cyrilzakka/clinical-trials huggingface dataset:
Effects of Pilates Method in the Range of Ballerina's Turnout

A high degree of turnout is desired by many dancers, because enables an efficient weight transfer; provides an excellent extension and control; and reduces the risk of injury when used properly. The dancer's body conditioning is worked and acquired through various types of training, among which stands out the Pilates Method. Thus, the aim of the study is to determine the effect of a training program of Pilates Method in the range of ballerinas' turnout. The study will be conducted with young dancers, between 10 and 14 years, who practice classical dance twice a week. They will be randomly divided into two groups: intervention and control, but only the intervention group will do Pilates classes. To verify the extent of the turnout, tests will be applied in both groups, before the start of Pilates classes (pre-test) and after 24 sessions (post-test). In the evaluation protocol will be collected kinematic data, while performing the movements of demi plié and elevé. Anthropometric variables of height and body mass will be obtained; and also the extent of the passive and active turnout in dancers.


Eligibility Criteria:
Inclusion Criteria:

* be female; age between 10 and 14 years; have practiced classical ballet classes for at least three years; attend classical ballet classes at least twice a week; have a minimum frequency of 80% during the whole intervention period.

Exclusion Criteria:

* present some injury during intervention period and data collection; have more than two consecutive absences in classical ballet and Pilates classes; not to continue with their routine of physical activities throughout the intervention period.
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens

The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, post menopausal women ages 45 to 70

Exclusion Criteria:

* Male subjects
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
* Hb \<100g/L, TSAT\>=20%, and ferritin \>=100 mcg/L at screening.

Exclusion Criteria:

* anticipating to go on renal replacement therapy;
* anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
* uncontrolled hypertension;
* congestive heart failure;
* active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC \< 0.70

* Male or female patients aged ≥ 40 years
* Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
* Patients who present
* Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)
* Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
* Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
* Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
* Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
* Written informed consent obtained

Exclusion Criteria:

* Pregnant or lactating females or females at risk of pregnancy
* Unstable patients who developed an exacerbation during the last 4 weeks
* Inability to carry out pulmonary function testing
* Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
* Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
* Patients with a QTc interval (Bazett's formula) at the screening visit electrocardiogram (ECG) test \>450 msec
* Cancer or any other chronic disease with poor prognosis and /or affecting patient status
* History of alcohol or drug abuse
* Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
* Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
* Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
* Patients treated with any non-permitted concomitant medication
Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Eligibility Criteria:
Inclusion Criteria:

-Patients with Haemoglobin A1c (HbA1c) \[Japan Diabetes Society (JDS) value\] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Exclusion Criteria:

-Patients contraindicated for alogliptin.

1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
3. Patients with a history of hypersensitivity to any ingredient of alogliptin.
Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)

A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.

Long-lasting insecticidal nets (LLINs) are the established vector control product for malaria control. In Bomi County Liberia, LLINs have been distributed but malaria prevalence in children under 5 remains high, with prevalence in study villages found to be 42% in April 2014. The major malaria vector species are resistant to pyrethroid insecticides approved for use in LLINs, and new control measures with non-pyrethroid active ingredients may protect the population.

Eligibility Criteria:
Inclusion Criteria:

* Child resides in village
* Child presents with parent or guardian

Exclusion Criteria:

* Child or guardian has history of Ebola exposure
* Child has 3 symptoms of Ebola
Adipose Expression of Leptin, Adiponectin and IL-6 and Plasma Levels of Adipocytokines in Women With and Without Polycystic Ovary Syndrome (PCOS)

The purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators investigated lean and obese women with and without PCOS.


Eligibility Criteria:
Inclusion Criteria:

* women with PCOS according to the Rotterdam criteria

Exclusion Criteria:

* other known diseases
Comparison of Erector Spinae Plane Block and Intravenous Patient-controlled Analgesia in Percutaneous Nephrolithotomy

The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times.

ASA I-III patients aged 18-65 years who underwent percutaneous nephrolithotomy at Van Yüzüncü Yıl University Faculty of Medicine were included in the study.

The patients were informed about the study during the preoperative evaluation. In the randomized single-blind closed-envelope study, 30 patients ineach group and a total of 60 patients were included. Standard general anesthesia procedure was applied to all patients. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.

VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, p1, 3, 6 and 12 hours after the operation.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I-III,
* Between 18-65 years old,
* Percutaneous nephrolithotomy surgery,
* Patients who agreed to participate in the study

Exclusion Criteria:

* Obesity (BMI≥ 35)
* Coagulopathy
* Active Infection
* Drug allergies
* Pregnancy
* 65 years and older
Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

The investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. The investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus patients (as defined by WHO)
* Diet, oral hypoglycaemic or insulin therapy
* Undergoing elective and urgent coronary artery bypass surgery

Exclusion Criteria:

* Non-diabetics
* Emergency and redo CABG
* \< 18 years
* Pregnancy
* Dialysis-dependence
* History of CVA/TIA \< 6 months
* Heart valve disease requiring surgery
* STEMI \< 3 months
The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease

The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Sleep quality impairment is a known risk factor for memory impairment. There is increasing evidence of a link between measurable sleep parameters, in particular a reduction of slow waves of deep sleep in cognitive deficits. Also, breathing pauses during sleep are associated with increased daytime sleepiness and cognitive impairment. This observational study is intended to establish a possible link between subjective memory disturbances and altered sleep quality or respiratory breaks during sleep. In the run-up to this study, they performed a special MRI scan of the head and a lumbar puncture (removal of nerve water) in a different context. The aim of this imaging study and the new biomarker in brain water was to investigate the function of the blood-brain barrier that occurs in Alzheimer's disease. The results of the studies on the quality of sleep should be evaluated in the context of this study in connection with the findings of the MRI examination and lumbar puncture.

Eligibility Criteria:
The eligibility criteria are defined by the study protocol from the observational study DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).
EFFECTIVENESS OF ORAL HYGIENE INSTRUCTIONS GIVEN BY AI-GENERATED VIDEOS VS. TRADITIONAL APPROACH IN PERIODONTAL PATIENTS

Patients attending Dubai Dental Hospital and requiring nonsurgical periodontal therapy will be invited to take part in the study. Potential participants will be screened and selected based on the inclusion and exclusion criteria

The aims of the randomized controlled trial are:

1. To compare the influence of AI-generated instructions versus traditional methods in improving the oral hygiene habits of patients diagnosed with periodontitis
2. To assess the time and cost effectiveness of applying AI-generated oral hygiene instructions in daily practice
3. To evaluate the level of patients' engagement, preference, and satisfaction with technology-based interactions vs. patient-doctor interaction

Research design

* Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
* Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.

The study will involve two stages, 1) Digital Avatar creation and 2) Clinical component.

The participants will be randomly allocated to two equal sized groups (30 per group) using computer-generated numbers:

Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics resident.

Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice.


Eligibility Criteria:
Inclusion Criteria:

Aged 18 or over.

Diagnosed with gingivitis or generalized periodontitis, Stage I-IV and Grade A-C.

Good compliance and commitment to attend follow-up review appointments.

Willing to provide informed consent.

Exclusion Criteria:

Received periodontal treatment in the last 12 months.

Received systemic anti-inflammatory or antibiotic treatment in the last 3 months.

History of malignancy, radiotherapy, or chemotherapy.

Pregnant or lactating women.

Use of medication known to cause gingival overgrowth.

Participants that require prophylactic antibiotic.
Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing

Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors have referred them for a right heart catheterization (RHC). Heart catheterization involves inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube, called a catheter, is guided through the IV into the blood vessel and guided to the heart (sometimes this procedure can be done through a vein in the groin instead). Once the catheter is in place, small instruments can be inserted into the catheter to measure the pressures in different areas of the heart. These measurements can help the doctor diagnose possible problems with the heart functioning.

The purpose of this study is to evaluate the measurements provided by a device, called Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. While the device has been approved for use in any patient, it remains possible that patients with PH will have differences in the way the device calculates measurements. In this study, the investigators will compare the in-the-body (right heart catheterization) measurements to the non-invasive, outside-body measurements provided by the NICOM device to evaluate any differences.

The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the right heart catheterization procedure that is scheduled as part of the patients' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and up
* have Pulmonary Hypertension (PH)
* Scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH

Exclusion Criteria:

* unable or unwilling to give informed consent
Ultrasound Efficacy in Moderate Rheumatoid Arthritis

The objectives of this research study are to determine the frequency of low synovitis scores by ultrasound in patients with Rheumatoid Arthritis in moderate or high disease activity and to compare physician treatment recommendations for patients before versus after receiving ultrasound results. Participants will answer questionnaires about their disease activity and complete a musculoskeletal ultrasound in accordance with the study procedures.

The purpose of this research study is to determine whether ultrasound technology can improve treatment decisions for patients with rheumatoid arthritis who have elevated disease activity scores. To do so, the investigators will be evaluating rheumatoid arthritis patients with moderate to high disease activity and how ultrasound scans can reveal any new information about the severity of their arthritis. Patients will answer questionnaires to gauge their disease activity as well as the depression, fatigue, and pain they experience as a result of their arthritis. The patients will then undergo an ultrasound examination to evaluate their synovitis levels, which will then be made available to their physician. Physicians will be asked about their disease activity assessments and treatment recommendations before and after ultrasounds are performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the American College of Rheumatology's 2010 criteria for rheumatoid arthritis. They must be undergoing treatment with a disease-modifying anti-rheumatic drug, and their Clinical Disease Activity Index (CDAI) must be greater than 10 while their swollen joint count must be less than or equal to two.

Exclusion Criteria:

* Patients with evidence of large joint (knee, hip, shoulder, elbow) disease activity, including warmth and swelling, and patients who have had a joint MRI or musculoskeletal ultrasound in the past 3 months will not be eligible to participate in the study.
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants

The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.

Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from parent or legal guardian
* Birth weight 500 to 1250 g, inclusive
* Age 3 - 5 days (49 to 120 hours), inclusive
* Expected to require IV access for medical care through day of life 14

Exclusion Criteria:

* Already received or likely to receive prior to first infusion of Study Drug:

  * IGIV or \*immune globulin for prevention of Hepatitis B
* Receiving an agent for prevention of staphylococcal catheter related or nosocomial infections (e.g., vancomycin)
* Active sepsis, as defined by one of the following:

  * culture proven early onset sepsis and not clinically stable; or
  * clinical signs of sepsis and pending blood cultures; if the blood cultures are negative after 48 hours and the infant is clinically stable, the infant may be randomized
* Severe congenital anomaly, where the prospects for survival, the medical complications and treatment, would compromise the study related outcome evaluation(s) in the Investigator's opinion
* Diagnosis of congenital immunodeficiency
* Evidence of significant fluid overload or significant volume depletion
* Evidence of abnormal renal function as measured by serum creatinine \> 1.6 mg/dL