cyrilzakka/clinical-trials huggingface dataset:
Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation

Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60 years
* Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell transplant
* Must have the ability to observe the efficacy and events
* Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
* Must have suitable donor

Exclusion Criteria:

* Must not have an advanced malignant hepatic tumor
* Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
* Must not be receiving any other investigational agents within 14 days of first dose of study drug
* Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
* Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
* Must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study
* Must not have a known or suspected hypersensitivity to decitabine
* Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with decitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes

What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-65 years of age.
* Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
* Type 2 Diabetes Mellitus or impaired fasting glucose with BMI \>35 AND not interested in surgery but are interested in supervised caloric restriction.

Exclusion Criteria:

* Previous treatment with thiazolidinediones.
* Chronic antibiotic therapy.
* Active microvascular or macrovascular complications of diabetes.
Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care

Thrombotic Thrombocytopenic Purpura (TTP) is a potentially life-threatening thrombotic microangiopathy caused by a severe deficiency of ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif member 13). Decreased ADAMTS13 activity leads to an accumulation of ultralarge von Willebrand factor (vWF) multimers which induce aggregation of platelets and microthrombi. These microthrombi may involve the brain, heart, kidneys and lead to life-threatening organ failures.

In experimental models, magnesium sulfate increases cleavage of newly released vWF by ADAMTS13, decreases the endothelial secretion of ultralarge vWF and inhibits the interaction of vWF with platelets. In another thrombotic microangiopathy, magnesium sulfate has been shown to reduce the risk of seizures in women with severe pre-eclampsia. In analogy with its evidence-based therapeutic application in pre-eclampsia and based on a strong rationale for magnesium supplementation in TTP, we propose a phase 3, double blind, placebo controlled, and randomized study to evaluate the efficacy of magnesium sulfate in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis in patients with Thrombotic Thrombocytopenic Purpura.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Health insurance
* Signed inform consent by patient or relatives

Exclusion Criteria:

* Pregnancy
* No health insurance
Preemptive Versus Preventive Antiemetic Treatment

Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.

Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery.

In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III patients
* Surgical procedure: scheduled for laparoscopic cholecystectomy
* Type of anesthesia: general

Exclusion Criteria:

* Antihistamines the last three days
* Antiemetic drugs the last three days
* Hiatus hernia
* reflux
* Gastrointestinal disease
* Pregnancy
* BMI \> 35
* parkinson
* known allergy to the drugs of the protocol
* epilepsy
"Sandwich" Chemotherapy With Radiotherapy in Newly Diagnosed, Stage IE to IIE, ENKTL

A phase 2 study was conducted of "sandwich" protocols, with earlier RT after an initial 2 of P-CHOP (Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone ), followed by further two "consolidation" cycles,to explore the appropriate mode of combined modality therapy (CMT) in early stage ENKTL.

The extranodal natural killer/T-cell lymphoma (ENKTL) shows high local or systemic failure rates when radiotherapy (RT) is taken as the primary treatment, suggesting a role for chemotherapy (CT) added to RT for this disease. However, the appropriate mode of combined modality therapy (CMT) has not been fully defined.We conducted a prospective phase II study of "Sandwich" Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone (P-CHOP) regimen in combination with radiotherapy.The "sandwich" protocols, refer to earlier RT after an initial 2 cycles of P-CHOP followed by further two "consolidation" cycles.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ENKTL
* age:18-69years
* Ann Arbor stage IE,or stage IIE with cervical lymph node involvement
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Eastern CooperativeOncology Group performance status of 0 to 2.
* Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement
* previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
* primary lesion not from the upper respiratory
A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients

Crohn's disease (CD) is a chronic, nonspecific inflammatory disease that can affect the entire digestive tract. It is difficult to cure and often relapses, causing long-term suffering for patients. This persistent condition significantly impacts their mental and psychological well-being, leading to a noticeable decline in their quality of life. Furthermore, these negative emotions can contribute to disease recurrence and the worsening of symptoms. Positive psychological intervention (PPI) refers to the enhancement of positive emotions, cognition, and behaviors to increase well-being and alleviate symptoms. Therefore, this study aims to use psychological methods to help CD patients better recognize and understand their positive experiences, thus aiding them in coping with stress and adversity more effectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Crohn's disease according to the 2018 diagnostic criteria established by the Inflammatory Bowel Disease Group of the Chinese Medical Association's Gastroenterology Branch;
* Patients aged between 18 and 75 years;
* Patients with a score of 5-14 on the GAD-7 (indicative of mild to moderate anxiety) or a score of 5-14 on the PHQ-9 (indicative of mild to moderate depression);
* Patients who understand and agree to comply with the study requirements and have signed informed consent;
* Patients who are able to read and access the internet, either independently or with assistance from a family member, and are capable of using WeChat and mobile applications;
* Patients who are able to complete all course trainings and/or follow-up procedures.

Exclusion Criteria:

* Individuals with a history or current diagnosis of psychiatric illness or cognitive impairment, or those currently taking psychiatric medications; Individuals working in the field of psychology, or those who have previously studied or are currently studying positive psychology;
* Individuals with concurrent other intestinal diseases or malignancies;
* Individuals with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, or renal systems.

Withdrawal Criteria:

* Patients lost to follow-up due to withdrawal or other reasons during the intervention period;
* Patients who develop severe complications or experience significant changes in their condition that prevent them from continuing the study.
SweetDreams Sleep Study for Children With Autism

This proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.

Access to effective treatments for sleep disorders is a persistent challenge. This is due to the lack of trained clinicians as well as caregiver resources to seek out and utilize such critical services. The SweetDreams intervention will solve this problem with on-line delivery of educational materials and treatment strategies for an evidence-based intervention. It will be readily available to caregivers at any time and through multiple outlets such a computer, tablet, and telephone, modes of delivery favored by and effective for parents of children in this age group.

This adaptation will address key challenges to sleep health care for children with ASD: (1) Learning differences of children with ASD by incorporating intervention principles from the TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of qualified providers by developing didactic videos for online and mobile device delivery (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing "more effective interventions...by targeting interventions to the identified needs of community members," SweetDreams will use a dynamic process involving extensive collaboration with children, parents, developmental pediatricians, and other experts on youth with ASD.

Eligibility Criteria:
Inclusion Criteria:

* have poor sleep health
* have a diagnosis of ASD

Exclusion Criteria:

* any regular sleep medication use (this does not include occasional over the counter sleep aid)
* known sleep apnea
* unstable major medical conditions (e.g. severe asthma, diabetes).
Delayed Positioning in Cesarean Section

Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The possible explanation for this is combined aortocaval compression by gravid uterus in parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The investigators evaluated if the incidence of hypotension would be decreased by delayed supine positioning, by maintaining lateral position for 6 min after spinal injection, in patients undergoing elective cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* singleton parturients undergoing elective cesarean section
* gestational age over 37 weeks

Exclusion Criteria:

* pregnancy with hypotension
* expecting fetal depression
Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis

The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH \[1-34\] transdermal delivery in comparison to subcutaneous injection of rhPTH\[1-34\] following 3-month treatment in postmenopausal women with Osteoporosis


Eligibility Criteria:
Main Inclusive Criteria:

* Post-menopausal women aged between 55 to 85 years (inclusive)
* Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.
* Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.

Main Exclusive Criteria:

* Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation
* Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
* Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.
* Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.
* Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.
* Subject is in general good health.
* Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.
* Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).
* Subject's caregiver must agree to comply with the following study restrictions:

  * will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel.
  * will not shampoo, wash, or rinse the subject's hair or scalp until the Day 2 treatment evaluation has been completed.
  * will not cut or chemically treat subject's hair in the period between screening and follow-up on Day 15.
  * will use only study-provided shampoo on the subject for the duration of the study.
  * will follow all study instructions.

Exclusion Criteria:

* Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.
* Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.
* Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.
* Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.
* Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \> 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.
* Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
* Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation.
* Subjects who have been treated with a systemic antibiotic within 2 weeks before screening.
* Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening.
* Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress

Israel ministry of defense is examining a new protective undergarment of GORE company (chempark fabric) for the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by a BC protective undergarment under exercise-heat stress conditions.

In order to physiologically evaluate a new BC protective garment for the Israeli police use under exercise-heat stress conditions, 10 young and healthy civilian volunteers will participate in this study.

The subjects will undergo 5 experiment days: Recruitment day, one day of acclimatization to heat, and 3 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC protective undergarment + standard combat uniforms, new BC protective undergarment + standard combat uniforms + NBC mask).

Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Psychiatric condition.
* Any muscles or skeleton condition.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.
Correlation Between End-tidal CO2 and Degree of Compression of Heart During CPR Measured by Ultrasound

Individual optimization of cardiopulmonary resuscitation (CPR) in real time may increase the success rate of the procedure. End-tidal CO2 (EtCO2) levels reflect cardiac output induced by CPR. Other potential marker of haemodynamic efficacy of CPR is direct measurement of the extent of induced compression of left ventricle (LV), right ventricle (RV) and inferior caval vein (IVC) by ultrasound. We plane to evaluate whether these ultrasound parameters correlate with EtCO2 levels during CPR for out-of-hospital cardiac arrest (OHCA) of non-traumatic origin.

Pre-hospital observational study will be realized in the setting of physician-based Emergency Medical System in the Czech republic. 20 patients resuscitated for OHCA of nontraumatic origin are planned to be included to the study. Transthoracic echocardiography will be performed from subcostal view during ongoing chest compressions in all of them and in the time of this investigation EtCO2 level will be recorded. This will be repeated three times during CPR in each patient if possible. Later on, maximal and minimal diameter of LV, RV and IVC will be obtained from the recorded loops and compression index (%) of LV (LVCI), RV (RVCI) and IVC (IVCCI) will be calculated as (maximal-minimal/maximal cavital diameter)x100. Correlations between EtCO2 and LVCI, RVCI and IVCI and CImax will be expressed as Spearman's correlation coefficient.

The results of the study will answer the question whether echocardiographic evaluation of compression of heart cavities during CPR reflect haemodynamic efficacy of CPR. If so, this study will be followed by an interventional clinical trial evaluating the effect of compression depth changes as a response to measured compression of the heart.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient resuscitated for out-of-hospital cardiac arrest of non-traumatic origin.

Exclusion Criteria:

* Technical unavailability of intra-arrest ultrasonography and capnography.
Evaulation of Interaction Between Herbal Products and Anticoagulants

The purpose of this study is to determine if the use of herbal products interferes with normal anticoagulation, leading to either excessive thinning of the blood and bleeding problems or inadequate thinning of the blood and clotting problems. Many patients who are on long term anticoagulation, or blood thinning, for a variety of medical problems, also take herbal products. It is not yet known whether use of herbal products interferes with this anticoagulation, and puts patients at risk for bleeding or clotting. This study will carefully monitor patients who are taking herbs and anticoagulants to determine if their laboratory tests show signs of being affected by the herbs. The study will ask all patients about their herbal product use, so all reported herbs will be included and monitored.


Eligibility Criteria:
Inclusion criteria:

* Taking longer-term (\>6 months) anticoagulation
* Enrolled in one of Kaiser Permanente Northern California anticoagulation clinics