cyrilzakka/clinical-trials huggingface dataset:
Home-based Exercises for Patients With Stroke

The aim of this study is the development and the implementation of a new protocol about home-based exercises, supported by an illustrated manual, for the treatment of individuals with stroke.

The hypothesis is that this group of patients who are going to carry out the training of this study protocol are going to show improvement in measured parameters (functionality and physical performance), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

1. Program Development: 27 exercises were selected, based on the most frequent motor alterations present in hemiparesis. Three modes were created for each exercise: assisted active, active and resisted active executions. Besides explanatory text, there were illustrative photos for all exercises and their modes.
2. Program Execution: All groups were submitted to a motor evaluation utilizing the Fugl-Meyer Assessment (FMA) and functional evaluation utilizing the Functional independence measure (FIM). After assessment, for the patients of the home-based exercise group (HBG) a group of home exercises was selected for each patient; these exercises were explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when any necessary correction was made. The next steps stipulated by the manual were taken, providing the patients with more complex exercises according to their progress. The patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions two times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).The control group (CG) was assessed but reluctant or unable to regularly attend a supervised exercise program. The groups were reassessed after six months.
3. Program assessment: The Fugl-Meyer Assessment score and the Functional independence measure score, measured at baseline and after six months, were compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke, confirmed by clinical and radiological evidence
* Ability to understand and follow commands
* willing and able to regularly attend a supervised exercise program

Exclusion Criteria:

* severe cognitive impairment
* Commodity that preclude them from undergoing training and assessment
* Neurological disease other than stroke
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial.

The device under investigation is the Axone system, consisting of:

* Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT).
* Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead.

The primary endpoint data will be used to support CE marking of the Axone system.

The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

Eligibility Criteria:
Inclusion Criteria:

* Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines
* De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM)
* Reviewed, signed and dated informed consent form

Exclusion Criteria:

* LV lead previous implant attempt
* Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement
* Known allergy to contrast media used for imaging during cardiac catheterization
* Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
* Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula \< 30ml/min/m²)
* Active myocarditis
* Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant
* Previous heart transplant or currently on heart transplant list
* Life expectancy less than 1 year
* Already included in another clinical study that could confound the results of this study
* Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women
* Less than 18 years old or under guardianship
* Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol
* Diagnosis of drug addiction (substance use disorder)
Effect of Hyperbaric Oxygen Therapy

The goal of this tudy will be to investigate the effects of a single session of hyperbaric oxygen therapy (HBOT) on recovery and performance after a football match in elite youth football players.

The main questions this study will aim to answer are:

Will a single session of HBOT improve recovery parameters such as biochemical markers and physical fitness in elite youth football players after a football match? Will a single session of HBOT enhance the performance of elite youth football players after a football match?

Participants in this study will include twenty elite youth male football players. They will be randomly assigned to either the HBOT group or the control group. All participants will undergo evaluations for biochemical parameters, physical fitness tests, and the Hooper Index (HI) at multiple time points: before the match, at the end of the match, one hour after the HBOT session, and 12 hours after the HBOT session.

In the HBOT group, participants will receive 100% oxygen under elevated pressure in a hyperbaric chamber for a duration of 70 minutes immediately after the football match. Meanwhile, the control group will be exposed to normal atmospheric pressure.

Biochemical analysis will involve collecting blood samples to measure markers such as myoglobin, creatine kinase, lactate dehydrogenase, alanine aminotransferase, and aspartate aminotransferase. Physical fitness tests will include vertical jump height measurements (squat jump, countermovement jump, and countermovement jump with arm swing) and linear speed assessments at various distances (5 m, 10 m, and 20 m). The Hooper Index (HI) will be used for subjective assessment of fatigue and well-being.

This study aims to provide insights into the potential benefits of HBOT as a recovery strategy for elite youth football players and its impact on performance in the future.


Eligibility Criteria:
Inclusion Criteria:

* football player
* free of injuries
* free of medical conditions contraindicated by hyperbaric oxygen therapy (HBOT)
* written parental consent

Exclusion Criteria:

* pre-existing injuries or medical conditions that are contraindicated by hyperbaric oxygen therapy (HBOT)
* participation in severe physical activity within 24 hours before the study
* participants who do not comply with the requirement to abstain from breakfast, caffeine, and alcohol prior to the first blood collection
* an active respiratory illness, such as a cold, at the time of the study
NSABP Biospecimen Discovery Project

This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing.

This study will be conducted at select NSABP sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadjuvant therapy as a pilot for a comprehensive 'omics approach using next generation sequencing and protein expression and post-translational modification analysis using mass spectrometry (MS) based and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at baseline and 48 to 72 hours after initial drug treatment to study variation in the biological responses to these agents. The study of tumors both before and early after the first treatment probes the biological responses to treatment and is rich source of predictive biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
* The breast cancer must be HER2-positive based on current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer.
* The patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. Patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy.
* Planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. Schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator.

Exclusion Criteria:

* Excisional biopsy or lumpectomy performed prior to registration.
* Previous therapy with chemotherapy or targeted therapy for any malignancy.
* Treatment, including radiation therapy (RT), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration.
* Other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy.
Effect of Chronic Supplementation of L-arginine in the Muscular Performance

The primary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular force the quadriceps.


Eligibility Criteria:
Inclusion criteria:

Healthy young adults for both sex; Age between 20 and 55 years; Slight or moderate physical activity, 30 minutes per day, at least 3 times a week;

Exclusion criteria:

Cardiac or pulmonary disease; Previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; Athletic person (intensive anaerobic activity); None practiced of physical activity regularly; Medications usage

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Anesthesia Lumbar Puncture In Children

The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.

The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP) and comfortable LP will be established upon completion of this study.

Eligibility Criteria:
Inclusion Criteria:

* children with indications of lumbar puncture;
* voluntarily signed the informed consent

Exclusion Criteria:

* topical anesthetic skin allergies;
* skin infection in lumbar puncture site;
* severe intracranial hypertension;
* unstable vital signs;
* coagulopathy;
* intracranial hemorrhage and occupying;
* low back pain;
* headache and low back pain before lumbar puncture;
* past headache after lumbar puncture;
* mental retardation, neuropsychiatric symptoms;
* children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);
* the case with repeated puncture in one operation
High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter

The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.

The proposed study aims to

1. assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA) combined with behavioural speech training on stuttering recovery in terms of a reduction of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;
2. investigate the maintenance of combined tDCS-behavioural speech training effects on speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.

Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a control group. Both groups will receive behavioral treatment for stuttering, including the speech prolongation technique, for five sessions. Concurrent with behavioural training, the experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech satisfaction will be assessed independently before, immediately after, one week and six weeks after treatment. It is anticipated that AWS will experience reduction in their stuttering severity after stimulation, and the improvement will be maintained for a longer period as compared with receiving behavioural treatment alone.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrated features of stuttering;
* More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.

Exclusion Criteria:

* Personal or family history of epilepsy or seizures
* History of a neurological condition
* Speech disorders
* Hearing impairment
* Metallic foreign body implant
* On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
* Pregnant
* Had speech therapy for stuttering in the past four months
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.

Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed per patient)

Secondary Objective(s)

* To determine how many times a telemedicine visit triggered an action (inpatient admission/ outpatient observation status)
* To determine how many patients were detected to have cytokine release syndrome and/or neurotoxicity based on their telemedicine visit

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma
* Age ≥ 18 years
* ECOG or Karnofsky performance status of ≤ 2
* Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after CAR-T cell infusion
* Patients must stay within a 30-minute distance from the cancer center
* Patients must have access to wifi network or a cellular network
* Patients and caregiver(s) participating in patient's care must attend the education session for outpatient CAR-T and demonstrate competency to collect vital signs with equipment provided
* Must have the ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

* Patients who have acute lymphoblastic leukemia/lymphoma
* Patients who have a high tumor burden (\> 10 cm largest mass) have a high risk of CRS who will receive CAR-T as an inpatient
* Patient or caregiver unable to understand and follow English language
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Verification of Kimmerle's Anomaly by X-ray Methods of Research

Kimmerle's anomaly is a bony bridge over the posterior arch of the first cervical vertebra that forms a bony ring. The vertebral artery passes through the opening. This bone bridge could theoretically be an extravasal compression of the artery and disrupt the normal blood flow to the brain. Evaluating the data of X-ray methods, determine the frequency of occurrence and types of Kimmerle anomaly.

It is planned to conduct an examination of 30 patients on the basis of the Department of Radiation Diagnostics and Therapy of the Samarkand State Medical Institute. Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region Among those who have passed the study, it is necessary to identify patients with Kimmerle's anomaly and determine the age at which it often occurs, whether it is a congenital pathology or the result of degenerative-dystrophic changes. It is also planned to calculate the frequency of occurrence among the population, the type of this pathology (complete and incomplete bone bridge, right-sided and left-sided location), the size of the hole formed. The condition of the posterior parts of the brain will be assessed in the presence of Kimmerle's anomaly on a CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Kimmerle's anomaly

Exclusion Criteria:

* patients in whom the structure of the first cervical vertebra is not clearly visible
Patient Reported Outcomes in Chronic Myeloid Leukemia

Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison.

The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose.

The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

The development process will follow the international guidelines published by the EORTC Quality of Life Group (QLG). This process will follow three main phases.

Phase 1 of will deal with the review of the literature, identification of an item list and interviews with experts in the treatment of CML and CML patients (undergoing all possible treatments).

In Phase II the identified issues from Phase I will be worded and translated into possible items for the provisional questionnaire using existing EORTC questionnaires and the EORTC QLG Item Bank.

In the Phase III the provisional CML questionnaire will be pre-tested by to a larger sample of CML patients (not the same patients involved in previous phases) and individual structured interviews will be conducted as well. These latter will identify questions that might be irrelevant or whether there will be additional issues not previously included.

Overall up to 480 patients will be enrolled in this study (up to 180 in phase I and up to 300 in phase III).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years of age or older)
* Confirmed diagnosis of Philadelphia chromosome positive CML
* Informed consent provided
* Patients enrolled in investigational treatment trials are eligible
* Ability to speak and read language of the Questionnaire

Exclusion Criteria:

* Freedom from overt cognitive impairment or major psychiatric conditions that may confound HRQOL evaluation
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis B
* Previous participation in study ML18253
* Administration of at least one dose of the study drug during ML18253 study

Exclusion Criteria:

* Patients not satisfying the above inclusion criteria will not be enrolled in the study
Effect of Home-Based Exercise Program in Older Adults With Sarcopenia

In the prospective, randomized, controlled multi-centre study, 100 patients who were clinically diagnosed with sarcopenia were assigned to either a home-based exercise group or the control group. The home-based exercise program was performed three days per week for 12 weeks. Before and three months after the exercise program, all the patients were evaluated.

Sarcopenia is a complex and multifactorial syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength.The randomized, multicenter study was conducted at the physical medicine and rehabilitation departments of five different centers. One hundred patients met the inclusion and exclusion criteria and were randomly allocated to either a home-based exercise group (n=50) or a control group (n=50). The patients were evaluated before and 3 months after inclusion using the timed up and go test, the Berg balance scale, the 6-minute walk test , a numeric rating scale to determine QoL, and the number of falls.

Eligibility Criteria:
Inclusion Criteria:

community-dwelling older adult diagnosis of sarcopenia according to the clinical examination; and able to walk independently. The physical performance of patients with a SARC-F score ≥4 were tested using a gait speed test and a short physical performance battery (SPPB). The diagnosis of sarcopenia was confirmed in cases where the patient's gait speed was ≤0.8 m/s and the SPPB score was ≤8

Exclusion Criteria:

having cardiovascular, pulmonary, and/or chronic diseases that may affect participation in the exercise program; impaired cognition; previous diagnosis of a neurological condition that severely affected mobility and balance; malignancy; metastatic cancer; serious vision loss or vestibular impairment