cyrilzakka/clinical-trials huggingface dataset:
Adjunct Minocyline in Treatment-resistant Depression

This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD).

This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The respective AD, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration for each patient will be 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* male or female
* between age 18 and 75
* BMI between 18 and 40 inclusive
* Non-lactating, non-pregnant females of child-bearing potential must be willing to use an effective contraceptive method
* All participants must fulfil diagnostic criteria of moderate or severe MDD according to the DSM-5.
* HAMD-17 score of at least 16 points at baseline and a
* CGI-S score of at least 4.
* AD-ST must have been administered at a sufficient dose for at least 6 weeks in the current episode and at a
* stable regimen for at least 14 days prior to baseline.
* Dose and duration of AD-ST must be verifiable

Exclusion Criteria:

* prevalence of neurodegenerative disorder
* prevalence of any neurological disorder that caused the depressive symptoms
* prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
* prevalence of any other psychiatric disorder that better explains the presence of depressive symptoms
* Improvement by more than 50% in HAMD-17 score during the last 14 days prior to baseline
* pregnant or nursing women will not be allowed.
* substance or alcohol abuse within past 6 months or positive urine drug screening
* abnormal thyroid function (euthyroid at presentation), liver or kidney dysfunction
* history of autoimmune disease (except Hashimotos thyroiditis)
* clinically significant laboratory abnormalities (outside normal ranges)
* current medication with anti-inflammatory substances (NSAIDs, corticosteroids)
Zinc Supplementation in Cirrhotic Patients

The purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.

Taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality.

It has been proposed that zinc deficiency is one of the causes for development of taste disorders. The aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients by any etiology, with any dysgeusia

Exclusion Criteria:

* Patients with hepatic encephalopathy at the time of dysgeusia evaluation
* Patients with any neurological disease
* Patients with respiratory diseases ath the time of dysgeusia evaluation
* Patients with active alcohol consumption
Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients

Acute stroke patient will undergo one month (20 sessions) of physical therapy and anodal tDCS.

Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.

Recruitment :

Patients with acute stroke (24-48h after stroke) who have upper and / or lower sensorimotor deficits

• Treatment : After being selected according to the inclusion and exclusion criteria of this study, patients will be randomized and placed in one of two groups: placebo (P) or transcranial anodic stimulation (A).

Once placed in one of two groups, patients will all receive intensive physiotherapy for functional improvement in order to increase motor, postural and motor control. This physiotherapy will be established 5 times a week (Monday to Friday).

In addition to physiotherapy, the patient will have electrodes placed on his head, attached via a system of straps, to deliver either a continuous current (A) or no current (P) and at a rate of 5 times per week for 4 weeks. Neither the physiotherapist nor the patient will know what treatment he will have received.

• Evaluations and measurements:

Patients will be required to perform functional tests of the upper limb (Wolf Motor Function Test (WMFT)), filmed and timed, a test of spasticity (Tardieu) as well as to answer certain questionnaires concerning their perception of the evolution of the disease and their disability (Stroke Impact Scale, Barthel Index), their emotional state (HADS), if they have experienced side effects, sensitivity test with monofilaments or Semmes and Weinstein test, the Fugl Meyer, the timed up and go, the test of 10m, the four step square test, the berg balance scale, the postural assessment scale and the trunk impairment scale. These evaluations will take place at Day 0 (corresponding to the first day after the 48h of strict bedtime), Day 7, 15, 30, 90, 6 months and 1 year. They will be done in two stages, on two successive days, so as not to exhaust the patient.

Eligibility Criteria:
Inclusion Criteria:

* Woman or man
* Between 18 and 80 years old
* First ever stroke
* Capable of signing the consent form

Exclusion Criteria:

* One on the TSST (in high and relatively high risk sections)
* Previous neurological or orthopedic pathologies affecting limbs
* Cognitive deficits
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer.

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Age:18-70 years（including 18 and 70）.
* Predicted survival ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function.
* All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma.
* Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted;
* HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+.

Exclusion Criteria:

* Active central nervous system (CNS) metastases.
* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal.
* Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study

The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Chronic HCV genotype 1 infection
* Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
* CD4 count \>200 cells/mm3 at screening and no CD4 count \<200 in previous 12 weeks
* HIV RNA PCR \<50 copies/ml at screening and no HIV RNA PCR \> 200 copies/ml in previous 12 weeks

Exclusion Criteria:

* History of integrase inhibitor resistance
* History of integrase inhibitor failure
* Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans \<1200/mm3
* Patients with cirrhosis
* Platelet count under 90,000 per cubic millimeter
* Hemoglobin levels \<11 gm/dl in women or \<12 gm/dl in men
* Previous treatment with a DAA
* Hepatocellular carcinoma
* AFP\>100 ng/mL
* hepatitis B virus (HBsAg positive)
* Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia

Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of intolerance to statins
* Patients currently receiving ezetimibe
* Patients willing and able to provide signed informed consent

Exclusion Criteria:

* Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
* Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
* Cancer undergoing active treatment
* Creatinine clearance \< 40 ml/minute
* Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level
* Participation in any clinical study within the last 30 days
* Drug addition or alcohol abuse within the past 6 months
* Use of cyclosporine within the last 3 months
* Use of gemfibrozil within the last month
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential
* History of rhabdomyolysis due to statins
Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice

A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange juice, when consumed together with the high-fat meal, is able to revert the increase in inflammatory markers. The present study will assess the effect of a single HFHC meal taken with water, orange juice or an isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of healthy individuals. Twelve healthy, normal weight individuals consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design with at least one week interval between the meals. Blood samples were collected before, 1, 3 and 5h after the meals.

BACKGROUND:

A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange juice, when consumed together with the high-fat meal, is able to revert the increase in inflammatory markers.

OBJECTIVES:

To study the effect of a single HFHC meal taken with water, orange juice (500ml) or an isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of healthy individuals.

DESIGN AND METHODOLOGY:

Twelve healthy, normal weight individuals consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design with at least one week interval between the meals. Blood samples were collected before, 1, 3 and 5h after the meals. Blood glucose, insulin and lipid profile were measured. Also, proteome analysis using TMT labeling was performed on peripheral-blood mononuclear cells collected before and at times 3 and 5h after the meal.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal weight
* non-vegetarian

Exclusion Criteria:

* use of medication
* alcohol consumption,
* intense physical exercise
* pregnant or lactating
* overweight
* obese
* drug abuse
* any disease such as diabetes, inflammatory conditions.
Biofeedback Training to Control Pain Processing

The purpose of this study is to test whether a novel form of biofeedback training can help individuals regulate their pain more effectively.

Relaxation is a low-cost treatment for managing pain with little or no side effects. The proposed study will use a novel biofeedback procedure to try to enhance the ability of relaxation to engage pain inhibition. Specifically, a biofeedback system will be used to provide training in conditioned pain regulation. The biofeedback system will monitor the trainee's level of sympathetic arousal and use it to control the intensity of painful stimulations delivered to the trainee during biofeedback. So when the trainee successfully relaxes (and reduced arousal), the intensity is lowered and produces pain relief. Efficacy of the training will be tested in a randomized controlled trial in which healthy, pain-free trainees are assigned to receive 3 training sessions or 3 sessions of a control procedure (2 other procedures will serve as controls; 3 groups total). The aim will be to assess whether the training results in inhibition of experimental pain and the nociceptive flexion reflex (NFR, a physiological marker of spinal pain signaling) to determine whether brain-to-spinal cord inhibitory circuits are engaged.

Eligibility Criteria:
Inclusion Criteria:

* healthy pain free individuals over the age of 18.

Exclusion Criteria:

* under 18 years of age (given the nature of the study)
* history of serious cardiovascular, neuroendocrine, or neurological disorders
* hypertension (due to a relationship between blood pressure and pain);5 4) history of chronic pain
* current opioid, antidepressant, or anxiolytic medication use
* psychosis or apparent cognitive impairment
* body mass index\>35 (due to difficulty eliciting an NFR in persons with high adiposity)
* inability to understand and read English (questionnaires and consent form are in English)
* recent use of an over-the-counter pain medication (within the last 24 hours) or narcotic medication (within the last two weeks)
* history of panic attacks. No one will be excluded based on ethnic, racial, or gender characteristics.
Mitigating PTSD-CUD After Sexual Assault

683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.


Eligibility Criteria:
Inclusion Criteria:

1. Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites
2. English speakers
3. 18+ years of age
4. Able to provide informed consent
5. Have a smartphone with continuous service \>1 year
6. Report \>1x/weekly cannabis use on a substance use screener
7. Report elevated AS (\>17 on the Anxiety Sensitivity Index-3)

Exclusion Criteria:

1. Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening)).
2. Prisoner
3. Currently pregnant
4. Lives with assailant and plans to continue to do so
5. Admitted patient
6. No mailing address
7. Previously enrolled
8. No sexual assault nurse examiner (SANE) examination
9. Reporting current plan and intent for suicide or homicide
10. Does not understand written and spoken English
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation

Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
* Living donors
* Compatible ABO blood type
* PRA \< 20%

Exclusion Criteria:

* Re-transplant patients
* Those with peripheral vascular disease affecting the lower limbs
Physical Activity in Children With Type 1 Diabetes Study

This study aims to test the feasibility of a physical activity intervention called the Steps To Active Kids (STAK) programme in children aged 9 - 11 years with Type 1 Diabetes Mellitus (T1DM).

The STAK programme promotes physical activity in children who have a chronic condition, low levels of physical activity, are overweight or who lack confidence to take part in physical activity. The intervention involves an Activity Diary, circuit training, pedometer step counting, daily physical activity monitoring and goal setting to promote long-term increases in physical activity and its associated health benefits. This randomised single-centre feasibility study will test whether the STAK programme is feasible for children with T1DM, in terms of acceptability, attractiveness and compliance and a qualitative process evaluation will aid the assessment of feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Be aged between 9 and 11 years
* Have a clinical diagnosis of Type 1 Diabetes Mellitus for at least 3 months
* Be willing and able to comply with the study protocol
* Be physically able to participate in physical activity
* Have a parent/carer who provides informed consent

Exclusion Criteria:

* Be under the age of 9 years and over the age of 11 years
* Have been diagnosed with Type 1 Diabetes Mellitus for less than 3 months
* Have an injury or physical health condition that precludes their participation in physical activity
* Have a psychiatric disorder that interferes with provision of assent, completion of measurements, intervention, or follow-up
* Insufficient proficiency in English to comply with treatment or provide data
Treatment of Uncomplicated Malaria in Benin

Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.

The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.

Expected total enrollment: 225 patients

Study start: April 2007; expected completion: December 2007


Eligibility Criteria:
Inclusion Criteria:

* 6-119 months old
* fever or history of fever of less than 24 hours
* p falciparum parasitemia \> 1000 trophozoïtes/µL
* informed consent signed

Exclusion Criteria:

* \< 5 kg
* danger or severity signs of malaria
* known underlying chronic disease
* Hb \< 5g/dL
* adequate malaria treatment taken within 3 days before visit
Individualized Exercise Combined With Manual Therapy in Severe Hemophilia Patients With Polyarthropathy

The aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.

The main clinical manifestations of hemophilia are muscle and joint bleeding. Recurrent bleeding leads to a degenerative process known as hemophilic arthropathy. Past studies investigated the effect of manual therapy of exercise for individuals with hemophilia and found to enhance muscle strength, balance, fitness and promote quality of life. However, less study has evaluated the safety and effectiveness of manual therapy combined with exercise for individuals with multiple hemophilic arthropathy. Therefore, the aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.

Eligibility Criteria:
Inclusion Criteria:

* over 20 years old and diagnosed with severe hemophilia
* those who receive prophylaxis regularly
* there are more than 2 target joints (hemophilic arthropathy)

Exclusion Criteria:

* unwilling to sign the informed consent
* any neurological disease or specific musculoskeletal condition (such as fracture) one year ago
* more than 3 (excluding 3) joint replacement surgeries (different joints)
* unable to walk due to hemophilia joint disease or any other diseases
* major bleeding events that pose risks or hinder research
* unable to follow instructions due to cognitive impairment