cyrilzakka/clinical-trials huggingface dataset:
BUILT Family Lifestyle Program for Children with ADHD

The investigators have developed BUILT in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. Over 6-weeks, the BUILT program will explore what science says about the effects of sleep, nutrition, and exercise on brain development and behavior; investigate the food, sleep, and exercise routines of the world's best athletes and intellectuals; and experiment with home routines to find those that best fits with participating families.

It is hypothesized that families participating in BUILT (N=150) will show significant improvements in child health behaviors (sleep, nutrition, physical activity, recreational screen time), child mental health (ADHD symptoms \[primary outcome\], child functional impairment), child physical literacy, and family dynamics (cohesion, structure, communication) from baseline to posttest.

Families enrolled in Chicago Park District programs will be offered the opportunity to participate in the BUILT family lifestyle program. Using a single group design, measures will be taken within two weeks of program start and two weeks after completion. Additional feasibility measures will be taken during the program itself to inform refinements across iterations. The BUILT program will occur largely on-line and consist of weekly home challenges related to food, sleep, and exercise that add up to form a comprehensive home routine--the routine will optimize neurocognitive development and home structure. The program will be co-facilitated by UIC students and Chicago Park District staff. For more information visit the program website: https://built.ahs.uic.edu.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 6 to 12 years old
* Parent orientation session summarizing activities
* Child free of conditions that preclude aerobic activity
* Child enrolled in Chicago Park District programming

Exclusion Criteria:

* Boys and girls \< 6 years old or \> 12 years old
* Parent does not participate in orientation session summarizing activities
* Child has conditions that preclude aerobic activity
* Child not enrolled in Chicago Park District programming
Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

The goal is to have a small spectrometer (pocket size) , reliable and rapid tool that can be used during liver harvesting, which enables macrosteatosis to be evaluated reproducibly and selectively, at any time.

This tool must be minimally invasive, inexpensive and without significantly impacting the general organization of multi-organ harvesting.

In the operating room, the surgeon will perform an intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta. The surgeon will not be informed of the results of the spectrometer, and will carry out (or not) the biopsy. The spectrometers' results will be compared with definitive histological findings.


Eligibility Criteria:
Inclusion Criteria:

* Brain-dead donor
* Age ≥18 years old
* No restriction on the part of the donor or his family regarding the use of the data for research purposes.
* No fibrous appearance of the graft (visual assessment), corresponding to a Metavir score ≥ F2

Exclusion Criteria:

* Living donor
* Donor within the Maastricht III criteria (cardiac arrest)
* Pre-existing hepatic injury / trauma preventing the intraoperative use of the pocket spectrometer
* History of supra-mesocolic surgery or peritonitis leading to perihepatic adhesions (preventing the use of pocket spectrometer)
* History of chemotherapy -- Biological cholestasis:

  * GGT\> 400 IU / L
  * or total bilirubin ≥ 60micromol / L
  * or conjugated bilirubin ≥ 30micromol / L
CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome

This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must have refractory or relapsed Acute Myeloid Leukemia (AML) according to previously established criteria:

   1. Primary induction failure (PIF) after ≥ 2 cycles of chemotherapy
   2. First relapse
   3. Relapse refractory to salvage chemotherapy
   4. Second or subsequent relapse
2. Subjects with Myelodysplastic Syndrome (MDS):

   (a) Either Refractory Anemia with Excess Blasts I or Refractory Anemia with Excess Blasts II (RAEB I or RAEB II)
3. Karnofsky performance status ≥ 70
4. Willing to participate as a research subject and sign an informed consent form
5. Adequate physical function measured by:

   1. Cardiac: asymptomatic, or if symptomatic then Left Ventricular Ejection Fraction (LVEF) at rest must be ≥ 45% and must improve with exercise
   2. Hepatic: ≤3 x upper limit of normal (ULN) alanine aminotransferase (ALT) and ≤ 1.5 total serum bilirubin, unless liver is involved with the disease or there is congenital benign hyperbilirubinemia
   3. Renal: serum creatinine within normal range, or if serum creatinine is outside the normal range, then calculated creatinine clearance ≥ 60 ml/min
   4. Pulmonary: asymptomatic, or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 45% of predicted (corrected for hemoglobin)
6. If subject has prior malignancy, must be without any evidence of disease of that prior malignancy for at least 2 years (excludes skin cancers that may have been excised within that 2 year period).

Exclusion Criteria:

1. Serious active or uncontrolled infection or medical condition
2. Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
3. Prior daunorubicin therapy with a cumulative dose of more than 368 mg/m2 or equivalent
4. Other systemic anticancer therapy or ongoing clinically relevant toxicities from such therapy (at discretion of the investigator)
5. History of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, congestive heart failure), resulting in heart failure by New York Heart Association Class III or IV staging.
6. Subjects with Wilson disease or other Copper-related disorders.
A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists

The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool in improving SDM and communication between 100 older patients with AML and their oncologists.

The investigators have developed a patient-centered communication tool (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia or UR-GOAL) that 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. The investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. This was further adapted in a qualitative study of 15 older patients with AML. In a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed AML to a single arm study, as well as their caregivers and oncologists.

Eligibility Criteria:
Inclusion Criteria:

Patients

1. Age ≥60 years
2. Newly diagnosed AML or being worked up for possible AML
3. Able to provide informed consent
4. Agreement of their oncologist to participate in the study
5. English-speaking

If patients screen positive for cognitive impairment on the Mini-Cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist

Caregivers

1. Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom the patient discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient
2. Able to provide informed consent
3. English-speaking

Oncologists

1. A practicing oncologist
2. At least one of their patients are recruited to the study
3. English-speaking
Anti-Smoking Program for Parents: Effects on Child Smoking

The purpose of this study is to determine whether an anti-smoking program for parents who smoke will lower the odds that their children will start smoking. The study will evaluate an activity-based program for parents and their children. The program is home-based and uses the mail for program delivery.

Youth whose parents smoke cigarettes are at high risk for early initiation of cigarette smoking, and youth who first smoke cigarettes during childhood are at high risk for subsequent addiction to tobacco. Parents influence their children's perceptions of the prevalence of smoking, the acceptability of smoking, the accessibility of cigarettes, and the personal and social consequences of smoking. All parents, including parents who smoke, can engage in anti-smoking socialization, which may lower children's risk of smoking.

Although there are some programs available that are directed at preventing initiation of smoking during childhood, none of these prevention programs engage parents who smoke in altering children's smoking-specific socialization. This study will evaluate a program to change smoking-specific socialization of children in households where parents smoke cigarettes.

Consenting volunteers will be randomly assigned to either treatment (anti-smoking socialization program) or control groups. Parents in the treatment group will participate in the "Smoke-free Kids" program and receive activity magazines, newsletters, and support calls. Parents in the control group will receive a fact sheet about youth smoking. Parents involved in the study will be assessed through a telephone interview 1 month after completion of the three-month anti-smoking program. Assenting children will complete surveys administered at school at 12, 24, and 36 months after completion of the anti-smoking program. Primary and secondary dependent variables include initiation of cigarette smoking and susceptibility to cigarette smoking by children. The child survey will also assess risk and protective factors.

Eligibility Criteria:
Inclusion Criteria

* Parents or guardians who smoke
* Have children in the 3rd grade
* Belong to participating school districts in North Carolina, South Carolina, or Colorado
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts

Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.

METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent will be explained and signed. In those patients who ERP fails, a second attempt will be performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance cholangiopancreatography will be performed (Group 2).

Eligibility Criteria:
Inclusion Criteria:

1. Pancreatic pseudocyst that fulfilled the Atlanta Classification
2. Symptomatic pancreatic pseudocyst
3. Informed consent obtained

Exclusion Criteria:

1. Patient unwilling to participate
2. Absence of duration time of the pancreatography procedure in the record
3. Absence of the number of weeks between the drainage and the pancreatography
Oral Enteral Nutrition Tube Feeding on Stroke Survivors

The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

Stroke is happening increasingly more. The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
The Effect of Anesthetic Methods on Gastrointestinal Motility

The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. The main question it aims to answer is how do inhalation anesthesia and total intravenous anesthesia effect the gastrointestinal peristalsis during anastomosis.

Participants will be American Society of Anesthesiology (ASA) physical status II and III, between 18- 60 ages.

Researchers will compare inhalation anesthesia where desflurane is used with total intravenous anesthesia to see if the gastrointestinal motility differs between the groups.

Aim of this study is to evaluate the effect of two anesthetic methods on gastric motility during laparoscopic sleeve gastrectomy. Patients scheduled for laparoscopic sleeve gastrectomy with American Society of Anesthesiology (ASA) physical status II and III will enrolled into two groups. Computer based randomization will be used for the group selection. Patients will be monitored with standard monitorization (peripheral oxygen saturation, non-invasive blood pressure, 3-lead electrocardiography and patient state index (PSI)). Preoxygenation will be performed via a face mask with 6 L/min oxygen for 5 minutes. All patients will receive intravenous 2 mg/kg propofol, 0.25 mcg/kg/min remifentanil for anesthesia induction. Rocuronium bromide will be used intravenously with a dose of 0.6 mg/kg for muscle relaxation. Endotracheal intubation will be performed. In Group 1, inhalation anesthetic, desflurane and in Group 2, propofol infusion will be used with a 2 L/ min fresh gas flow as a mixture of 50 %- 50 % oxygen- medical air for maintenance of general anesthesia. Remifentanil infusion with a dose of 0.05-2 mcg/kg/min will be used in both groups during anesthesia maintenance. Anesthesia depth will be monitored with EEG monitorization where a score of 25-50 will be achieved in PSI . End-tidal carbon dioxide pressure will be kept between 35 and 45 mmHg. End-expiratory positive pressure will be set to 8 mmHg and intraabdominal pressure will be set to 12 mmHg. The surgeon will assess the gastric motility during anastomosis. The peristalsis during 1 minute period will be counted. 1 gram paracetamol and 1 mg/kg tramadol will be given intravenously for pain management. Sugammadex will be used for the reversal of neuromuscular blockade. Postoperative nause and vomiting, the time of first fart will be noted. Surgeon's satisfaction during anastomosis will be assessed with 5 points Likert Scale. Data will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 ages
* ASA II-III
* Patients scheduled for elective laparoscopic sleeve gastrectomy
* Body mass index 35 kg m2 and over

Exclusion Criteria:

* Hepatic disease
* Kidney disease
* Congestive heart disease
* Diabetes mellitus
* Neurological deficit
* Psychiatric disease
* Pregnancy
* Delayed gastric empting
* Previous bariatric surgery
* Patient's refusal
* Open surgery
The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases

In order to obtain suitable exercise intervention model for children and adolescents with obese or metabolic syndrome in China, we conduct a RCT to examine the effects of different intensity exercise intervention on weight, and other cardiometabolic risk factors among children and adolescents, we also test the effects of exercise interventions on multi-omics such as metabolomics, gut microbiome, genetics, and explore the potential mechanisms by which exercise interventions modulate cardiometabolic risk. This is a randomized controlled study. Children and adolescents with obesity or metabolic syndrome were randomly divided into three groups, including low intensity exercise training group, moderate and intermittent high intensity exercise training group. The investigators will obtain organ hydrodynamics indexes by abdominal ultrasound and computational fluid dynamics technology, and obtain the metabolic regulation mechanism of the body in response to exercise through the detection of metabolism related small molecules in blood and urine and the analysis of intestinal flora, so as to explore the potential value and mechanism of different exercise modes in the treatment of obesity and metabolic syndrome. At the same time, the behavior and self-consciousness of children and adolescents will be investigated to obtain the suitable exercise intervention model for Chinese children and adolescents with obesity and metabolic syndrome. In conclusion, this study aims to demonstrate which exercise mode can alleviate obesity or reverse metabolic diseases, analyze which factors can sense exercise, and explore the potential mechanisms through mutil-omic approach, so as to improve metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of overweight or obesity or metabolic syndrome;
* Good academic performance in school;
* Willing to sign informed consent.

Exclusion Criteria:

* Clinical diagnosis of Cushing syndrome;
* Pathological obesity such as Prader-Willi syndrome and obesity caused by drug factors；
* Participated in other intervention studies within the previous three months;
* participant or their guardian has obvious intellectual or mental abnormalities.
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)

This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.

\<Phase I\>

Primary Objective:

To establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.

Secondary Objective:

To observe the efficacy of this regimen in these patients.

\<Phase II\>

Primary Objective:

To assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.

Secondary Objectives:

To determine the adverse reactions of this regimen in these patients. To determine TTP(Time to progression) of patients treated with this regimen. To determine MST(Median survival time) of patients treated with this regimen.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan
* ECOG performance status 0-1
* 20 years and older
* Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor
* Tissue from tumor must be available
* Patients must have measurable disease
* Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month
* Life expectancy \> 3 months
* Laboratory values as follows
* 3000/mm3 \< WBC \< 12000/mm3
* 1500/mm3 \< granulocyte count
* 8.0 gm/dl \< hemoglobin
* Platelet count \> 100000/mm3
* Aspartate transaminase \< 150 IU/L
* Alanine transaminase \< 150 IU/L
* Creatinine \< 1.5 mg/dl
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
* Active or uncontrolled infection
* Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week
* Clinically significant heart disease
* Patients with a history of myocardial infarction within the previous three months
* Patients with uncontrolled diabetes mellitus or hypertension
* Presence of clinically apparent central nervous system metastases
* Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
* Decision of unsuitableness by principal investigator or physician-in-charge