cyrilzakka/clinical-trials huggingface dataset:
Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. Recent laboratory studies demonstrated that these cytokines may also modify T-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.

The aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor \[G-CSF\] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 16 years and \< 46 years
* Geno-identical allogeneic bone marrow transplantation
* Myeloablative conditioning regimen
* Haematological malignancies and acquired aplastic anemia
* Written and informed consent

Exclusion Criteria:

* ECOG performance score \> 2
* T-cell depletion
* Serum creatinine level \> 133 µmol/L
* Abnormal liver function
* Positive HIV test
* Pregnant women
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

The goal of this clinical trial is to learn if adding Shiatsu therapy to standard treatment can improve quality of life in children and adolescents with chronic pain that is not caused by inflammation. The main question it aims to answer is: Does Shiatsu therapy help improve the quality of life in children with long-lasting pain?

All participants will continue their regular treatment and will also:

* Receive a 30-minute Shiatsu session once a week for six weeks
* Complete questionnaires about their quality of life and family impact before, during, and after the treatment period

The study includes about 40 participants between the ages of 10 and 18, who are already being followed at the pediatric pain and rheumatology clinics at Tel Aviv Sourasky Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 10-18 years
* Diagnosed with non-inflammatory chronic pain syndromes
* Actively followed by the Pediatric Rheumatology and/or Pediatric Pain Clinics at Tel Aviv Sourasky Medical Center (at least twice a year)
* Informed consent signed by at least one legal guardian (or both guardians in cases of separated parents)
* If participant is 16 years or older, they must also sign the informed consent

Exclusion Criteria:

* Informed consent cannot be obtained from the participant or their legal guardians
* Legal guardians unable to provide informed consent
* Patients with severe conditions (e.g., bone metastasis)
* Patients unable to participate in Shiatsu therapy sessions
* Participation in Shiatsu therapy within 6 months prior to study enrollment
* Participant or legal guardian refuses participation
To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.

Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.

Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.

Safety, growth and tolerance parameters will be followed and collected throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Chinese term infants ≤ 44 days
2. Birth weight within normal range
3. Head circumference within normal range
4. Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age

Exclusion Criteria:

- The mothers of infants:

1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
2. known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;

   - Parents/Legally acceptable representatives/Caregivers of infants:
3. who are incapable to comply with study protocol

   - Infants:
4. who have to be fed with a special diet other than standard cow's milk based infant formula;
5. known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
6. known or suspected to have an allergic condition towards cow's milk, soy or fish;
7. with any history of, or current participation in any other study involving investigational or marketed products.
Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome

Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis.

The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome.

Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular fluid of IVF patients.

Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis patients. Normal sperm count. Heavy metals concentrations will be measured using atomic absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.

Eligibility Criteria:
Inclusion Criteria

* Age of female patients: \<=39
* Age of male patients: 18-50

Exclusion Criteria:

* Smoking
* Alcohol/drug abuse
* Long-term/chronic medications
* Severe health/mental problems
* Dental or other transplants
* Fragile X mutations
* Fertility preservation
Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. Specifically, the investigators want to know how well vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib can improve how well the patient functions.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.
* Histologic proof of melanoma reviewed and confirmed by MSKCC.
* A confirmed EBRAFV600E or KBRAFV600K mutation.
* Stage IV melanoma, or advanced stage III not curable by surgery. Patients with active CNS metastases will be allowed on the study.
* Measurable disease by RECIST v1.1.
* ECOG performance status 3 or 4. The basis for the grading of performance is strict; there must be clear justification of the performance status grade (e.g. patient is confined to bed \> 50% of time, or cannot carry out ADLs, or is otherwise disabled by burden of disease such as requiring supplemental O2).
* Patients must be able to swallow pills
* Adequate hematologic, hepatic and renal function as defined by the following:
* Absolute Neutrophil Count ≥ 1.0 x 109/L
* Hemoglobin ≥8.0g/dL, occasional transfusions are acceptable as vemurafenib does not have significant hematologic toxicities.
* Total bilirubin ≤2.0x the upper limit of normal, ≤3.0x the upper limit of normal if the patient has Gilbert's Syndrome.
* Alkaline phosphatase ≤2.0x the upper limit of normal.
* AST and ALT ≤2.0x the upper limit of normal.
* Serum creatinine ≤ 1.5x the upper limit of normal.

Exclusion Criteria:

* Uveal melanoma as primary.
* Concurrent chemotherapy, immunotherapy, or radiotherapy.
* Prior treatment with a RAF inhibitor. Other prior chemotherapy, immunotherapy, or radiotherapy will be allowed including prior treatment with a MEK inhibitor Patients must have had complete recovery from any adverse events or toxicities of prior cancer-directed therapies.
* Pregnant or lactating women.
* A second active malignancy. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 2 years. Patients with indolent B-cell malignancies will not be eligible.
* QTc interval \> 500 msec.
Impact of Renovations in Long Term Care Living Spaces on Residents With Dementia, Their Families and Staff

A long-term care facility in central Canada planned to renovate their existing dementia care units. The overarching objective of this study was to examine the effects of the renovations on residents, family, and staff.

A long-term care facility in central Canada renovated their existing dementia care units, which accommodates 60 residents with intermediate and advanced stages of dementia. The primary features of the renovation include physical upgrades and the addition of a large u-shaped activity pavilion. The overarching objective of this study was to examine the effects of these design transformations in the facility and grounds on residents, family, and staff. The overall project addressed the following questions:

* How does the long-term care unit renovation affect the health outcomes, quality of life, and lived experiences of residents?
* What are the effects of the long-term care unit renovation on care staff and family members?
* What aspects of the transformation were responsible for observed changes? And what aspects worked or did not?

A multi-component, mixed-methods (qualitative and quantitative) research plan was used in this project. Personal (resident, families, staff) and environmental variables (social interactions, implementation and use of technology and physical space) were assessed pre-renovation (spring/summer 2017) and post-renovation (summer 2019 and 2020). Due to the COVID-19 pandemic, plans for additional data collection in the summer of 2020 were not completed. With this mixed-methods research plan, the investigators gained valuable information about the renovation that is important for long term care facilities.

Eligibility Criteria:
Resident Inclusion Criteria:

* Currently living on special care unit for residents with intermediate to advanced dementia or cognitive impairment in a long-term care facility

Family Member Inclusion:

* Must have a family member/friend/neighbour currently living on the special care unit.
* For the QUALID, the family member must have visited the resident at least three out of the last seven days

Family Member Exclusion Criteria:

* Must be able to participate in-person.
* Must be able to communicate in English.
* Must be cognitively able to participate.

Staff Inclusion Criteria:

* Must currently work on the special care unit (either full or part-time or occasional)
* For the survey, staff must be able to read and understand English.
Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction

1. This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence.
2. LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.

Collect 120 women(A. Overactive bladder、B. Stress incontinence、C. Interstitial cystitis D. Female sexual dysfunction), Low Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 8 weeks(B.、C. PRP treatment at 1, 5, 9 weeks), and to complete all treatment after 4 weeks and 24 weeks back to the clinic, evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI)、Urinary tract dynamics test、Urination log、Cotton pad test、Blood test(ESR、CA125、CBC、CRP). ○DLow Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 4 weeks, and to complete all treatment 4th and after 4 weeks back to the clinic, Pelvic Doppler ultrasound ,evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI).

Eligibility Criteria:
Inclusion Criteria:

1. One of the following symptoms can be included:

   1. Overactive bladder
   2. Stress incontinence
   3. Interstitial cystitis
   4. Not Menopause and female sexual dysfunction (FSFI scores\< 26)
2. The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal.
3. Women over 20 years.

Exclusion Criteria:

1. No UTI during the past week.
2. Patients with poorly controlled diabetes, spinal cord injury, brain disease and neurogenic disease.
3. urinary symptoms of inflammation(Bladder stones、hematuria、urethral syndrome).
4. Patients with acute or chronic infectious diseases.
5. Patients with acute or chronic cardiovascular disease.
6. Patients with a history of chronic liver and kidney disease.
7. Patients receiving anticoagulant therapy(Aspirin and NSAIDs COX-1).
8. Patients with bleeding disorders.
9. Receive low energy extracorporeal shock wave treatment within 1 month before entering the trial.
10. Urinary incontinence need to install the catheter.
11. Pregnant women.
12. Unable to sign the consent form.
Enoxaparin as Treatment for Vulvodynia

The investigators hypothesize that injections of Low molecular weight heparin (LMWH) \[enoxaparin\] will reduce pain in women with vulvodynia.


Eligibility Criteria:
Inclusion Criteria:

* women with vulvodynia

Exclusion Criteria:

* women without vulvodynia
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects

The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference product after two single oral administration separate by 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject aged 18 to 50 years (inclusive)

Exclusion Criteria:

* Presence of any significant medical finding or significant history that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Presence of any clinically significant abnormal finding at examination in the Investigator's opinion
Development and Evaluation of THRIVE

Investigators will test the feasibility and acceptability, as well as efficacy (exploratory aim) of a text messaging intervention for Adolescents and young adults (AYA) transitioning off active treatment for cancer. Texting Health Resources to Inform, motiVate, and Engage (THRIVE) is intended to improve knowledge about health promotion and health vulnerability and importance of continued engagement in care, while also providing support and improving efficacy to achieve health-related goals.

Adolescents and young adults (AYA) with cancer are recognized as an understudied and underserved population in oncology. AYA engagement in ongoing disease management is compromised by lack of awareness of their continued health vulnerabilities and need for continued care, their desire to be "normal" and remove themselves from the cancer experience, and lack of AYA-appropriate support and services. Thus, AYA with cancer, especially those completing active treatment, are extremely vulnerable and in need of support to maintain remission and assure optimal health into adulthood. To address the immediate need for innovative interventions targeting AYA completing cancer treatment, the proposed study will test the efficacy, feasibility, and acceptability of a tailored text messaging intervention for AYA transitioning off active treatment called THRIVE (Texting Health Resources to Inform, motiVate, and Engage).

A pilot randomized controlled trial testing the acceptability and feasibility (primary) and initial efficacy (secondary) of a health promoting mobile health texting intervention with AYA transitioning off active cancer treatment to follow-up care.

The intervention compares a texting intervention to a receipt of an AYA survivorship handbook. Acceptability and feasibility are primary outcomes. Efficacy outcomes include measures of knowledge, healthcare utilization, adherence, engagement in care, and psychosocial well-being measures.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with cancer
2. Males or females between the ages of 12 and 25
3. In remission (per documentation in chart)
4. Within 12 months of completing active treatment for cancer
5. Cognitively capable to complete measures (per documentation in chart of impairment or parent or provider report).
6. Able to read and speak English.
7. Parent available to provide consent for those ages 12 to 17

Exclusion Criteria:

1)Subjects that do not meet inclusion criteria described above will be excluded.
The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)

Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection.

The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2
* Is medically healthy with no clinically significant medical history

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has history of gastrointestinal disease which may affect food and drug absorption
* Has history of cancer (malignancy).
Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

This study will evaluate the efficiency of dietary intervention on intradialytic weight gain. Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. One month after the intervention, their intradialytic weight accumulation will be measured.

Inter Dialytic Weight Gain (IDWG) ascribed to fluid retention is one of the major clinical problem that patients in hemodialysis need to cope with between 2 subsequent hemodialysis especially in patients with no residual renal function. Fluid retention is associated with morbid conditions such as lower-extremity edema, ascites, pulmonary vascular congestion or edema, hypertension, and worsening heart failure. Gain weight above 2 kg between 2 subsequent hemodialysis found to be in higher risk of all-cause mortality and cardiovascular death .Lowering daily sodium intake found to mitigate fluid retention ,however there are only a few researches that check it. 2IDWG also associated with poorer quality of life. Dietary sodium restriction recommendation since the beginning of hemodialysis are based on association of this restriction with balance of hypertension and fluid retention. Sodium intake recommended for patients in hemodialysis is limited to 2 grams a day. Nevertheless, there are only a few studies that examine the efficiency of this restriction because of the complexity of measurement of sodium intake. One recently published study which used a 24-h recall to measure sodium intake, found a direct correlation between IDGW and mortality form any reason. In spite of this complexity, IDWG has been found to be in a direct relation with patients' nutrition status.

One of sodium-related issues is malnutrition. Malnutrition in dialysis is a risk factor for patients' morbidity and mortality. Higher sodium intake is associated with higher calorie and protein intake, while adherence to restriction of sodium intake is poor in hemodialysis. This is a reason for high importance to study effects of sodium restriction in people with more than 2.5 kg (or 4% of dry body weight) IDWG while following up their nutritional status

Eligibility Criteria:
Inclusion Criteria:

1. Adults \>18 years providing signed informed consent.
2. Any patient more than 3 months in hemodialysis who reach his assigned dry weight.
3. Intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions.
4. residual renal function of less than 200 ml per 24 hr.
5. expected to stay on hemodialysis for at least 6 month.

Exclusion Criteria:

1. Malnutrition as assessed by SGA: score C.
2. Dementia
3. Active malignancy
4. Active infection
Normative Data of Brain Network Activation in Adolescents and Young Adults

Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults.

Currently, there is no reliable, practical, and non-invasive method for assessing changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.

The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-24 years.
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).

Exclusion Criteria:

* Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
* Currently with lice or open wounds on scalp.
* Any chronic disease as determined by clinical evaluation and medical history.
* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation
* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
* Substance abuse in the last 3 months.
* Significant sensory deficits, e.g., deafness or blindness.
* History of any clinically significant brain trauma as determined by the investigator.