cyrilzakka/clinical-trials huggingface dataset:
Teaching Method With Simulation in Gestational Diabetes Mellitus Management

Gestational Diabetes Mellitus is one of the common risk factors of pregnancy and occurs for the first time during pregnancy. It adversely affects maternal and fetal health and causes an increase in morbidity and mortality rates. In this context, it is very important to identify possible risks for GDM, plan, implement and evaluate initiatives, provide emergency crisis management in a short time without damage, and increase the self-confidence of midwives. In recent years, interest in simulation methods and skill acquisition training in midwifery education has increased. Research; In the management of GDM, to increase the satisfaction and self-confidence level of midwifery students in learning, to evaluate the simulation design and educational effectiveness, it was planned to use the scenario-based near-realistic simulation method in the form of randomized control-intervention quantitatively, and in qualitative design to evaluate the students' views on the method and educational effectiveness. The research will make it easier for midwifery students to intervene with the patient in a shorter time, with confidence and with sufficient clinical skills, and patient safety will be increased. In addition, it will allow the reduction of erroneous clinical practices and malpractices. This study aims to evaluate the satisfaction and self-confidence status of midwifery students and the educational effectiveness of the scenario-based simulation method with high closeness to reality in GDM management and to examine the opinions about this method to fill the gap in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,
* Being a midwifery 3rd year student and taking the "risky pregnancy" course,
* Those who have no previous clinical experience in GDM (Health College, Health Vocational High School Graduate, etc.)

Exclusion Criteria:

* To fill in the data collection forms of the study incompletely,
* Not participating in all applications of simulation training with high proximity to reality,
* Desire to leave the research.
Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)

The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.

It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a primary renal graft from a deceased or living, related or unrelated donor and who require basiliximab induction therapy
* Cold ischemia time \< 30 hours

Exclusion (Non inclusion) criteria:

* Patients undergoing multi-organ transplantation, including both kidneys, or who have previously undergone organ transplantation, including renal transplantation
* Patients receiving a graft from a non-heart-beating donor
* A-B-O incompatible graft or positive T cell crossmatch
* Patients receiving a graft from an expanded criteria donor according to the UNOS definition (donor older than 60 years or donor aged between 50 and 60 years and presence of at least 2 of the following factors: hypertension, serum creatinine concentration ≥ 132 µmol/mL, cardiovascular cause of death)
* Positive anti-HLA antibodies (Luminex) prior to transplantation
* Patients whose original renal disease was primary focal and segmental hyalinosis or was related to atypical hemolytic uremic syndrome
* EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-)

Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of a Non-Invasive Central Venous Pressure Device and Physical Examination in Patients With Chronic Kidney Disease

The primary objective of this study is to determine whether a correlation exists between the Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous pressure (CVP), and assessment of CVP via physical examination.

The estimation of central venous pressure (CVP) is part of routine clinical examination. Central venous pressure is the indication of the pressure in the right atrium of the heart and it can be measured by determining the height of the blood column in the internal or external jugular vein. Clinical use of CVP has a wide range of applications including diagnosis of heart failure, pleural effusion, hypervolemia, hypovolemia, and sepsis. The standard clinical method for attaining CVP non-invasively is the physical examination of jugular venous pulse (JVP). The JVP provides a useful estimate of the CVP.

It is often difficult to identify the internal jugular vein to determine the JVP. The internal jugular vein is deep and adjacent to the carotid artery and pulsations derived from the artery may obscure the subtle venous pulsations. Manoeuvres to differentiate carotid pulsation and jugular pulsation are helpful in identifying the internal jugular vein, however determining the JVP based on the internal jugular vein examination is difficult.

Examination of the external jugular vein to determine JVP is an appealing alternative. The external jugular vein is easier to visualize and studies have demonstrated that this is a reliable method that correlates highly with catheter measured CVP.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at the time of enrolment
* Chronic Kidney Disease patients and healthy volunteers
* Participants should be able to provide written informed consent
* Subject is termed eligible as determined by Pre-Screening Phase (as defined in protocol)

Exclusion Criteria:

* Unable to identify external jugular vein (EJV)
* Unable to identify internal jugular vein (IJV)
* Unable to access right side of subject's neck
* Allergic to adhesive tape
* History of central vein stenosis
* Undergoing photodynamic therapy (PDT)
* Presence of an arteriovenous fistula
Efficacy of Adding Early Scapular Muscles Strengthening Exercise After Rotator Cuff Repair on Scapula Kinematics

The study investigates the effect of accelerate rehabilitation protocol(adding scapular strengthen exercises (lower trapezius and serratus anterior) from week 1) after arthroscopic rotator cuff repair on scapular upward rotation during shoulder elevation.

the study will consist of 2 group Both groups will participate in an accelerated rehabilitation program starting the first week after surgery till week 12, but they will follow different protocols. Accelerated rehabilitation protocol with Early Strengthening of Scapular stabilizer muscle (LT and SA) and GH Active range of motion protocol will be starting gradual active ROM for GH from week 3 post operative till week 12 and gradual scapular muscles strengthening exercises (serratus anterior, lower trapezius) from day 1 while Accelerated rehabilitation protocol with Delay strengthening of Scapular stabilizer muscles and Active GH range of motion protocol will start active ROM for GH and scapular activation exercises (protraction, retraction, and depression) from week 6 till week 12. Patients will wear the sling for the first 6 weeks or as the physician recommends and remove it only during the session and home program.

7 The outcomes will be measured 3 times, at week 3 as a baseline for assessment, then reassess at weeks 6, and 12

Eligibility Criteria:
Inclusion Criteria:

1. Patients after arthroscopic rotator cuff repair.
2. Both gender between age 30 to 50 years
3. Small and medium supraspinatus tear
A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* Uncontrolled diabetes type I and II
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.
The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients

Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it. In recent years, there has been more and more recognition of a very high prevalence of CV calcification in the ESRD population. Many observational cohort studies have shown that CV calcification in these patients can predict mortality, CV mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may result in vessel calcification. Calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of CVD. Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. Thus, life safety and quality would be influenced severely and early detection might prevent future amputation. Uremic patients also have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in HD patients, are needed for future management and preventions of CV related morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Patients at National Taiwan University Hospital (NTUH)
2. patients who have received HD more than 3 months
3. Patients who sign the informed consents

Exclusion Criteria:

1. Patients who refuse to sign informed consents
2. Patients who refuse to draw additional blood for research
Effects of Caffeinated Gum on a Basketball-specific Tests in Basketball Players

This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free throw accuracy and basketball -specific performance. Fifteen trained basketball players with at least a top 8 national ranking were recruited to be participants in this study. After 2 simulation tests to familiarize the experimental procedure, we employed a double blind, randomized crossover design to divide participants into caffeine trial (CAF) and placebo trial (PL). The CAF trial chewed caffeine gum containing 3 mg/kg for 10 minutes, whereas the PL trial chewed a placebo gum without caffeine. After 15 minutes rest, the stationary free throw shooting test, countermovement jump, t-test, 20-meter segmented dash test, squat in the flywheel device and running based anaerobic sprint test were conducted.


Eligibility Criteria:
Inclusion Criteria:

* 6 years of professional basketball training and with at least a top 8 national ranking
* 6 months of continuous training,
* 3 months of recovery from sports injuries such as strains and sprains.

Exclusion Criteria:

* Non-specialized basketball players.
* has not trained regularly for the past 6 months.
* has recovered from from a sports injury for less than 3 months, or had epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.
* Subjects with previous caffeine allergy response.
Crassostrea Gigas for Liver Health

This study aimed to observe whether a hydrolyzed oyster extract improves liver health in participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total of 96 participants will be randomly allocated to active (oyster) or placebo group (1:1). Each group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary outcome will be the change in ALT level and secondary outcomes will be; (1) ratios of participants with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT); (2) the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the changes in serum lipids; (5) the changes in antioxidant enzymes.


Eligibility Criteria:
Inclusion Criteria:

* Age over 19
* AST, ALT, and GGT levels above the upper limit of the normal but less than 3 times the upper limit of the normal
* Participants with normal physical activity who sign an informed consent form
* Fatty liver detected by ultrasound

Exclusion Criteria:

* Allergic reaction to oyster
* Uncontrolled diabetes mellitus
* Active viral hepatitis and any liver diseases that can affect trial outcomes (positive for HBs Ag or HCV Ab)
* Liver cirrhosis of Child-Pugh class B or C
* Chemotherapy or radiation therapy for cancer within 6 months
* Cholelithiasis
* Systemic medications that can affect liver function such as INH, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen and diclofenac within 4 weeks
* Medication of cholagogues, cholelitholytics \& hepatic protectors, antidotes, detoxifying agents, and drug abuse (drugs used in substance dependence) within 4 weeks
* Alcoholism or excessive alcohol intake of more than 168 g/week in men and 112 g/week in women
* Kidney diseases or serum creatinine level above 2.0 mg/dL
* Uncontrolled hypertension or angina pectoris or myocardiac infarction
* History of bowel resection (not including surgery on simple appendicitis)
* Medication of antipsychotic drugs
* Herbal medication within 2 months
* Pregnancy or breastfeeding
* Participation of other clinical trial(s) within 1 months from screening day
* Uncooperativeness
* Intake of dietary supplements within 4 weeks
Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)

This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT).

There is a potential role to systematically implement MRI to establish appropriate workflow of the implementation for tumor motion management in liver SBRT. Compared to CT, MRI has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. MRI solely based liver SBRT will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21
* Patients with primary stage I, II, III liver cancer or metastatic tumor in the liver from any cancer site
* Signed, specific informed consent prior to study entry
* Women of child bearing potential must have a negative serum pregnancy test

Exclusion Criteria:

* Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel.
* Pregnant or breast-feeding women are excluded.
* Subjects who have difficulty lying flat on their back for extended periods of time
MR Fingerprinting for Diagnostic of Prostate Cancer

The diagnostic pathway for suspected prostate cancer relies greatly on radiological imaging. Establishment of magnetic resonance fingerprinting (MRF) has the potential to significantly improve patient experience and outcomes. MRF is a novel and innovative approach to a long-standing challenge of recording and reconstructing MR image

The aim is to conduct a clinical pilot study in which patients will be scanned using the newly refined MRF sequence in addition to the conventional scanning protocols.

The patient is at the center of all medical interventions and innovations. For those with prostate cancer, the pathway for new patients has scope for improvement. MRI is an important and necessary part of that pathway, but scanning capacity is often stretched, and there is need for effective and efficient scan techniques. Beyond mere detection of lesions, the modality has potential to differentiate and categorize the clinical significance of prostate cancer. By virtue of quantitative imaging, the determination of biomarkers could lead to a non-invasive method of prostate cancer diagnosis. The Prostate Imaging Reporting and Data System (PIRADS) scoring is a standardized system of acquiring and categorizing multi-parametric-MR images (mp-MRI) of the prostate. The PIRADS system works to grade to clinical significance of prostate cancer, however this relies on qualitative information.

Patients referred for a typical MRI of the prostate will in addition receive the MR Fingerprinting scan, which will add about 8 minutes to their time on the scanner. The direct comparison of the fingerprint maps and multi-parametric images can then be made. Conclusions will be drawn with focus to potential improvement of the PIRADS protocol.

The main aim of the project is therefor to implement, validate, and optimize sequences for MR Fingerprinting of the prostate.

Eligibility Criteria:
Inclusion Criteria:

- Men referred to an MR examination for prostate cancer diagnostic

Exclusion Criteria:

- None
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.

In this two-month follow-up study, the patients with overactive bladder will be randomly assigned into two groups (solifenacin or oxybutynin in their usual doses) and will be assessed with respect to baseline characteristics and complaints before treatment. After initiation of the treatment at first and second months follow-up visits the patients will be reassessed with respect to compliance, satisfaction, degree of improvement, reasons for dropouts, number and severity of side effects.

Eligibility Criteria:
Inclusion Criteria: Women between 18-70 years of age, diagnosed to have overactive bladder (presence of at least two of the following three main criteria: urgency, urge incontinence, frequency and nocturia)

Exclusion Criteria: Presence of stress urinary incontinence, patients who are still using a drug for overactive bladder, pregnant women, women in postpartum period (women on lactation), patients who have closed angle glaucoma, patients with chronic constipation, having allergy to the ingredients of the drugs, patients having the contraindicated conditions listed in the printed instructions of the drugs.

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Assessing the Ability of the T-SPOT®.TB Test

The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 680 subjects (based on previous enrolment rates of approximately 300-350 subjects enrolled for 50 active TB and 50 active TB excluded).

Study Duration: 6 months

All subjects enrolled in this study will be men or women, aged 18 years or older.

Eligibility Criteria:
Inclusion Criteria: Cohort 1a and 1b

* • Must be at least 18 years of age

  * Must be able to provide informed consent
  * Must be able to provide a minimum of 10 mL of whole blood at each visit (16mL for immunocompromised i.e. HIV+)
  * Must be T-SPOT.TB positive
  * First visit suspect TB subjects with no prior history of TB diagnosis Inclusion Criteria: Cohort 2a and 2b
  * Must be at least 18 years of age
  * Must be able to provide informed consent
  * Must be able to provide a minimum of 10 mL of whole blood at each visit (16mL for immunocompromised i.e. HIV+)
  * Must be T-SPOT.TB positive
  * No prior history of TB diagnosis

Exclusion Criteria: Cohort 1a and 1b

* • Negative in the T-SPOT.TB test

  * Previous or pre-existing confirmed TB diagnosis
  * On anti-TB treatment for more than 1 week\*
  * Not meeting inclusion criteria Exclusion Criteria: Cohort 2a and 2b
  * Negative T-SPOT.TB test
  * Previous or pre-existing confirmed TB diagnosis
  * On anti-TB treatment
  * Symptoms of active TB
  * Not meeting inclusion criteria
Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer

The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.


Eligibility Criteria:
Inclusion Criteria:

* no prior treatment for metastatic disease
* PS 0-2
* measurable disease

Exclusion Criteria:

* neuropathy \> or equal to grade 2
* concomitant radiation therapy or other systemic cancer therapies
* brain mets