cyrilzakka/clinical-trials huggingface dataset:
High-intensity Interval, Low Volume Training in Metabolic Syndrome

The primary objective of the study is to compare the efficacy of an intervention with high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE) on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in adults with metabolic syndrome (MS).

The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma levels of musclin and apelin in adults with MS.

The investigators hypothesized that HIIT-LV is more effective in decreasing insulin resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh, than CAE.

This study is a randomized, controlled, masked (single blind, outcomes assessor) clinical trial, with allocation by the minimization method, with two parallel groups and intention of superiority. It was designed to test the hypothesis that a 12-week program of HIIT-LV, yields larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine function than CAE.

Although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and decreases mortality risk, there is currently controversy and gaps in knowledge over the efficacy of more intense and low-volume physical activities on muscle metabolism in patients with metabolic disorders.

The primary outcome will be the insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function. The secondary outcomes will be the glycosylated hemoglobin, mass and muscle fibre type composition of thigh and plasma levels of musclin and apelin. Assessments will be made before and after the 12-week program. Calculations based on previously results (difference mean 10% and SD 15%) suggest that a total number of 60 patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to detect larger beneficial effects with HIIT-LV with a p-value of 0.05 (two-sided test) and statistical power of 0.80 (primary endpoint is insulin sensitivity).

Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome defined according to the International Diabetes Federation-criteria.
* Insulin resistance defined according to the HOMA greater than 2.25
* Sedentary lifestyle (less than 60 min of physical activity per week)

Exclusion Criteria:

* Vegetarian diet
* Vitamin D3 supplementation
* Oral contraceptives
* Musculoskeletal diseases or injuries
* Physical, sensory or cognitive impairment
* History of cardiovascular disease (coronary, cerebrovascular, peripheral arterial disease, uncontrolled cardiac arrhythmias).
* Pulmonary diseases
* Acute or chronic inflammatory conditions
* Cancer
* Human immunodeficiency virus infection
* Diabetes mellitus
* Hyperthyroidism
* Pregnancy
Establishing Clinical Utility Evidence for Chronic Disease Management Testing

This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 300 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to an intervention group in this study, they will receive education materials on a diagnostic test currently available for use in the market after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes.

Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following criteria to be enrolled in the study:

  1. Board-certified physician currently practicing in the following areas:

     1. Internal medicine
     2. Family medicine
  2. Have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years
  3. Community / non-academic based practice setting
  4. ≥ 40 patients under care weekly
  5. Commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia
  6. Practicing in the U.S.
  7. English-speaking
  8. Access to the internet
  9. Informed and voluntarily consented to be in the study

Exclusion Criteria:

1. Non-English speaking
2. Practicing in an academic setting
3. Unable to access the internet
4. Not practicing in the U.S.
5. Do not voluntarily consent to be in the study
Covid 19 Vaccine Acceptance in Egyptian Pregnant Women

To determine vaccine acceptance and hesitancy attitudes toward coronavirus disease 2019 (COVID-19) vaccines in Egyptian pregnant women.

Although 2 years passed since the Covid 19 pandemic started, no specific treatment against the disease is available. According to WHO, more than two million deaths have been recorded worldwide . Therefore, it is important to avoid infection. In the absence of an effective treatment for coronavirus disease 2019 (COVID-19) non-pharmaceutical interventions are the only available methods of disease control. Social distancing, face masks, and personal hygiene are the most effective precautions, but maintaining these actions is not practicable in the long term. As a result, vaccination becomes the most effective eradication method. (1,2) Research into development of a vaccine for SARS-CoV-2 was undertaken immediately after the disease was identified.(3) The success of a vaccine depends not only on its efficacy, but also its acceptance.

However, vaccine hesitancy has become an important threat to global health, which was pointed out by WHO in 2019.(4) Several key factors behind vaccine hesitancy include fear or mistrust of the vaccine, underestimation of the value of the vaccine, and lack of access to the vaccine.(5) Pregnant women are at increased risk of severe disease, ICU admission, and ventilation when compared with non-pregnant patients of the same age.(6-8) Therefore, pregnant women are classified as a high-risk population for COVID-19 infection.(9) Regarding this information, pregnant women have not been included in any COVID-19 vaccine clinical trials to date.(10) Even so, public health authorities, including the ACOG and the SMFM recommend that COVID-19 vaccines should be available for pregnant women if they prefer to be vaccinated.(11,12)

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at any gestational age

Exclusion Criteria:

* Covid 19 suspicious patients at time of survey.
* patients refusing survey
* obstetric emergency.
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest.

Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.

AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
* Patients ≥ 21 and ≤ 75 years of age

Exclusion Criteria:

* Patient refusal
* Patients who will undergo any of the following:
* Single-stage implant reconstruction
* Combined autogenous tissue expander/implant reconstruction
* Patients with a history of prior irradiation
* Patients with a history of prior surgery with breast implants
* Patients with a history of prior axillary lymph node dissection
* Patients who are pregnant

The following eligibility will be confirmed at the time of surgery.

* Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia.
* Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients, diagnosed of ischemic stroke;
* Onset of stroke is less than or equal to 48 hours;
* There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
* Patients signed written inform consent

Exclusion Criteria:

* Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
* Iatrogenic stroke;
* Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
* The mRS score prior to this onset is greater than 1;
* Transient ischemic attack (TIA);
* SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
* Patients with severe mental disorders and dementia;
* ALT or AST is greater than 2.0×ULN; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min;
* Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
* Thrombectomy or interventional therapy has been applied or planned after this onset;
* Patients with malignant tumors or receiving concurrent antitumor treatment;
* Patients with severe systemic disease, life expectancy is less than 90 days;
* Allergic to edaravone , taurine or related excipients;
* Pregnant or lactating women;
* Have major surgery within 4 weeks before enrollment and not recovered enough to start the study;
* Participated in other clinical studies within 30 days before randomization;
* The investigators consider the patients are not suitable for this trial.
Acute Carotid Sinus Endovascular Stimulation II Study

The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter, prospective, non-randomized study that is being conducted to evaluate the feasibility of endovascular stimulation of carotid sinus nerves via an electrophysiology (EP) catheter advanced into the internal jugular vein (IJV). The current study investigates the hypothesis that intraoperative electrical stimulation of the carotid sinus from the IJV will result in an acute and dose-dependent reduction in blood pressure and heart rate.

All study objectives are being assessed during the intraoperative baroreceptor stimulation. No subsequent testing will be performed. The follow-up visit is only intended to assess for adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old
* Subject is hypertensive (defined as at least one in-office Systolic BP measurement ≥140 mm Hg or Diastolic BP ≥90 mm Hg within three months prior to enrollment
* Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures.
* Subject (or subject's legally authorized representative) is able and wiling to give informed consent

Exclusion Criteria:

* Subject has an ejection fraction (EF) less than 35% (by most recent echocardiography in the past 6 months) and there has been no change in clinical status relative to EF
* Subject is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
* Subject is enrolled or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager, documenting that there is not a concern that co-enrollment could confound the results of this trial.
* Subject is unable or unwilling to participate with study procedures
Burnout, Covid 19, Smarthphone Addiction

We investigate burnout syndrome and smartphone addiction in healthcare workers, including doctors, nurses, medical secretaries, security guards, and cleaning staff, who have been actively working from the beginning of the COVID-19 pandemic. target population included 1190 healthcare workers, from which a total of 183 agreed to participate in the study and met the inclusion criteria for participation. A sociodemographic data form, the Maslach Burnout Inventory, and the Smartphone Addiction Scale-Short Version were used as the data collection tools.

Significant differences in burnout syndrome were found in doctors and nurses. A relationship was observed between emotional burnout (EB), desensitization, and smartphone addiction, as well as between doctor and nurse group, and smartphone addiction. According to the linear regression analysis, it was determined that 17% of the change in the smartphone addiction score was related to age and 16% to master education level.Doctors and nurses experience the highest rate of burnout syndrome and smartphone addiction, and EB and desensitization were more likely to have smartphone addiction. Age and high education can affect smarthphone addiction

Eligibility Criteria:
Inclusion Criteria:

1. Being older than 18 years of age
2. Working as medical staff
3. Having no systemic or psychiatric disorders
4. No psychotropic substances use
5. No alcohol or substance use

Exclusion Criteria:

-
Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program

The aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. All subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27 - 30 Kg/m2 with 1 weight-related comorbidity and/or BMI 30 - 50 Kg/m2
* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation in English

Exclusion Criteria:

* Medications and supplements that affect body weight and appetite
* Type 2 diabetes on insulin treatment
* Contraindications to low calorie diet
* Any allergies to study product ingredients
* Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
To Evaluate the Efficacy and Safety of HUC3-053 in Patients with Dry Eye Syndrome

This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.

After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks.

This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.

During a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. Randomization will then occur as 1:1 where patients will be assigned to receive HUC3-053 or Hyalein Mini Drops given bilaterally five to six times a day. The treatment period is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age over 19
* Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.
* Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes
* Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit

Exclusion Criteria:

* The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c\>9%
* Wearing contact lenses within 72 hr of screening visit
* Pregnancy or Breastfeeding
The Serum Tissue Factor Level in Lung Cancer Patients as a Prognostic Factor

This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status with clinical staging and prognosis.

The staging of lung cancer was according to tumor size, involvement of lymph node and metastatic status. But there is a different prognosis in cancer patients of the same stage. The coagulation status of cancer patients was considered as an important possible prognostic factor. So in this study, we want to evaluate patients' coagulation status and find the relation of coagulation status and cancer status.

We thus propose a prospective study using coagulation factors in order to search for the relationship between cancer stage and pre-coagulation status in Taiwanese lung cancer patients. We will also evaluate the potential use of tissue factor as a prognosis predictor in lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly-diagnosed lung cancer
* Serum from cancer-free healthy volunteers

Exclusion Criteria:

* Chronic renal failure or end-stage renal disease \[ESRD\] (creatinine \[Cr\] \> 2 )
* Hyperlipidemia on statin therapy
* Acute myocardial infarction
* Tapal or Plavix use
* Active thromboembolic event
* Severe liver disease (\> child B)
A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.


Eligibility Criteria:
Inclusion Criteria:

* The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder
* Patients who have organic constipation
* Patients who received intestinal resection
Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital Cardiac Arrest

It has been shown that elevation of the heart's respiratory quotient after cardiac surgery is predictive of the complications occurrence. In addition, a high heart's respiratory quotient is predictive of anaerobic metabolism after cardiac surgery. In the wake of cardiorespiratory arrest, the presence of anaerobic metabolism reflected by hyperlactatemia is an important prognostic factor. However, this monitoring is invasive and discontinuous. The hypothesis of the study is to show that a rise in the respiratory quotient by a non-invasive monitoring is a factor of poor prognosis in the wake of a Cardiac Arrest.


Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years
* Admission to intensive care unit after a non-hospital cardiopulmonary arrest.
* Resumption of spontaneous cardiac activity.
* Non-opposition of the patient or his relatives

Exclusion Criteria:

* Pregnancy
* Prior neurological impairment
* Persons deprived of their liberty by a judicial proceeding, or administrative decision.
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate\<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate\<60 beats.min-1) every 30 seconds when systolic blood pressure was \<90% of baseline.

A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate\<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate\<60 beats.min-1) every 60 seconds when systolic blood pressure was \<90% of baseline.

Eligibility Criteria:
Inclusion Criteria:

* age 21-45 years old,
* weight 40-90 kg,
* height 145-170 cm

Exclusion Criteria:

* contraindications to spinal anaesthesia,
* allergy to drugs used in the study, and
* those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease