cyrilzakka/clinical-trials huggingface dataset:
Repeated Muscle Vibration in Acute Stroke

prospective randomized double-blind sham-controlled study aimed to investigate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients, treated within 72 hours from symptoms onset

This is a prospective randomized double-blind sham-controlled study. After enrollment (T-0), patients are randomly placed into the vibration group (VG) or the control group (CG), by using a computer-generated randomization list. VG patients receive rMV treatment while those of CG receive the sham one. Both treatments are carried out during the 1st, 2nd and 3rd day after enrollment. Physiokinesitherapy (PT) is carried out in all patients every day, starting soon after T-0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), at the end of treatment.

Upon admission, all participants' demographic details and medical history are recorded. All patients undergo a clinical examination, performed at all time-points by an experienced investigator, blinded to group assignment and different from the recruiting one. Clinical evaluation consists of stroke severity evaluation, by means of NIH Stroke Scale; motor and functional limbs abilities are evaluated by using both the Fugl-Meyer scale and the Motricity Index; post-stroke spasticity is assessed with Ashworth scale, modified by Bohannon and Smith.

All participants undergo a daily rehabilitation program. The physical therapist is instructed about duration, frequency, and content of therapy in order to ensure uniformity in treatment procedures, and blinded to patients' treatment allocation.

Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).

The rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break.

During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle.

Otherwise, the CG participants undergo the sham rMV by positioning the vibrator close to the tendon but without touching the skin. In this condition, patients are only subject to the faint buzzing sound of the vibrator

Eligibility Criteria:
Inclusion Criteria:

* age \>18,
* first ever stroke detected by Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) scan
* ischemic or hemorrhagic stroke within 72 hours from symptom onset
* motor deficit of the upper and/or lower limb;
* ability to perform at least a minimal isometric voluntary contraction of the affected limb

Exclusion Criteria:

* TIA, or rapidly improving stroke
* cerebral venous thrombosis
* patients presenting with aphasia, neglect, or apraxia
Evaluation of Feconomics for Diagnosis of Intestinal Parasitic Infections

People of all ages are affected by intestinal parasitic infections(IPIs) ; however, children are the most commonly affected, which is linked to their poor hygienic practices, and weak immune status. In children, IPIs are associated with malabsorption, weight loss, anemia, poor growth rate, learning difficulties, mental retardation and intellectual problems . The difficulty of diagnosis is the main problem in the control of intestinal parasitic infections. The choice of a particular technique is usually influenced by affordability, simplicity, cost, sensitivity in addition to the level of technical skills involved. Microscopic examination remains the cornerstone of parasitological diagnosis which is time consuming and requires an experienced observer to identify the organism. Formalin-ether sedimentation technique is commonly used in laboratories owing to its ability to isolate a large variety of parasites. However, it's a labor intensive procedure and is usually associated with hazards of using the inflammable lipid solvents. The drawbacks of the previous techniques have encouraged the development of commercial products such as Feconomics which is a new ready to use kit for concentration of stool samples in parasitological diagnosis.

The aim of the study is :

evaluation of the efficacy of Feconomics technique in comparison to traditional techniques i.e., direct smear and formalin ethyl acetate sedimentation technique for the diagnosis of intestinal parasites in school children.


Eligibility Criteria:
Inclusion Criteria:

* school children whose age is between 6-12 years

Exclusion Criteria:

* children taking anti-parasitic drugs within the previous two weeks of stool sample collection .
Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases

The present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently.

Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven initial diagnosis of adenocarcinoma of the prostate;
* Clinical stage T1-4 N0 M0;
* Prostatic assessment by multiparametric (mp) MRI;
* Pelvic lymph node was assessed by PSMA PET/CT and mpMRI;
* No distant metastasis was proven by PSMA PET/CT;
* Patients may received neoadjuvant hormonal therapy;
* 45≤ Age ≤85;
* Adequate performance status (ECOG 0-1);
* No previous pelvic radiation therapy (RT);
* No previous prostatectomy;
* No previous invasive cancer (within 5 years before the prostate cancer diagnosis);
* Ability to understand character and individual consequences of the clinical trial;
* Written informed consent;

Exclusion Criteria:

* No pathologically confirmed adenocarcinoma of the prostate;
* Distant metastasis (M1);
* Previous pelvic radiotherapy;
* Previous prostatectomy;
Team-based Ergonomics Educational Model for Workplace WELLNESS Improvement: A Pilot Study

This research is being done to explore the potential benefit of a physical therapist-guided stretching program on musculoskeletal pain and well-being.


Eligibility Criteria:
Inclusion Criteria:

* HMC/COM staff (faculty, residents, fellows, APPs, physical/occupational therapists, nurses, schedulers, etc.)
* At least 18 years old
* Willing and able to participate in all study procedures
* Willing and able to provide informed consent
* Group 2 subjects must have access to a computer with internet or an iPhone or Android smartphone

Exclusion Criteria:

* Subjects who do not meet all inclusion criteria will be excluded from the study.
Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia

RATIONALE: Studying samples of blood or tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with Down syndrome and acute megakaryoblastic leukemia.

OBJECTIVES:

* Determine whether megakaryocyte differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor can lead to proliferation arrest, polyploidization, and terminal differentiation of blasts in specimens from patients with Down syndrome and acute megakaryoblastic leukemia.

OUTLINE: Cryopreserved specimens are cultured and treated in vivo (in mice) and in vitro with megakaryocytic differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute megakaryoblastic leukemia
* Diagnosis of Down syndrome
* Cryopreserved specimens available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Electrical Neuromodulation for Focal Epilepsy

The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.


Eligibility Criteria:
Inclusion Criteria:

Part 1

* Age ≥ 20 years old.
* Focal epilepsy patients having received EEG and brain imaging studies and on standard medication.

Part 2

* Age ≥ 20 years old.
* Focal epilepsy patients having received EEG and brain imaging studies and on standard medication for at least 1 year.
* Having received part I intervention.

Exclusion Criteria:

Part 1

* Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
* Patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants.
* Patients with allergies to the sponge material used for stimulation.
* Patients with wounds or infections at the site of sponge application.
* Patients with intellectual disabilities, manic episodes (with a score of greater than 12 on the Young Mania Rating Scale), major physiological illnesses (such as stroke, brain tumors, or heart attacks), or pregnant or breastfeeding women.
* Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.

Part 2

* Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
* Patients who could be considered for single focus resection based on the neurologist/neurosurgeon's judgment. However, patients who clearly refuse resection surgery are not subject to this limitation.
* Patients who experience serious adverse events (SAEs) during the part 1 trial.
* Patients who are unable to undergo magnetic resonance imaging (MRI).
* Patients who are planned to receive hyperthermia therapy or transcranial magnetic stimulation.
* Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation

TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.

This is a prospective, single-arm, multi-center study comparing to a historical control for cold storage.

The study is conducted in accordance with the Standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice), and other legal requirements.

The study objective is to assess the safety and performance of the TB1-K device in donor kidneys intended for transplantation.


Eligibility Criteria:
Donor Inclusion Criteria:

1. Donor kidney suitable for preservation
2. Only one kidney per donor will be included
3. Cold ischemia time (CIT) ≤ 24 hours
4. Donor age over 18 years old
5. Donor meets one of the following:

   1. Donor after brain death (DBD), standard and extended criteria
   2. Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
6. Signed written informed consent

Donor Exclusion Criteria:

1. Kidney, which investigator is unwilling to use, or presence of moderate or severe traumatic kidney injury, or anatomical kidney vascular abnormalities, which would preclude the organ from being acceptable by the transplant surgeon
2. Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14)
3. Living donors
4. Previous usage of a perfusion machine (PM)
5. Kidneys not considered suitable for preservations
6. Positive serology (HIV, Hepatitis B surface antigen \& C)

Recipient Inclusion Criteria:

1. Registered primary kidney transplant candidate, male or female
2. Age ≥ 18 years old
3. Signed written informed consent

Recipient Exclusion Criteria:

1. Prior solid organ or bone marrow transplant
2. Multi-organ transplant
3. Active malignancy
4. Active infection
5. Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method.
6. Participation in another clinical trial.
7. Patient with known donor-specific HLA antibody
Preventing Anxiety Disorders in Urban Youth

This study will determine the effectiveness of a cognitive-behavioral group therapy program in preventing anxiety disorders in at-risk children exposed to community violence.

Community violence is a major public health problem in low-income, urban communities. The mental health impact of living in a violent community is significant, particularly for children. Community violence exposure is associated with various symptoms of anxiety. Unfortunately, little research on the prevention of community-related anxiety in youth has been conducted. This study involves a school-based prevention and cognitive behavioral therapy program that will involve predominantly African American children who live in urban areas and are at risk for developing anxiety disorders.

Children in this study will be randomly assigned to either an anxiety prevention and early intervention group or a nonintervention group for approximately 3 months. Child, parent, and teacher assessments of anxiety symptoms will be made at the end of the study and at a 6-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Mild exposure to community violence
* Mild to moderate anxiety symptoms or disorders
* Attending public elementary school in an urban area
* In 3rd to 5th grades

Exclusion Criteria:

* Diagnostic and Statistical Manual-IV disruptive behavior disorder
* Too many or too few anxiety symptoms
Adaptation of a Knowledges Exchange Portal Between (KEP) Healers and Patients : Obstacles and Sources to KEP Use for Breast Cancer Women

The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context

One of the French Cancer Plan 2014-2019 objectives is to improve the town-hospital coordination and information's exchange between professionals. This research project aims to reach this important objective of exchange development and the amelioration of the coordination concerning breast cancer women. Breast cancer requires the integration of aggressive treatments implying physical, psychological and social consequences. That's why an optimized care pathway needs a coordinated and multidisciplinary organization, and more particularly a personalized approach taking into account the whole patients' needs in physical, psychological and social perspectives. To reach this goal, it is important to support those patients, to answer their needs for a better disease management in their own health pathways. The research issues lie in this outcome.

The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway.

The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context

Eligibility Criteria:
Inclusion criteria of patients :

* Age ≥ 18 y.o;
* With a diagnosis of breast cancer,
* treated at the Bergonié Institute;
* Patients who express a non-opposition to participate to SAVAQ research;
* Patients who have an Internet access at home.

Inclusion criteria of healers :

- Doctors, Nurse, Senior health manager, Technologist medical imaging from the center participated to the research

Exclusion criteria of patients:

* Patients with a severe psychiatric pathology (medical diagnosis);
* Patients who doesn't speak French
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:

1. Cardiac valve regurgitation
2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
3. Heart failure
4. Total, cardiac and respiratory mortality


Eligibility Criteria:
Inclusion Criteria:

* At least one year registered with the general practitioner (GP), one year of valid data from the GP, or the date of software conversion (if GP software systems had changed) and meeting criteria for any one of the 4 cohorts as defined.

Exclusion Criteria:

* rheumatic heart disease
* congenital heart disease: includes structural defects, congenital arrhythmias, and cardiomyopathies
* dilated cardiomyopathy (congestive cardiomyopathy
* pericardial, pleural, pulmonary or retroperitoneal fibrosis
* endocarditis or myocarditis
* carcinoid syndrome
* intravenous drug abuse
* fibrotic valvular heart disease
* pleural/pulmonary/pericardial/retroperitoneal fibroses
* use of fenfluramine or amiodarone within 3 years prior to date of diagnosis of fibrotic valvular heart disease
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)

The purpose of this study is to determine if acupuncture is effective in preventing prolonged postoperative paralysis of the gastrointestinal tract among patients undergoing colostomy/ileostomy closure.


Eligibility Criteria:
Inclusion Criteria:

* Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure
* Hospital admission must be same day as surgery

Exclusion Criteria:

* Incapacitating disease
* Concurrent herbal or laxative use
* Use of Heparin or Coumadin
* Upper or lower extremity deformities
* Chronic constipation prior to cancer diagnosis
* History of cerebrovascular accident or spinal cord injury
* Chronic pain that has been treated with any form of major opioid or weak opioids (=/\> 30mg/24 hours)
* Pacemaker or metal implants
* Concurrent alternative medicine/herbal use
Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain

The aim of this study is to investigate the use of Interoceptive Exposure (IE) in treatment of disabling fear of pain using a single-case series design.

The intervention Interoceptive Exposure (IE) is an exposure to bodily sensations used in treatment of variety of problems where body sensations are experienced as threatening. The application of IE is expected to reduce the threat value of pain and subsequently promote recovery. This study will evaluate the effects of IE and will briefly comprises of: education session explaining the rationale behind IE practice, teaching of the technique, supervised IE practice and self-monitored home practice twice daily for the period of two weeks. Depending on the length of baseline (i.e. observation period before the start of intervention) the study will last between 6 and 8 weeks. Daily Diary, a short nine item instrument was designed to measure the pain experience (intensity and interference) and fear of pain on a daily basis. Other, standard outcome measures include: pain related anxiety, pain catastrophising, pain related disability, knowledge about pain and general anxiety and depression. Study participants will be recruited during routine psychology screening assessment at the Pain Clinic at St James' Hospital. This study will recruit from clinical psychology waiting list patients.

Eligibility Criteria:
Inclusion Criteria:

* Presence of chronic pain (i.e. pain present for minimum of 3 months following tissue damage)
* 18 years or older
* Capacity to give informed consent
* Appropriate diagnostic investigations in other specialties as appropriate have been exhausted and first line interventions, like analgesia, have been tried.
* Participant has appropriate expectations regarding psychological treatment, i.e. does not expect injections etc.

Exclusion Criteria:

* Insufficient understanding of English or additional needs which mean the potential participant is unable to complete questionnaires independently. This is because the research project does not have the resources to make significant adaptations to the materials i.e. translation into another language or into Braille.
* Unable to meet the demands of the study (i.e. daily recording of data, daily practice of IE, coming for sessions to St James' Hospital).