cyrilzakka/clinical-trials huggingface dataset:
Hormonal Contributors to COVID-19 Infection (COV-ENDO)

The goal of this observational study is to measure the changes in the parameters of endocrine function and tissue sensitivity to hormones induced by SARs-CoV-2 infection.

The main questions it aims to answer are:

* Does SARs-CoV-2 infection causes endocrine dysfunctions?
* Does the treatment of the underlying endocrine dysfunctions, improves the clinical outcome or the occurrence of late onset complications of SARs-CoV-2 infection?
* Are patients with previously known endocrine diseases more fragile in case of SARs-CoV-2 infection? Participants will undergo blood testing and a physical examination at admission, during hospitalization at discharge and 3 and 6 moths after discharge They results will be compared to those of patients admitted for other reasons in order to assess whether the prevalence of endocrine dysfunctions is increased compared with controls.

The objectives of the study are the following:

Primary objectives:

1. to measure endocrine function tests in patients affected by COVID-19, in order to evaluate whether SARs-CoV-2 causes endocrine alterations and whether endocrine diseases/dysfunctions correlate with the severity of SARs-CoV-2 infection and mortality.
2. to evaluate whether genetic variants in the sex-steroid or vitamin D (VDR) nuclear receptors or ACE are more prevalent in patients with SARs-CoV-2 infection than controls.
3. to evaluate whether vitamin D supplementation in subjects with vitamin D deficiency may influence the outcome of SARs-CoV-2 infection
4. To correlate the influence of overweight/obesity/neck circumference with the evolution of SARs-CoV-2 infection

Secondary objectives:

Correlate the endocrine function tests with patients' age, disease's outcome, markers of inflammation.

The identification of endocrine conditions associated with a worse outcome of SARs-CoV-2 infection, would identify significant risk factors to be reduced/prevented in these patients. For example, if endocrine patients will result more fragile in case of infection, we could systematically screen some parameters and early treat associated defects in order improve the outcome of SARs-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* Nasal swab positive for Sars-CoV-2
* Moderate to severe respiratory dysfunction due to COVID-19, requiring hospitalization.

Exclusion Criteria:

* History of thyroid diseases before admission
* History of adrenal diseases
* History of hypogonadism (primary/secondary)
* History of pituitary diseases
WalkLink: Internet-based Walking Program

The investigators propose a randomized controlled trial based on the Social Networks for Activity (SNAP) Model to evaluate: (1) the effectiveness of an internet-based fitness walking program delivered to patients with risk factors for cardiovascular disease and stroke; and (2) the contribution of social support networks to enhancing the effectiveness of the internet-based fitness walking program. The investigators will recruit 308 patients who are sedentary and have risk factors for cardiovascular disease and randomly assign them to one of the following groups: 1. Internet-based fitness walking program (WalkLink); 2. Internet-based fitness walking program plus additional social network intervention (WalkLink+); and 3. Minimal treatment control.

The primary specific aims of this study are to:

1. Evaluate the effects of WalkLink and WalkLink+ relative to a minimal treatment control group on change in: physical activity, aerobic fitness, blood pressure, body composition, and body mass index (BMI), from baseline to posttest, and at 6-month follow-up.
2. Compare the differential effectiveness of WalkLink+ to WalkLink on change in: physical activity, aerobic fitness, blood pressure, body composition and BMI from baseline to posttest, and at 6-month follow-up.
3. Evaluate the mediator and moderator effects of selected individual-level self-management skills (goal setting, planning, self-monitoring), social support variables (number of activity partners, social cues for walking, social praise/reinforcement), and physical-ecological variables (neighborhood walkability, physical cues for walking) on WalkLink and WalkLink+ treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary, defined as less than 150 minutes per week of moderate intensity activity
* Between the ages of 35 and 64
* Able to speak English
* Able to provide informed consent
* Able to participate in moderate-intensity physical activity (e.g., moderate pace walking)

Exclusion Criteria:

* No access to home or private work computer with Internet access
* Body mass index (BMI) greater than 39.9
* Systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg
* Bone, joint, or foot problems that interfere with walking
* Diabetes, pulmonary, or cardiovascular disease
* Consume 5 or more drinks of alcohol a day
* Currently pregnant
* Not living within the preselected study neighborhoods or plan to move from the local area during the study period
Comparison of Two Formulations of Androxal

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Speaks, reads, and understands English or Spanish and is willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures;
* Male, between the ages of 18-60 years;
* No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
* Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
* Subject is willing to remain in the clinic overnight for the Day 1 and Day 6 visits;
* Must be able to swallow gelatin capsules

Exclusion Criteria:

* Known hypersensitivity to Clomid;
* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
* Subject with a significant organ abnormality or disease as determined by the Investigator;
* Any medical condition that would interfere with the study as determined by the Investigator;
* Slow Cytochrome P4502D6 (CYP2D6) metabolizer
* Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
* An acute illness within 5 days of study medication administration;;
* A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
* History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
* History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of (corrected QT) QTc interval prolongation;
* An employee or family member of an employee of the study site or the Sponsor.
Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients

Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.

Central venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.


Eligibility Criteria:
Inclusion Criteria

* Spontaneous breathing without mechanical assistance
* Central venous catheter (superior vena cava) and monitoring of central venous pressure
* Urinary catheter and monitoring of intra-abdominal pressure

Exclusion Criteria:

* Intolerance to ventilatory manœuvre including Severe basal dyspnea/Symptomatic heart failure (pulmonary edema)
* Contraindication to passive leg raising (intracranial hypertension)
* Passive leg raising unsuitable for measuring hemodynamic response : High grade aortic insufficiency/ Poor echogenicity unsuitable to measure the velocity-time /integral of aortic blood flow/ Pregnancy/Abdominal hypertension with abdominal compartment syndrome/ Lower leg amputation
* Necessity of urgent hemodynamic therapy (within 90 min)
* Modification of hemodynamic therapy during study protocol (vascular filling, increase catecholamine dose
Platelet Count（PC）/Spleen Diameter(SD) Ratio to Predict the Variceal Haemorrhage in HBV Cirrhotic Patients in China

To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.

Esophageal variceal bleeding remains the leading cause of acute mortality in patients with cirrhosis. Using noninvasive parameters for high-risk variceal haemorrhage may reduce the need for endoscopies. The ratio of platelet count/diameter of the spleen (PC/SD ratio) is the principal noninvasive predictor of esophageal varices. This was an analytical cross-sectional study to validate the diagnostic test for HBV hepatic cirrhosis and was performed between January 2013 and August 2015. This study is to validate the PC/SD ratio to identification of those patients with high bleeding risk and selection for prophylactic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of HBV hepatic cirrhosis

Exclusion Criteria:

* Patients with hepatocellular carcinoma,
* use of medications for the primary prophylaxis of variceal bleeding,
* history of esophageal variceal bleeding,
* alcohol consumption within the admission and a history of ligation,
* sclerotherapy, and/or
* portal hypertension surgery
Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Karnofsky score \> 60,
* Expected survival \> 3 months,
* Liver, kidney function and routine blood test within normal range
* No serious cardiopulmonary dysfunction
* No acute infection

Exclusion Criteria:

* Pregnant or lactating women
* Uncontrolled internal diseases
* Past or the presence of other malignancy
* Those who had received immunosuppressive therapy
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery

The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* pregnant woman scheduled for elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* patients who refuse involved
* patients who have pre-eclampsia
* patients who have heart disease
* patients who fetal distress is suspicious
Intrathecal Versus Intravenous Dexmeditomedine in Transurethral Resection of the Prostate

This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate

This study will carried out in Tanta University hospital on75 male patients Patients will randomly classified into 3 groups Group I: will receive intrathecal hyperbaric bupivacaine 10mg in 2.5 ml and .5 ml saline with 3ml total volume Group II: will receive dexmeditomedine 5Mic diluted in.5 ml saline and hyperbaric bupivacaine 10mg in 2.5ml with 3ml total volume Group IIl: Will receive intravenous dexmeditomedine started at loading dose of 1 mic/kg diluted in 50 ml saline and administered within 10 min as loading dose , followed by maintenance at a dose of .4mic/kg/h diluted in200 ml saline till the end of surgery and hyperbaric bupivacaine 10 mg in 2.5 ml total volume

Eligibility Criteria:
Inclusion Criteria:

* male gender
* 50:70years old
* ASA:I,II

Exclusion Criteria:

* contraindications of spinal anesthesia
* Patient refusal
* Patient taking alpha agonist or antagonist
* Uncontrolled cardiac diseases
* Allergy to local anesthetic drugs
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* moderate to severe active rheumatoid arthritis;
* inadequate response to previous or current treatment with 1 anti-TNF agent;
* receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \>=4 weeks.

Exclusion Criteria:

* previous treatment with MabThera;
* use of an anti-TNF alpha agent within 8 weeks of study start;
* concurrent treatment with any DMARD other than methotrexate;
* active infection, or history of serious recurrent or chronic infection.
The NeoBeat Efficacy Study for Newborns

In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth.

Heart rate assessment immediately after birth in newborn infants is the most important clinical indicator to evaluate the status of a newborn, and critical to the correct guidance of resuscitation efforts.

One of the knowledge gaps identified by the International Liason Committee on Resuscitation (ILCOR) is how best to assess ventilation during newborn resuscitation, and improved technology for rapid application of ECG.

Laerdal Medical has developed a novel heart rate meter, NeoBeat, implementing ECG dry-electrodes in a snug-fit abdomen-shaped buckle for for rapid application on the newborn.

In a multicenter randomized controlled trial the investigators will study the efficacy of NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous respiration after birth.

Eligibility Criteria:
Inclusion Criteria:

Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment

Exclusion Criteria:

Congenital malformations that interfere with the intervention, Non-consent
Novel Non-Invasive Monitoring Parameter in a Hospital Setting

Data collected from this study will be used to evaluate the performance of a monitoring algorithm.

The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years old or older
2. Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
3. Subjects on general care floor

Exclusion Criteria:

1. Severe contact allergies to standard adhesive materials
2. Abnormalities that may prevent proper application of the device
3. Women who are pregnant or lactating
4. Subjects with significant arrhythmia
RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

This study offers 5 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
* Age\>50.
* Maximum pathologic tumor size \<2.0cm if invasive carcinoma or \< 2.5cm if pure DCIS.
* Estrogen receptor (ER) positive (\>10%).
* Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
* Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
* Zubrod Performance Status 0-2.

Exclusion Criteria:

* Multifocal or multicentric cancer.
* Reception of neoadjuvant chemotherapy.
* Pure invasive lobular histology.
* Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
* Measured maximum PTV of \>124cc.
* Lumpectomy cavity within 5mm of body contour.
Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men

This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Data will also be compared to those from age group-matched transgender women and cisgender women and men.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years old or 50-75 years old
* Identify as a transgender woman
* Have taken testosterone for at least one year
* Currently taking testosterone parenterally (injections) or transdermally (patches or gels)

Exclusion Criteria:

* Don't identify as a transgender man
* Not currently taking testosterone
* Have been on testosterone for less than one year
* History of hysterectomy/oophorectomy
* Current tobacco smoker
* Current illicit drug use
* History of prior or active estrogen-dependent neoplasms
* Acute liver or gallbladder disease
* Venous thromboembolism
* Hypertriglyceridemia \>500 mg/dL
* Fasted plasma glucose \>7.0 mmol/L or previously treated diabetes
* Resting blood pressure \>140/90 mmHg
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures.
* Patients must be male or female between the age of 12 and 17 years, inclusive.
* Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.

Exclusion Criteria:

* Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®.
* Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth.
* Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
Hot Water Drinking Therapy in Achalasia

From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.

1. Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.
2. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
3. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation

Eligibility Criteria:
Inclusion Criteria:

* achalasia patients diagnosed by endoscopy, barium esophagram and manometry

Exclusion Criteria:

* could not drink water
* poor compliance
* severe comorbidities
* esophageal stenosis secondary to erosions and cancer