cyrilzakka/clinical-trials huggingface dataset:
MRI Imaging of Chronobiologic Abnormalities in Depression

The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.

The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.

Eligibility Criteria:
Inclusion Criteria:

* WEIGHT: less than or at 20% over ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted.
* HEALTH: healthy, ambulatory normal or depressed adults

Exclusion Criteria:

* Presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps.
* Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities.
* Pregnancy.
* Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
* Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
* Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Patients on antidepressants may not be taking any other medication, except at the discretion of the investigator. Untreated depressed or healthy subjects must be free of all medications except as approved by the investigator.
* Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
* Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.
Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.

This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.

Eligibility Criteria:
Inclusion Criteria

* Age: ≥18 years of age
* Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥ 75%.
* Unilateral or asymmetrical subjective tonal tinnitus
* Tinnitus present for at least 6 months, but not longer than 3 years
* Tinnitus that is disruptive

  * THI score in the severe range (≥56/100)
  * TFI score in the severe range (≥52/100)
  * Tinnitus VAS ≥50/100
* Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking

Exclusion Criteria

* Age: \<18 years of age
* Tinnitus present less than 6 months or longer than 3 years
* Current pregnancy
* History of brain or major ear surgery
* Prior major head trauma

  * Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHAI

    * GAD-7 \>9 (indicates clinically significant anxiety)
    * PHQ-8 \>9 (indicates clinically significant depression)
    * SHAI \>25 (hypochondriacal level illness anxiety)
  * Inability to assess, continue or complete trial
* Currently on antidepressants, anxiolytics or antipsychotics
* Active use of other tinnitus treatments (not including non-masking hearing aid use)
* Normal contrast-enhanced MRI of the head
* Normal temporal bone CT
Randomised Ischaemic Mitral Evaluation (RIME) Trial

The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG). Patients will be randomised to receive either CABG alone or CABG plus mitral annuloplasty. The objective of the study is to determine if mitral annuloplasty in addition to CABG improves outcome in patients with moderate functional ischaemic mitral regurgitation.

70 patients with moderate functional ischaemic MR who are undergoing CABG will be recruited. Patients will be randomised to undergo either CABG alone or CABG combined with mitral annuloplasty. Patients will be investigated at baseline, 3 months and 1 year after surgery to determine functional capacity, quality of life, and cardiac function.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing CABG.
2. Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.

Exclusion Criteria:

1. Patients with severe LV dysfunction (EF less than 30%).
2. Patients with associated significant aortic valve disease.
3. Patients with significant co-morbidities: renal impairment (creatinine \> 160), liver impairment (INR \> 2.0, bilirubin \> 40), or underlying chronic obstructive lung disease (FEV1:FVC ratio \< 0.6).
4. Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock.
5. Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent.
6. Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc.
7. Patients with associated conditions which would significantly increase the risk of surgery.
8. Patients who have had previous cardiac surgery.
9. Patients with a previous history of endocarditis
A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg

To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg taken without or with water and the Glucobay standard tablet 100 mg taken with water.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening examination / visit
* Ethnicity: White
* Body mass index (BMI): above/equal 18 and below/equal 28 kg / m²

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
* Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Chronic intestinal disorders associated with distinct disturbances of digestion and absorption
* States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, Crohn´s disease, ulcerative colitis, malabsorptions)
* Fasting blood glucose level outside normal range
* Impaired glucose tolerance in glucose tolerance test
Effect During Pregnancy and Intrapartum Health

Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.

The aim of this randomized controlled trial was to evaluate the effect of combined exercise (aerobic and strength exercise) on maternal and newborn intrapartum variables.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines.
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Puerta de Hierro (Majadahonda); Hospital Universitario Severo Ochoa (Leganés).

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old
Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer

RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body.

PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.

OBJECTIVES:

Primary

* To compare identification of circulating breast cancer cells (CBCCs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) to the standard technique using the CellSearch® system in women with metastatic breast cancer.

Secondary

* To determine whether CBCCs have the potential to grow into metastatic lesions.

OUTLINE: Patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) in isolating circulating breast cancer cells (CBCCs) from blood and pleural or peritoneal fluid. Blood may also be drawn to measure the number of circulating tumor cells using the standard CellSearch® system.

Mononuclear cells are isolated by density centrifugation. Cells are stained against surface antigens that provide specific expression patterns for CBCCs (CD44, CD24). Cells are analyzed on a fluorescence activated cell sorting (FACS) Calibur flow cytometer and sequentially gated (ALDHhigh→CD44+ vs CD24-/low or CD44+ vs CD24-/low→ALDHhigh) for detection of CBCCs. For further confirmation of epithelial origin, ALDHhighCD44+CD24-/low cells are isolated using a FACSAria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. Using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by FACS and assayed for clonogenic growth.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the breast

  * Metastatic disease (stage IV)
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19

There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.

ICU COVID-19 patients show high risk of death mainly due to sepsis and respiratory disfunction. Prevention of these critical conditions is mandatory to reduce mortality and to improve patient's outcome.

Melatonin is an endogenous hormone involved not only in circadian rhythm control, but also in the cell protection due to its outstanding anti-inflammatory and antioxidative effects. High doses of melatonin have shown high efficacy against bacterial (sepsis) and viral infections. Melatonin is a safe product that consistently has shown lack of side-effects when it is administered to humans.

SARS-CoV 2 infection may yield severe forms of the disease that require the patients admission to the ICU. These patients may develop an excessive inflammatory response and a burst of free radicals, constituting the major cause of death in these subjects.

Our hypothesis is that high doses of melatonin intravenously administered to COVID-19 ICU patients might reach enough blood levels able to prevent/counteract the developing of sepsis and the production of free radicals, reducing mortality and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patient, family member or legal guardian has provided written Informed Consent.
* Age ε 18 years.
* Confirmed SARS-CoV-2 infection with compatible symptoms AND a positive RT-PCR.
* Admission to the ICU with acute hypoxemic respiratory failure attributed to SARS-CoV-2 infection.
* ICU length of stay of less than 7 days prior to randomization with or without MV and without signs of improvement in respiratory failure (MURRAY score at randomization greater or equal to the MURRAY score at ICU admission).

Exclusion Criteria:

* Participant in a different COVID-19 study in which the study drug is under clinical development and hasn't been previously authorized for commercialization.
* Liver enzymes \> 5 times the upper normal range.
* Chronic kidney disease with GFR \< 30 mL/min/1.73 m2 (stage 4 or greater) or need for hemodialysis.
* Pregnancy. A pregnancy test will be performed on every woman younger than 55 years of age prior to inclusion.
* Terminal surgical or medical illness.
* Autoimmune disease.
* Any patient condition that can prevent the study procedures to be carried out at the treating physician's judgement.
Myocardial Infarction Prediction

prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks

Myocardial infarction remains one the leading causes of mortality and morbidity and involves a high cost of care. Early prediction can be helpful in preventing the development of myocardial infarction with appropriate diagnosis and treatment. Artificial neural networks have opened new horizons in learning about the natural history of diseases and predicting cardiac disease.

Methods: A total of 935 cardiac patients with chest pain and nondiagnostic electrocardiogram (ECG) were enrolled and followed for 2 weeks in two groups based on the appearance of myocardial infarction. Two types of data were used for all patients: nominal (clinical data) and quantitative (ECG findings). Two different artificial neural networks - radial basis function (RBF) and multi-layer perceptron (MLP) - were used.

Eligibility Criteria:
Inclusion Criteria:

* patient with chest pain refered to ER with nondiagnostic ECG

Exclusion Criteria:

* 1) Absence of a history of myocardial infarction
* 2) Absence of bundle branch block, Wolf-Parkinson-White abnormality, ventricular hypertrophy or previous ECG signs of myocardial infarction,
* 3) Absence of a history of percutaneous coronary surgery or coronary artery bypass grafting,
* 4) Absence of ECG abnormalities attributable to drugs such as digoxin or tricyclic antidepressants.
Postmenopausal Hormone Therapy in Unstable Angina

To determine if estrogen therapy in postmenopausal women with unstable angina reduces the incidence of ischemic episodes.

BACKGROUND:

Unstable angina is a frequent diagnosis in post-menopausal women and is associated with a significant risk of myocardial infarction and need for revascularization. The pathogenesis of unstable angina involves vasoconstriction superimposed on fixed disease, causing a temporary decrease in coronary blood flow. Recent catheterization studies in patients with atherosclerosis utilizing quantitative angiography and intracoronary doppler measurements of blood flow velocity suggest that endothelial dysfunction results in a paradoxical coronary vasoconstriction response to certain neurohumoral stimuli including acetylcholine, catecholamines, and serotonin with resultant myocardial ischemia. Therapeutic agents which prevent or limit this vasoconstriction may prevent recurrent ischemia and/or myocardial infarction in unstable angina patients. Recently, estrogen receptors were identified in the smooth muscle of post-mortem human coronary arteries. Work in animal models and studies in post-menopausal women suggest that intravenous estrogen acutely decreases coronary vascular resistance, increases coronary blood flow, and prevents the paradoxical response to acetylcholine in patients with endothelial dysfunction.

DESIGN NARRATIVE:

The randomized, double-blind, placebo-controlled, multi-center trial tested the hypothesis that intravenous estrogen followed by oral estrogen and the combination of intravenous and oral estrogen and progesterone in the routine management of unstable angina were beneficial compared with placebo in post-menopausal women. Subjects with rest angina and no contraindications to hormone therapy were randomized to receive intravenous followed by oral conjugated estrogen for 21 days, intravenous estrogen followed by oral conjugated estrogen plus medroxyprogesterone for 21 days or placebo. The primary end point was the number of ambulatory electrocardiographic ischemic events over the first 48 hours. Clinical events were also determined over six months of follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Postmenopausal women with unstable angina.
Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.

Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs, endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or in conjunction with other weight loss treatment modules for patients who cannot or do not want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30 kg/m2) or BMI \>27 with comorbidities.

This research is being done in order to find out if endoscopic bariatric therapies work as well as, or better or worse than, other currently available treatment modules to achieve weight loss.

The study is to create a registry to analyze a longitudinal observational cohort of patients who have undergone endobariatric procedures. We will collect information through standard of practice visits and through chart review.

Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who is considering undergoing EBT for weight loss within 6 months, or has undergone clinically indicated EBT for weight loss within the past 6 months
* Above or equal to 18 years of age.

Exclusion Criteria:

* Any patient who has not undergone or will undergo EBT for weight loss
* Below 18 years of age.
A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing

This is a single center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing. The purpose of this study is to assess the immediate effect one-time low-dose acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will also try to determine the immediate effect of one-time low-dose acetazolamide on subjects' resting ventilation and ventilatory response slope compared to subjects' baseline evaluation without acetazolamide.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 to 80 years
* TE-CSA
* Subjects are capable of giving informed consent

Exclusion Criteria:

* Hypersensitivity to acetazolamide or other sulfonamides
* Intake of carbonic anhydrase inhibitors within the last 72 hours
* Intake of medication that influences breathing, sleep, arousal or muscle physiology
* Cheyne-Stokes respiration
* Heart failure
* Renal failure
* Liver failure
* Chronic hypercapnea
* Hyponatremia
* Hypokalemia
* Pregnancy
* Breastfeeding mothers
* Active drug/alcohol dependence or abuse history
A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced/metastatic non-small cell lung cancer
* Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria:

* Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
* History of or known brain metastases
Quality Gaps in Screening and Monitoring for Postoperative Hyperglycemia in a Canadian Hospital

Patients with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. Previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. Using a framework for perioperative glycemic management, we sought to measure quality gaps in perioperative glycemic care.

This cross-sectional study used administrative data to measure the proportion of surgical patients with and without known diabetes who underwent preoperative hemoglobin A1c measurement, postoperative point-of-care testing for glucose (POCT), had hyperglycemia, and received basal bolus insulin regimens for treatment. We performed an exploratory analysis comparing length of stay (LOS) in patients with and without diabetes who had and did not have postoperative hyperglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Underwent inpatient surgical procedure at the Foothills Medical Centre between Apr 1 2019 and March 31 2020
* Stayed in hospital for more than 24-hours after surgery

Exclusion Criteria:

* Younger than 18 years of age
Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome

The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.

The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification.

Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index more than or equal to 25 kg/m2
* Patients with metabolic syndrome
* Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.

Exclusion Criteria:

* Uncontrolled diabetes patients
* Patients with gastrointestinal abnormalities
* Patients with cardiovascular diseases
* Patients with hematologic disorders
* Patients with Glomerular filtration rate less than 60 ml/min/1.73m2
* Patients with drug or alcohol abuse
* Pregnancy and lactation