cyrilzakka/clinical-trials huggingface dataset:
Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients

The aim of this study was to investigate the effects of preoperative operating room environment introduction on preoperative hypertension and blood pressure in hypertensive patients.

Procedure to be Applied:

In order to eliminate the other factors that cause essential HT, the patients' blood pressure due to HT should be controlled, the surgery will be planned as the first case in the morning and the patients will need 8 hours fasting period.

Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will be recorded. Hemodynamic parameters (blood pressure, heart rate and SpO2 values) will be recorded in the services of the patients, in the preop unit and in the operation room. Hypertension requiring intervention or additional medication will be excluded from the study. A randomized number of patients will be included in the study according to the results of power analysis.

Introduction of the operating room environment (IORE): The procedure to be performed on the day of surgery will be simulated and accompanied by an anesthesiologist. The patient's hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the time of operation, between 16: 00-18: 00 hours prior to the operation, and will be brought to the operating room with a service nurse. The hemodynamic data of the patient will be measured in the preop unit and the patient will be taken to the operating room with anesthesia doctor. Here, in addition to the patient's hemodynamic data, the instantaneous state anxiety scale (ST-STAI) will be completed and the patient will be left in service again. The procedure will be similar to the process that the patient will experience on the operation day.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* informed consent,
* essential hypertension was diagnosed,
* Between the ages of 40-80,
* American Society of Anesthesiologists (ASA) class II-III

Exclusion Criteria:

* drug allergy,
* with a history of malignant hyperthermia,
* uncontrolled hypertension,
* cancer and psychological problems,
* patients with cardiac and endocrine diseases
* emergency surgery
Cardiac Amyloidosis in Spinal Stenosis: the CASS-study

Background: A significant portion of cardiac amyloidosis patients have a 5 to 10 years prior history of spinal canal stenosis, reflecting a diagnostic red flag that should raise suspicion for amyloidosis presence. Mild troponin release and NT-proBNP elevation, both serum cardiac biomarkers, often coincide with cardiac amyloidosis. Early cardiac amyloidosis treatment improves survival, warranting timely diagnosis.

Study aim: to test a prospective screening strategy, based on serum cardiac biomarkers, to increase early detection of cardiac amyloidosis in patients with spinal canal stenosis.

Design: Single-centre prospective observational non-interventional diagnostic study.

Methods: Consecutive patients during a one-year period in AZ Sint-Jan Bruges, without known cardiac amyloidosis history and scheduled for spinal canal stenosis surgery, will have cardiac evaluation including serum cardiac biomarker (high-sensitive troponin T and NT-proBNP) assessment, electrocardiography and transthoracic echocardiography. During surgery, all patients will undergo ligamentum flavum biopsy to evaluate presence and burden of transthyretin amyloid deposition (Congo-red staining and immune histochemistry). All patients with suspicion for cardiac amyloidosis will undergo further diagnostic testing (including laboratory test and bone scintigraphy). A chronologic cascade screening process will be used starting with abnormal serum cardiac biomarkers (high-sensitive troponin T ≥ 14 ng/ml and/or NT-proBNP \> 125 pg/ml), followed by electrocardiography, transthoracic echocardiography and finally ligamentum flavum biopsy results. The diagnostic performance of this biomarker-based strategy will be compared to electrocardiography, echocardiography and ligamentum flavum biopsy.

Conclusion: It is hypothesised that serum cardiac biomarker testing in patients undergoing spinal canal stenosis surgery represents a simple and valuable prospective screening strategy for early detection of cardiac amyloid(osis).


Eligibility Criteria:
Inclusion Criteria:

* Cervical or lumbar spinal canal stenosis, scheduled for spinal surgery
* \> 18 years old

Exclusion Criteria:

Prior diagnosis of cardiac amyloidosis and evident alternative explanations for troponin and/or NT-proBNP elevation are the main reasons for exclusion.

* known cardiac amyloidosis
* severe valvular regurgitation or stenosis
* Left ventricular ejection fraction (LVEF) \< 40%
* Glomerular filtration rate (GFR) ≤ 25 ml/kg/min or dialysis
* recent heart failure admission ≤ 1 month
* recent myocarditis ≤ 3 months
* recent acute coronary syndrome ≤ 1 month
* recent percutaneous coronary intervention (PCI) ≤ 1 month
* recent cardiac surgery ≤ 3 months
* active or planned pregnancy
* unwilling to participate or provide signed informed consent
Second-Line Treatments for Anovulatory Infertility in PCOS Patients

To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin administration, alone or combined with clomiphene citrate (CC), has shown to be an effective and attractive second-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC administration in the treatment of the CC-resistant PCOS patients.

A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo LOD followed by observation. Anovulatory patients will receive IM progesterone. The treatment will be of six months followed by nine-month of observation for pregnant patients. The incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* PCOS
* Clomiphene citrate-resistance
* Anovulation
* Infertility

Exclusion Criteria:

* Age \< 18 or \> 35 years
* Body mass index \>35
* Neoplastic, metabolic, endocrine, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs affecting hormone levels, carbohydrate metabolism, or appetite
* Pelvic diseases
* Previous pelvic surgery
* Suspected peritoneal factor infertility/subfertility
* Tubal or male factor infertility or sub-fertility
Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial

The goal of this study is to better understand in changes in lung compliance as indicated by driving pressure (a non-invasive marker) following changes in positive end expiratory pressure (PEEP; a standard of care ventilator parameter).

The main question it aims to answer is: The time to stability of driving pressure after a change in PEEP is made Type of study: observational study participant population/health conditions

Participants will undergo a "best PEEP trial" which is a standard intensive care intervention for patients undergoing invasive mechanical ventilation. This involves changing the patient's PEEP and looking for response in driving pressure. This will be done in a more protocolized format and data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years of age
* Undergoing intubation and mechanical ventilation in Medical Intensive Care Unit (MICU) or Medical Critical Care Unit (MCCU) at the University of Alabama Birmingham.

Exclusion Criteria:

* Prisoner
* Pregnant
* Age \<18 years of age
* Intensive Care Unit (ICU) team declines participation
* Unstable oxygenation (requiring 100% FiO2 to maintain saturations greater than 90% oxygen saturation following initial PEEP titration by primary team)
* Hemodynamic instability: vasopressor requirement of \>0.3 mcg/kg/min of norepinephrine or equivalent
* Pneumomediastinum
* Pneumothorax without chest tube
* Previous enrolled in trial
* Need for immediate travel out of ICU following intubation for procedures, tests
Impact of Acthar on Everyday Life of Participants With Severe Keratitis

We will need about 36 participants for this study.

Volunteers might be able to participate if:

* they have bad noninfectious keratitis
* early treatments failed or were not well tolerated

Participants will be in the study for about 22 weeks:

* 4 weeks for tests to see if the study might be good for them
* 12 weeks of treatment with Acthar gel
* 4 weeks to wean off Acthar gel and follow-up with the doctor


Eligibility Criteria:
Inclusion Criteria:

* Has severe or recalcitrant keratitis
* Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
* If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
* Has normal eyelids, and protocol-defined physical and medical eye attributes
* Agrees to avoid wearing contact lenses during the trial

Exclusion Criteria:

* Is pregnant or breast-feeding
* Is defined as vulnerable, or is employed by, or related to anyone involved in the study
* Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis
Physical Activity, Cognition, Motor Skills, and Well-beings

The objective of this quasi-experimental study design was to examine effects of the coordinated-bilateral ball skills (CBBS) intervention on cognitive functions and aerobic fitness in elementary school students. The hypotheses of the study were: students in the intervention group will show a significant higher level of cognitive functions and aerobic fitness compared to the control students.

Fourth-grade students at 5 elementary schools were recruited to participate. At each participating school, two fourth-grade classes were assigned to the CBBS intervention group and other two fourth-grade classes were assigned to the control group. The students in the intervention group received two, 30-min CBBS physical education (PE) lessons taught by the physical education teacher who were trained in implementation of the two CBBS lessons per week for 16 weeks. In contrast, the students in the control group received regular two PE lessons per week for 16 weeks taught by the other physical education teacher who were not be involved in the CBBS intervention training. All participating students who returned their parent/guardian' signed consent form were pre-tested and post-tested (immediately after the 16-week intervention) in cognitive functions and aerobic fitness. Descriptive statistics and linear mixed models were performed to analyze the data. All data analysis were conducted in Physical Activity and Health Lab of the School of Kinesiology at University of Michigan

Eligibility Criteria:
Inclusion Criteria:

* Being fourth-grade students in the class taught by either the intervention PE teacher or the comparison PE teacher.
* Consent/assent to participate in the study.
* Being able to complete all outcome measures without physical, cognitive, and mental constrains.

Exclusion Criteria:

* Having illness.
* Being injured.
* Having physical or mental impairment.
Study of New Mutations in Cone Disorders

High throughput sequencing gives the opportunity to improve the genetic diagnosis for patients suffering from retinal dystrophies and specially from cone disorders. However, a large number of mutations are identified, mostly in introns of the genes, and in silico analysis are not sufficient to assign the pathogenicity of these mutations, without which the diagnosis confirmation cannot be done. For that purpose, a functional analysis of intronic variants of unknown significance detected in patients, with minigene splice assays in parallel with the analysis of the effect of the variant on splicing directly in the cells of the patient, by analyzing the RNA from leucocytes, fibroblasts, lymphoblastoïd cells or precursor of photoreceptor cells, which is the only proof of pathogenicity for variants


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cone disorder
* identification of a variant of unknown significance
* possibility of samplings
* informed consent

Exclusion Criteria:

* no variant of unknown significance identified
* no informed consent
The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation of thyroid gland and destroys thyroid tissue.

Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis(RA) for more than one century.

The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment of Hashimoto's thyroiditis.

Hashimoto's thyroiditis is an autoimmune thyroid disease, and when the disease progresses, thyroid function finally declined to hypothyroidism.

There was no medical treatment recommended for patients with Hashimoto's thyroiditis, but currently at euthyroid state. Levothyroxine replacement therapy starts if patients become hypothyroid state.

Hashimoto's thyroiditis is a T-cell mediated autoimmune thyroid disease. The major auto-antigens include thyroid peroxidase (TPO) and thyroglobulin. Anti-TPO antibodies induce antibody-dependent cell-mediated cytotoxicity (ADCC) and cause destruction of thyroid tissues.

Antimalarial agents like hydroxychloroquine have several pharmacologic effects which may be involved in the treatment of rheumatic diseases, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, nicotinamide adenine dinucleotide hydrogen-cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosome membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis.

This study is to investigate the treatment effect of hydroxychloroquine on autoantibodies and disease progression of Hashimoto's thyroiditis.

Eligibility Criteria:
Inclusion Criteria:

* Hashimoto's thyroiditis
* Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit)
* Never receive immunomodulators or immunosuppressants

Exclusion Criteria:

* Planned pregnant or already pregnant women
* Renal insufficiency
* Hepatic insufficiency
* Anemia
* Agranulocytosis
* Thrombocytopenia
* Glucose-6-phosphate dehydrogenase deficiency
* Porphyria cutaneous tarda
* Allergy to 4-aminoquinolone
REALM China Extension Study

The purpose of this study is to conduct an investigator initiated observational study to continue to follow up the China subset of study participants for another 5 years after they complete participation in the REALM Study


Eligibility Criteria:
Inclusion Criteria:

1. Patients completed REALM Study in China
2. Patients willing to sign the consent to continue anti-viral treatment or post-treatment follow up, and agree his/her legacy data and blood/liver histology samples collected in REALM Study may be used for the analyses planned for this new study.

Exclusion Criteria:

1. Patients who do not provide consent to participate in this study;
2. Patients are formally enrolled into any investigational drug clinical trial after the REALM study.
Methods of Weight Loss in Overweight Coronary Patients

We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

The study population consists of overweight (BMI \>27) patients with established coronary heart disease. The exercise and counseling program was of 4 months duration with extended follow up at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Coronary heart disease
* BMI \> 27
* Peak Vo2 \> 14.4 ml/kg/min

Exclusion Criteria:

* Presence of diabetes
A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335 will also be evaluated during the study.

This is an open-label (the name of the study drug will be known to the healthy volunteers participating in this study as well as to all study staff), randomized (volunteers will be assigned by chance to 1 of 6 possible treatment sequences of a single dose of 3 different capsule formulations of JNJ-39439335) to evaluate the pharmacokinetics (blood levels of drug) and relative bioavailability (i.e., the rate and extent of absorption of the drug in the body) of JNJ-39439335 (Part 1 of the study). The effect of food on the administration of JNJ-39439335 will then be evaluated on 1 capsule formulation of JNJ-39439335 (Part 2 of the study). The safety and tolerability of JNJ-39439335 will be monitored throughout Part 1 and 2 of the study. In Part 1, healthy volunteers will be randomly assigned to 1 of 6 treatment sequences and will receive a total of 3 single doses of JNJ-39439335. Each dose (2 capsules) will be separated by 21 days. In Part 2, healthy volunteers will be randomly assigned to 1 of 2 treatment sequences and will receive a total of 2 single doses of one formulation selected from Part 1; each dose will be separated by 21 days. Doses will be administered to healthy volunteers under fed and fasted conditions.

Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
* Agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Have a body mass index (weight \[kg\]/height2 \[m\]2) (BMI) between 18 and 30 kg/m2 (inclusive), body weight not less than 50 kg, blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg, systolic, inclusive, and no higher than 90 mmHg diastolic, and an electrocardiogram with results consistent with normal cardiac conduction and function
* Non-smoker for at least 3 months

Exclusion Criteria:

* History of or current medical illness, laboratory values, vital signs, physical examination findings, or electrocardiogram findings deemed clinically significant by the Investigator
Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.


Eligibility Criteria:
Inclusion Criteria:

- For cases, admitted within the first 36 hours of an acute neurological symptom related to :

* An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,
* A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,
* An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission \>4.

OR

* For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score.
* Express consent to participate in the study.
* Member or beneficiary of a social security.

Exclusion Criteria:

* Pre-existing functional and/or cognitive disability
* Patient under legal protection.
* Pregnant or breastfeeding woman.
* Patient with secondary haemorrhagic transformation.

Secondary exclusion criteria :

* Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy.
* Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.).
* TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.

Excluded patients will be replaced.