cyrilzakka/clinical-trials huggingface dataset:
Effects of Clinical Pilates and Yoga Training in Lymphedema

The aim of our study is to compare the effects of clinical Pilates and yoga training on lymphedema, upper limb muscle strength, proprioception, functions and quality of life in women with lymphedema after breast cancer.

A total of 60 post breast cancer lymphedema individuals will be included in our study. The study will be performed in individuals who live in T.R.N.C and who develop mild, moderate or severe lymphedema after breast cancer in the 35-70 age range.

A randomized controlled trial design with three groups were used; 1) A Hatha yoga intervention group, 2) Clinical Pilates intervention group, 3) Control group.

Individuals in the intervention groups will be given 24 sessions of yoga or Clinical Pilates training 3 times a week for 8 weeks. Control group will not receive any treatment. During the training, and control group individuals will be asked to wear compression stockings during the 8 weeks and an educational booklet will be given to the each group.

The yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow. Before starting the Clinical Pilates exercise program, the patients will be trained on Pilates exercises and postures. During training, the patients will be taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques.

As a result of the research, the data will be analyzed to determine which treatment method is more effective in lymphedematous individuals.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivors,
* who are between the ages of 35-70,
* who have unilateral mild, moderate or severe
* lymphedema in the upper extremities after breast cancer treatment,
* who have taken any of the Lymphedema treatment methods at least 6 months ago will be included.

Exclusion Criteria:

* Presence of metastatic breast cancer,
* Currently receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy),
* Severe heart failure (Class III),
* Infections in extremities (fungal, redness, temperature increase),
* Severe pain in the axillary region (eg: axillary web syndrome,
* reflex sympathetic dystrophy, neuropathy),
* Persons participating in a regular exercise program in the last 6 months will be excluded from the study.
Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse

The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the disease coming back after a stem cell transplant in patients with MDS and AML. This study will also be looking at the side effects of this medicine.

5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients whose disease came back after transplant, where it helped going into remission. It is unclear if 5'-Azacitidine can prevent the disease from coming back after transplant. This study will help show if getting 5'-Azacitidine soon after transplant can lower the risk of your disease coming back.


Eligibility Criteria:
Inclusion Criteria:

Patients who have undergone T cell depleted allogeneic hematopoietic stem cell transplantation at MSKCC for:

* De novo myelodysplastic syndromes (MDS): IPSS-1 with poor risk cytogenetics or higher IPSS.
* Acute myelogenous leukemia (AML) in first remission that required more than 1 cycle of treatment to achieve remission or with the following cytogenetic abnormalities: FLT3 mutation, deletion/monosomy of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. Also patients in second or greater remission.
* Patients with Secondary MDS/AML.
* Patients will be considered eligible for the study if after transplant they achieved hematologic (\<5% blasts) and cytogenetic remission.
* Patients will be eligible to enter the study between 60-120 days post transplant.
* Age: pediatrics and adults patients - 1 year old-75 years old.
* Karnofsky performance status \>=60% for patients \>16yo and Lansky performance status \>=60% for patients ≤16yo
* Stable blood counts (ANC\>1000/uL, Hb\>8gr/dL, Plt\>50,000/ uL) not supported by transfusions.
* Renal: Serum creatinine \<1.5 ULN
* Hepatic: \<3xULN ALT and \<1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
* Cardiac: Adequate cardiac function measured by LVEF\>50%. If asymptomatic, pretransplant echocardiogram is adequate. If symptomatic, echocardiogram needs to be repeated.
* Each patient must be willing to participate as a research subject and must sign an informed consent form.

Exclusion Criteria:

Patients will be excluded from the trial if at time of enrollment:

* Active uncontrolled bacterial, fungal or viral infection.
* Evidence of uncontrolled graft-versus-host disease.
* Pulmonary: new onset hypoxia
* Known or suspected hypersensitivity to 5'-azacitadine or mannitol.

  * Evidence of residual disease either by increased blasts count (\>5%) or persistence of previous known cytogenetics abnormalities.
* Peripheral blood neutrophil chimerism: less than 95% donor.
Prevention of Iron Deficiency in 2nd Year of Life

Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy babies without iron deficiency

Exclusion Criteria:

* Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease
Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP.

The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP.

The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP. During the observation, study visits will occur at the end of each month. During the 1-year follow-up period which is lasting 6 months after the treatment, all participants will be required to check the various efficacy indicators.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed PAP patients
* Aged 17-80
* Signed informed consent

Exclusion Criteria:

* Secondary PAP
* Received whole lung lavage therapy within 4 weeks before enrollment
* Received previous GM-CSF therapy within 6 months before enrollment
* WBC≥12,000/ul
* fever≥38℃
* Severe edema, severe liver, kidney, lung and cardiovascular disease.
* Pregnant，planning to get pregnant or nursing
* Inability to express the subjective discomfort
* Serious drug allergy history, E.coli preparation or rhGM-CSF serious allergy history
Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation

A current complication after lung transplantation is diaphragmatic dysfunction. These dysfunction result to several factors: duration of mechanical ventilation, chest tube, atelectasis, denutrition, phrenic nerve injury during surgical dissection... Only monocentric and retrospective studies collected diaphragmatic paralysis after lung transplant are published. The incidence of diaphragmatic paralysis in post-operative lung transplantation varies from 3.2% to 16.8%.

The main hypothesis of the study is to defined the incidence of diaphragmatic dysfunction in post-operative lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years old)
* Admitted for intensive care that can be spontaneously ventilated after bi- pulmonary transplantation

Exclusion Criteria:

* Minor patient
* Ventilated patients less than 24 hours
* patients in controlled ventilation
The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS

The status of axillary lymph node (ALN) is an important reference indicator for breast cancer surgery and systemic treatment, which is also an important prognostic indicator for breast cancer. Therefore, it is extremely important for surgeons to accurately determine whether axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of ultrasound diagnosing the status of axillary lymph nodes was controversial in recent publications. Therefore, there is a high need to prove the accuracy and precision of ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters to build a clinical useful categorization system

To facilitate the non-invasive assessment of lymph node status preoperatively, we use ultrasound to detect lymph node metastasis. We designed this study to obtain in vivo and vitro ultrasound features and parameters. Before surgery, the detailed ultrasound features are collected during routine ultrasound examination. After the completion of the axillary surgery, fresh lymph node specimens are collected for in vitro ultrasound evaluation one by one in a specially-designed detection system. Statistical models are built to categorize the probability of metastasis of lymph node according to a proposed categorization system similar as BI-RADS(Breast Imaging Reporting and Data System), which is named NI-RADS (Node Imaging Reporting and Data System).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer.
* Pathological axillary lymph node staging planned.
* Axillary lymph node not removed prior to the study.

Exclusion Criteria:

* Refusal participation in the study.
The Acute Effect of Protein or Carbohydrate Intake on Testosterone Levels and Food Intake in Children and Adolescent Boys

The purpose of this study was to determine the effect of acute protein and glucose intake on testosterone levels measured in adolescent boys and determine whether changes in testosterone levels are associated with alterations in short-term food intake. It was hypothesized that 1) ingestion of a protein beverage would result in no change of testosterone levels whereas glucose would result in a significant decrease of testosterone levels 60 minutes after ingestion and 2) decreases of testosterone levels as a result of the glucose preload would predict food intake for boys of similar body size. The first objective was to investigate the effect of an acute protein or glucose drink on testosterone levels and the second objective was to determine whether changes of testosterone levels associate with food intake.


Eligibility Criteria:
Inclusion Criteria:

* 9-18 years, healthy, male.

Exclusion Criteria:

* History of prematurity, chronic illness, were taking any medications known to affect glucose homeostasis, appetite or pubertal development.
An Observational Study of Patients With Moderate Parkinson's Disease

The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 50-68 years (both inclusive) at the time of signing informed consent.
* Diagnosed with Parkinson's disease using the Movement Disorder Society (MDS) criteria (fulfilling the definition of clinically probable Parkinson's disease).
* Moderate Parkinson's disease, e.g. as defined by i) modified Hoehn and Yahr stage 2-3 in OFF state and ii) MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score greater than or equal to (≥) 30 in OFF state, both as judged by the investigator.
* Patient has symptoms that are not adequately controlled by existing oral anti-Parkinson's disease medications, i.e., having both ON and OFF periods, as judged by the investigator.
* Parkinson's disease duration greater than (\>) 5 years and lesser than or equal to (≤) 12 years from diagnosis at the time of signing informed consent.
* Potential candidate for a future cell therapy transplantation, as judged by the investigator.
* Life expectancy \>7 years as judged by the investigator.

Exclusion Criteria:

* Any atypical or secondary Parkinson's disease, or non-Parkinson's disease-suspected cause(s) of, or contributors to, parkinsonism, as judged by the investigator.
* Significant drug-induced dyskinesias as judged by the investigator, e.g., as defined by a score of \> 2 in the Abnormal Involuntary Movement Scale (AIMS), in any body part in the ON state.
* Tremor-dominant Parkinson's disease, as judged by the investigator.
* Cognitive impairment predictive of dementia (including Parkinson's disease dementia) or other cognitive dysfunction as judged by the investigator, e.g., as defined by Montreal Cognitive Assessment (MoCA) score ≤ 24, or evidence of major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria.
* Major medical or psychiatric disorder (e.g., depression (Montgomery-Asberg Depression Rating Scale (MADRS) \>20) or psychosis), or other disease making the patient unsuited for participation in the study, as judged by the investigator.
* Treatment for dystonia or spasticity within 3 months of screening (Botox for a focal dystonia is allowed).
* Substantial neurological symptoms not accounted for by Parkinson's disease, including active seizure disorder, as judged by the investigator.
Long-Term Follow Up Study

The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study population of patients every six months and continuing over a five-year period. This will provide information on the longitudinal progress in mood, functioning, and quality of life of the CAN-BIND sample with a view towards long-term outcome and treatment.

This is a long-term follow up study of the 'Canadian Biomarker Integration Network in Depression' (CAN-BIND) study. The CAN-BIND study examines biological markers of antidepressant treatment response. The examined biomarkers included clinical, imaging, and genetic components. The Long Term Follow up (LTFU) study will continue to follow the patients in this study each six months over a five year period. By doing so, a comprehensive clinical outcome data on a well characterized cohort of depressed patients will be obtained.

The research team will conduct a naturalistic study of CAN-BIND participants and will monitor the longitudinal progress in mood, functioning, and quality of life, with a view towards advising future treatment options. Each patient completing CAN-BIND will be asked to participate in the LTFU study.

Eligibility Criteria:
Inclusion Criteria:

* Each patient completing the 16 weeks of CAN-BIND who have previously met DSM-IV-TR criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.

Exclusion Criteria:

* Any Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
* Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia or schizoaffective disorder.
* Presence of a significant Axis II diagnosis (borderline, antisocial).
* High suicidal risk, defined by clinician judgement.
* History of drug or alcohol use, with a severity of at least moderate or severe, according to DSM criteria, within the previous 6 months.
* Presence of significant neurologic disorder, head trauma, or other unstable medical conditions.
* Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.

As of protocol amendment 2 (approved 01-Dec-2021), all participants are unblinded and discontinued from study therapy, and will be switched to non-study antiretroviral therapy. Participants who received ISL + ulonivirine will be followed for ≥6 months.

Eligibility Criteria:
Inclusion Criteria:

* Is HIV-1 positive with plasma HIV-1 RNA \<50 copies/mL at screening
* Has been virologically suppressed on BIC/FTC/TAF for ≥6 months
* Has a screening CD4+ T-cell count \>200 cells/mm\^3 (completed by the central laboratory)
* Is male or female, at least 18 years of age, at the time of signing the informed consent
* female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
* Is not a woman of childbearing potential (WOCBP)
* Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)

Exclusion Criteria:

* Has HIV-2 infection
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive)
* Has a current (active) diagnosis of acute hepatitis due to any cause
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
* Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
* Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
* Is female and expecting to conceive or donate eggs at any time during the study
Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.

Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* history of seizures
* epilepsy
* brain trauma or injury
* insomnia
* sleep apnea
* medications that may affect the EEG.