cyrilzakka/clinical-trials huggingface dataset:
Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children

The purpose of this study was to determine:

* If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children.
* If there are any changes in risk of falling in CP spastic hemiplegic children or not.

With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 8-12 years old.
* Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
* the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
* (Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
* Ability to understand and follow simple instructions.
* Parent or guardian consent obtained

Exclusion Criteria:

* Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
* Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
* Previous participation in a tDCS study within the past 6 months.
Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices

This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy.


Eligibility Criteria:
Inclusion Criteria:adult

* (\>=18 years),ASA I-III, non-emergent upper and/or lower endoscopy

Exclusion Criteria:

* Emergent indications for upper and/or lower endoscopy (i.e., acute hemorrhage, cholangitis)
* Baseline respiratory rate of \< 6 breaths per minute
* Baseline hypotension (systolic blood pressure \< 90 mm Hg)
* Baseline arterial oxygen saturation \< 90% on room air
* Baseline bradycardia: heart rate \< 50 beats per minute
* Baseline tachycardia: heart rate \> 110 beats per minute
* Allergy or inability to tolerate any of the sedatives or analgesics to be administered during the procedure
* Inability to squeeze the Automated Responsiveness Test hand piece (last 50 subjects only)
* Significant hearing impairment
* Actively abusing alcohol, opioids, benzodiazapines or sedatives, or other drugs
* Are considered tolerant to opioids, benzodiazapines and/or other sedatives through prescription.
A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Age ≥18 years.
3. Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast.

   HER2-positive defined as:
   1. 3+ by immunohistochemistry \[IHC\] in \>10% of cell areas.
   2. 2+ by IHC in \>10% of cell areas and HER2/CEP17 ratio ≥2.0 or HER2 copy number ≥ 6.0 by in situ hybridization \[ISH\]).

      HER2-borderline positive defines as:
   3. 2+ by IHC and HER2/CEP17 ratio \<2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization \[ISH\]) ("equivocal").
   4. 2+ by IHC and HER2/CEP17 ratio \<2.0 and/or HER2 copy number \<4.0 by in situ hybridization \[ISH\]) ("2+ ISH negative").
   5. Known inhomogeneous HER2-expression in the primary tumor with HER2-positive areas \<10% ("inhomogeneous").
4. Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
5. At least one tumor lesion ≥ 10 mm.
6. At least one tumor lesion available for biopsy.
7. Newly diagnosed or confirmed progression and planned for therapy with trastuzumab emtansine or anti-HER2 targeted therapy(-ies) concomitant with chemotherapy (HER2-positive cohort) or chemotherapy (HER2-negative patients).
8. WHO performance status ≤ 2.
9. Predicted survival \> 12 weeks.
10. Negative pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization). Women of childbearing potential must use highly effective method of contraception, i.e combined hormonal contraception, or progestogen-only hormonal contraception, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomized partner, or sexual abstinence

Exclusion Criteria:

1. Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
2. Other manifest malignancy.
3. Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.
4. Inadequate organ function, suggested by the following laboratory results:

   * Absolute neutrophil count \<1,500 cells/mm3
   * Total bilirubin ≥1.5 x ULN (unless the patient has documented Gilbert's syndrome)
   * AST (SGOT) or ALT (SGPT) \>5.0 × ULN
   * Serum creatinine clearance \<30 ml/min
5. Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
6. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian Cystectomy

Objective: To compare the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy

Methods: The medical records of all consecutive women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed. Perioperative outcome and ovarian size were compared.

Expected results: We can get the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy. The above information should be important for consultation.

Eligibility Criteria:
Inclusion Criteria:

* \>20 years old women
* women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed.

Exclusion Criteria:

* Patients who underwent myomectomy at the same time.
Radiosurgery Before Surgery for the Treatment of Brain Metastases

This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.

PRIMARY OBJECTIVE:

I. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis.

SECONDARY OBJECTIVES:

I. To evaluate the immune niche in brain metastasis following SRS in the presence of low or high dose dexamethasone.

II. To evaluate the impact of pre-operative SRS on survival outcomes.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM A: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone orally (PO) or intravenously (IV) for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.

ARM B: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.

After completion of study intervention, patients are followed up for 120 days, and then every 12 weeks thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Prior or suspected diagnosis of malignancy
* Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Life expectancy \> 12 weeks as determined by the investigator
* Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
* Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions
* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
* Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy

Exclusion Criteria:

* Patients on any immunosuppressive medication other than dexamethasone
* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
* 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
* Human immunodeficiency virus (HIV)-positive
* Pregnant or nursing women are excluded
* Prior whole brain radiotherapy or SRS to the same site planned for surgery
Clinical Evaluation of the Next Generation Phaco System

This study is a prospective, open-label clinical study of the VERITAS Vision System.

The study will be conducted at up to three sites, with minimum 55 eyes and up to 150 eyes to be treated. The investigator or designee will perform the cataract surgery with the VERITAS Vision System on the subjects. The data from the system log files, the questionnaire, the operative report and other medical records will be used to assess the clinical utilization of the VERITAS Vision System.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 22 years of age.
* Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned.
* Availability, willingness, ability and sufficient cognitive awareness to comply with study requirements, examination procedures, and visits.
* Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures in the governing countries.

Exclusion Criteria:

* Expected surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled intraocular pressure change, or significant vitreous prolapse or loss).
* Subjects with only one good eye (e.g. amblyopic condition etc.).
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects.
* History or current use of alpha-1 antagonist medication (e.g., Flomax).
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated.
* Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils).
* Is pregnant, or is breast feeding, or intend to become pregnant during the study.
* Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Community Based Obesity Prevention Among Black Women

This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.

Obesity prevention among Black women is a major public health priority; presently, nearly 54% of the adult Black female population is obese. To date, most intervention attention has been focused on weight reduction among the overweight and obese. However, both conditions are notoriously recalcitrant to treatment, particularly among Blacks. We posit that obesity prevention might represent a particularly effective intervention strategy for overweight Black women. Most studies have shown that Black women have a greater social acceptance of overweight, less body weight dissatisfaction, and higher ideal body weights, compared to Whites. Furthermore, numerous studies have shown that obesity is less lethal and causes fewer co-morbidities among Black vs. White women, suggesting that maintaining overweight may be an appropriate public health goal for Black women. We posit that an intervention approach that emphasizes maintaining overweight, while preventing the transition to obesity will resonate among the target population. Very few obesity prevention RCTs appear in the published literature and, to our knowledge, none have been conducted solely among Black women.

We propose to randomize overweight, Black women (n=184) to either usual care (UC) or an obesity prevention (OP) intervention condition. The OP condition is comprised of several intervention components that will be delivered over 12 months; each participant will receive a tailored action plan, tailored print materials, monthly coaching calls, and weekly self-monitoring via an interactive voice response system. Assessments will be taken at baseline, 6, 12, and 18 months post baseline.

Eligibility Criteria:
Inclusion Criteria:

* African-American
* Female
* Ages 25-44
* BMI between 25-34.9 kg/m2
* Patients with at least 1 visit in the previous 24 months to a participating Community Health Center

Exclusion Criteria:

* Not currently pregnant
* Not given birth within the past 12 months
* No history of myocardial infarction or stroke in last 2 years
Acute Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals

Purpose of the study is; to investigate the acute effects of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. The investigators hypothesized that blood flow restriction exercises has a positive effect on strength, proprioception and functional motor performance.

60 healthy individuals will randomized into 3 groups of 20 people each. Participants will be held in a familiarization session before 3-4 days the actual evaluation. Elbow bending exercises with blood flow restriction will be performed to the blood flow restriction (BFR) group, elbow bending exercises without blood flow restriction will be performed to the exercise group and control group will not receive any interventions. Participants will be evaluated before and after the exercise session. Control group is going to rest for 10 minutes before the second evaluation. Evaluation protocol includes; muscle strength measurement with digital hand dynamometer, shoulder and elbow proprioception evaluation with inclinometer, Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index and Modified Pull-Up Test.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-40
* Do not smoke
* Having full range of motion in neck, shoulder, and elbow
* Body mass index (BMI)˂30 kg/m2
* Able to complete the entire study procedure

Exclusion Criteria:

* Having fracture and surgical history for the upper extremity, cervical or thoracic area
* Having any systemic musculoskeletal disease
* Having neck and upper extremity pain
* Having a diagnosis of scoliosis and chest deformity
* Regularly playing sports with overhead activities (tennis, volleyball, handball, etc.)
* Have been exercising regularly for the last 6 months
* A history of anemia
* A history of cerebrovascular disease or myocardial infarction
RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life

Allogeneic hematopoietic transplantation (AlloHCT) is a robust therapeutic that is used as a consolidation strategy in a number of haematological cancers. It provides durable responses as compared to chemotherapy alone. Despite the potential of the graft-versus-tumor effect that is driven by AlloHCT, relapse after AlloHCT remains common. Yet, the psychological impact of relapse after allograft is poorly appreciated.

For patients with hematological cancers of poor prognosis (acute myeloid leukemia, myelodysplastic syndromes...), proceeding to allogeneic hematopoietic transplantation (AlloHCT) is the definitive curative approach. While AlloHCT is an invasive procedure, patients experience social isolation and distressing symptoms when hospitalized. Indeed, patients often report high levels of anxiety and/or depression during hospitalization and upon discharge. A number of risk factors have been linked to psychological morbidity and their impact on post-AlloHCT relapse have been less investigated. Of note, the health locus of control may play a significant role in determining patients' health-related behaviors. The health locus of control is defined as the set of beliefs a person has about his or her personal influence on health, including an internal locus of control (i.e. personal actions or thoughts can affect outcomes) and an external locus of control (i.e. outcome is believed to be determined by powerful others: God, health professionals, chance...). In this context, the aim of the study REACT is to identify the types of locus of control in relapsed patients after AlloHCT and the possible association with current disease perception as well as further therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

* Major patient who has been informed about the study;
* Allografted patient with molecular or clinical relapse.

Exclusion Criteria:

* Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity;
* Not able to understand and complete surveys.
Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on admission to the Neonatal Intensive Care Unit (NICU).

Newly born preterm infants that develop abnormal temperature after birth have higher morbidity and mortality. Placing infants \< 32 weeks' gestation in a polyethylene bag (PB) in the delivery room (DR) reduces the rate of hypothermia on admission to the Neonatal Intensive Care Unit (NICU). Since 2012, the rate of admission hypothermia in preterm infants, placed in a PB in the DR at the National Maternity Hospital (NMH), has increased significantly. This may be as a result of heat loss while the infant remains attached to the cord.

Our primary objective is to determine if placing preterm infants in a PB immediately after birth, before the umbilical cord is clamped will increase the number of preterm infants with a normal temperature on admission to the NICU.

Eligibility Criteria:
Inclusion Criteria:

Infants who are inborn at the National Maternity Hospital at \< 32 (up to 31+6) weeks' gestation by best obstetric estimate will be included in the study.

Exclusion Criteria:

* Infants with a large abdominal wall or neural tube defects
* Infants with an imperforate anus
* Infants to whom resuscitative measures are not initiated in the DR
Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Primary Objective:

To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria

Secondary Objectives:

* To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs)
* To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria
* To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria
* To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A

The total duration per patients will last approximately 28 ± 2 days broken down as follows:

* A screening phase up to 12-hours
* A 28 ± 2 days study period

Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed with symptomatic infection by Plasmodium falciparum microscopically confirmed in blood smear at Day-1 visit
* Fever (tympanic or rectal temperature ≥ 38 C) or documented history of fever within the last 24h
* Asexual parasitemia of ≥ 2 000 parasites/μL in blood smear at D-1 visit
* Signed Informed Consent Form by the parents or legal guardian
* Age: 12 to 17 years old for step 1
* Age: 2 to 11 years old for step 2 and step 3

Exclusion criteria:

* Participation in another clinical trial within the last 3 months or participation within a different cohort in this PDY11737 clinical trial or participation to previous trial with SAR97276
* Documented history of adequate treatment with antimalarials expected to be effective within the preceding 72 hours
* Severe concomitant disease (including concomitant febrile illnesses or infection)
* Any sign suggestive of severe malaria
* Severe malnutrition
* Asexual parasitemia: Plasmodium falciparum \> 100,000 parasites/μL in blood smear at D-1 visit
* Previous treatment within 3 weeks prior to inclusion, and concomitant treatment with potent CYP3A4 inhibitors or CYP3A4 inducers or CYP2D6 substrates or potent CYP2D6 inhibitors
* Known serious adverse event reaction or hypersensitivity to Artemisinin-Based Combination Therapy (ACTs) or any contraindications from the positive control therapy (Artemisinin Combined Treatments) or warning/precaution of use as defined in the respective National Product Labeling
* Pregnant or breast-feeding women
* Women of childbearing potential not protected by effective contraceptive method of birth control, or not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g.: double barrier method), and/or who are unwilling or unable to be tested for pregnancy,
* CPK above 3 ULN,
* Underlying hepatobiliary disease or ALT\>3 ULN.

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