cyrilzakka/clinical-trials huggingface dataset:
Effect of Pilates Exercises On Fatigue In Post Menopausal Women

Pilates is a system of exercises using special apparatus, designed to improve physical strength, flexibility, and enhance mental awareness. Regular exercise of post-menopausal women has benefits of increased cardio-respiratory fitness, increased muscle strength and endurance, reduced body fatigue, improved morale, and increased ability to perform daily tasks with greater force.Thus the main objective of regular exercise is prevention of physical deterioration and optimizing functional capacity to improve overall postmenopausal women's quality of life.

Fatigue has a negative impact on quality of life of postmenopausal women. Fatigue can be an overwhelming experience impacting the physical, emotional and social aspects of them. Fatigue can prevent them from carrying out their usual activities of daily living ,Menopause-related fatigue can be caused by changing estrogen levels, but it is often compounded by common symptoms, chief symptoms among these are vasomotor symptoms, which are experienced by up to 80% of women and include hot flashes and night sweats that can disrupt sleep , Pilates exercise considered a complementary therapy to treat fatigue in postmenopausal women. Pilates exercises are a healthy and effective method for improving the functional capacity, flexibility, fatigue, depression and quality of life of post menopause women ,They include stretching and strengthening exercises with controlled and precise movements that have indicated both mental and physical effects on post-menopausal women healthThe purpose of physical training using Pilates is to improve body functioning based on core strengthening that include rectus abdomens, transverse abdomen, erector spine, diaphragm and pelvic floor muscles. The six basic principles of Pilates exercise are centralization, concentration, control, precision, respiration and flow .

Eligibility Criteria:
Inclusion Criteria:

. All participants will be sedentary.

* All participants' ages will be ranged from 50-55 years.
* All participants body mass index will not exceed 30 kg/m2.
* All participants will be medically stable.
* All participants will be able to ambulate independently.
* All participants suffering from fatigue, when assessed with fatigue assessment scale (FAS) their scores should be \>22.

Exclusion Criteria:

* • Post-menopausal women who have Uncontrolled hypertension.

  * Post-menopausal women who have Thyroid gland disorders.
  * Post-menopausal women who have History of syncope or arrhythmia induced by physical exercise.
  * Postmenopausal women who have any mental, neurological, vestibular, cardiovascular disorders or metabolic disease.
  * Postmenopausal women whose visual or hearing impairment did not allow possibility of intervention.
  * Postmenopausal women who have been received hormonal replacement therapy or any drug known to affect their physical activity.
  * Post-menopausal women who have any other problems that make it impossible to perform physical exercises.
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation

Lactic acidosis is a common phenomenon occurring during orthotopic liver transplantation (OLT), especially during the anhepatic and early postreperfusion phases. However, little drugs effectively decrease the degree of lactic acidosis when it happens. The aim of this study is to explore whether glucose-Insulin-Potassium(GIK) infusion can relieve metabolic acidosis and improve perioperative outcome in patients undergoing OLT.

Intraoperative metabolic acidosis begins soon after graft reperfusion and persists for several days. The current standard treatment for severe acidosis during OLT is NaHCO3, although it may compromise myocardial performance, exacerbate lactic acid accumulation and cause central nervous system demyelination. Surgical procedure is a primary source of endogenous lactic acid production, especially visceral ischemia originating from anhepatic stage. The present study thus hypothesized that GIK solution may improve metabolic acidosis in OLT patients through its unique effects of metabolic alleviation. Patients for orthotopic liver transplantation was enrolled and received either GIK or placebo. GIK or placebo infusion started after anesthesia induction. Intraoperative measures were mean arterial pressure, HR, arterial blood gases, lactate, glucose, Na, liver and renal function indexes. Outcome measures were time to tracheal extubation, intensive care unit, length of stay, complications, hospital length of stay, requirement for postoperative plasma transfusion, retransplantation, and perioperative mortality.

Eligibility Criteria:
Inclusion Criteria:

* patients who were to undergo OLT

Exclusion Criteria:

* diabetes mellitus, hyperkalemia on arrival (K+ \> 5.5 mEq/L) and the inability to give informed consent
Photovoice for Spinal Cord Injury to Prevent Falls

Falls is a health crisis that costs health care systems billions of dollars each year. This crisis is especially relevant for people living with spinal cord injury (SCI) as most of these people will fall at least once per year. Falls can cause injury and a fear of falling, which often causes people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI is understudied, and as a result, there is a lack of treatments to address their high fall risk. We will evaluate a new treatment for fall prevention. Photovoice is a method that uses photographs and dialogue to share experiences, understand an issue and promote positive change. Specifically, we aim to evaluate the effects of photovoice on confidence related to balance and falls, occurrence of falls, participation in daily activities and quality of life among people living with SCI. We also aim to understand participants' experiences with photovoice as a fall prevention program. To achieve these aims, 40 individuals living with SCI will participate in this study. Participants will complete a six-week photovoice program that involves photo assignments, individual interviews and group meetings. The program will be led by a person with SCI and a member of the research team with a background in physical or occupational therapy or kinesiology. Questionnaires will be used throughout the study to measure confidence, participation and quality of life. The occurrence of falls will be tracked for 12 weeks before and after the photovoice program. At the end of the study, each participant's experiences with photovoice will be collected through interviews. The proposed research will address a critical gap in SCI rehabilitation, namely effective fall prevention, to improve well-being after SCI. The research findings will inform the need for, and design of, a larger clinical trial, and has the potential to transform fall prevention after SCI.

The data sharing plan includes sharing study-related information with people living with spinal cord injury. Dissemination activities targeting this group will be developed with input from study participants (e.g., photos may be converted to printed and online art displays and shared through community SCI organizations). Dissemination initiatives will also target health care administrators and rehabilitation clinicians. Study information will be shared with the professional associations representing these groups. To reach researchers in the SCI rehabilitation field, study findings will be presented at academic conferences and in rehabilitation-focused journals.


Eligibility Criteria:
Inclusion Criteria:

1) traumatic or non-traumatic, non-progressive SCI \>12 months ago; 2) American Spinal Injury Association Impairment Scale (AIS) rating A-D; 3) ≥18 years old; 4) community-dwelling; 5) experienced \>1 fall since sustaining a SCI; 6) free of other conditions besides SCI that affect balance (e.g., vestibular disorder); 7) understand spoken English; and 8) have access and ability to use the internet
Post-operative Anxiety and Depression Among Older Adults Who Undergo Surgery for Fragility Fractures

Patients who present with falls and fractures can experience increased symptoms of depression and anxiety due to the trauma of falling, hospitalisation and surgery. Additionally after surgery, patients may be limited in their mobility, resulting in a loss in their independence which can lead to further feelings of frustration and helplessness. In this study we want to know how common this problem is among older people who are admitted to hospital with broken bones and subsequently receiving surgery.

We will use a questionnaire called the Hospital Anxiety and Depression Scale (HADS) to explore this. We will recruit 60 patients for this study, 30 participants who received operative management and a further 30 participants who did not receive surgery for comparison. Patients who are not able to consent to the study or those who are not able to complete the questionnaire will not be recruited. We will collect routine data from the patients to provide a description of the patients that we are studying. Patients will complete the HADS questionnaire once during their hospital stay and then in 1 month's time. We will contact patients through telephone for the 1 month follow up.

This study will enable us to determine how common are the symptoms of anxiety and depression among this group of patients. This will help raise awareness of the problem which may prompt further intervention and management plan to address this important issue.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and above
* Received operative or non-operative management of fragility fracture
* Able to provide written consent

Exclusion Criteria:

* Patients receiving end of life care
* Patients with known diagnosis of severe dementia and/ or lack capacity to consent
* Non-fragility fracture
Dose-response: Exercise Therapy on Hip Osteoarthritis

Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate.

We hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.


Eligibility Criteria:
Inclusion Criteria:

* At least three month since debut of the disease
* Age above 45 years
* Ability to complete the intervention

Exclusion Criteria:

* Pain above 4 on VAS during gait
* Pregnancy
* Autoimmune disease
* Cardiovascular disease
* Respiratory disease
* Metabolic disease
* Neurological signs
* Planned hip-replacement surgery within the next year
* Received exercise therapy within the last 3 months
Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.


Eligibility Criteria:
Inclusion criteria:

* Moderate to severe AtD (confirmed by a dermatologist) according to the Hannifin and Rajka criteria or Eichenfield revised criteria.
* Onset of AtD symptoms occurring at least 6 months prior to Screening, with stable disease for at least 1 month prior to Screening.
* Eczema Activity Severity Index greater than or equal to (\>=)16; Investigator Global Assessment score \>=3.
* Group 1- Biologic Naïve: Topical First Line Treatment: Documented recent history (within 6 months before Screening) of: a) either an inadequate response (IR) to out-patient treatment with at least one topical treatment (intermittent topical corticosteroid, topical calcineurin inhibitor), topical inhibitors or Phosphodiesterase 4 inhibitor (Crisaborole); b) or that topical treatments were otherwise not recommended.
* Group 2- Dupilumab-Inadequate Responder: Documented history of an IR to dupilumab: a) either following at least 16 weeks of treatment according to the Investigator's judgement; b) or intolerant to dupilumab owing to adverse events.

Exclusion Criteria:

* Other than AtD, the presence of a significant skin morbidity that will influence the Investigator's ability to assess the severity of the disease (e.g. psoriasis, confirmed or suspected cutaneous T-cell lymphoma, autoimmune bullous disease, fixed drug reaction and Stevens Johnson Syndrome).
* Participants with any uncontrolled medical conditions, other than AtD, that in the opinion of the investigator puts the participant at unacceptable risk or will likely interfere with study assessments or data integrity. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study.
* Treatment with biologic agents (investigational and marketed monoclonal antibodies) within 12 weeks or 5 pharmacokinetic half-lives (whichever is longer) prior dosing on Day 1.
* Treatment with Janus Activated Kinase inhibitors (e.g. baricitinib, upadacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to dosing on Day 1.
* Mycophenolate mofetil, azathioprine, methotrexate, or calcineurin inhibitors within 4 weeks of Screening.
Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery

National, randomized, open, parallel, multicenter clinical trial of two comparison groups that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the surgery time in antiaggregated patients with proximal femur fracture.

The experimental group will undergo surgery as soon as platelet aggregability, according to the PLATELETWORKS® method is correct within 24-48 hours.

The control group will undergo surgery according to the usual practice of the center taking into account the safety time of the antiplatelet agent.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients of both sexes
* Patients with a proximal femoral fracture requiring surgery
* Patients receiving antiplatelet agents at the time of admission to the emergency room: AAS\> 100 mg / d (Aspirin®), Trifusal\> 300 mg / d (Digren®; Edigen®), clopidogrel (Plavix®), prasugrel ®), ticagrelor (Brilique ®) and ticlopidine (Tiklid ®).
* Patients who give their signed consent

Exclusion Criteria:

* Multiple fractures
* Pathological fractures
* Patients receiving vitamin K antagonist oral anticoagulants (warfarin and acenocoumarol) or new oral anticoagulants (apixaban, rivaroxaban and dabigatran) or who have acquired congenital or acquired coagulopathy
* Patients with AAS ≤100mg, trifusal ≤300mg
* Patients who do not give their informed consent or their legal guardian
Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries

General anaesthesia results in developement of atelectasis in dependent areas of the lungs exposing patients to an increased risk of hypoxaemia.During pelvic robotic surgeries pneumoperitoneum and steep trendelenburg position further increases atelectasis. Lung Ultrasound imaging is a promising , noninvasive , non-radiant, portable tool to study intraoperative lung atelectasis.

Methodology -In the Operation Room 5 lead Electrocardiogram (ECG) , Pulse Oximetry (SPO2 ) , Noninvasive blood pressure (NIBP), End tidal carbon di Oxide (ETCO2 )and core temperature will be monitored , intravenous assess will be established with large bore cannula ,under Local anesthesia Radial artery cannulation will be performed , standard general anesthesia with oral cuffed Endotracheal tube and Intermittent Positive Pressure Ventilation (IPPV ) will be provided to all patients.Anaesthesia will be induced with Fentanyl 1-2 mcg/kg-1 , Morphine 0.5mg/kg-1 ,Propofol sleeping dose , Atracurium 0.5mg/kg-1,and maintained with Air/O2 Sevoflurane , Propofol infusion @100- 150 mcg/kg-1 to maintain Bispectral Index (BIS) between 40 -60 and atracurium infusion to maintain Train -of - Four (TOF Ratio) \< 0.5 Baseline Lung Ultrasound Imaging will be performed to record 4 point Lung aeration score ( 0= Normal lung /No aeration loss , 1= mild aeration loss, 2=moderate aeration loss ,3=severe aeration loss ) at T1 - 5 minutes after induction of anaesthesia and before docking robotic instruments in 6 basal zones in both lungs ( 3 zones in each lung ) and labelled as Zone I (Right anterior basal ) Zone II ( Right lateral basal) and Zone III (Right posterior basal) . Zone IV ( Left anterior basal) , Zone V (Left lateral basal ) , Zone VI ( Left Posterior basal ).T2 - Lung Ultrasound Imaging will be performed to record aeration score after removal of robotic arms at the end of robotic surgery and before extubation in 6 basal zones in both lungs.Ti Arterial blood gas 5 minutes after induction of anesthesia and before docking robotic instruments.Tii -Arterial blood gas 5 minutes after the end of robotic surgery and de docking robotic instruments.All patients will receive Positive End Expiratory Pressure (PEEP) 5 cms of water (H2O) intraoperatively . Intraabdominal Pressure will be maintained at 15 cms H2O. Any decrease in Oxygen saturation \< 96 % and intervention required will be noted. At the end of surgery , neuromuscular blockade will be reversed , trachea extubated and patient shifted to Postanaesthesia Care Unit.

Eligibility Criteria:
Inclusion Criteria:

\* Patients undergoing Robotic Pelvic surgeries under general anaesthesia

Exclusion Criteria:

* Lung consolidation
* Lung fibrosis
* Cardiac failure
* Previous thoracic surgery
* BMI \> 32
APPEndicitis and Laparoscopic Criteria; APPEL Study

A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis. However, laparoscopic criteria for determining appendicitis are not defined. If there is any doubt about the presence of an abnormal appendix, it is usually removed. However, an appendectomy of a negative appendix has a certain morbidity and for that reason it should be avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis appendicitis during diagnostic laparoscopy.

The UMCG hospital protocol of suspicion of appendicitis includes a diagnostic laparoscopy. The laparoscopic inspection of the appendix is carried out according to a specific protocol. In case of appendicitis the appendix is removed laparoscopically, a normal appendix is not removed. The primary outcome of the study is: appendicitis according to pathologic examination following appendectomy, or appendicitis according to clinical follow-up in case the appendix is not removed.

The clinical diagnosis of appendicitis in the follow-up should be confirmed radiologic examination (ultrasound, CT-scan, MRI) or by a re-operation.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients who will undergo a diagnostic laparoscopy for suspicion of appendicitis
* No age or gender limits

Exclusion Criteria:

* Elective scheduled appendectomy
* Unable to give informed consent
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on global cognitive function.

Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility Criteria:
Inclusion Criteria:

* born, raised and currently living \<1300m
* No overnight stays at altitudes \>1500m 4 weeks before the study

Exclusion Criteria:

* previous altitude intolerance \<3000m
* pregnancy
* health impairment, which requires regular treatment
Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia

The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or non-pregnant, non-breastfeeding female, at least 18 years of age
* Patient must agree to use contraception and/or birth control if sexually active
* Patient may not be on lipid-lowering therapies at least 6 weeks prior to study and must have a fasting LDL-C 130 mg/dl or greater at Screening
* Patient must have an average of two fasting LDL-C measures greater than/equal to 130 mg/dl but less than/equal to 210 mg/dl with a difference in the two measures less than/equal to 15%. Patient may not have a fasting serum triglyceride less than 300 mg/dl during Pre-treatment Period
* Patient's BMI must be greater than/equal to 18.5 but less than 35.0 at Screening
* Patient must complete a physical exam, 12-lead ECG, and other laboratory tests (including pregnancy test) with no clinically-significant findings prior to the first dose of study medication
* Patient agrees to comply with the TLC diet
* Patient completes a 6-week washout of previous lipid-lowering medication including over-the-counter products

Exclusion Criteria:

* Patient has a medical condition that is prohibited per protocol or a condition that the Investigator believes may limit the patient's ability to participate in the study
* Patient has a TSH level \>1.5 X the upper limit of normal
* Patient has history of cardiovascular or coronary artery disease, uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, or patient has history of NYHA Class III or IV congestive heart failure
* Patient is diabetic or presents with fasting blood glucose greater than/equal to 126 mg/dl at any time prior to randomization
* Patient has uncontrolled hypertension with a systolic blood pressure greater than/equal to 180 mm Hg or diastolic blood pressure greater than/equal to 110 mmg Hg at two study visits prior to the first dose of study medication
* Patient has a 10-year CHD risk of \> 20%
* Patient has ALT or AST \> 1.5 X the upper limit of normal prior to randomization
* Patient has a history of alcohol or drug abuse within 12 months of Screening
* Patient has used a prohibited medication (per protocol) during the 14-day Pre-treatment Visit