cyrilzakka/clinical-trials huggingface dataset:
Whole- Body Vibration Among Egyptian Elderly With Sarcopenia

To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly.

Participants will be assigned randomly into two groups of equal number (study group A and study group B ) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects.

c- Subject selection 84 patients with sarcopenia will participate in this study and will be divided randomly into three equal groups with 28 participants in each group.

d- Groups: Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.

Group C (Control Group): will receive conventional progressive resistance exercises and diet modification life style.

During the study, the participants will receive study information form, instructions and signed the consent form.

Eligibility Criteria:
Inclusion Criteria:

1. patients age older than 60 years
2. patients with Skeletal muscle index (SMI) below 8.87 kg/m2 and 6.42 kg/m2 in males and females, respectively.
3. patients with hand grip strength below \< 27 kg in men and \< 16 kg in women.
4. patients with no regular exercise habit for more than 3 months .
5. patients with gait speed \> 0.8 m/s.
6. patients with proper conscious and cognition that will be detected by using Mini Mental State Examination(scores \> 21).

   -

Exclusion Criteria:

acute injury. 2- severe heart diseases. 3- pacemaker. 4-history of orthopedic surgery of the lower limbs and/or fracture less than 1 year earlier.

.5 - inability to walk without assistance. 6-neurological diseases or acute conditions that would interfere with testing and training.

7-patients with improper conscious and cognition that will be detected by using Mini Mental State Examination(scores \< 21).

8- patients who cannot exercise at all due to conditions like deep vein thrombosis or blood clotting issues.

9- patients with severe illnesses that influence assessments and interventions, such as those with disabilities or musculoskeletal conditions (such as fracture, dislocation, osteoporosis, and rheumatoid arthritis).

10- People with major spinal conditions or surgical histories, such as cauda equina syndrome, tumor, vertebral fracture, inflammatory joint disease, spondylolisthesis, and ankylosing spondylitis.

Every participant will get a primary checkup to get a full picture of their health, find out if there are any restrictions, and decide whether they can take part in the study.

-
Exercise Intervention Combined With Metformin in the Treatment of Type 2 Diabetes

Background: Both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (T2DM), while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients. This study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients.

Background: Both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (T2DM), while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients. This study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients.

Methods: A total of fifty-seven T2DM patients with a mean age of 46.2±8.3 years were randomized to three study groups; each group included nineteen patients. The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted thrice weekly for consecutive twelve weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), and maximal oxygen uptake (VO2max) were evaluated before and after study intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM
* Glycated hemoglobin (HbA1c) ≥8.0%
* A previous inactive lifestyle
* Not receiving insulin or diabetic medications except for metformin
* Metformin dosage of 1000-1500 mg daily.

Exclusion Criteria:

* Cancer
* Pregnancy
* Corticosteroid medications
* Uncontrolled systemic diseases
* Any physical limits that affect exercise training
A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell

Infants often present to the hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, known as brief resolved unexplained event. Many studies have tried to address why infants have these symptoms and if there is a way to prevent them from happening again. Currently, there is no clear agreement on the most common cause of these symptoms or how to prevent them. Some studies have suggested that gastroesophageal reflux can cause these symptoms. The investigators are conducting a study of infants who are admitted to Boston Children's Hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, symptoms that could be reflux. The investigators want to determine if these symptoms can be prevented by changing the way infants are fed, either by giving them a formula to treat reflux or by thickening their feeds to treat reflux. The goal of the study is to determine if different types of feeding interventions prevent infants from coming back to the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event

Exclusion Criteria:

* Patients with any pre-existing significant medical diagnosis (congenital heart disease, known neurologic impairment with or without seizure disorder, other congenital anomalies)
* Patients with any prior hospitalization for BRUE
* Patients with food allergies such that they cannot be on a milk or rice based diet
* Any patient exclusively breastfed because change to a formula or adding thickening is not possible unless patients choose to pump breast milk and stop all nursing
Computed Tomography-Guided Nasotracheal Intubation Procedure

Background: Nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition. The present study aimed to evaluate the effectiveness of Computed tomography-guided nasotracheal intubation in predicting tube advancement difficulty and preventing epistaxis.

Material and Methods: 60 maxillofacial surgery patients were included in the study. The space where the tube will be passed in the internal nasal valve region was measured horizontally (distance between inferior concha and septum) and vertically (distance between inferior concha and hard palate) by Computed Tomography. The patients were divided into two groups, 'easy' (n=28) or 'difficult' (n=32), according to the effort required to advance the tube through the nasal passage.

ROC analysis was performed, and cut-off values were determined to reveal the distance values at which difficulty may be experienced while advancing the tube. The cut-off values were 1.09 cm and 0.39 cm for the vertically and horizontally distances, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 who underwent bimaxillary orthognathic surgery
* defined as ASA (American Society of Anesthesiology) I or II

Exclusion Criteria:

* The lack of preoperative CT scans
* airways evaluated and considered difficult by the anesthesiologist
* airways assessed and considered not appropriate for right angle endotracheal (RAE) tube with7.0 mm internal diameter
* history of sinusitis or head trauma
* anticoagulant therapy
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon

Previous study showed that afternoon cosyntropin testing was associated with a sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a short 2.5 cm tube.

In earlier studies investigators claimed that subnormal cortisol response using plastic tubes might result from cosyntropin adherence to the tube and loss of the delivered dosage. It was shown that 21.6-58.6% of ACTH dosage had not been recovered when pushed through 20.3 cm plastic tube, and loss of ACTH may be up to 70% when cosyntropin was delivered through a plastic 30 cm scalp vein set.

Moreover, it was previously shown that afternoon cosyntropin testing was associated with a sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a short 2.5 cm tube.

Eligibility Criteria:
Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

Clinical suspicion of hypoadrenalism Medical condition or treatment that might alter blood cortisol levels Pregnancy
Immersive Virtual Reality in Simulation-based Bronchoscopy Training

The purpose of this single-center randomized study is to investigate whether bronchoscopy training in an immersive Virtual Reality (iVR) environment will make the surgeon better at handling distractions and increase the quality of the bronchoscopy.

The participants will be stratified according to gender and randomized into two groups. Both groups will initially train on the bronchoscopy simulator without VR. Afterwards the intervention group will train in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.

Afterwards both groups will be tested in the iVR environment in a test scenario


Eligibility Criteria:
Inclusion Criteria:

* Residents working in Denmark in thoracic surgery and pulmonary medicine
* Participants are required to have a medical license.

Exclusion Criteria:

* Previous participation in trials involving bronchoscopy training.
* Experience with independent bronchoscopy.
* No informed consent.
* Unable to speak Danish on a conversational level.
SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians.

Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality.

NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment.

A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction.

The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure requiring non invasive ventilation
* ICU patient equipped with an arterial line.

Exclusion Criteria:

* Contra-indications to NIV:
* impaired consciousness
* absence of patient cooperation
* severe hemodynamic instability
* vomiting
* facial lesions
* indication for immediate intubation
* Acute neurological problem
* Poor short term prognosis
Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Outcomes in Older Adults

Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. One of the home-based exercise programs that was found effective in reducing the risk of falling and the rate of subsequent falls in older adults is the Otago exercise program (OEP). The OEP is an individualized home based retraining program that works mainly on balance and lower extremity strength through several progressive resistive exercises.

Therefore, this study aims to assess the effectiveness of this program on falls prevention and falls-related outcomes using a Randomized Controlled Trial in a sample of Jordanian older adults.

❖ Research ethics: This study got the ethics approval from the IRB at Jordan University Hospital at University of Jordan. A consent form that contains the study procedures will be prepared and signed from all participants. To insure the privacy of participants, every older adult will be assigned a study identification number. All results will be stored in a locked cabinet/computer only accessible by the researchers.

❖ Participants: Data will be collected prospectively from older adults in Jordan. Older adults will be approached to complete the program via Jordan University Hospital, community based organizations (e.g. Help-Age International Jordan) and social media platforms such as Facebook and WhatsApp.

❖ Design:

● This will be a single blinded randomized controlled trial study with 2 groups: treatment group who will receive the OEP plus health awareness videos every 2 weeks and a control group who will receive the same health awareness videos only every 2 weeks.

1. Eligible older adults will be recruited for the RCT.
2. Baseline assessment will be conducted by a blind assessor.
3. Participant will be randomized using a computer-based randomization tool into either the treatment (OEP) or the control group (awareness videos). The treatment group will receive the OEP for 8 weeks plus health awareness videos. The control group will receive the same health awareness videos every 2 weeks for 8 weeks. The treatment group will be trained by a researcher different from the one conducting the assessments.

The following topics will be covered in the health awareness videos:

* Be physically active.
* Maintain healthy bones, joints and muscles.
* Combat depression.
* Sleep.

Eligibility Criteria:
Inclusion Criteria:

* Adults who are 60 years of age and older.
* Who can read and write in Arabic language.
* Who are able to walk outdoors with no more support than a single point cane.

Exclusion Criteria:

* Who have a serious orthopedic condition (e.g., recent lower limb surgery, severe arthritis of a lower limb) or major neurological disorder (e.g., stroke with unilateral or bilateral paresis, Parkinson disease or multiple sclerosis) that could restrict functional mobility.
* Who are unable to comprehend study information and consent processes due to any illness including dementia.
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.


Eligibility Criteria:
Inclusion Criteria:

* Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
* Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
* Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
* Patients who signed written informed consent.

Exclusion Criteria:

* Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
* Severe arrhythmias;
* Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
* Pulmonary hypertension due to venous occlusive disease.
* Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
* Pregnancy and lactation
* Age below 18
The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study on Hebei Province before and to evaluate the durability of protection of the bivalent HPV vaccine on 90m and 114m after dose 1.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;
2. Participants can fully understand the study content and sign an informed consent form；
3. Able to comply with the requests of the study;

Exclusion Criteria:

1. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.
2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
OM202JP Clinical Study of KNP2002

The goal of this clinical trial is to evaluate safety and efficacy of KNP2002 in patients with common warts aged 15 to 50 years old.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 15 to 49 years old
* Subjects with common warts on the upper or lower limb
* Subjects who agree to contraception from obtaining consent to 4 weeks after the end of administration
* Subjects who have given their voluntary written consent to participate in this clinical trial

Exclusion Criteria:

* Subjects with 5 or more warts on the upper or lower limbs
* Subjects who are scheduled to undergo treatment such as physical therapy or chemotherapy for warts
* Subjects with a history of allergy to topical skin preparations
* Subjects with a history of malignant tumor within 5 years before administration of study drug
* Subjects with any of the following diseases: Malignant tumor; Serious heart disease; Poorly controlled diabetes/hypertension
* Women who are pregnant, may become pregnant, or are breastfeeding
Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration

The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)


Eligibility Criteria:
Inclusion Criteria:

* Cancer patient who has plan to receive first cycle of cisplatin \>= 60 mg/m2
* Normal serum creatinine and creatinine clearance \>= 50 ml/min
* Age \< 75 years old
* Serum albumin \>= 3 g/dl
* Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist

Exclusion Criteria:

* The patient who receives other chemotherapy with adminstration volume higher than 500 ml
* Prior heart failure or known left ventricular ejection fraction \> 50%
* Prior renal dysfunction within 3 months
* Uncontrolled renal disease
* current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months
Effect of the Aquaretic Tolvaptan on Nitric Oxide System

Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones.

The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal dominant polycystic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

1. Caucasian men and women
2. Age between 18-65 years
3. ADPKD, diagnosed by genetic testing of PKD1 (\>85%) or PKD2 mutations, or by ultrasonography:

   1. patients with negative family history for ADKPD and more than 10 cysts in each kidney and no extrarenal or renal findings that suggest causes to cyst formation.
   2. patients with positive family history for ADPKD:

      * 15-39 yr of age and at least 3 or more unilateral or bilateral.
      * 40-59 yr of age and 2 or more cysts in each kidney.
      * 60 yr of age and at least 4 cysts in each kidney.
4. Kidney function corresponding to CKD stages 1-3(eGFR\> 30 mL/min/1,73 m2),
5. BMI between 18.5 and 35.5 kg/m2.

Exclusion Criteria:

1. Clinical signs of diseases in the heart, lungs, endocrine organs, brain or neoplastic disease,
2. clinically significant abnormalities in blood or urine sample at the inclusion
3. previous cerebrovascular insults,
4. previous clinical evidence for aneurysm
5. Alcohol or drug abuse,
6. smoking,
7. pregnancy or breastfeeding,
8. clinically significant changes in the electrocardiogram,
9. medication except antihypertensive agents and oral contraceptives,
10. blood pressure\>170/105 mmHg despite treatment with metoprolol and/or amlodipine.