cyrilzakka/clinical-trials huggingface dataset:
Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon

This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes.

This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes. The study will aim to quantify the effect of a blood alcohol content on the anti-hypoglycemic efficacy of glucagon using a hyperinsulinemic -normoglycemic clamp technique in volunteers with type 1 diabetes in a randomized crossover trial.

Eligibility Criteria:
* Inclusion Criteria:

  * Age 21 to 80 years old with type 1 diabetes for at least one year.
  * Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), or insulin glulisine (Apidra) for at least one week prior to enrollment.
  * Alcohol exposure on at least one occasion in the last year consisting of at least 4 drinks in one sitting.
* Exclusion Criteria:

  * Unable to provide informed consent.
  * Unable to comply with study procedures.
  * Unable to refrain from the consumption of alcohol at least 24 hours prior to study start.
  * Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
  * Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
  * Aldehyde dehydrogenase deficiency as determined by a screening questionnaire
  * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
  * History of pheochromocytoma (because glucagon has been reported to precipitate hypertensive crisis in the setting of pheochromocytoma). Fractionated metanephrines will be tested in patients with a history increasing the risk for a catecholamine secreting tumor:
  * Paroxysms of tachycardia, pallor, or headache. Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease, Episodic or treatment of refractory (requiring 4 or more medications to achieve normotension) hypertension.
  * History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
  * Inadequate venous access as determined by study nurse or physician at time of screening.
  * Liver failure or cirrhosis
  * Hemoglobin \< 12 gm/dl.
  * History of problem drinking or alcoholism, regardless of whether active or in remission.
  * Use of benzodiazepines or barbiturates or opiates or other central nervous system depressant drugs that could act synergistically with ethanol to lower the level of consciousness
  * Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

Eligibility Criteria:
Key Inclusion Criteria:

* forced Expiratory Volume in one second ( FEV1) \>= 40% predicted
* patients who completed CQGE031B2201 study

Key Exclusion Criteria:

* life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study
* new malignancy
* ongoing SAE from CQGE031B2201 that was assessed as related to study drug
* patient experienced platelets drop to \< 75,000/uL
* patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions
* patient is pregnant
High Low Biphasic Energy Defibrillation (HiLoBED)

This inhospital study aims to compare the efficacy of high-versus low-energy biphasic shocks in order to determine the optimal level for defibrillation. Time is the essence when attending to a VF patient. Hence, it is important to determine the optimal amount of defibrillation energy that should be delivered at first shock, thereby increasing the patient's chances of survival. In addition, this study provides an opportunity to evaluate the impact on myocardial integrity/function of different levels of defibrillation energy in an inhospital clinical environment.

This is a prospective, randomised study to be conducted in the Emergency Medicine Departments and Cardiology Departments of four major hospitals, viz. Singapore General Hospital, National University Hospital, Changi General Hospital and Tan Tock Seng Hospital. The four hospitals were selected as they generally handle the most patients experiencing ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT) in the inhospital setting in this country. The study will include patients with cardiac arrest, who have a shockable rhythm (VF and pulseless VT) and aged 21 years and above. Patients who have received defibrillation pre-hospital will also be included if they are still in VF at time of arrival at the hospital.

Patients will be administered one of the following:

* Defibrillation with progressive high-energy biphasic shocks using the Medtronic Physio-Control LifePak 12 at 200J, 300J and 360J. If still unsuccessful, further shocks at 360J plus anti-arrhythmics as per American Heart Association (AHA) and Singapore National Resuscitation Council (NRC) guidelines for mega VF will be applied.
* Defibrillation with low-energy biphasic shocks using the Medtronic Physio- Control LifePak 12 at 150J, 150J and 150J. If still unsuccessful, shocks will be continued at the higher energy range (as above) plus the use of anti- arrhythmics as per the AHA and NRC guidelines for mega VF.

Results will be analysed to obtain first/subsequent shock defibrillation efficacy and post-shock myocardial function/dysfunction. This randomised study is the first of its kind to explore the efficacy of different biphasic energy levels and their impact on myocardial integrity/function in an inhospital clinical setting. After completion, the study will be expected to produce at least Level 2 results, which would be useful to international resuscitation committees in determining future guidelines and recommendations for defirillation in cardiac arrest victims.

At the conclusion of the study, the results will be analysed and published as soon as possible. This will be the responsibility of the Principal Investigator.

Eligibility Criteria:
Inclusion Criteria:

* patients with cardiac arrest, who have a shockable rhythm (ventricular fibrillation and pulseless ventricular tachycardia)
* aged \> or equal to 21 years

Exclusion Criteria:

* aged below 21 years (young patients whose ages cannot be determined accurately will not be included)
Essential Hypertension

The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 75 years (inclusive) at screening.
* Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
* 12-lead ECG without clinically relevant abnormalities measured at screening.
* Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
* Signed informed consent in the local language prior to any study-mandated procedure

Exclusion Criteria:

* Mean SBP \> 180 mmHg.
* Severe, malignant, or secondary hypertension.
* Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
* E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
* Angina pectoris within 6 months prior to enrollment
Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer

The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ovarian cancer

Exclusion Criteria:

* All others
A Phase I/II Study of GX15-070MS in Untreated CLL

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed B-CLL
* Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
* Age ≥18 years
* ECOG Performance Status ≤1
* Life expectancy of \>8 weeks

Exclusion Criteria:

* Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
* Patients with history of seizure disorders
* Pregnant women and women who are breast feeding
* HIV-positive patients receiving combination anti-retroviral therapy
Compare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis

This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.

This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.

This study will be conducted in the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.

Patients attending the outpatient clinic in Pediatric Dentistry and Dental Public health Department - Faculty of Dentistry - Cairo University - Egypt will be screened until the target population is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 10-14 years.
* Children with a gingival index score of ≥ 1 and a plaque index score of ≥ 1.
* Children in good medical health and free from major oral hard or soft tissue lesions. \[Medically fit children (ASA I, II)\].
* Children classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
* Children mentally capable of communication.

Exclusion Criteria:

* Parental refusal for participation.
* Children under antibiotics treatment during the last six weeks prior to the study.
* Children wearing fixed or removable orthodontic devices.
* Patients who underwent oral prophylaxis in the last six months.
Playing AVI During Tennis Training Process

Developing movement capabilities and efficiently acquiring and assimilating movement information and knowledge in middle childhood stages is of great importance for performing complex movement structures in later stages of life. Our study is directed to researching the influence of active video games (AVG) on assessment of tennis motor skills and visual capabilities in middle childhood, as a part of two separate sub-researches.

In the first sub-research, which included a sample of 55 children aged between 7 and 9, the investigators measured the physiological responses of bodies after acute and chronic exposure to playing AVG. The investigators established a significant difference in skin conductance before beginning the intervention between the virtual and actual game. After the intervention, the experimental group had a significantly higher average value of heart rate frequency and breathing frequency while playing AVG in comparison to the control group.

In the second sub-research the investigators measured progress in tennis technique (TRSC test), development of gross motor skills and change in reaction time on the same group of children. In the TRSC test, the control group improved in all sub-groups with both strokes. The experimental group made no improvements in sub-group 3d with the ''forehand'', 1d and 3d with the ''backhand''. In the gross motor skill development test the investigators have not established a significant interaction effect. In the analogue reaction time measurement test, the investigators recorded a significant interaction between time x group. The same goes for Simon's test with incongruent stimuli, with congruent the interaction was of no relevance.

The investigators established that the use of AVG can represent a new strategy for combining movement/sports activities and cognitively directed tasks aiming at effective assessment of tennis skills.

Eligibility Criteria:
Inclusion Criteria:

* Age limit

Exclusion Criteria:

* excluded were players with injuries or long-term body impairments that prevented them from performing shots as they are usually instructed.
Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile

The purpose of this study is to compare the effect of dark chocolate with green tea in healthy subjects on clot formation (platelet activity) cholesterol profile and markers of inflammation in two groups.

The first group will be on a regimen of dark chocolate, and the second group will be on a regimen of green tea. Clinical outcomes will be determined after seven days of each treatment and both groups will undergo both treatments subsequently and serve as their own control.

The hypothesis is that both green tea and dark chocolate will reduce platelet activity and reduce LDL, hsCRP and increase HDL.

Flavonoids are polyphenolic compounds ubiquitous in fruits and vegetables. They appear in especially high concentrations in the form of flavanols in green tea as well as in cocoa, and are known to have beneficial antioxidant effects in vitro. Flavonoids have been proposed as a key protective dietary component, reducing the risk of coronary heart disease, including the reduction of elevated blood pressure in persons with hypertension and capable of decreasing LDL.

The aim of this prospective single cross-over study is to assess the effect of green tea and dark chocolate consumption on inhibiting platelet activation, Lipid levels, and hsCRP in healthy volunteers.

This research will be done at Sinai Hospital of Baltimore and will include 35 subjects who will be randomized equally between the two groups.

All blood work will be processed at the Sinai Center for Thrombosis Research. Clinical outcomes will be recorded using a standard case report form.

Eligibility Criteria:
Inclusion Criteria:

* non-smokers between the ages of 18-60
* BMI of 19 to 30

Exclusion Criteria:

* prior usage of Vitamin C \> 1000 mg, Vitamin E \> 400IU, Beta Carotene \> 1000IU, Vitamin A \> 5000IU, Selenium \> 200mcg, Folic Acid \> 1mg, Aspirin or NSAIDs four weeks prior to study initiation
* regular ingestion of Flavonoid rich food (EG green tea, dark chocolate, grapes, red wine and others) prior and during the study except what was provided by the study protocol
* Alcohol or Caffeine consumption 24 prior to blood draws
* Nursing or pregnant women
* blood donation up to eight weeks prior to study initiation
* subjects with coagulation disorders
* known cardiovascular disease (prior myocardial infarction)
* drug abuse
* Diabetes
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.


Eligibility Criteria:
Inclusion criteria:

* Patients who have undergone a heart or lung transplantation more than 12 months ago.
* Patients receiving Neoral® or Prograf®.
* Patients with a measured or calculated glomerular filtration rate (GFR) \> 20 and \< 70 mL/min/1.73m\^2. For patients with a GFR \> 60 and \< 70 mL/min/1.73m\^2, a deteriorated renal function since the time of transplantation must be documented by at least one post-transplant GFR level that is \> 10% above the GFR level at the time of inclusion.
* Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
* Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.

Exclusion criteria:

* Patients who are recipients of multiple organ transplants.
* Patients with measured GFR \< 20 mL/min/1.73m\^2 or \> 70 mL/min/1.73m\^2.
* Patients with a treated acute rejection episode within the last 3 months.
* Patients with a platelet count of \< 50,000/mm\^3 or with a white blood cell count of ≤ 2,500/mm\^3 or with a hemoglobin value \< 8 g/dL.
* Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
* Patients currently treated or who have been treated with a mammalian target of rapamycin (mTOR) inhibitor.
* Patients who have received an investigational drug within 4 weeks.
* Patients who are human immunodeficiency virus positive or who have a current severe systemic infection requiring continued therapy according to investigator judgment.
* Present use of any immunosuppressive drugs other than Neoral®/Prograf®, mycophenolic acid/azathioprine (MPA/AZA), and/or steroids.
* Patients with a known hypersensitivity to drugs similar to everolimus.
* Symptoms of significant mental illness which, in the opinion of the investigator, may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
* Inability to cooperate or communicate with the investigator.
* Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
* Females of childbearing potential that are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
* Patients with a planned coronary revascularization or patients who have experienced a major adverse cardiovascular event (MACE) within the last 3 months.
The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients

This clinical trial is being conducted to assess whether the comprehensive education before gastroscopy could reduce the adverse reactions, such as nausea, vomiting and improve patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18 years undergoing routine gastroscopy
2. Informed consent

Exclusion Criteria:

1. Serious coronary heart disease and myocardial injury with serious heart failure
2. Stenosis of the esophagus or cardia obstruction
3. Acute pharyngitis and tonsillitis
4. Acute upper gastrointestinal bleeding
5. Hemodynamically unstable
6. allergy to topical lidocaine
7. Patients did not cooperate or spirit was not normal
8. Pregnancy
Effect of Environment on the Central and Peripheral Nervous System

The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.

This study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. A total of 95 participants will be randomly assigned to either a built or natural environment. Each participant will take part in a 2.5-hour session. Initially, an electrocardiogram (ECG) will be attached to measure heart activity. Participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the ABC engagement task). Following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. After baseline, participants will complete a challenging task (the Remote Associates Test (RAT)), which is designed to induce sympathetic arousal. Afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. Finally, participants will complete post-task surveys through Qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years of age or older.

Exclusion Criteria:

* Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment

The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.


Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease
* newly formed hemodialysis access with native vein
* 20\~70 years

Exclusion Criteria:

* hemodialysis access surgery with ePTFE graft
* hemodialysis access surgery with basilic vein transposition
* hemodialysis access surgery with brachial vein transposition
* cephalic vein \< 2.5mm in diameter
* radial artery diameter \<2.0mm in radiocephalic arteriovenous fistula