cyrilzakka/clinical-trials huggingface dataset:
Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)

To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction

Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in coronary artery. So we designed a prospective randomized multi-center trial named the pioglitazone could reduce the recurrence of myocardial infarction in patients with DM and myocardial infarction(PPAR study) to evaluate whether pioglitazone could reduce the recurrence of myocardial infarction in patients with DM(HbA1c\<6.5%) and myocardial infarction.

More than 100 hospitals will participate in the PPAR study. Patients with DM who have history of prior myocardial infarction are randomly allocated to receive pioglitazone or (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents. The number of patients to be recruited is 720 and this study will continue at least 2 years until 7 year or the end of the study. The primary end-points are (1) cardiovascular mortality and (2) hospitalization for cardiovascular events. Effects in suppression of new diabetes development also will be evaluated.

We should recognize DM as important therapeutic target to decrease recurrence of cardiovascular events. PPAR study, a large scale multi-center trial in Japan, will provide us new evidence how to treat DM patients with prior myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

1. diabetes mellitus (fasting plasma glucose levels of\>126 mg/dL, or 2-hour 75g oral glucose tolerance test (OGTT) value of \>200 mg/dL, and HbA1c levels of\<6.5% (47.5 IFCC))
2. History of myocardial infarction
3. Age between 20-79 years old

Exclusion Criteria:

1. acute MI occurring within the last 7 days
2. New York Heart Association (NYHA) symptoms of no fewer II or with left ventricular ejection fraction of not more than 40%
3. suspected type I DM
4. scheduled coronary angioplasty or history of coronary artery bypass graft surgery
5. serious liver or kidney damage
6. history of allergy or drug hypersensitivity
7. arteriosclerosis obliterans with Fontaine stage III or worse
8. inability to understand and/or comply with study medications, procedures and/or follow-up or any conditions that may render the patient unable to complete the study in the opinion of the investigator.
Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis

Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.

Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(PRGFs) in OA of the knee, using parameters of pain, function, quality of life and safety.

Eligibility Criteria:
Inclusion Criteria:

* age 40-75 years old
* diagnosed Oa of the knee more then 1 year
* no knee deformation

Exclusion Criteria:

* mental of physical disabilities
* pregnancy
* deformities of the knee
Vaccine Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

OBJECTIVES:

* Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma.
* Determine the longevity of melanoma-specific immunity in patients treated with this regimen.
* Perform serial analysis of T-cell and B-cell function in patients treated with this regimen.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation.

Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression.

Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic melanoma
* HLA-A2-01 phenotype
* Measurable disease
* No active CNS or hepatic metastases

PATIENT CHARACTERISTICS:

Age:

* 21 and over

Performance status:

* Karnofsky 80-100%

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* See Disease Characteristics
* No viral hepatitis

Renal:

* Not specified

Cardiovascular:

* No prior venous thrombosis, angina pectoris, or congestive heart failure
* Lactate dehydrogenase less than 2 times normal

Pulmonary:

* No prior asthma

Immunologic:

* Intradermal skin test positivity to mumps, Candida, or streptokinase antigen
* No known sensitivity to E. coli drug preparations
* No prior allergy to influenza vaccine
* No active infection
* No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis)

Other:

* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 8 weeks since prior interleukin-2
* At least 4 weeks since prior interferon alfa

Chemotherapy:

* At least 8 weeks since prior chemotherapy

Endocrine therapy:

* At least 2 weeks since prior corticosteroids
* No concurrent corticosteroids

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent immunosuppressive agents
* At least 2 weeks since prior immunosuppressive agents
Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy

This is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg/day) in renal and cardiac function protection in people with diabetic nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* 1.Voluntarily sign informed consent;2.Meet the diagnosis of diabetic nephropathy: In the case of identifying diabetes as the cause of kidney damage and excluding chronic kidney disease caused by other causes, at least one of the following is present:①. In the case of excluding interference factors, at least 2 UACR≥30mg/g or UAER≥30mg/24h (≥20ug/min) in 3 tests within 3\~6 months. ②. eGFR\<60ml/min/(1.73m2)-1 for more than 3 months. ③. Renal biopsy consistent with pathological changes of DKD;3.DKD staging is 3 and before，eGFR\>30ml/min/(1.73m2)-1；

Exclusion Criteria:

* (1) History of cardiovascular or cerebrovascular events (defined by the patient's medical history and/or instrumental examination results); (2)Insufficient glycemic control (i.e., glycated hemoglobin ≥8%); (3) Uncontrolled blood pressure despite taking antihypertensive drugs (≥140/≥85mmHg); (4) Previous major bleeding (i.e., intracranial hemorrhage); (5) Previous gastrointestinal ulcers; (6) Clinical diagnosis of type 1 diabetes mellitus (diagnosis of diabetes mellitus and use of insulin before age 35);(7) Patients with CKDG4 or G5 (i.e., eGFR\<30 mL/min/1.73 m2 or dialysis) ;(8) chronic active infection or; (9) evidence of malignancy within the past 5 years. Patients with tumour disease in situ who are successfully treated only by local resection can be included in the study (including non-melanoma skin cancer in situ); (10) Autoimmune diseases; (11) Persistent arrhythmias requiring anticoagulation therapy (i.e., atrial fibrillation). In this category, isolated ventricular/supraventricular presystoles; (12) Use of NSAIDs or other antiplatelet drugs in the past 30 days; (13) cirrhosis of any etiology; (14) use of anticoagulants; (15) Life expectancy less than 1 year; (16) Known aspirin allergy; (17) Known pregnancy; and (18) Severe mental illness.
Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.

The study is a prospective randomized, multi-center, double-blind, parallel, sham-controlled study, designed for comparison of two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.

The study period will begin with a four-week run-in period, during which there is no investigational treatment. The purpose of the run-in period will be to establish a baseline of the subject's headache/migraine history for longitudinal comparison.

The run-in period will be followed by a 12-week randomized period when the subjects will be randomized (1:1) to either active treatment or sham (inactive) treatment.

Subjects will dose themselves 3 times per day for 12 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Between the ages of 18 and 75 years
* Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
* Experiences between 8 to 20 headaches days per month (during the last 3 months), with at least 5 of them being migraine days
* Onset of migraine at age 50 years or younger
* Agrees to refrain from initiating or changing any prophylactic medications for indications other than migraine

Key Exclusion Criteria:

* Concomitant medical condition that will require oral or injectable steroids during the study
* Currently on a stable regime of more than 1 migraine preventative therapy
* Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder)
* Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
* Known or suspected cerebrovascular disease
* Previous cervical vagotomy
* Currently implanted with an electrical and/or neurostimulator device
* Been implanted with metal cervical spine hardware or has a metallic implant near the nVNS stimulation site
* Known history or suspicion of secondary headache
* Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 6 months
* Currently takes simple analgesics or NSAIDs \>15 days per month or triptans, ergots, or combined analgesics \>10 days per month for headaches or other body pain
* Currently takes prescription opioids more than 2 days per month for headaches or body pain
* Failed an adequate trial (2 months or greater) of at least 3 classes of a drug therapy for migraine prevention
* Surgery for migraine prevention
* Undergone nerve block (occipital or other) in the head or neck within the last 3 months
* Received Botox or CGRP mAb injections within the last 6 months
* Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
* Previously used gammaCore
Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.

High flow nasal cannula administration in critically ill patients is frequently used to improve acute respiratory failure or to prevent respiratory failure after extubation.

It acts generating a mild positive pressure in the airways and by reducing respiratory effort of patients.

However to the best of our knowledge, no study to date has directly measured the amount of positive pressure generated in the trachea of patients.

The primary aim, therefore, of this study measures this positive pressure after extubation in critically ill patients.


Eligibility Criteria:
Inclusion Criteria: CRITICALLY ILL PATIENTS AFTER MECHANICAL VENTILATION LASTED AT LEAST 72 HOURS

* age 18-80 years

Exclusion Criteria:

* COPD stage \>1 according to GOLD classification
* end stage organ disease (liver, kidney, heart, lung)
* neuromuscular disease
* neoplasm
* previous tracheostomy
* obesity with BMI \> 35 Kg/m2
* non collaborative patient
A Trial In Patients With Advanced Cancer And Leukemia

This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients with advanced cancer and leukemia


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced cancer that is resistant to standard therapy or for which no standard therapy is available
* Patients with acute T cell leukemia/lymphoblastic lymphoma that is resistant to standard therapy or for which no standard therapy is available
* Men and women \>16 years old

Exclusion Criteria:

* Prior treatment with a gamma secretase inhibitor for treatment of cancer
* Patients taking Tamoxifen
* Patients with active graft versus host disease
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
* Patients who are pregnant or breast feeding
* Patients with clinical evidence of central nervous system disease
VR and Script Training of PWA

The goal of this intervention study is to investigate the effects of immersive virtual reality in rehabilitation of language and communication of individuals with post-stroke aphasia. The main research questions are:

1. Is VR-based script training a feasible treatment to Cantonese-speaking PWA?
2. Will VR-based script training, when compared to conventional script training, better enhance treatment outcomes in functional communication of PWA?

Participants will be assessed before, in the middle of, immediately after treatment and 8-week post treatment in terms of their performance on:

1. Accuracy and time for producing trained scripts.
2. Accuracy and time for producing un-trained scripts
3. Standardized aphasia test on severity of language impairment
4. Standardized aphasia test on functional communication

The participants will be randomly allocated to receive one of the treatment:

1. Virtual reality-based computerized script training; or
2. Computerized script training without virtual reality Researchers will compare the treatment outcomes of the two treatment conditions and see if treatment with virtual reality would better promote outcomes when compared to training without virtual reality.


Eligibility Criteria:
Inclusion Criteria:

1. a stroke onset more than six months, with an Aphasia Quotient (AQ) below 96.4, as evaluated by the Cantonese version of Western Aphasia Battery (CAB; Yiu, 1992),
2. premorbid fluent Cantonese speakers,
3. aged between 30 and 80 years,
4. no reported progressive neurogenic disorders such as dementia or Parkinson's disease,
5. no motor speech disorders of moderate to severe level, and
6. normal or corrected-to-normal vision and hearing functions

Exclusion Criteria:

1. concurrent participation in other aphasia treatment trials, and
2. incompatibility with immersive VR exposure such as complains of nausea, headache, or other severe discomforts during trial use of a head-mounted device during screening.
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)

This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.


Eligibility Criteria:
Inclusion Criteria:

* All Ages
* Definite diagnosis of Tuberous Sclerosis according to the modified Gomez criteria
* At least one Subependymal Giant Cell Astrocytoma of at least 1 cm in diameter
* Evidence of SEGA worsening as compared to prior MRI scans
* Females of child bearing potential must use birth control
* Written informed consent

Exclusion Criteria:

* SEGA related surgery is likely to be required in the opinion of the investigator
* Recent heart attack, cardiac related chest pain or stroke
* Severely impaired lung function
* Severe liver dysfunction
* Severe kidney dysfunction
* Pregnancy or breast feeding
* Current infection
* History of organ transplant
* Surgery within two months prior to study enrollment
* Prior therapy with a medication in the same class as Everolimus
* Uncontrolled high cholesterol
* Uncontrolled diabetes
* HIV
* Patients with metal implants thus prohibiting MRI evaluations

Other protocol-defined inclusion/exclusion criteria may apply
Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy. Different second-line therapeutic options are available. However, the success of second-line therapy has not been addressed or reported from Saudi Arabia.

Objectives The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment.

A prospective, open-label, single arm study was conducted. Patients were recruited from a tertiary care hospital in Saudi Arabia from June 2013 to April 2014. A total of 55 patients had previously received standard triple therapy and/or sequential therapy in the period from 2011 to 2014 and failed to eradicate the infection. The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily. Urea-breath-test (UBT) was done at a minimum of 6 weeks after completion of the treatment to confirm the H. pylori eradication. Compliance and tolerability of the regimen were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Received previous treatment with triple therapy, sequential therapy or both
* Has evidence of persistence H. pylori infection by a positive urea breath test (UBT), histology or rapid urease test (HP Fast. GI supply™, PA, USA)

Exclusion Criteria:

* Previously treated with quadruple or levofloxacin-based therapy
* Had an allergy to doxycycline, levofloxacin or esomeprazole
* Pregnant or lactating
* Significant hepatic, renal, or cardiopulmonary disorders, or active malignancy.
Outcomes of Intra-Cytoplasmic Sperm Injection in Infertile Men With Non-tense Vaginal Hydrocele

Infertile men due to oligoasthenospermia with non-tense hydroceles are subjected to ICSI

Sixty male infertile patients with Oligoasthenospermia were recruited from outpatient clinic of Urology Department, Tanta University. Patients were selected according to inclusion and exclusion criteria. The inclusion criteria were: (a) infertile couples due to male factor (b) Oligoasthenospermia (c) Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH), (d) presence or absence of non-tense vaginal hydrocel. The exclusion criteria were: (a) Presence of varicocele, (b) History of recent testicular trauma, (c) History of recent or old testicular inflammation, (d) Tense vaginal hydrocele and (e) presence of potential female pathologies.

Sample size calculation: With H0 denoting higher success rates for ICSI in absence of non-tense hydrocele and confidence level of 95% and interval of 5 the sample size was 30. The program used was Epi info 0.7.

Randomization and allocation: Enrolled patients were randomly allocated into 2 groups. The first group (n=30) who have oligoasthenospermia with non-tense vaginal hydrocele (Study group) and the second group (n=30) who have oligoasthenospermia with no hydrocele group (Control group). Randomization was done by computer-generated serial numbers where each number was enveloped. Each number denotes a certain allocation group. Allocation was by alternate method and envelope opening did not change allocation.

Methods: Males were assessed by genital examination, ultrasound and scrotal Doppler. Female partners were given long agonist stimulation protocols, Ovum pickup fertilization by sperms and then embryo transfer on day 5. Demographic data of both couples, duration of infertility, seminal parameters (WHO-2010) and results of ICSI in these couples were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Infertile couples due to male factor
* Oligoasthenospermia
* Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH)
* Presence or absence of non-tense vaginal hydrocele

Exclusion Criteria:

* Presence of varicocele
* History of recent testicular trauma
* History of recent or old testicular inflammation
* Tense vaginal hydrocele
* Presence of potential female pathology
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.

Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion of alfa-ketoglutarate to ammonia via glutamine.

We intend to study the effect of oral administered BCAA on the metabolism of ammonia and amino acids across the leg-muscles by means of catheters inserted into the femoral artery (A) and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of indocyanine green and indicator dilution principle. Arterial blood flow and A and V concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0.45 g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be estimated by means of 13N-NH3 PET scans.

Hypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial ammonia.

Eligibility Criteria:
Inclusion Criteria:

* 18 patients with liver cirrhosis
* 6 healthy subjects age and sex matched

Exclusion Criteria:

* Non-treated diabetes
* Pregnancy/breast-feeding
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE
* Disease duration longer or equal to 6 months
* Stable, mild to moderate active SLE
* Receiving stable maintenance therapy

Exclusion Criteria:

* Significant lupus nephritis
* Active central nervous system (CNS) disease
* Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
* Active vasculitis requiring treatment
* Body weight over 120 kg
* History of cancer
* Infections
* viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
* tuberculosis (TB)
* Severe systemic microbial infections within the past 12 months prior to dosing
* Immunosuppressive and immune modulating therapy