cyrilzakka/clinical-trials huggingface dataset:
Turkish Version of Mini-BESTest, Validity and Reliability for Adult Participants With Sensoriomotor Impairments

The aim of this study is to present the Turkish version of miniBESTest which evaluates the reasons of balance deficit and postural control. Accordingly, a practice of validity and reliability on adult patients with sensoriomotor impairments will be performed by utilizing the Turkish version of miniBESTest in this study.

Physical therapists encounter postural control problems frequently. These problems require multifaceted assessment. Therefore, the treatment of postural control problems should be planned after a multifaceted assessment.

Balance Evaluation Systems Test (BESTest) comprises 27 items and evaluate all components of postural control. MiniBESTest is a shortened version of BESTest with 14 tasks. MiniBESTest still addresses almost all components of postural control and can be performed 15 min. MiniBESTest is one of the most common methods which practiced on adult patients.

The aim of this study is to present the Turkish version of miniBESTest which evaluates the reasons of balance deficit and postural control. Accordingly, a practice of validity and reliability on adult participants with sensoriomotor impairments will be performed by utilizing the Turkish version of miniBESTest in this study.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of sensoriomotor impairment Able to walk with or without an assistive device (e.g. walker, cane, ankle-foot orthosis...) Ability to tolerate the balance tasks without fatigue.

Exclusion Criteria:

Severe cognitive or communication impairments Hemodynamic or clinical instability.
Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting

optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting.

One of the gold standards for analgesia following cesarean delivery is intrathecal morphine, which is not devoid of complications namely postoperative nausea and vomiting. We evaluated the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after cesarean delivery under spinal bupivacaine plus morphine anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* females
* 18-40 years of age
* elective cesarean delivery under bupivacaine spinal anesthesia

Exclusion Criteria:

* renal disease
* preeclampsia
* liver disease
* cardiac disease
* Coagulopathy
* chronic cough
* nausea
* vomiting
* patient refusal
Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm

There is a need to determine actual compliance of direct oral anticoagulants and how to improve this to reduce risk of stroke in patients with atrial fibrillation. Mobile health tools have been implemented world-wide in various patient populations as means of reducing cardiovascular risk and improving disease management. Results of these interventions have been mixed with some interventions demonstrating significant improvement while others demonstrated no difference between the intervention group and the control group. More importantly, these studies indicate that implementation of mobile health tools is feasible in various patient populations and it may just be a matter of finding the correct intervention for a given disease state. The aim of this study is to increase awareness of atrial fibrillation as a means of improving compliance with anticoagulant medication.

The primary hypothesis of this study is that patients with atrial fibrillation will have improved compliance with apixaban therapy if they complete a daily measurement of heart rhythm via a smartphone electrocardiogram monitor, as compared to patients managed in a conventional manner.

Primary Endpoint

1. Primary Endpoint 1: is the percent compliance with apixaban therapy as measured by the amount of apixaban medication that was consumed per month. Compliance is defined as "the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen." Percent compliance will be measured as a continuous variable and strict cutoffs for 'compliant' and 'non-compliant' status will not be imposed.

   Secondary Endpoints
2. Secondary Endpoint 1: is the number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure. Given the low numbers of patients in this study, this will be a composite endpoint of all of these outcomes, since there is insufficient sample size to examine each outcome individually.
3. Secondary Endpoint 2: is the self assessment of atrial fibrillation symptom severity through the use of a standardized scale.

While the secondary endpoints are not directly related to the primary endpoint, there is a possibility that the intervention may lead to changes in health maintenance behavior, which may lead to differences in the secondary endpoints. While this study may not be powered to differentiate between these secondary endpoints, if a trend is noted, this may be hypothesis generating for future studies.

Eligibility Criteria:
Inclusion Criteria:

1. Non-valvular atrial fibrillation that is either paroxysmal, persistent or permanent
2. CHA2DS2VASc score of 2 or more
3. Eligible for therapy with apixaban for at least 6 months
4. Possession of a smartphone capable of pairing with the AliveCor Kardia cardiac monitor

Exclusion Criteria:

1. Contraindication to anticoagulation with apixaban for at least 6 months
2. No access to a smartphone capable of pairing with the AliveCor Kardia cardiac monitor
3. Unable to provide informed consent for this protocol
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)

This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years and \<= 75 years of age
* LDL-C concentration \>= 3.3 mmol/L (130 mg/dL) to \<= 4.9 mmol/L (190 mg/dL) at baseline.
* Triglyceride concentration \<3.99 mmol/L (350 mg/dL) at baseline.
* Documented coronary heart disease (CHD), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of MI; history of PCI (primarily PTCA with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-Q wave MI.
* Stable weight history for at least 4 weeks prior to entry into study at baseline.
* Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.

Exclusion Criteria:

* Body mass index (BMI) \>=35 kg/m\^2 at baseline.
* Subjects whose liver transaminases (ALT, AST) are \>1.5 times the upper limit of normal and with active liver diseases at baseline.
* Subjects with evidence of current myopathy (including subjects with CK\>1.5 times above the upper limit of normal) at baseline.
* Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline.
* Subjects with Type II diabetes mellitus who are poorly controlled (HbA1c\>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline.
* Subjects with Type I diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control.
* Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
* Female subjects who consume \>14 units and male subjects who consume \>21 units of alcohol per week.
* Female subjects who are pregnant or breast feeding.
* Subjects who have not observed the designated washout periods for any of the prohibited medications.
Remote Evaluation in Patients With Multiple Sclerosis

This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis.

The population of the research will be participants with multiple sclerosis. The 30-second sit-to-stand test will be performed in the participant's home environment. . Patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 seconds, standing until fully upright and then sitting until the hips touch the chair without the assistance of the hands. Inter-rater reliability will be assessed by two different raters in the same video interview. In contrast, intra-rater reliability will be evaluated by analyzing the number of repetitions recorded by the same rater in two different video interviews conducted 24-28 hours apart.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with MS according to the McDonald criteria by a neurologist
* having and being able to use a device with Internet access (e.g. smartphone, computer or tablet)
* having EDSS between 1.5 and 6.5,
* being between the ages of 18-65.

Exclusion Criteria:

* Patients who have had a recurrence of the disease in the last 30 days,
* have an additional health problem (orthopedic, neurological, internal or cardiorespiratory) that prevents standing/walking,
* do not agree to participate in the study.
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Allocation: Randomized Stratified

Eligibility Criteria:
Key Inclusion Criteria:

* Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
* HCV RNA viral load ≥10,000 IU/mL
* No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
* No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
* Body mass index of 18 to 35 kg/m\^2
* Negative for HIV and hepatitis B virus

Key Exclusion Criteria:

* Evidence of decompensated liver disease
* Evidence of medical condition other than HCV contributing to chronic liver disease
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)

The purpose of the study is to evaluate the safety and efficacy of NGX-4010 administered at intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for the treatment of painful HIV-AN and PHN. Participation is limited to former study subjects from previous trials of NGX-4010 at selected sites.

Study C118 is a multicenter, open-label, single-arm study for subjects who successfully completed a previous NGX-4010 study and have not received open-label or blinded NGX-4010 study patches within the 12 weeks prior to study entry. One hundred eligible subjects will receive an initial open-label NGX-4010 study patch application and up to three additional open-label NGX-4010 applications at intervals of no less than 12 weeks, based on the presence or return of pain. Eligible subjects will have moderate to severe neuropathic pain secondary to HIV-AN or PHN, with average pain levels deemed appropriate for further treatment with NGX-4010 as judged by the Investigator.

Eligibility Criteria:
Summary eligibility criteria:

* Subjects must be in good health and have successfully completed a past trial of NGX-4010 with no past occurrence of adverse events that would contraindicate further treatment.
* The time between the last study patch on the previous study and the first study patch on this study must be at least 12 weeks.
* Topical pain medications are exclusionary and require washout prior to study patch application for this study.
* Chronic, nontopical pain medications are allowed but must be stable (not as needed) for a defined period prior to first study patch application.
* Other specific inclusion and exclusion criteria must be met prior to enrollment on the study.
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses.

Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success.

Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro.

Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus.

Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO

Main study parameters/endpoints:

1. Primary endpoint is device success at 30 days

   Defined by
   * Absence of procedural mortality AND
   * Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
   * Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
* Written informed consent

Exclusion Criteria:

* Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
* Multi-valve defects requiring intervention
* Clinically unstable and/or inotropic/vasopressor /mechanical support.
* Known mural thrombus in the left ventricle
* Presence of a mechanical aortic valve
* History of recent (within 1 month) stroke or TIA
A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury

The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury

This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit

Exclusion Criteria:

* Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.

Dermatomyositis (DM) and polymyositis (PM) are inflammatory disabling neuromuscular disorders. Despite partial benefit of pharmacological treatments, muscle strength, functional status and quality of life remain impaired. Although the use muscle exercises in (DM) and (PM) have been reported, its efficacy on disability and quality of life has not been proved.

Te aim of the study is to evaluate the benefit at mid term (12 months) of an active rehabilitation program administrated to patients affected by PM and DM.

Method: a 3 year prospective, multicentric, randomized controlled trial A program of 12 individual exercise sessions (3 per week during 4 weeks) is compared to conventional care. Patients are followed 12 month after the inclusion.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Dermatomyositis ore polymyositis according to the International Myositis Assessment and Clinical Studies Group
* functional impairment (an HAQ score greater than 0.5)
* stability of muscle impairment
* medical insurance

Exclusion Criteria:

* no recent inflammatory activity
* other chronic disease
* cognitive impairment
* patients who participated to a rehabilitation program before inclusion
Prediction of Patient-specific Outcomes After Interventional neuroRadiology Procedures

Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency.

An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain. It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There will then be a neurological deficit (paralysis) more or less important corresponding to the affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a part of the body (upper or lower limb) and sometimes is associated with facial paralysis and/or language disorders.

A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also occur later in life due to illness, head injury, oral contraceptives or certain lifestyle habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress or strenuous exercise can serve as a trigger.

Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using imaging to perform the medical procedure and thereby limit openings and their associated risks. This specialty has a growing place in modern medicine.

In order to improve the quality of care, patient safety and functional outcomes, it is necessary to keep patient information. A database storing patient data from the NRI department will make it possible to track patients since their arrival at the Brest University Hospital. Thanks to this structured database, clinical studies will be facilitated, making it possible to advance knowledge of the pathology and its treatments.

From the bibliographical research, we can conclude as to the current state of the facts: there is currently no method for predicting the functional results of the interventional neuroradiologist's patient based on automated learning.

A strategy based on an innovation programme is therefore being implemented over several years, the first stage of which is the retrospective data study which was approved by the ethics committee on 12/09/2019 and the second stage is the prospective data study.

This innovation program requires the most complete and homogeneous data possible.


Eligibility Criteria:
Inclusion Criteria:

- Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy, with in both cases, a treatment procedure carried out in the interventional neuroradiology department of the Brest CHRU.

Exclusion Criteria:

* Age \< 18 years old
* Incapacitated patients of full age (under guardianship or curatorship)
* Refusal to participate
* Follow-up impossible
Ultrasound Evaluation of the Rotator Cable and Associated Structures.

This study will use healthy volunteers and patients with shoulder problems (pain or impaired movement). Ultrasound will be used to image and document the appearance of both normal and abnormal shoulder structures.

The purpose of this study is to document normal and abnormal appearances of various shoulder structures (rotator cable and rotator cuff).

This study will recruit healthy volunteers and patients who have been referred to Radiology for a symptomatic shoulder (a shoulder that is causing the patient pain, or is limited in its ability to move.) Both groups will undergo ultrasound imaging of the shoulder.

Eligibility Criteria:
Inclusion Criteria:

* Patients with shoulder pain referred to radiology for ultrasound of shoulder

Exclusion Criteria:

* Patients less than 18 years of age
Effects the Glycemic Index on Metabolic Risk Markers

Recent population studies have shown that the glycemic index (GI) of food products is positively associated with the risk of developing type 2 diabetes and cardiovascular disease (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of developing the metabolic syndrome. People, however, spent most of their time in the postprandial period. Therefore, there is a need to study the postprandial effects of low-GI vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in lean subjects, while especially overweight and obese people suffer from metabolic aberrations related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A second research objective is to compare these effects with those in lean subjects.


Eligibility Criteria:
Inclusion Criteria:

* healthy and obese men

Exclusion Criteria:

* smoking
A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Eligibility Criteria:
Inclusion Criteria:

* at least 2 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
* have ocular health within normal limits

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
* be pregnant, nursing, or planning a pregnancy