cyrilzakka/clinical-trials huggingface dataset:
Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)

Teens with ASD ages 14-19 will be screened for eligibility, complete a baseline interviewer/ACASI-administered survey, and randomly assigned to either intervention or control group. The enrollment goal is 500 teens. The 12-hour intervention will be run in groups of up to 12 teens, with health educators leading the group and actors assisting, role playing with participants, and performing a skit. Teens in the intervention group will take a post satisfaction survey, and teens in both conditions will take a 6-month and 12-month interviewer/ACASI-administered outcome survey. Fidelity will be monitored by observers and rated by health educators.


Eligibility Criteria:
Inclusion Criteria:

* meets age limits and
* parent/self-identifying as having an autism spectrum disorder, Asperger's Syndrome, or autism-similar social challenges, and/or
* mild intellectual disability

Exclusion Criteria:

* screen-out with screening tool, if not screened in by documented staff observation

  * Hospitalization within the last 3 months for a behavioral or mental cause
  * Inability to participate in group setting (sensory, extreme social/communication challenges)
  * Previous criminal conviction for sex offense
  * Sibling previously randomized to control
* screen-out with KBIT-2: Score \< 50 OR Score above 70 on KBIT-2 and not receiving services for or having a diagnosis of ASD
* capacity to consent
Influence of IPV on GOR in Infants From 0 to 12 Months.

The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* infants from 0 to 12 months
* impedance monitoring

Exclusion Criteria:

* gestational age \< 24w
* anti-reflux medication
* Nissen fundoplication
* no parental consent
Endocrinology Auto-Triggered e-Consults

Diabetes currently affects 25.8 million people in the U.S. Patients with diabetes are generally managed, at least initially, by a primary care practitioner (PCP). As the prevalence of diabetes continues to rise, PCPs are under increased pressure to achieve recommended glycemic targets. Failure to achieve these targets has been shown to increase clinical complications and cost of care.

Endocrinology referral is common for those patients not meeting A1c goals. Unfortunately, access to specialty endocrinology care is limited and patients routinely wait weeks or months before being seen. Electronic consultation (e-consult) is a new and innovative delivery model that has the potential to provide greater access to specialty care. The current system at Massachusetts General Hospital (MGH) allows PCPs to electively place an e-consult to solicit specialist input. Specialists in turn review the patients chart, relevant data and the clinical question and respond within the electronic medical record. E-consults have been well received by both patients and physicians, not only at MGH, but also across many centers in the US. With that said, the e-consult system remains in its infancy and current literature largely focuses on process metrics without hard clinical end-points.

One way to optimize care for patients with diabetes is to automatically trigger an endocrinology e-consult for those not meeting A1c targets. The goal of this project will be to conduct a rigorous scientific evaluation of auto-triggered e-consults across Massachusetts General Hospitals affiliated primary care practices. The e-consults will be unsolicited and triggered based on inclusion criteria that include a1c and date of last PCP visit. This project will leverage an existing diabetes population health registry that is being used currently for ongoing diabetes care initiatives.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with a PCP at Massachusetts General Hospital and HbA1c between 8-10 who have seen their PCP in the office within 18 months

Exclusion Criteria:

* Terminal Illness
* Prior visit with MGH diabetes center
* Prior diabetes e-consult completed
Transcranial Direct Current Stimulation Combined With Oral Feeding on Dysphagia

The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for ischemic stroke;
* Age \> 18 years;
* First-time stroke;
* Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
* Requires enteral nutrition support;
* Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate with treatment;
* Transferred to the rehabilitation department within fifteen days of onset; Stable vital signs.

Exclusion Criteria:

* Presence of contraindications for invasive oral endoscopy;
* Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
* Concurrent presence of other neurological disorders;
* Tracheostomized patients;
* Concurrent liver, kidney failure, tumor, or hematological disorders;
* Pregnancy;
* Presence of contraindications for transcranial direct current stimulation, such as epilepsy, cerebral edema;
* Recent use of centrally acting drugs that interfere with the effects of transcranial direct current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.
Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic lymphocytic leukemia.

OBJECTIVES:

* Evaluate the safety, toxicity, and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome; newly diagnosed, relapsed, or refractory acute myelogenous leukemia; or relapsed or refractory chronic lymphocytic leukemia.
* Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population.

OUTLINE: Patients receive oral sodium salicylate twice a day. Intrapatient dose escalation or de-escalation is permitted. Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression. Responding patients may continue to receive sodium salicylate beyond the 6-week period.

Patients with acute myelogenous leukemia are followed until the end of therapy. Patients with myelodysplastic syndrome are followed until death or progression to leukemia.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Relapsed or refractory acute myelogenous leukemia OR
* Elderly patients with newly diagnosed acute myelogenous leukemia not eligible for standard therapy OR
* "High-risk" myelodysplastic syndrome, including:

  * Refractory anemia with excess blasts
  * Refractory anemia with excess blasts in transformation
  * Chronic myelomonocytic leukemia OR
* Relapsed or refractory chronic lymphocytic leukemia
* Not eligible for transplant protocols at MSKCC or refuses transplant
* Not eligible for a higher priority protocol (e.g., bone marrow transplantation)

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Platelet count at least 25,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* Transaminase levels less than 3 times upper limit of normal
* PT no greater than 14 seconds
* PTT no greater than 34.6 seconds

Renal:

* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Other:

* Not pregnant or nursing
* No history of abnormal bleeding or unexplained bleeding disorders
* No history of peptic ulcer disease
* No salicylate allergy
* No other concurrent active malignancy
* No other concurrent illness that would preclude study assessment to a significant degree

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana

Schistosomiasis and soil-transmitted helminhtiasis occur throughout the developing world and are most prevalent in the poorest communitites. These worms have been linked to several nutritional and intellectual deficiencies in many endemic populations worldwide. Helminth control, though crucial has been neglected for varied reasons. Currently, interests towards the control of neglected diseases including schistosomiasis and soil-transmitted helminths has been revived through many interventions including repeated chemotherapy to help improve public health outcomes and prevent long term morbidity. This will contribute to achieving several of the Millennium Development Goals at a favourable cost. A community-directed treatment of human schistosomiasis and STH in school-aged children in rural notrhern Ghana using praziquantel and albendazole is proposed. It is planned to test the hypothesis that community-based volunteers are non-inferior and more cost effective than rural school teachers at reaching school-aged children.

The primary objectives of the study are:

To compare coverage rate of community based volunteers and rural school teachers in the distribution of praziquantel and albendazole to scholl-aged children To determine the cost effectiveness of using community based volunteers to distribute praziquantel and albendazole to school-aged children in rural Ghana.

Study methods:

A list of all school-aged children (6-15 years) in the study area will be generated from the Navrongo Demographic Surveillance System database and registers produced and given to all school teachers and community based volunteers who will be responsible for the distribution of the antihelminithics. The school teachers and community based volunteers will provide the drugs to both enrolled and non-enrolled school-aged children. Percentage coverage of school-aged children will be the outcome measure and compated between the school teachers and the community based volunteers. Stool and urine samples will be collected from a representative sample (916) of the children for laboratory analysis before the administration of the drugs for baseline data. Sample collection and laboratory analysis will be repeated 6 and 12 months after the first round of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Children between 6 and 15 years of age
Effects of Napping in Sleep-Restricted Adolescents

To examine the neurobehavioural responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15 days. The nap group received an afternoon sleep opportunity lasting 1 hour.

57 participants (aged 15 to 19 years old) were grouped into nap and no nap groups. Both groups took part in a 15-day protocol that started with 2 9-hour adaptation and baseline nights, followed by two successive cycles of sleep restriction (5-h time-in-bed \[TIB\]; 01:00-06:00) and recovery (9-h TIB; 23:00-08:00) intended to simulate the weekday sleep loss and weekend attempt to 'catch up' that are familiar to high school students. The nap group received a 1-hour nap opportunity at 14:00 following each sleep-restricted night, while participants in the no nap group watched a documentary. Sleep was monitored with polysomnography on 9 selected nights. Cognitive performance, subjective sleepiness, and mood were assessed 3 times daily (10:00, 15:45, and 20:00).

All participants stayed in air-conditioned, twin-share bedrooms with en-suite bathrooms. Bedroom windows were fitted with blackout panels to ensure participants were not woken up prematurely by sunlight. Earplugs were also provided, and participants were allowed to adjust the temperature of their bedrooms to their personal comfort. 3 main meals were served each day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and strenuous physical activities were prohibited.

Outside of scheduled sleep, meal, and cognitive testing times, participants spent the majority of their free time in a common room that was illuminated by natural and artificial lighting. They were allowed to read, play non-physically exerting games, watch videos, and interact with research staff and other participants. Participants were under constant supervision by the research staff.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* no sleep disorder
* body mass index not greater than 30

Exclusion Criteria:

* smoker
* habitual short sleeper (time in bed during term time of less than 6 hours and no sign of sleep extension of greater than 1 hour on weekends)
* consumption of more than 5 cups of caffeinated beverages a day
* travelling across more than 2 time zones in the month prior to the study protocol
* diagnosed with any psychiatric conditions
Building Regulation in Dual Generations - Telehealth Model

Families who experience maternal mental illness and a variety of chronic stressors are currently underserved by the parenting programs. The investigators propose that impairments in maternal self-regulation, which result in unsupportive parenting, directly impact children's own self-regulation and neurobiology, leading to risk for intergenerational transmission of mental illness. The objective of this study is to develop and evaluate a program that is targeted at improving underlying self-regulatory mechanisms in both mothers with depression and their 3- to 5-year-old children. It is hypothesized that children exposed to maternal mental illness will have greater self-regulatory deficits across emotional and behavioural domains compared to children not exposed to mental illness. The effects of maternal mental illness are expected to be compounded for children of mothers reporting a higher degree of chronic stressors, including poverty, housing instability, violence, and low social support. Further, it is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the mother, child, and dyad (i.e. parenting interactions) will improve both maternal capacities and child outcomes. A feasibility study has been conducted in-person (NCT04347707). Results from this trial showed positive effects on child and mother well-being as well as parenting skills. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The objectives for this study are two-fold: 1) establish a better understanding of the self-regulatory processes that are altered in preschool-aged children exposed to maternal mental illness, and determine the mediating role of parenting behaviours, as well as the moderating impact of chronic stress exposure; and 2) evaluate a novel dual-generation intervention for mothers with mental illness using a virtual format and their 3- to 5-year-old children based on existing gold-standard evidence-based approaches.


Eligibility Criteria:
Inclusion Criteria:

* Must have a 3-5 year old child
* The child must not have a diagnosed developmental delay
* Must have full or joint custody of the child
* Must meet current criteria for a Major Depressive Episode
* Must be 18 years of age

Exclusion Criteria:

* Child is outside of the 3-5 year old age range
* The child has a diagnosed developmental delay
* Mother does not have full or joint custody of the child
* Mother did not meet current criteria for a Major Depressive Episode (control group)
Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

Multicentric retrospective study about the comparison of two different techniques of vaginal breach suturing after eradication surgery for deep infiltrating endometriosis and the surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional outcomes.

Treatment of vaginal endometriosis can be successfully performed by vaginal or laparoscopic approach.

The results of the surgical treatment confirm its validity with regard to the reduction of dyspareunia in the short to medium term but show less efficacy in the long follow-up. The long-term impact of surgery on sexual function may be influenced by multiple factors, such as recurrence of symptomatic or anatomical disease, preservation of autonomic nerve fibers responsible for the arousal and genital sensitivity and residual vaginal length. These factors are potentially dependent on the surgical approach performed to treat vaginal endometriosis.

Particular importance as a surgical step assumes the closing phase of the vaginal defect that can be performed through a transverse or longitudinal suture. The longitudinal suture could guarantee, theoretically, a greater residual vaginal length and a better sexual function in the postoperative period than the vaginal closure by transversal suture, as demonstrated in previous studies about the suture techniques of vaginal cuff after hysterectomy.

Up to date, there are no studies comparing surgical, clinical and functional outcomes of the vaginal suture neither the two surgical approaches (laparoscopic or vaginal) for vaginal endometriosis eradication.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of vaginal endometriosis
* Women undergoing surgical removal with complete endometriotic lesions involving the vagina
* Informed consent for the processing of personal data for scientific purposes

Exclusion Criteria:

* History of previous or ongoing neoplastic pathology
* Patients committed to hysterectomy
* Previous vaginal surgery
* Not complete eradicating surgery
* Vaginism-vulvodynia
* Psychiatric disorders
* Genital prolapse
* Surgical menopause or spontaneous or pharmacological menopause
Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease

To explore whether there is a different response to omega-3 fatty acid rich diet with respect to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor allele (GG) and the common allele homozygous (CC) of PNPLA3.

Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention than the common allele homozygous supplementation.

Nonalcoholic fatty liver disease (NAFLD) is emerging as one of the most common complications of childhood obesity. It is associated with and predicts the metabolic syndrome, independent of overall obesity. Increased ALT levels are associated with deterioration in insulin sensitivity and glucose tolerance, as well as with increasing free fatty acid (FFA) and triglyceride levels. The prevalence of metabolic syndrome and prediabetes increases with the increases in hepatic fat content in a cohort of obese adolescents.

Fatty liver, independent of visceral and intramyocellular lipid content plays a central role in the impairment of liver, muscle and adipose insulin sensitivity in obese adolescents. Thus, fatty liver disease may be the hepatic component of the metabolic syndrome.

Omega 3 fatty acids lower plasma triglyceride concentrations. The subjects entering the omega diet study will be consuming an omega rich diet that is tailored to their caloric needs. This calculation is based on the patient's weight, age, and gender with the purpose of not modifying their weight at all. Weight maintenance is a very important factor in this arm of the study. They will be on the diet for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 10 to 19 years of age
* BMI equal or greater than the 95th percentile for age and gender
* Genotype PNPLA3 CC or GG
* Liver MRI Hepatic Fat fraction ≥5.5%

Exclusion Criteria:

* Food allergy to fish or any components of the pills which include alpha tocopherol partially hydrogenated vegetable oils including soybean oils, gelatin, glycerol, corn or iron oxide
* Pregnant or breastfeeding
* Known bleeding disorder or coagulopathy or treatment with anticoagulant mechanisms or low platelet counts, abnormal PT or PTT
* Impaired glucose tolerance, Type 1 or 2 diabetes
* Birth control pills
* Alcohol consumption
* Other liver disease
* Taking any medication that alters triglyceride levels, liver function, blood pressure, glucose or lipid metabolism
* Taking over the counter supplements that affect triglycerides or lipid metabolism including fish oil supplements
* Treatment for or diagnosis of thyroid disorder or have an elevated TSH at baseline
* Use of any antipsychotic medication
* Taking chronic anti-inflammatory medications
* Less than 100 pounds (45 kg)
The Role of Histamine in Muscle Protein Synthesis Following Resistance Training

Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses the following research question: "What is the influence of histamine H1 signaling on training adaptations following ten weeks of resistance training in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-45 years
* Not to medium physically active

Exclusion Criteria:

* Smoking
* Chronic disease
* High blood pressure
* Supplement or medication intake
* Seasonal allergies
* Vegetarian / vegan
* Resistance trained