cyrilzakka/clinical-trials huggingface dataset:
Diastasis Recti Abdominis and a Combined Treatment With Abdominal Exercise and Radiofrequency

Diastasis recti abdominis is a pathology that appears in a high percentage of women during the postpartum period. However, there is little evidence about its treatment. The present protocol aims to evaluate the efficacy of radiofrequency as an alternative for the treatment of abdominal diastasis along with abdominal exercises compared to the only intervention through abdominal exercise.

An aleatory clinical testing will be conducted where 44 women diagnosed with diastasis recti abdominis in the postpartum period will be recruited. A common exercise protocol will be applied for two groups of participants, and both of them will have to be able to carry out the activities autonomously at home. In addition, control sessions will be held weekly for both groups where one of the groups, the control group (n=22), will receive radiofrequency therapy with the machine in athermic mode, while the other group, the experimental group (n=22), will receive a weekly session under the established diathermy protocol. The sessions will last 30 minutes and will take place for 10 consecutive weeks.

Three variables will be evaluated: the width of the diastasis measured in centimeters, life quality measured using the Short form (36) questionnaire, and the perception of the pain measured with the visual analogue scale. Three evaluations will be done: at the beginning of the study, after ten weeks and three months later.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with diastasis recti abdominis (DRA)
* Age range18-45 years old
* Women not DRA treated previously
* Women not diagnosed with umbilical hernia

Exclusion Criteria:

* DRA width less than 2.5cm
* Women diagnosed with intestinal disease such as irritable bowel syndrome (IBS) or Chron disease.
* Women looking for a new pregnancy or pregnant women.
* Women who can not receive diathermy treatment (e.g tumoral process, open wound in the abdominal area or any diathermy contraindication).
EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer

This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.

This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
* Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria
* ECOG performance status 0-2
* Estimated life expectancy of ≥ 12 weeks
* No known active/symptomatic CNS metastases
* No previous chemotherapy for breast cancer in the advanced setting
* Adequate organ function including ( Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5 x 10\^9/L; Platelets ≥ 100 x 10\^9/L; Bilirubin ≤ 1.5 mg/dL; ALT and AST ≤ 3 x ULN (with or without known hepatic metastases); ALP ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance (CrCl) ≥ 50mL/min according to the Cockcroft Gault formula
* Written informed consent (according to ICH/GCP and national/local regulations)

Exclusion Criteria:

* Significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria)
* Clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
* Other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
* Intake of any concomitant medications or therapies that may potentially interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
* Presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration
Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study

Study will look at the effect of a game-based, task-oriented home exercise program on adherence in persons with chronic (\> 6 months post) stroke as compared to a standard home exercise program. The study will also look at the effect of a game-based, task-oriented home exercise program on upper extremity motor function and occupational performance in persons with chronic (\> 6 months post) stroke as compared to a standard home exercise program. Finally, the study will look at barriers and facilitators to successful use of the game-based, task-oriented home exercise program in the home setting.

Approximately 26% of stroke survivors are still fully dependent in activities of daily living (ADLs) when they enter the chronic phase at 6-months post stroke, and over half have hemiparesis that impacts upper extremity motor function. Exercise and activity in the chronic phase of stroke are essential in reducing disability, improving balance, increasing mobility, and improving overall quality of life. Without regular activity and exercise in the chronic phase, survivors are at risk for a developing comorbid conditions (e.g., diabetes) and experiencing a recurrent stroke. Unfortunately, people with stroke report many barriers to exercise, such as fatigue or pain, and lack of motivation and engagement. A promising solution may lie in interactive video games and virtual reality (VR), which have been used as intervention tools to potentially increase patient engagement and adherence, over the past 15 years. The investigators have developed an interactive, customized VR system called Mystic Isle that has shown to be feasible for general home-based rehabilitation. Mystic Isle utilizes portable, low-cost technology (the Microsoft Kinect® sensor, Microsoft) and can provide a customized program with remote monitoring by an occupational therapist (OT). This study will explore the preliminary effect of the game-based home program on adherence to a home program in comparison to a control. It will also explore the barriers and facilitators to home use of a virtual reality-based intervention.

Eligibility Criteria:
Inclusion Criteria:

* Stroke Subjects

  1. Have a cerebrovascular accident diagnosis at least 6 months prior to study enrollment
  2. Age 45-85
  3. Can comprehend English
  4. Have an internet connection in the home
  5. Mini Mental Status Examination score \> 24 (no more than mild cognitive deficits)
  6. Mild to moderate motor deficits (range of motion screening- \> 45 degrees shoulder flexion, some wrist movement, partial extension of the fingers)
  7. Functional balance (Berg Balance Scale score \> 45)
* Caregivers:

  1. Provide care or support to a subject that is participating in this research study. This person does not need to be related to the stroke subject.
  2. Over the age of 18
  3. Can comprehend English

Exclusion Criteria:

* Stroke Subject:

  1. A medical condition that prevents interaction with a television or video games
  2. Receiving occupational or physical therapy services at the time of study involvement
* Caregiver: NONE
The Effect of a Protective Message on Critical Evaluation of Fake News

Background: Disinformation has become an increasing societal concern, especially due to the speed that news is shared in the current digital era. In particular in the healthcare sector disinformation can lead to serious casualties, as the current COVID-19 crisis clearly shows.

Objective: The main aim of this study was to experimentally examine the effects of information about the source's and a displayed protective warning message on users' critical evaluation of news items, as well as the perception of accuracy of the news item.

Methods: A 3(unreliable versus reliable versus no identified source) x 2 (protective message: with versus without) between subject design has been conducted among 307 participants (mean age = 29 years, SD = 10.9 years).


Eligibility Criteria:
Inclusion Criteria:

* Facebook user
* older than 18
* Dutch

Exclusion Criteria:

* younger than 18 years
* no facebook
Study of SkQ1 as Treatment for Dry-eye Syndrome

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;

Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye;
* Have a history of use of eye drops for dry eye symptoms ;
* Ocular Discomfort;
* Schirmer's Test score;
* Have corneal fluorescein staining ;
* Have lissamine green conjunctival Staining ;
* Have a conjunctival redness;

Exclusion Criteria:

* Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
* Have any clinically significant slit lamp findings at Visit 1;
* Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;
* Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a known allergy and/or sensitivity to the study drug or its components ;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.


Eligibility Criteria:
Inclusion Criteria:

* The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
* The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion Criteria:

* Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)

This study was a basket trial designed to establish safety, tolerability and efficacy of MHV370 in Sjögren's Syndrome (SjS) and Mixed Connective Tissue Disease (MCTD).

This was a randomized, participant and investigator blinded, placebo-controlled, multi center parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren's Syndrome (SjS) or with Mixed Connective Tissue Disease (MCTD). Participants first underwent a screening period of up to 6 weeks, followed by a treatment duration of 24 weeks and a follow-up period of 4 weeks. Total study duration for each participant was up to 34 weeks. Participants with SjS were randomized in a 1:1 ratio to MHV370 or placebo and participants with MCTD were randomized in a 1:1 ratio to MHV370 or placebo.

Eligibility Criteria:
Inclusion Criteria:

SjS and MCTD:

• Fully vaccinated with any locally approved COVID-19 vaccination including booster vaccinations if required by local guidelines

SjS:

* Unstimulated whole salivary flow rate of \> 0 mL/min at screening
* Classification of Sjögren's Syndrome according to the 2016 ACR/EULAR criteria at screening
* Screening ESSDAI (based on weighted score) ≥ 5 from 8 defined domains (biologic, hematologic, articular, cutaneous, glandular, lymphadenopathy, renal, constitutional).

MCTD:

* Diagnosis of MCTD based on criteria like a) Raynaud's phenomenon b) At least two of the four following signs: i) synovitis, ii) myositis, iii) swollen fingers and vi) interstitial lung disease
* Patients with overlap syndromes, i.e. patients meeting diagnostic criteria for systemic autoimmune disease other than MCTD may be included unless they have major organ involvement as judged by the investigator

Exclusion Criteria:

SjS and MCTD:

* Prior use of B-cell depleting therapy within 6 months of baseline. For participants who received B-cell depleting therapy within 6 -12 months of baseline visit, B-cell count should be within normal range
* Prior treatment with any of the following within 3 months of baseline: CTLA4-Fc Ig (abatacept), Anti-TNF mAb, Intravenous Ig, Plasmapheresis, i.v. or oral cyclophosphamide, i.v. or oral cyclosporine A
* Screening CBC laboratory values as follows: Hemoglobin levels \< 8 g/dL (\< 5 mmol/L), Total leukocyte count \< 2,000/µL (2 x 109/L), Platelets \< 50,000/µL (50 x 109/L), Neutrophil count \< 1,000/µL (1 x 109/L)
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they use a highly effective method of contraception

SjS:

* Sjögren's Syndrome overlap syndromes where another autoimmune disease constitutes the primary illness
* Required regular use of medications known to cause, as a major side effect, dry mouth / eyes

Other protocol-defined inclusion/exclusion criteria may apply
Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability

This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes are used clinically and may improve neuromuscular control by increasing lower extremity muscle activation, which may improve gait patterns. The investigators' purpose is to determine whether a 4-week rehabilitation program that includes ankle destabilization shoes (experimental) has beneficial effects on self-reported function and ankle gait kinematics compared to traditional rehabilitation without destabilization shoes (control) in CAI patients. In addition, the investigators will compare ankle strength and balance between CAI patients and healthy individuals with no history of ankle injury prior to the 4-week rehabilitation. The investigators hypothesize the experimental group will have greater improvement in self-reported function and frontal and sagittal plane kinematics during walking compared to the control group. In addition, the investigators hypothesize that patients with CAI will have a decrease in ankle strength and balance when compared to healthy individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients will complete baseline self-reported function questionnaires and walking gait trials and then be randomized into control and experimental groups. Both groups will complete 4-weeks of supervised rehabilitation with or without destabilization shoes and then repeat the questionnaires and walking trials.


Eligibility Criteria:
Inclusion Criteria:

* CAI with a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI
* All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion Criteria:

* Neurological or vestibular disorders affecting balance
* Currently seeking medical care for CAI
* History of prior ankle surgery
* History of ankle sprain within the past 6 weeks
* History of ankle fracture
* Diabetes mellitus
* Current self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
* Lumbosacral radiculopathy
* Pregnant
* Soft tissue disorders including Marfan's syndrome and Ehlers-Dandros syndrome
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients
* \>18 years and \<75 years of age
* \>6 months post Tx
* on stable dose of immunosuppression
* Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
* Ability to give informed consent

Exclusion Criteria:

* Biopsy proven acute cellular rejection; greater than grade 1A
* Baseline creatinine \>3.5mg/dL
* Patients with active infection, including Hepatitis B and C, HIV
* Current or prior invasive malignancy
* Patients who are pregnant or breastfeeding
* Patients who are unable to give consent
* Prior intolerance of/allergy to IL2
* Inability to comply with treatment
* History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura
* Symptomatic congestive cardiac failure or uncontrolled cardiac angina
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
* WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control \[defined in protocol \& ICF\] during study treatment, and for 6 months after completion of treatment.
Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).

In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.

Exclusion Criteria:

* Hypersensitivity to dexmedetomidine
* Bradycardia: Sinus rhythm slower than 50 bpm
* Known or suspected obstructive sleep apnea
* Suspected difficult intubation
* Pregnancy
* Under 18 years of age or over 85 years of age
* Cognitive disability impairing understanding the experiment or signing the informed consent form
Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed

The purpose of this study is to find an alternative to the six minute walk test by validating six minute step test and four metre gait speed in healthy children. Both tests were previously validated in adults and are easier to achieve in non-hospital settings.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* a lung disease
* an overweight
* an orthopedic disability which can slow down the subject during tests execution
Metaphyseal Distal Radius Fractures

The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.

The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.

Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.

The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.

These clinical facts need of course to be validated.

Eligibility Criteria:
Inclusion Criteria:

* - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
* age 60 years or older

Exclusion Criteria:

* open fracture
* fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
* polytraumatized patient
* fractures older than 15 days
* infection of the operating site
* previous osseous disease
Effects of Costovertebral Joint Mobilization on Respiratory Function in Asthmatic Patients

The aim of this randomized controlled trial is to determine the effectiveness of costovertebral joint mobilization on lung function in asthmatics. By targeting the thoracic region, costovertebral mobilization can play a valuable role in enhancing respiratory function and improving the overall well-being of individuals with respiratory conditions.

Costovertebral joint mobilization can help to improve this by increasing the mobility of the ribs and thoracic spine, which can help to expand the chest and improve lung function. Additionally, costovertebral joint mobilization can help to reduce muscle tension in the chest and upper back, which can also contribute to improved respiratory function. This is because tense or tight muscles can restrict the movement of the rib cage, limiting the ability of the lungs to expand and contract. Mobilization are performed in three positions, sitting, supine lying and side lying with arm abducted of the side to be mobilized. The improvement by regular physical training of breathing technique and chest wall mechanics may be explained by mobilization of the costovertebral articulations.

Eligibility Criteria:
Inclusion Criteria:

* Force Expiratory Volume 1/Force Vital Capacity ratio less than 0.7
* Mild asthma (Force Expiratory Volume 1 over 70% predicted)
* Chest tightness (inspiratory muscle tightness)
* Altered Dyspnea index.

Exclusion Criteria:

* presence of any underlying lung condition other than asthma.
* significant cardiovascular or musculoskeletal disease that may compromise the participant's capacity to participate in physical activity;
* active cancer.
* uncontrolled hypertension or diabetes.