cyrilzakka/clinical-trials huggingface dataset:
Effects of Tai Chi Exercises With Cycling in Subacute Stroke

Stroke, a debilitating cerebrovascular event, frequently leads to severe motor and sensory impairments resulting in a diminished quality of life. Tai Chi, an ancient Chinese martial art known for its slow, flowing movements, emphasis on breath control, and mindfulness, presents an intriguing avenue for stroke rehabilitation. While cycling exercises facilitates muscle control of the lower limbs, which may allow putting more weight on the affected leg while standing, also beneficial for stroke survivors.

This is two-arm parallel design randomized controlled trial. Participants will be selected by non-probability consecutive sampling technique, fifty stroke patients meeting the inclusion criteria will be randomly allocated into two groups (experimental and control) by online randomizer tool. The experimental group will receive tai chi exercises with cycling exercises and the control group will receive tai chi exercises alone. Treatment session of 60 min will be given 3 times a week for 6 weeks. The following primary and secondary assessment tools will be used, Functional Reach Test and Berg Balance scale for balance, Dynamic Gait Index and Wisconsin Gait Scale for gait assessment and Stroke Specific Quality of life (SS-QOL). The data will be analyzed using SPPS software version. 26.

Eligibility Criteria:
Inclusion Criteria:

* Participants with the age ranged between 50-65 years.
* Participants with either gender.
* Patients who are in the sub-acute phase (from 2 weeks to less than 3 months after onset).
* No visual field defect.
* No abnormality of the vestibular organs.
* No orthopedic disease.
* The ability to understand and perform the exercise as instructed by the researcher
* Muscle power of at least grade three.
* Could walk at least 10 meters with or without assistive devices.

Exclusion Criteria:

* Chronic stroke patient.
* Participants with aphasia and cognitive impairment.
* Cardiac arrhythmias
* Any condition for which exercise is contraindicated
* Fracture of the lower limb.
* Participants who are currently participating in another clinical trial or research study.
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.


Eligibility Criteria:
Inclusion Criteria:

* Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
* Patient is to be discharged home.
* Age 18-70 Enrollment will be limited to adults \<70 years because of the increased risk of adverse medication effects in older adults.
* Pain duration \<2 week
* Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
* Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
* Functionally impairing radicular LBP: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

* Not available for follow-up
* Pregnant
* Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
* Allergic to or intolerant of investigational medications
* Chronic steroid use
* Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR \<60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)
Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.


Eligibility Criteria:
Inclusion Criteria:

For non-lens wearers:

* Normal eyes.
* Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
* Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
* Other protocol-defined inclusion criteria may apply.

For contact lens wearers:

* Currently wearing soft contact lenses.
* Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
* Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
* Reports only occasional use of contact lens rewetting drops or artificial tears.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

For non-lens wearers and contact lens wearers:

* Pregnant.
* Participating in another research study.
* Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
* Other protocol-defined exclusion criteria may apply.
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

This trial was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese subject aged 18-45 years (both inclusive)
* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
* Body mass index 19.0-24.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period
Continuous Glucose Monitoring in Intensive Care Unit

Glucose control in ICU patients is challenging and exerts high burden on the nursing staff. Continuous glucose monitors (CGM) are now approved and widely available in the outpatient setting for patients with diabetes mellitus. However, only minimal evidence on CGM performance, reliability and benefit in achieving desired glucose control in the intensive care setting has been gathered so far.

The objective of this study is to assess whether the use of CGM helps to maintain blood glucose levels within the time in range recommended for patients in the intensive care.

In addition, accuracy of the sensor will be evaluated and compared to measurements of blood glucose by standardized biochemistry methods.

This will be a non-commercial, investigator-driven, active comparator-controlled, randomized, open-label and non-inferiority clinical study to be performed at the Institute for Clinical and Experimental Medicine in Prague. Patients that are being prepared for one of the surgical procedures mentioned below will be asked to participate:

1. pancreas surgery - total or partial pancreas resection
2. orthotopic liver transplantation
3. simultaneous pancreas and kidney transplantation
4. patients with diabetes mellitus undergoing major surgery

After obtaining the informed consent, they will be randomized into one of two treatment groups:

1. Study arm with continuous glucose monitor added to standard treatment, where the values obtained by CGM will aid in adjusting the insulin treatment.
2. Control arm with blinded continuous glucose monitor that will be treated according to the standard of care, where the CGM data will be collected in a blind fashion and evaluated after completion of the follow-up.

Each surgical group will be randomized and evaluated separately and independently.

Continuous glucose monitoring will be initiated after completing the surgical procedure in order to avoid interferences during the procedure.

Insulin therapy will be adjusted according to the standard in-house ICU protocol for insulin dose adjustment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, of 18 to 80 years of age, undergoing one of the following surgical procedures and post-operative care at ICU:

   1. pancreas surgery - total or partial pancreas resection
   2. orthotopic liver transplantation
   3. simultaneous pancreas and kidney transplantation
   4. patients with diabetes mellitus undergoing major surgery
2. Patient must have signed the Patient Informed Consent Form.

Exclusion Criteria:

Any criteria that would disable surgical procedures involved
Mulligan Mobilization With Movement Method in the Treatment of Shoulder Problems

To determine whether Mulligan mobilization with movement (MWM) and Conservative treatment CT give different results on pain, ROM, and functional activities in participants with shoulder problems.

Shoulder problems are one of the common orthopedic problems. Patients with shoulder problems experience an increase in pain and a decrease in joint movement and functionality. With conventional treatment, patients' symptoms improve. However, the MWM is one of the manual therapy techniques frequently used to reduce pain in musculoskeletal system problems. It is extremely important to evaluate patients' functionality after rehabilitation. Although there are studies comparing the effect of MWM in the literature, studies evaluating patient-specific functionality are also limited.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old,
* Having any shoulder problems (impingement, rotator cuff syndrome, glenohumeral joint problems, etc.),
* Having a history of shoulder pain lasting at least 3 months, and volunteering to participate in the study.

Exclusion Criteria:

* Having systemic or degenerative disease, a neurological disease, and
* Having more than one upper extremity pathology.
Evaluation of Brain Functional Changes With 18F-FDG PET and Cognitive Processes After Brain Radiotherapy for Cavernous Sinus Meningiomas and Non-secreting ACTH Adenomas

The use of radiotherapy for irradiation of all or part of the brain, in the treatment of extracerebral intracranial neoplasms, is growing rapidly, both due to the increase in diagnoses of primary tumors thanks to new imaging methods, and for the increase in the number of new cases of cancer.

Cerebral neurotoxicity linked to radiation treatment is an adverse effect that is not always accurately evaluated based on the prognosis of some brain pathologies. The progression of diagnostic and therapeutic methods has recently generated a modification of therapeutic protocols and some categories of radiotreated patients may incur acute, subacute and late effects. These include manifestations of acute neurological deterioration, more frequently effects classified as sub-acute such as "somnolence syndrome" (from 2 to 6 weeks after the end of treatment) and finally late effects, which manifest themselves as a variety of neurological deficits in particular a decline in cognitive brain functions, probably linked to a direct effect on neurons or the result of an imbalance in the connections between white matter and cerebral gray matter. In relation to the myelin function of conduction of axonal transmission, the result of radio-induced damage in this site would manifest itself with a significant reduction in the speed of transmission of the impulse and consequently with a dramatic worsening of cognitive processes. In particular, clinically, radiologically and in some cases also from a pathological point of view, the damage from rays on the brain parenchyma would have aspects similar to those of a degenerative pathology such as Alzheimer's disease. These effects are usually measured on the patient by subjective assessments or using neuropsychological tests. The use, not only experimental, of neurophysiological methods for the study of cognitive processes in neurology and in degenerative disorders such as dementia is increasingly frequent. These methods are based on the study of specific neuronal circuits involved in the cognitive functions of the human brain in normal conditions and in the presence of pathology. Among the techniques that allow an analysis of molecular alterations in vivo there are scintigraphic ones, i.e. nuclear medicine ones, including single photon emission tomography (SPET) and positron emission tomography (PET).


Eligibility Criteria:
Inclusion Criteria:

* lesion dimensions compatible with a GAmma Knife treatment or tomotherapy;
* adequate hematological, hepatic and renal function;
* signed informed consent.

Exclusion Criteria:

* patients \< 18 years
The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.

This multi-center study will evaluate the long-term clinical and radiographic outcomes of Early Onset Scoliosis (EOS) and other Early Onset Spinal and Chest Wall Deformities in a large population of patients.

The study will attempt to answer the following clinical questions:

1. How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:

   1. Age groups
   2. Etiologic groups
   3. Treatment types including operative and non-operative methods
   4. Patients who receive definitive spinal fusion versus those who do not
2. How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:

   1. Age groups
   2. Etiologic groups
   3. Treatment types including operative and non-operative methods
   4. Patients who receive definitive spinal fusion versus those who do not
3. How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:

   1. Age groups
   2. Etiologic groups
   3. Treatment types including operative and non-operative methods
   4. Patients who receive definitive spinal fusion versus those who do not
4. What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?
5. For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?
6. What are the mechanisms that cause rod breakage in growing rod constructs? (This study question is a collaborative research study with the U.S. Food and Drug Administration).

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples
* Patients of any age and any diagnosis who undergo casting
* Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine
* Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring \> 25 degrees. Observed and braced patients included

Exclusion Criteria:

* Cervical spine anomalies alone will not be included
* Patient/family is unwilling to participate in the study
Preanalgesic Effect of Gabapentin in Total Knee Repair

The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee replacement who received pain management by the following modality:

  * Intravenous patient-controlled analgesia (IV-PCA) opioid
  * Local femoral nerve block with 1.5% mepivacaine 20 ml and 0.5% ropivacaine 20 ml

Exclusion Criteria:

* Age \< 18 years old
Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

* A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.
* No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier

Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.

Eligibility Criteria:
Inclusion Criteria:

* A successive series of patients referred for routine colonoscopy

Exclusion Criteria:

* Age under 18 years
* Pregnant women
* Persons with pacemaker
* Unwillingness to restrict sedation to "on demand"
* Inability to understand the information given
XELOX for Metastatic Breast Cancer

Both capecitabine and oxaliplatin have single agent activity in breast cancer. The combination has improved activity in other solid tumors. This study seeks to assess the activity of the combination in breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* preserved organ function
* good performance status
* no more than one prior therapy
* no active brain metastasis

Exclusion Criteria:

* No prior capecitabine or oxaliplatin
* no con-current therapy
European CMR Registry

1. The main aim of the first specific protocol initiated by the European CMR registry, suspected CAD, is to demonstrate that patients presenting for work up of suspected coronary artery disease, which have a completely normal CMR scan will have a low risk for cardiovascular events.
2. The main aim of the second specific protocol initiated by the European CMR registry, HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic cardiomyopathy(HCM).
3. This registry is sought to collect data on the general use of CMR in the European clinical practice, its safety and its therapeutic implications in a high number of cases to 1) substantiate the clinical yield of CMR and 2) to define additional clinical questions worth to be investigated in detail as additional specific protocols in the future.


Eligibility Criteria:
Inclusion Criteria:

- European clinical practice: Consecutive patients with accomplished CMR.

-Suspected-CAD: Consecutive patients with suspected coronary artery disease undergoing a combined CMR protocol including evaluation of LV function, assessment of myocardial ische¬mia by adenosine stress perfusion or high-dose dobutamine CMR and detection of myocardial infarction using contrast-enhanced CMR.

- HCM-SCD: Consecutive patients with hypertrophic cardiomyopathy undergoing a combined CMR protocol including LV function, rest perfusion, and detection of myocardial scarring by contrast-enhanced CMR. The diagnosis of hypertrophic cardiomyopathy is based on the demonstration of a hypertrophied, non-dilated left ventricle (wall thickness of at least 15 mm in adults or the equivalent relative to body-surface area in children) in the absence of another cardiac or systemic disease capable of producing a similar degree of hypertrophy. In adult relatives of the patients with hypertrophic cardiomyo¬pathy, a wall thickness of 13 mm or more will be considered a criterion for diagnosis.

Exclusion Criteria:

* European clinical practice: None
* Suspected-CAD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI.
* HCM-SCD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI. Patients with left ventricular hypertrophy of other causes (e.g. hypertension, valvular heart disease)
Effects of Vitamin B3 in Patients With Ataxia Telangiectasia

This clinical trial investigates the effects of nicotinamide riboside (vitamin B3) on the disease course of patients with ataxia telangiectasia.

Patients will be treated during four consecutive months with nicotinamide riboside (25mg/kg/day), followed by a washout period of two months.

Main study parameters/endpoints: Ataxia, dysarthria, quality of life, laboratory parameters.

Rationale: Ataxia Telangiectasia (A-T) is an autosomal recessively inherited neurodegenerative disorder, with a high cancer risk, that also affects the immune and respiratory system. Therapy for A-T is restricted to symptomatic treatment including rehabilitation care, combined with infection prevention and treatment, and screening for pulmonary dysfunction and malignancies. A-T is caused by mutations in the ATM gene. The ATM protein plays a pivotal role in more than 100 different biochemical processes, among which cellular energy metabolism, cell signaling, and DNA repair. Nicotinamide adenine dinucleotide (NAD+) is an essential molecule in many of these processes and studies have shown that NAD+ deficiency plays a role in disease mechanisms underlying DNA repair disorders such as A-T. NAD+ is available in food, but can also be synthesized in the body from its precursors nicotinamide, nicotinic acid, and nicotinamide riboside (NR), as a group called "vitamin B3". Treatment of experimental A-T animal models with NR showed beneficial effects. The aim of this study is to investigate whether treatment with NR during a period of six months may have positive effects on the disease course of patients with A-T.

Objective: To investigate the effects of NR on the disease course of patients with ataxia telangiectasia.

Study design: Single center, interventional, explorative, open-label proof of concept study.

Study population: Patients with A-T (age \>2 years).

Intervention (if applicable): Patients will be treated with nicotinamide riboside (25mg/kg/day), during four consecutive months, followed by a washout period of two months.

Main study parameters/endpoints: Ataxia, dysarthria, quality of life, laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* A-T patients who visit our outpatient clinic.
* Genetically confirmed diagnosis of A-T by the identification of pathogenic mutations of the ATM gene.
* Age ≥ 2 years or older and bodyweight ≥ 12 Kg.
* Informed consent.

Exclusion Criteria:

* Additional medical condition or illness that impair the patient's ability to participate in the study (e.g. actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant hematological or biochemical abnormalities different from the usual abnormalities in A-T)
* Elevated serum transaminases (\> 2 times upper limit of normal)
* Participation in another interventional study at start of the study or during the study
* Pregnancy.
* Breast feeding.