cyrilzakka/clinical-trials huggingface dataset:
Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities

The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.

An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).


Eligibility Criteria:
Inclusion Criteria:

Patient written informed consent is signed prior to any trial specific procedures participation

* male patients \> 18 years
* Mean seated SBP \> 130mmHg and/or DBP \> 85mmHg treated with antihypertensive drug(s)
* with at least 2 more criteria of metabolic syndrome (NCEPT III). Biological data available within 6 months prior to enrollment visit.
* abdominal obesity \> 102 cm at screening
* TG \> 1.5 g/l
* HDL \< 0.4 g/l
* Glycemia \> 6 mmol/l

Exclusion Criteria:

Patients with any of the following conditions will be excluded from trial:

* confirmed type 1 or 2 diabetic patients treated or not
* secondary hypertension
* Mean seated SBP\>180 mmHg and/or DBP \>110 mmHg at screening
* hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1:
* SGPT (ALT) or SGOT (AST) ¿ twice the upper limit of the normal range
* serum creatinine ¿ 2.3 mg/dL (or 203 ¿mol/L)
* bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
* patients post-renal transplant or with only one functioning kidney
* clinically relevant hypokalemia or hyperkalemia at visit 1
* uncorrected volume or sodium depletion at visit 1
* primary aldosteronism
* hereditary or known fructose intolerance
* biliary obstructive disorders
* patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-II receptor antagonists
* history of drug or alcohol dependency within the previous six months
* concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form
* symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
* unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
* stroke less than six months prior to informed consent
* sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
* known allergic hypersensitivity to any component of the formulations under investigation
* concomitant therapy with lithium, cholestyramine or colestipol resins continued after visit 1
Efficacy of Higher Cutting Rate in Microincision Vitrectomy for Proliferative Diabetic Retinopathy

The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome and incidences of intraoperative and postoperative complications were compared.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients who had persistent vitreous hemorrhage, fibrovascular proliferation affecting the macula, or tractional RD and who had a follow-up for more than 6 months.

Exclusion Criteria:

* The eyes with follow-up less than 6 months
Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid

Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored.

Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.

Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.

Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored.

Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.

Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.

Eligibility Criteria:
Inclusion Criteria:

* Level III NICU consultants, residents, and fellows trained in advanced airway management will be eligible to participate in the study

Exclusion Criteria:

* No exclusion criteria
Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator

Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin:

  * idiopathic (primary)
  * limited cutaneous Scleroderma associated
  * diffuse cutaneous Scleroderma associated
  * mixed connective tissue disease associated

Exclusion Criteria:

* Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates
* Smokers
* Systolic blood pressure (SBP) below 105mmHg at rest
Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis

Pulmonary hemosiderosis (PH) is a pulmonary hemosiderin deposition which caused by alveolar capillary hemorrhage. PH is easy to recurrent and can lead to pulmonary fibrosis and insufficiency if the disease was poor controlled. Steroid is the most common drug that was administered in acute phase of the disease. However, considered the side-effects, steroid is not suitable for long-time maintenance. Therefore, it is necessary to explore a new therapy. Bone marrow mesenchymal stem cells (BMSC) are a kind of adult stem cells with high self-renewal and multi-directional differentiation potential in bone marrow. It has become a hot topic in immunosuppressive and tissue repair therapy in recent years. To date, homing, colonization and differentiation of BMSCs in the lung have been observed in animal models of pulmonary hypertension, radiation pneumonitis and pulmonary fibrosis. It had been reported that BMSC transplantation in acute lung injury in mice, inflammation of lung injury can significantly improve. The aim of this study is to explore the effect of BMSC on PH and its mechanism, and to explore a new way to promote the repair of IPH. It is expected to improve the status of IPH therapy in children, especially improve the prognosis of refractory PH.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Pulmonary hemosiderosis at an age less than 18 years.

Exclusion Criteria:

* Patients who cannot finish the established causes or die during the causes.
Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA

The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (developmental phase)
* Healthy endurance-trained subjects
* Maximum age for males is 39
* Maximum age for females is 49
Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease

Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease.

Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease. A scale for Fear of ACTivity in patients with CAD (Fact-CAD) was created through semi-structured focus group interviews with patients. Face and content validity of Fact-CAD was verified. The scale was applied to 250 patients who had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months. Psychometric analysis included model fit, unidimensionality, reliability, local dependency, differential item functioning and external construct validity. Analyses were performed using the Rasch Analysis Model.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months.

Exclusion Criteria:

* Acute cardiac event within the last month
* Attendance to cardiac rehabilitation
* İnability to read and understand,
* İnability to ambulate or unwillingness to participate
Glasdegib Absolute Bioavailability Study

This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Healthy male and/or female subjects of non-child bearing potential who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:

  1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 24 consecutive months with no alternative pathological or physiological cause; with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) are considered to be of childbearing potential.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. -. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* -A positive urine drug test.
* Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
* Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and corrected calcium calculation at screening.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product and, refrain from sperm donation for the duration of the Study and for at least 90 days after the last dose of investigational product.
Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).


Eligibility Criteria:
Inclusion Criteria:

1. Males and females Ages of 18 to 65 years old.
2. History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
3. Capable to corporate with the study protocol and to sign an informed consent.

Exclusion Criteria:

1. Patients having received Botox treatment in the head region in the prior 4 months.
2. Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
3. History of Medication Overuse Headache.
4. Patients using opioid medication.
5. Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).
6. Implanted metal or electrical devices in the head (not including dental implants).
7. Patient having had a previous experience with the Relievion™ device.
8. Patients who have concomitant epilepsy.
9. History of neurosurgical interventions.
10. Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
11. History of drug abuse or alcoholism.
12. Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
13. Skin lesion or inflammation at the region of the stimulating electrodes.
14. Personality or somatoform disorder.
15. Pregnancy or Lactation.
16. Women with child bearing potential without medically acceptable method of contraception.
17. History of cerebrovascular event.
18. Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
19. Patients using Cannabis
20. Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

-list item one, The purpose of this study is to evaluate the overall response rate of belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix

* list item one, to evaluate toxicities of Belotecan
* list item two, to evaluate duration of primary response for responding patients
* list item three, to evaluate time to disease progression
* list item four, to evaluate progression free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
* One of the following histologic types
* Squamous cell carcinoma
* Adenocarcinoma
* Adenosquamous carcinoma
* Clinically measurable disease
* Performance status of 0, 1, 2 on the ECOG criteria

Exclusion Criteria:

* Histology of neuroendocrine tumors
* Patient previously treated with topoisomerase-I inhibitor
Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation

The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30 kg/m2
* No NSAID's for 14 days prior to baseline endoscopy

Exclusion Criteria:

* Pregnant/Nursing women
* History of documented gastroduodenal ulcer
Left-Atrium-Appendage Occluder Register - GErmany

* Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice
* Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
* Safety: How save is the implantation of LAA-Occluders?
* Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice?
* Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?

LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed by an implantable medical device. In particular the following questions should be answered:

* Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
* Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in the long term course)? How frequent are bleeding complications and what is the relation of observed and expected bleeding complications (according HAS-BLED score)?
* Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice (in hospital and in the long term course)? How frequent are strokes and what is the relation of observed and expected strokes (according CHADS-VASC score)?
* Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?

Eligibility Criteria:
Inclusion Criteria:

Intention to laa occluder

Exclusion Criteria:

Missing informed consent
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)

The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

20 patients will be included in this 6 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG Schafer 3 or 4
* Medicated IOP ≥ 21

Exclusion Criteria:

- Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma