressor will be treated until 24 hours after vasopressor withdrawal with a maximum treatment duration of 5 days.

Patients will be assessed at the End of Study (EoS) visit at day 28. After the last patient's day 28 visit, the study will be analyzed. Additional follow up (FU) visits will be conducted after 90 days, 6 and 12 months.

The objective of the study ist to compare the safety, tolerability and efficacy of two doses of nangibotide versus placebo, when given in addition to standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Age 18 to 85 years (inclusive)
3. Documented or suspected infection: lung, abdominal or urinary tract infection (UTI) in the elderly (≥65 years)
4. Organ dysfunction defined as acute change in total SOFA score ≥ 2 points
5. Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation
6. Hyperlactatemia (blood lactate \>2 mmol/L or 18 mg/dL).

Exclusion Criteria:

1. Previous episode of septic shock requiring vasopressor administration within current hospital stay
2. Underlying concurrent immunodepression with anti-CD52 alemtuzumab (Campath) or glucocorticoids \>75 mg prednisone daily or equivalent for more than 7 days
3. Immunosuppressive therapy related to recent (\<6 months) transplantation
4. Cancer chemotherapy (\<3 months) implying an immunodepression
5. Known HIV infection with low CD4 cell count (\<200) for at least 6 months
6. Known pregnancy (positive urine or serum pregnancy test)
7. Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
8. Ongoing documented or suspected endocarditis, history of prosthetic heart valves
9. Prolonged QT syndrome
10. End-stage neurological disease
11. End-stage cirrhosis (Child Pugh Class C)
12. Acute Physiology and Chronic Health Evaluation (APACHE II) score \<15 or ≥ 34
13. Home oxygen therapy on a regular basis for \> 6 h/day
14. Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
15. Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
16. Moribund patients
17. Decision to limit full care taken before obtaining informed consent
18. Participation in another interventional study in the 3 months prior to randomization
Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients

The main goal of the trial was to analyse the value of radiotherapy after breast conserving surgery for patients with breast cancer, and to find groups of patients where the treatment could be omitted.

The trial recruited patients between 1991-1996, and the primary outcome in terms of recurrences has been updated through the years since then. Tumour material has been collected in order to study prognostic and predictive factors for breast cancer patients that are treated today. Late side effects of the treatment are studied.

Eligibility Criteria:
Inclusion Criteria:

* female
* not over the age of 75 years
* operated because of stage 1-2 invasive adenocarcinoma of the breast
* radical excision of the tumour

Exclusion Criteria:

* earlier cancer except cancer in situ of the cervix or skin
* distant metastases