cyrilzakka/clinical-trials huggingface dataset:
Testosterone, Metformin, or Both, for Hypogonadism in Obese Males

The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction.

Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 50 years.
* BMI \> or = 30 kg/m2.
* Total testosterone levels \<2.3 ng/ml (\<8 nmol/l) or testosterone levels 2.3-3.49 ng/ml (8-12 nmol/l) and free testosterone levels \<70 pg/ml.
* LH levels \<7.7 mIU / ml.
* No evidence of any other pituitary hormone disruption in morning blood sample (normal concentrations of TSH, FT4, Prolactin, ACTH, cortisol and IGF-1
* Being able to provide informed consent before randomization and agree to comply with all the procedures included in the protocol.

Exclusion Criteria:

* Intolerance/allergy to metformin or testosterone undecanoate.
* Previous diagnosis of diabetes mellitus (HbA1c\> 6.5% or fasting glucose\> 126 mg/dl or glucose\> 200 mg/dl after an oral glucose tolerance test)
* Treatment with oral hypoglycemic agents, insulin or GLP-1 analogs.
* Poor kidney function: serum creatinine\> 2.0 mg / dl.
* Previous history of prostate cancer or breast cancer.
* Active cancer of any kind.
* History of liver tumor or acute or chronic liver disease with impaired liver function: total bilirubin\> 2.0 mg / dl or GOT levels three times the upper limit of normal.
* Central hypogonadism of organic cause
* Use in the past 12 months of any drug that affects the pituitary-gonadal axis.
* Use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry.
* Uncontrolled hypertension (SBP\> 160 mmHg or DBP\> 100 mmHg) despite adequate antihypertensive therapy.
* HIV infection or known active infection with HBV or HCV.
* Thrombotic or embolic disease.
* Heart disease, kidney or liver disease.
* Epilepsy or migraine not adequately controlled with treatment.
* Hematocrit\> 50% in the screening.
* PSA\> 4 ng / ml.
* Severe benign prostatic hypertrophy with an IPSS scale score over 19.
* Evidence of drug or alcohol abuse (\> 50 g alcohol / day)
* Hematological diseases that produce increased risk of bleeding after intramuscular injection.
* Serious underlying disease that might affect the patient's ability to participate in the study (eg ongoing infection, gastric ulcers, active autoimmune disease).
* Reduced life expectancy (\<12 months) by the presence of comorbidities or advanced terminals.
* Participation in another clinical trial within 30 days before study entry.
* Previous diagnosis of hemochromatosis
* Treatment with phosphodiesterase-5 inhibitors: sildenafil, tadalafil or vardenafil
Effect of Glutamine on Intestinal Permeability in Crohn's Disease

The purpose of this study is to see whether enteral glutamine supplementation improves intestinal permeability and small intestinal morphology in patients with Crohn's disease.

Glutamine is the most abundant amino acid in the body constituting 50% to 60% of total free amino acid pool in muscle and 20% in plasma. Recently it has been reclassified as a conditionally essential amino acid due to body's inability to synthesize sufficient amount under stressful conditions like trauma and sepsis. It is an essential fuel for fibroblasts, lymphocytes and enterocytes. It plays an important role in nitrogen balance and an integral role in glucose regulation and also in acid base homeostasis. It is an essential ingredient for glutathione, an important antioxidant. During the last decade a number of experimental and clinical studies, by using enteral and parenteral glutamine supplements, have shown its beneficial role in conditions like sepsis and infection, elective surgery and accidental injury, catabolic state, fetal and critically ill low birth weight neonates and cancer. A few experimental and clinical studies have also shown its positive role in inflammatory bowel disease, which is attributed to the effect of glutamine on intestinal permeability, growth of enterocytes, enhancement of gut immunity and glutathione synthesis. So far there is hardly any well-planned randomized trial of enteral glutamine supplements in Crohn's disease. Hence this study is planned to evaluate effect of enteral glutamine supplements on structure and function of intestine in patients with Crohn's disease.

Diagnosed cases of Crohn's Disease attending Gastroenterology OPD or admitted in ward at AIIMS will be randomized into two groups, glutamine and whey protein group. The parameters for intestinal function and structure tested will be, permeability, villous height, plasma glutamine and D-xylose absorption at the base line and at the end of the intervention. As per the available data improvement is expected in both structure and function of the intestine, which will be an important contribution in the management of this chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* All the consecutive patients with Crohn's disease in the remission phase with an abnormal intestinal permeability (IP)

Exclusion Criteria:

* Patients in the active phase of the disease i.e. CDAI score \>150
* Patients with a normal intestinal permeability i.e. LMR \< 0.0373
* Patients already taking a high protein nutritional supplement
* Patients with other associated systemic diseases like chronic liver disease, chronic kidney disease, diabetes mellitus, malignancy
* Patients with a special physiologic condition i.e., pregnancy or lactation.
* Patients lesser than 15 years (pediatric group) and more than 60 years of age (elderly patients)
Self- and Family-management Intervention in HIV+ Chinese Women

This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes.

The study will be conducted in 3 phases.

Phase 1: The PI conducted a secondary qualitative analysis of in-depth interviews to further illuminate the sociocultural and family context of HIV+ Chinese women. The data were obtained from three previous projects conducted in China from 2005 to 2011.

Phase 2: The PI developed and adapted a theory-driven, culturally sensitive and feasible intervention to improve the quality of life and clinical outcomes of HIV+ Chinese women and their families.

Phase 3: The PI conducted a feasibility, compliance, and acceptability study for a self- and family-management intervention with HIV+ women and of their family members.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for HIV+ women.

* be at least 18 years of age,
* be able to give informed consent for the study and to cognitively participate,
* be receiving clinical care at Ditan Hospital and SPHCC,
* have been diagnosed with HIV within the past 12 months,
* have disclosed their status to at least one family member and willing to invite that family member to the intervention,
* be well enough to attend counseling sessions at the hospital, and
* be able to attend follow-up visits at the hospital.

Inclusion criteria for family members.

* be 18 years of age,
* be able to give informed consent for the study and to cognitively participate,
* have a female family member who is HIV+, and is currently receiving clinical care at Ditan Hospital and SPHCC,
* be a family member who are taking care of the female HIV+ family member,
* be well enough to attend counseling sessions at the hospital, and
* be able to attend follow-up visits at the hospital.

Exclusion Criteria:

Exclusion criteria for HIV+ women

* history of an affective illness such as depression or bipolar disease,
* are under age 18, or
* are unwilling or unable to bring a family member to participate in the study.

Exclusion criteria for family members.

* have a history of an affective illness such as depression or bipolar disease,
* are under age 18,
* or are unwilling or unable to come with their HIV+ family member to participate the study.
Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy

The association of nutritional supplement TK3 to conventional treatment of cancer patients reduces the intensity and frequency of toxic effects and side effects caused by adjuvant or palliative treatments for the protection of healthy tissues, resulting in a better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient Consent: Informed Consent and informed consent signed and dated by the patient (or his legal representative) and the professional who has obtained the consent. Must be delivered before inclusion. This term must be read and explained to the patient.
* Patients female or male, regardless of race or color.Able to ingest oral medication.
* Patients 30-80 years, with malignancy, clinical stage III or IV on chemo or hormone therapy.
* Patients who have a Karnofsky level between 60 and 80.

Exclusion Criteria:

* no agreement to sign the Deed of Consent.
* Need for use of parenteral nutrition.
* The need for food supplement already approved.
* Inability to receive the drug orally.
* Participation in another clinical trial involving chemotherapy drugs.
* Women being sexually active, which does not agree to adhere to the contraceptive methods adopted.
* Women lactating
* Any problem or condition that the investigator in the trial could be harmful to the patient.
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.


Eligibility Criteria:
Inclusion Criteria:

* AHI \> 30
* Intolerance to CPAP therapy
* Signed informed consent

Exclusion Criteria:

* Epworth sleepiness scale \> 16/24
* Severe cardiac and/or respiratory disease
* BMI\>32 kg/m2
* Dental contraindication to oral appliance
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors

To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.


Eligibility Criteria:
Inclusion Criteria:

* Healthy African American men and women.
* 18-55 years of age.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
* Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
* Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
* Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \>1.5 X upper limit of normal.
* Positive pregnancy test in women of childbearing potential.
Diet, Insulin Resistance, and Cardiovascular Risk

To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in conjunction with insulin resistance.

BACKGROUND:

Clinical studies indicate that high carbohydrate intake may exacerbate the dyslipidemia often seen with insulin resistance. Consequently, there is much debate as to the optimal dietary pattern for individuals with NIDDM to minimize risk for microvascular disease. Data on this topic from free-living populations are scarce. In addition, associations of dietary antioxidants with CVD risk have not been evaluated in large community samples of persons with diabetes.

DESIGN NARRATIVE:

Potential dietary determinants of hyperinsulinemia or of insulin resistance were evaluated, including high intake of dietary fats and of simple sugars and low alcohol consumption. As a major focus, dietary factors that may contribute to elevated CVD risk among persons with existing insulin resistance, including impaired glucose tolerance (IGT) and non-insulin-dependent diabetes mellitus (NIDDM) were examined. Five datasets from epidemiologic studies were available to evaluate specific hypotheses for men and women of Black, Hispanic and non-Hispanic white ethnicity. The unique contributions of each dataset were as follows. The San Luis Valley Diabetes Study and the San Antonio Heart Study enabled prospective analyses for large numbers of subjects with IGT or NIDDM; the Mexico City Study provided a sample with contrasting dietary patterns in a non-white population; the Kaiser Permanente Women Twins Study allowed for the removal of genetic influences by evaluating associations within monozygotic twin pairs; and the Insulin Resistance Atherosclerosis Study (IRAS) provided direct measurement of insulin sensitivity and subclinical atherosclerosis across the spectrum of glucose tolerance in three ethnic groups.

An understanding of the accuracy of the dietary assessment instruments used in the three ethnic groups was critical to the interpretation of the findings related to diet and CVD risk variables. Therefore, a second component of research was also conducted, that being an evaluation of the comparative validity of the food frequency interview used in the multi- cultural IRAS population using a series of 24-hour dietary recalls as the standard.

Eligibility Criteria:
No eligibility criteria
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)

PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

10-12 centers in Europe will enroll up to 56 subjects who meet the inclusion/exclusion criteria and provide consent to participate in the study. Subjects will undergo an ablation for paroxysmal AF with the Medtronic PVAC GOLD (CE-Mark). To assess for ACE lesions, pre- and post-ablation procedure cerebral MRIs will be done along with a neurological exam (Mini Mental State Exam). Subjects will be followed for 1 month post-procedure when a repeat MRI and neurological exam will be conducted if the subject had a positive MRI at pre-hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic AF (\>/=2 recurrent AF episodes that self terminate or AF \</=48 hours that are cardioverted)
* Documentation of \>/=1 paroxysmal AF events within past year
* AF symptoms (e.g. palpitations, fatigue, exertional dyspnea, effort intolerance)
* Prescribed to vitamin K antagonist (e.g. warfarin/coumadin)
* Age 18-70 years old
* Clinically indicated for a pulmonary vein ablation
* Willing and able to give informed consent
* Willing, able and committed to participate in all study required activities for the duration of the study

Exclusion Criteria:

* Diagnosis of persistent or permanent AF
* Prior left atrial ablation
* Presence of intracardiac thrombus
* Contraindicated for vitamin K antagonist
* Prescribed to direct thrombin or factor inhibitors (e.g. dabigatran, rivaroxaban)
* Prescribed to any investigational drug that may confound the study results
* Cardiac valve prosthesis
* Significant congenital heart defect (corrected or not)
* Pulmonary vein stents
* Pre-existing pulmonary vein stenosis
* Cerebral ischemic event (e.g. stroke, TIA) that occurred within 6 months of study consent date
* If female - pregnancy
* Participation in any other cardiovascular clinical study
* Contraindicated for MRI
* Active sepsis
* Blood clotting abnormalities (genetic)
* Presence of left atrial myxoma
* Venous filtering device (e.g. Greenfield filter)
* Invasive cardiac procedure in past 90 days
Predictive Efficacy of Ratio of Median Frequency to Spectral Edge Frequency Used in the Depth of Anaesthesia Monitoring on Post-operative Cognitive Functions

The primary objective of this observational study is to evaluate the effectiveness of preoperative anaesthesia depth monitoring parameters in predicting postoperative cognitive functions in non-cardiac adult patients.

Participants will preoperatively perform cognitive tests such as the Nursing Delirium Screening Scale(Nu-DESC) and 4 'A's Test(4AT) to assess baseline cognitive performance. The same tests will be repeated twice daily until the postoperative 3rd day or discharge.

The primary objective of this observational study is to evaluate the effectiveness of preoperative anaesthesia depth monitoring parameters such as Bispectral Index(BIS), Spectral edge frequency(SEF) and Median frequency(MF) in predicting postoperative cognitive functions in non-cardiac adult patients.

Participants will preoperatively perform cognitive tests such as the Nursing Delirium Screening Scale(Nu-DESC) and 4 'A's Test(4AT) to assess baseline cognitive performance. Intraoperative haemodynamic and BIS parameters will be collected via manual data entry into printed forms. Also, a two-channel electroencephalogram(EEG) and BIS parameters(BIS Number, SEF, MF) will be collected digitally.

The cognitive tests will be repeated twice daily until the postoperative 3rd day or discharge.

Parameters such as mean intraoperative MF value and the ratio of MF over SEF will be compared against postoperative cognitive test scores.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (aged over 18 years), Patients undergoing elective surgeries, Patients consenting to participate in the study.

Exclusion Criteria:

Pediatric patients (aged under 18 years), Patients undergoing emergency surgeries, Patients requiring or anticipated to require postoperative intensive care for more than one day, Patients undergoing cardiac surgeries, Patients undergoing intracranial surgeries, Patients are undergoing endoscopic sinus or brain surgeries, Patients with pacemakers or implantable cardioverter-defibrillators (ICDs), Patients diagnosed with dementia (including Alzheimer's disease, Lewy body dementia, etc.), Patients with chronic opioid or benzodiazepine use, Patients with contraindications to Propofol, Remifentanil, or Fentanyl, Pregnant or breastfeeding women, Patients are not willing to participate in the study.
taVNS or TMS or Both for Depression

The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode
* Able to provide informed consent
* English speaking and can read and write
* 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20
* Not responding to talking therapy.

Exclusion Criteria:

* Preexisting neurological disorders, or dementia
* History of major head trauma
* Life expectancy \<1 year
* Any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation
* A score of \>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality
* Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded
* Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.
On-Demand Oxygen Delivery System Study

The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study.

The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I-III

Exclusion Criteria:

* Procedures scheduled for a lime less than 20 minutes
* Age \< 18 years
* Baseline SpO2 (arterial oxygen saturation as measured by pulse oximetry) \< 93% on room air
* ARDS (Acute respiratory distress syndrome), lung disease, cardiovascular disease
* ASA class IV or above
* Pregnant women.
The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.

This is a multicentric, prospective, randomized, double-blind, pragmatic, placebo-control study. Patients who are going to receive elective pancreaticoduodenectomy will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation, which will be compared between these two groups .

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥18 years of age;
2. An indication for elective PD surgery;
3. Patients understand the nature of this trial and are willing to comply;
4. Patients are able to provide written informed consent;

Exclusion Criteria:

1. Current or recent (within preceding 1 month) systemic use of glucocorticoids;
2. Distant metastases including peritoneal carcinomatosis, liver metastases, distant lymph node metastases, and involvement of other organs;
3. Patients may undergo left, central, or total pancreatectomy other than PD;
4. Palliative surgery；
5. Patients with high operative risk, as defined by the American Society of Anesthesiologists (ASA), with a score ≥ 4;
6. Synchronous malignancy in other organs or second cancer requiring resection during the same procedure;
7. Pregnant and lactating women.