cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers

A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age between 19 to 45, healthy male subjects(at screening)
* Body weight over 55kg, in the range of calculated Ideal Body Weight ± 20%
* Subject without a hereditary problems, chronic disease and morbid symptom
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Volunteer who had hypersensitivity reaction to medicines including Tenofovir
* Volunteer who has genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance
* Sitting systolic blood pressure \> 140mmHg or \< 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or \< 60mmHg, pulse ≥ 100 beats per minute
* Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
* Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
* Have the result of serum test(RPR Ab(VDRL), HBsAg, HCV Ab, Anti HIV(AIDS)) is a positive
* History of drug abuse, or a positive urine drug screen
* Having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
* Participation in any other clinical trial involving investigational drugs within 3 months
* Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
* Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
* Volunteers smoking over 10 cigarettes per day in the last 3 months and taking a surfeit of caffeine(caffeine\>400mg per day)
* Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
* Any condition that, in the view of the investigator, would interfere with study participation
LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention

The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.


Eligibility Criteria:
Inclusion Criteria:

* six or seventh grader in a Danish public school
* participating in normal math lessons

Exclusion Criteria:

* private school
* receiving extra math lessons because of special needs
The Listening Project at the ADD Centre and Biofeedback Institute of Toronto

Purpose: A research project will be conducted at the ADD ("Attention Deficit Disorder") Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. These improvements should translate into increase feelings of safety and calmness, thereby promoting improvement in social behavior.

Participants: 30 participants, males and females between ages 7-55 years, will be recruited for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of Toronto.

Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and 1 month post intervention assessment. Group 2 will have an additional pre-intervention assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the stability of the measures prior to starting the intervention. Pre-, post-, and 1 month followup assessment will include parent and/or self-report questionnaires, and measures of the individual's auditory processing ("SCAN"), affect recognition ("DARE" Dynamic Affect Recognition Evaluation), heart rate, prosody, "RSA" respiratory sinus arrhythmia (derived from non-invasive ECG recording), and middle ear transfer function ("MESAS" - Middle Ear Sound Absorption System).


Eligibility Criteria:
Inclusion Criteria:

1. Individuals must be between ages 7-55 years
2. Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
3. Individuals must be current or past clients at the ADD Centres Limited \& Biofeedback Institute of Toronto

Exclusion criteria:

1. Individuals who wear a hearing-device
2. Individuals with a history of heart disease
3. Individuals who are currently being treated for seizure disorder
4. Individuals who are non-verbal
The Analgesic Effect of QLB II After Robotic Prostatectomy. (QLB II: Quadratus Lomborum Block II Type)

The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.

Quadratus Lomborum Block II type will be performed before performing robotic-assisted laparoscopic radical prostatectomy.

The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.

The pain assessment will be evaluated during the first 24 hours from surgery. The opioids requirement and side effects will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist status I-III
* Written informed consent

Exclusion Criteria:

* Body mass Index \> 35 kg/m2
* Allergies to local anesthetics
* primaries or secondaries coagulopathies
* addiction to drugs
* severe kidney and liver diseases
* cognitive impairment
Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis

OBJECTIVES: I. Compare the pharmacokinetics and early bactericidal activity of paromomycin (aminosidine) vs streptomycin for the treatment of uncomplicated pulmonary tuberculosis.

II. Compare the tolerability of these two drugs in these patients. III. Establish the relationships between achieved serum concentration, minimal inhibitory concentration, and early bactericidal activity of paromomycin and streptomycin.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms. Patients in arms I and II receive one of two doses of paromomycin intramuscularly once a day for 3 days. Patients in arm III receive streptomycin intramuscularly once a day for 3 days. All patients then begin a course of standard therapy for tuberculosis.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Microbiologically proven uncomplicated pulmonary tuberculosis Positive direct sputum smear for acid-fast bacilli OR Presumptive diagnosis based on clinical and radiological findings
* No known risk factors for multidrug resistant tuberculosis (MDR TB) including: Domicile, shelter, or prison exposure to MDR TB within 6 months Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB Hospitalization, within 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred
* No clinical evidence of CNS or miliary tuberculosis
* HIV seronegative

--Prior/Concurrent Therapy--

* Biologic therapy: At least 12 weeks since immune modulators (including colony-stimulating factors, interferons, or interleukins)
* Chemotherapy: No concurrent chemotherapy
* Endocrine therapy: At least 12 weeks since corticosteroids
* Other: At least 2 years since treatment or prophylaxis for tuberculosis At least 12 weeks since treatment with any drug with activity against tuberculosis, including: All standard drugs used for tuberculosis Clofazimine Rifabutin Quinolones Aminoglycosides At least 12 weeks since pentoxifylline

--Patient Characteristics--

* Hematopoietic: Absolute neutrophil count at least 1,000/mm3
* Renal: Creatinine clearance greater than 60 mL/min
* Pulmonary: No chronic obstructive pulmonary disease
* Other: Not pregnant Fertile patients must use effective contraception No history of intolerance or known hypersensitivity to aminoglycosides No known or suspected Mycobacterium avium complex infection No other serious, acute infection No diabetes No major organ dysfunction No malignancy requiring chemotherapy
Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study

A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Ages of 18 to 75, male or female;
* Main renal artery, with or without accessary renal arteries, with length

  * 20mm;
* Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and

  * 180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring;
* Agrees to take part in the trial and signs the written, informed consent.

Exclusion Criteria:

* Renal artery abnormalities that are inappropriate for the procedure;
* Pregnant or plan to become pregnant;
* History of orthostatic hypotension;
* Type I diabetes;
* Estimated GFR\<40mL/min/1.73m2;
* Only one kidney or prior kidney transplantation;
* Bleeding tendency or other coagulation related diseases;
* Acute or severe systemic infection;
* Prior renal artery interventional procedures or prior RDN treatment;
* History of stroke or TIA;
* Malignant tumor or end-stage illnesses;
* Secondary hypertension;
* Acute coronary events within 2 weeks;
* Other conditions that deem unsuitable for the procedure, in the opinions of investigators.
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Eligibility Criteria:
Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
* Subjects chronically infected with HCV genotype 4 (Phase 2b only)
* HCV RNA viral load of ≥ 10\*5\* IU/mL at screening
* BMI of 18 - 35 kg/m² at screening

Exclusion Criteria:

* Cirrhosis (Phase 2a only)
* Decompensated cirrhosis (Phase 2b)
* Co-infection with HBV or HIV
* Hepatocellular carcinoma
* Prior treatment with anti-HCV drugs
Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer

RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer.

PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer.

OBJECTIVES: I. Determine the effects of vitamin E and pentoxifylline on lymphedema in patients previously treated with radiotherapy for breast cancer. II. Compare the normal tissue injury and quality of life in patients treated with this regimen vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vitamin E and oral pentoxifylline twice daily for 6 months. Arm II: Patients receive oral placebo twice daily for 6 months. Quality of life is assessed at baseline and at 3, 6, 9, and 12 months. Patients are followed at 6 and 12 months.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Prior diagnosis of breast cancer T1-3, N0-1, M0 Prior radiotherapy to breast/chest wall plus axilla and/or supraclavicular fossa At least 2 years since prior radiotherapy No disease recurrence Arm lymphedema due to prior radiotherapy Reduced shoulder movement, induration in breast/chest wall, radiation-induced brachial plexopathy, symptomatic lung fibrosis, or non-healing wounds (including fractures) allowed as evidence of disability in addition to arm lymphedema Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Not specified Sex: Female or male Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No liver failure Renal: No renal failure Cardiovascular: No ischemic heart disease No hypertension No hypotension No acute myocardial infarction No prior cerebral hemorrhage No prior retinal hemorrhage Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No allergy to coconut oil

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent insulin Radiotherapy: See Disease Characteristics Surgery: No prior axillary surgery Lower axillary sampling allowed Other: At least 3 months since prior daily vitamin E supplementation of more than 30 mg/day No prior pentoxifylline after radiotherapy No concurrent ketorolac or vitamin K No other concurrent vitamin E supplementation
Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease

This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease

Thirty both gender patients with gastroesophageal reflux disease enrolled in this study , study group And control group. To investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease

Eligibility Criteria:
Inclusion Criteria:

* patients with gastroesophageal reflux disease.
* the age will be ranged from 20 to 50 .
* body mass index from 20 to 34,9 kg/m2 .
* low level of physical therapy

Exclusion Criteria:

* Pregnancy
* open wound
* abdominal or spinal surgery
* Congenital or acquired disorder
Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension

The purpose of this study is to examine the effects of 12-week yoga training on blood pressure, heart rate, heart rate variability, arterial stiffness, and total peripheral resistance during rest and psychological stress in patients with hypertension. All eligible participants will be randomly assigned to either yoga (n=40) or usual care control (n=40) group. During the 1st lab visit, the experimenter will explain the purpose and procedures of the study. If the participants understand and agree to participate in this study, they will be asked to sign the informed consent. Next, participants will fill out questionnaires, including demographic information, Physical Activity Readiness Questionnaire, perceived stress scale, anxiety inventory, exercise behavior questionnaire, and quality of life scale. Participant's resting blood pressure will be measured. Participants will then be instructed to relax in a supine position for 15 minutes while ECG is recording. Next, participants will perform 5 minutes of stroop task and 5 minutes of mental arithmetic task (mental stressors). ECG and cardiac output will be monitored throughout the whole session. After the stress period, participants will be asked to relax until heart rate becomes stable and return to baseline. The participants will perform the sit-and-reach test. After completing all the baseline testing, the yoga group will begin the training program which is 60 minutes per session, 2 times per week for 12 weeks. The control group will be asked not to participate in any exercise program during the course of the study. Participants will be filling out the same questionnaires and receive measures of blood pressure, ECG, and cardiac output at week 6 and week 12. Additionally, participants will perform the stress tasks and the sit-and-reach test again at week 12.


Eligibility Criteria:
Inclusion Criteria:

* 20-65 years of age
* 18.5 \<=BMI\<=29.9
* have hypertension (clinical diagnosis)
* resting systolic blood pressure 120-160 mmHg, resting diastolic blood pressure lower than 110 mmHg

Exclusion Criteria:

* regular exercise behaviors or current participation in yoga programs
* have cardiovascular diseases, pulmonary diseases, diabetes
* have musculoskeletal problems that may affect yoga pose practice (e.g., herniated intervertebral disc, spondylolithesis, ankylosing spondylitis)
* current pregnancy or breastfeeding
* change of hypertension medication use within 4 weeks
A Prospective Study of Two Daily Disposable Contact Lenses

The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Three study visits occurred over the course of 28 ± 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
* Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
* Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
* Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
* Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
* Willing and able to follow instructions and maintain the appointment schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
* Requires monovision or presbyopic correction.
* Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
* Clinically significant lash or lid abnormality.
* Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
* History of ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotics use within 7 days of enrollment.
* Other protocol-defined exclusion criteria may apply.
Combined Nutrient Intake and Muscle Protein Synthesis

Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in elderly when compared with young subjects.


Eligibility Criteria:
Inclusion Criteria:

* males
* 70-85 years or 18-30 years
* BMI \< 30

Exclusion Criteria:

* Type II diabetes
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs
* Use of anticoagulants
* Patients suffering from Phenylketonuria
* Participation in any regular exercise programme
Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia

The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory, anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol from peripheral tissues for secretion via the liver.

The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory response following removal of unstable atherosclerotic plaques in the carotid artery. Such plaques can cause strokes and there is great benefit from early surgical removal, however such surgical procedures involve significant risks to the patient.

The investigators propose infusing HDL into patients prior to removal of their unstable carotid plaque and measuring the changes in inflammatory responses in comparison to a similar placebo controlled group of patients.

Following written informed consent, patients will be randomised to either the placebo or active arm of the study. Bloods will be taken for baseline measurements, and the infusion of either saline (placebo) or rHDL (active agent) will be carried out on the ward. Infusion will take 4 hours, and the active agent infused at 40mg/kg.

Just prior to CAE, bloods will be collected (24 hours post-infusion) and the atherosclerotic tissue collected into RNA stabilising agent for subsequent analysis. Further bloods will then be collected 24 hours post-operatively (48 hours post-infusion).

Patients vital signs will be monitored hourly following infusion and will be reviewed in out-patients at 6 weeks after the operation.

Eligibility Criteria:
Inclusion Criteria:

* patients listed for elective carotid endarterectomy

Exclusion Criteria:

* pregnant women and women of childbearing age
* patient with impaired renal function or liver function
* patients sectioned under the Mental Health Act
Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant

The objectives of this registry are to measure the outcomes, cost, adherence pattern and experience of patients treated as outpatients with rivaroxaban after being diagnosed with blood clots in the emergency department. The investigators hypothesize that patients will have a relatively low rate of adverse events and higher adherence than has been reported historically for warfarin treatment. Patients will be scheduled for follow up care with one of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital, Eskenazi Health Services and the Baylor University Medical Center (Dallas, TX) after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT).

Information will be obtained from the patient medical records, past medical history, physical examination at initial outpatient clinic visit 30 days (+/- 14 days) and 6 months or 180 days (+/- 14 days) post diagnosis or start of treatment, then annual follow ups for up to 5 years. The data will be collected and stored in a database, the IU RedCap database system will be used to develop a database and store information .

Eligibility Criteria:
Inclusion:

* DVT or PE diagnosed on imaging:
* Systolic always\>100 mm Hg in absence of history of low blood pressure
* No contraindication to anticoagulation treatment (active bleeding or high risk postoperative status, creatinine clearance \< 30 ml/min, history of heparin induced thrombocytopenia or warfarin skin necrosis);
* No other medical condition requiring hospital treatment (sepsis, new or decompensated existing organ failure, intractable pain);
* No social condition requiring hospital treatment (homelessness with history of non-adherence to treatment, suspected neglect or abuse, incarceration, untreated psychosis, severe alcohol or drug dependency);
* No coagulopathy or current anticoagulant resulting in an INR\>1.7, or thrombocytopenia (platelet count \< 50,000/uL);
* No need for supplemental oxygen (no respiratory distress and pulse ox always \>94%)

Exclusion:

- If active cancer, POMPE-C \<6%