cyrilzakka/clinical-trials huggingface dataset:
Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

This study will examine the feasibility and acceptability of a twice weekly yoga program for adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will also be examined.

The purpose of the current proposal is to test a yoga intervention for adults with T2DM and to gather data on the feasibility and acceptability of yoga compared to a contact control for glycemic control. The investigators will conduct a pilot randomized controlled study with participants randomly assigned to 1) Yoga intervention, or 2) A standard exercise (SE) group program (comparison-control). Focus groups will be conducted with participants at the end of the intervention to identify facilitators and barriers to yoga practice and to examine their perceptions and beliefs about yoga and its relationship to stress and diabetes management. The investigators will explore the effect of yoga on stress (biomarker = salivary cortisol) that may act as a mechanism of action underlying the efficacy of yoga for improved glycemic control. The investigators will also measure HbA1c levels, fasting and postprandial plasma glucose at baseline, end of treatment (12-weeks), 6- and 9-month follow-ups. Study feasibility and acceptability will be assessed using participant recruitment, attendance and retention rates, and compliance with study protocols and satisfaction with the program. Participants will also attend a focus-group discussion of the program at the end of treatment. Results from this study will provide scientific basis for a future larger clinical trial. Yoga, if found to offer advantages for glycemic control, can have potential for high impact on current practices of diabetes management.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for more than 6 months
* HbA1c \> 6.5
* Body Mass Index \< 42

Exclusion Criteria:

* Serious co-morbid condition (e.g. uncontrolled hypertension, glaucoma, heart failure)
* Complications of diabetes (e.g. diabetic retinopathy, neuropathy, nephropathy)
* Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence)
* Body Mass Index of 42 or greater
* Pregnancy or planned pregnancy
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer

The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerRecurrent or persistent elevated CA-125.
* For the purpose of this study, elevated CA-125 is defined as a value of â‰¥40 U/ml on two separate consecutive determinations made â‰¥1 week apart.
* CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into account.
* No definitive disease or clinical and findings of small volume disease (\&#163;1cm by spiral CT or \&#163;2cm by conventional CT or clinical exam).

Exclusion Criteria:

* No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide.
* No prior consolidation therapy with cytotoxic agents for ovarian cancer.
* Continuation of hormone replacement therapy is permitted.
* No requirement for concomitant anticoagulant therapy.
* Administration of low dose anticoagulants for maintenance of central venous access is permitted.No chronic oral or intravenous steroid use.
A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia

A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19
* Patients who understood the contents and purpose of this trial and signed informed consent form
* Patients with essential hypertension and dyslipidemia

Exclusion Criteria:

* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
* Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
* Concomitant administration of cyclosporine
* Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
* Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
* Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
* CPK normal range \> 2 times
* Secondary hypertension and suspected secondary hypertension
* Orthostatic hypotension with symptoms
* Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
* Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
* Active gout or hyperuricemia(uric acid ≥ 9mg/dL)
* IDDM or uncontrolled type 2 diabetes mellitus (HbA1c \> 9%)
* Ventricular arrhythmia
* Medical history

  * Severe heart disease(heart failure of NYHA class III-IV)
  * Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)
  * Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve
  * Ischemic heart disease(myocardial infarction, angina) within 6months
  * Angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.

The use of urinary catheters is a common medical practice in the perioperative setting.

As such, it exposes the patient to certain comorbidities, including urinary tract infections.

The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.

Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.


Eligibility Criteria:
Inclusion Criteria:

* Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.

Exclusion Criteria:

1. Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.
2. patients with a urinary tract infection in the past year.
3. Patients with a urinary tract infection when inserting a catheter.
4. pregnant women.
5. Patients under the age of 18.
6. without judgment.
European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a diagnosis of COPD
* FEV1\<50% and FEV1/FVC\<0.7 according to lung function data in medical records.
* Smoker or ex-smoker \> 10 pack-years
* Informed consent obtained

Exclusion Criteria:

* Ongoing exacerbation of COPD or within the previous 3 months
* Any other significant respiratory disease (including asthma and allergic rhinitis)
A Study in Adult Patients With Major Depressive Disorder

The purpose of this study is to assess whether LY2216684 is superior to placebo in the treatment of adult patients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-65 years
* Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (DSM-IV-TR) criteria without psychotic features
* Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
* Grid 17-item Hamilton Rating Scale for Depression (GRID-HAMD17) total score ≥18 at Visit 1 and Visit 2
* Clinical global impressions of severity (CGI-S) score ≥4 at Visit 1 and Visit 2

Exclusion Criteria:

* Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
* Have previously completed or withdrawn from this study or any other study investigating LY2216684
* Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
* Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of Visit 1
* Have an Axis II disorder that would interfere with protocol compliance
* Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia, or other psychotic disorder
* Have a history of substance abuse within the past 1 year
* Women who are pregnant or breast-feeding
* Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgment of the investigator, considered to have treatment-resistant depression
* Participants who are judged to be at serious suicidal risk
* Have a serious or unstable medical illness
* Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
* Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1
* Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
* Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year
* Have a history of any seizure disorder (other than febrile seizures)
* Require psychotropic medication other than sedative/hypnotic medication for sleep
* Have a thyroid stimulating hormone (TSH) level outside the established reference range.
* Are taking or have received treatment with any excluded medication within 7 days prior to Visit 2
* Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
* A positive urine drug screen for any substance of abuse at Visit 1
* Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment
PrEP Among MSM and TG in Myanmar

HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* No suspicion of acute HIV infection
* Substantial risk of HIV infection
* Creatinine clearance is more than 30 ml/min
* Willingness to use PrEP as prescribed, including periodic HIV testing
* Willingness to sign informed consent

Exclusion Criteria:

• Anyone who is not eligible with the inclusion criteria
Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART)

This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles.

Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies showing whether splitting the medication dose improves ART parameters. This study was undertaken to provide an answer to this important question.

Eligibility Criteria:
Inclusion Criteria:

* women \< 40 undergoing ART

Exclusion Criteria:

* women \> 40
* endometriomas
* severe cervical stenosis
* testicular sperm
Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Nasal Intubation

The purpose of this study is to determine whether nasal intubation assisted by GlideScope videolaryngoscopy is faster, easier, and less traumatic than nasal intubation with conventional direct laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* any patient who is at least 18 years old
* patient requires nasal intubation for surgical indications
* operator has performed at least 10 prior GlideScope intubations (oral or nasal)

Exclusion Criteria:

* cervical spine abnormalities
* known difficult airway
* requires rapid sequence induction
* any other patient in whom the attending anesthesiologist believes usage of the GlideScope is contraindicated
A Phase 2 in Adult Subjects With Hereditary Angioedema

A Phase 2 in Adult Subjects with Hereditary Angioedema

A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema

Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements.
* Males or females 18 to 70 years of age at the time of informed consent.
* Documented diagnosis of HAE-1/HAE-2.
* At least 2 HAE attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition
* Access to and ability to use ≥ 1 acute medication(s)
* Female subjects must be non-pregnant;non-lactating, and either surgically sterile
* Male subjects with WOCBP partners, dual contraception is required if no surgically sterile

Exclusion Criteria:

* Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
* Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
* History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
* Have undergone major surgery within 3 months prior to screening.
* History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk
* History of allergic reaction to an oligonucleotide or N-acetylgalactosamine
* Prior treatment with any oligonucleotides within 6 months if single dose or 12 months if multiple doses prior to screening.
* Exposure to another investigational drug or biological agent within 30 days or within at least 5 half-lives prior to screening.
* With ANY of the abnormalities in clinical laboratory tests at screening and run-in period
* Clinically significant findings on 12-lead electrocardiogram that would place the patient at risk or interfere with participation in the study at screening.
* Positive for Human immunodeficiency virus (HIV), HBsAg, Hepatitis C or syphilis infection
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to dosing.
Precise Measurement of Pediatric Defibrillation Thresholds

Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing at the end of the ICD procedure to measure the amount of energy able to successfully defibrillate the heart (defibrillation threshold testing, or DFT). This study proposes to perform that measurement in pediatric patients already undergoing clinically necessary ICD procedures, with the measurement performed using a binary search method that has been previously validated in adult cohorts. We hypothesize that pediatric DFTs, when precisely measured, may be lower than previously assumed from extrapolation of adult data.


Eligibility Criteria:
Inclusion Criteria:

* Current follow-up at Children's Hospital Boston
* Children with current or planned ICDs who are scheduled by their primary electrophysiologist for clinically necessary assessment/re-assessment of defibrillation threshold
* If the patient has an ICD system with a non-transvenous shock coil: weight ≤35kg at time of initial implant, with current weight \<50kg
* If the patient has an ICD system with a conventional transvenous shock coil: current weight ≤60kg

Exclusion Criteria:

* Clinical failure of any system component not able to be addressed by hardware repair or exchange
* Hemodynamic instability that in the judgment of the primary electrophysiologist warrants abbreviation of DFT assessment
* Unsuccessful induction of fibrillation during DFT testing
Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia

The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:

1. Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
2. What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 14 years.
* American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
* Scheduled or urgent surgery or radiological exploration under general anesthesia.
* Upper respiratory tract infection (URTI) symptoms present for less than 15 days.

Exclusion Criteria:

* Refusal of participation by parents.
* Children on long-term corticosteroid or bronchodilator therapy.
* Contraindications to the use of lidocaine or other drugs used in the protocol.
* Patients who did not adhere to the study protocol.
A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.

Patients will undergo:

* Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
* Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
* Injection of 99mTc-labeled nanocolloids
* Preoperative lymphoscintigraphy
* Intraoperative search by gamma probe of the sentinel lymph node
* Sentinel lymph node biopsy
* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
* In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
* Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.

Eligibility Criteria:
Inclusion Criteria:

* All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous
* Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, \>1 mitotic figure per high-power field.
* Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.
* Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion
* Patients with squamous cell Ca of the surface with Staging ≥3 and/or multicenter
* Signature of informed consent to participate in the study
* cNo

Exclusion Criteria:

* Age less than 18 years
* Patients with metastatic disease at diagnosis
* All patients who do not fit the inclusion criteria
* Failure to obtain informed consent
Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention

Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days

Eligibility Criteria:
Inclusion Criteria:

* women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin

Exclusion Criteria:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes

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