cyrilzakka/clinical-trials huggingface dataset:
Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students

Investigators are conducting a randomized controlled trial with overweight and obese college students on the University of Minnesota campus. The primary outcome will be weight loss measured 12 months after study enrollment (corresponds to 10 months after the end of treatment).

Approximately 30% of college students are overweight or obese. Intervening on excess weight early may eliminate obesity-related morbidity. Evidence supports use of monetary incentives to encourage weight-loss; questions remain about the efficacy of contingency management on weight loss maintenance.

"Lose 2 Win" contests in which participants who achieve weight-loss goals are eligible for cash prizes, appear well-suited for implementation on campuses. Our objective in this two-phase trial is to evaluate the feasibility, acceptability and efficacy of Lose 2 Win for weight-loss maintenance among college students.

Eligibility Criteria:
Inclusion Criteria:

* 18-24 years of age
* University of Minnesota Freshman, Sophomore, or Junior
* Plan on enrolling at the U of Minnesota through Spring 2013
* BMI greater than or equal to 26 and less than or equal to 35.5
* Have working internet and phone access
* Ability to read/write English
* Ability to safely engage in exercise

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Prior or planned weight loss surgery
* Having a special diet or being a member of an "organized weight loss program"
* Diagnosis of Diabetes
* Have had Binge Eating Disorder
* Have lost greater than or equal to 10 pounds in the last 3 months
Translating Neuroprediction Into Precision Medicine Via Brain Priming

The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.

This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Fit the age requirement: age 5-9
2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
3. Be in good medical health
4. Be cooperative with testing
5. Speak English in the family
6. Successfully complete an fMRI scan
7. Full-scale intelligence quotient (IQ)\>70

Exclusion Criteria:

1. Any metal or electromagnetic implants, including:

   1. Cardiac pacemaker
   2. Defibrillator
   3. Artificial heart valve
   4. Aneurysm clip
   5. Cochlear implants
   6. Shrapnel
   7. Neurostimulators
   8. History of metal fragments in eyes or skin
2. Significant hearing loss or other severe sensory impairment
3. A fragile health status.
4. Current use of prescription psychotropic medications that may affect cognitive processes under study.
5. A history of significant head trauma or serious brain or psychiatric illness
Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients

The aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese PCOS population.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective study was to investigate the effect of the antiobesity medical therapy (combination of metformin and liraglutide (COMBI)) on short time weight loss in the specific infertile obese PCOS population. Additionally, we analyzed eventual impact of the short term weight loss 5% or more before IVF on oocyte maturity and embryo quality in infertile obese PCOS population.

Eligibility Criteria:
Inclusion Criteria:

* polycystic ovary syndrome (rotterdam criteria)
* BMI of 30 kg/m² or higher
* Infertility for IVF with normal male sperm

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of multiple endocrine neoplasia 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma

The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1or more lines of standard therapy.
* Participants with pathologically confirmed R/R NHL after non-response to or failure of 1or more lines of standard therapy, including, but not limited to, R/R primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL).
* Participants with pathologically confirmed R/R NHL after non-response to or failure of 2 or more lines of standard therapy, including Burkitt lymphoma (blast count \<25% malignant Burkitt cells and/or per the investigator's clinical assessment of risk status), lymphoblastic lymphoma (blast count \< 25% of marrow nucleated cells and/or per the investigator's clinical assessment of risk status), NK/T-cell lymphoma (nasal and non-nasal NK/T-cell lymphoma subtypes, but not aggressive NK/T-cell leukemia/lymphoma subtype).
* The participant's current disease state must be R/R to standard therapy.
* Participants must have measurable PET positive disease in both cHL and NHL cohorts.

Exclusion Criteria:

* Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie, from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with leptomeningeal seeding.
* Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies.
* Prior treatment with lymphocyte activation gene-3 (LAG-3)-targeted agents.
* Participants with clinically significant systemic illnesses unrelated to the cancer as judged by the investigators, which would compromise the participant's ability to tolerate the study treatment.
* Participants with autoimmune disease.
* Prior allogeneic bone marrow transplantation.

Other protocol-defined inclusion/exclusion criteria apply
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.


Eligibility Criteria:
Inclusion Criteria:

* individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
* individuals who are available for all visits and telephone calls scheduled for the study;
* individuals who are in good health

Exclusion Criteria:

* individuals with a previous or suspected disease caused by N. meningitidis
* individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* individuals with previous or suspected disease caused by N. meningitidis
* individuals with any serious acute, chronic or progressive disease
* individuals who are pregnant or breastfeeding
Thrombolytic Care During Inter-hospital Transfer

Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during air ambulance transfer

The purpose of our study is to evaluate the effect of air ambulance transport on patients presenting with an ischemic stroke and receive tissue plasminogen activator (rtPA). Primary outcome will be the evaluation of air ambulance transfer and if it leads to protocol violations or significant delays in therapy. Protocol violations include inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight and adverse events (intracranial bleeding, allergic reaction) associated with transfer process. Additional evaluation will include the effects of vibration of the air ambulance and its effects on the lytic activity of rtPA. rtPA is not supposed to be significantly agitated after it is prepared in solution and there is significant vibration and agitation during air ambulance transfer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received tissue plasminogen activator for acute ischemic stroke
* presented directly to comprehensive stroke center or were transferred by our air ambulance service

Exclusion Criteria:

* Transferred by another air ambulance service or ground ambulance
Falls Prevention: Gait-Synchronized Vibration System

The purpose of this study is to develop an abnormal gait detection algorithm and a vibratory stimulation system on a lower limb to improve gait stability and prevent falls. The investigators want to detect, assess and communicate fall risk indicators obtained via the shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar surface in reducing fall risk.The system consists of a gait measurement module, an abnormal gait detection module, and a vibratory stimulation module.

Forty (40) Individuals with decreased confidence in ambulatory scores (\<80%) as per the Activities Specific Balance Confidence questionnaire, will undergo functional assessments for visual (Snellen chart, Humphrey Visual Field Testing, Gaze Stabilization test, depth perception evaluation), vestibular (Dizziness Handicap Inventory, Head Thrust test) and proprioceptive (Balance Master, Berg Balance Scale, Joint Position Sense) impairments, to evaluate factors which might contribute to increased falls risk.

Participants will be asked to walk return for a second visit and to walk with a shoe sensor and gait synchronized vibratory stimulus under conditions of (1) Baseline performance on the Six Minute Walk test (2) Performance on the Six Minute Walk test and Dynamic Gait Index without vibratory stimulus (3) Performance on the Six Minute Walk test and Dynamic Gait Index with vibratory stimulus.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 65 or greater.
2. Low balance confidence (scores \<80%) on the ABC Balance Confidence Scale
3. Berg Balance Scale (BBS) scores between 21 (moderate fall risk) and 56 (low fall risk).

Exclusion Criteria:

1. No internal implantable device (i.e. Pacemaker, Intrathecal Baclofen Pump)
2. Significant painful arthritis (scores 15 or greater) as per the Short Arthritis Assessment Scale.
3. Significant cognitive deficits (scores \<2) as per Ascertain Dementia 8 (AD8) questionnaire.
4. Significant visual field deficits as per the Humphrey Visual Field Analysis or significant uncorrected visual acuity deficits as per the Snellen Eye Chart.
5. Current treatment with anticoagulation medication
6. Parkinson's Disease or known Peripheral Neuropathy
7. Limitations to exercise related to cardiac, neurological or pulmonary diseases
8. Orthostatic hypotension
9. Severe osteoporosis defined by fracture history, BMD by DEXA (T score more than 2.5 standard deviations below controls in the last 2 years), or height loss of more than 3 cm
10. Current treatment with corticosteroids or aromatase inhibitor
11. Current treatment with seizure medication
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)

This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 8 to 17 years old
* Duration of type 1 diabetes between 2 months and 6 years
* Residence in New England or New York
* At least 1 outpatient visit in the past year

Exclusion Criteria:

* Major co-morbid psychiatric or medical illness in youth
* Diagnosis of an active major psychiatric disorder in either parent
* Diagnosis of a life-threatening medical illness in either parent
Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)

The specific aim of this protocol is to examine differential expression of specific mRNAs and proteins that occur when the dietary intake of zinc is acutely reduced below the dietary requirement for a period of ten days.

Methods to assess the dietary zinc status of individual humans or populations are lacking. The study is a three period observational study of biomarkers of zinc status before, during and after zinc depletion. The entire dietary study will take 24 days composed of three parts:

* Dietary Acclimation (Phase 1): 7 days
* Dietary Zinc Restriction (Phase 2): 10 days
* Dietary Zinc Repletion (Phase 3): 7 days

The dietary treatments and all blood draws will be carried out in the General Clinical Research Center (GCRC) at University of Florida. Previous research from has shown that both metallothionein gene expression and specific zinc transporter genes in blood leukocyte subsets are directly proportional to dietary zinc intake. By using cDNA array analysis and quantitative PCR technology with blood RNA, those genes most sensitive to zinc nutrition will be identified for the purpose of developing zinc status assessment methods on how zinc functions in human biology.

Additionally, buccal mucosal cells will be collected in the GCRC by using swabs, i.e., in a noninvasive manner, to further characterize the expression pattern of the genes under study. This method has the potential for nutrition studies in the field (international nutrition, etc).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* 21-35 years
* Body weight above 110 lb

Exclusion Criteria:

* Use of dietary supplements
* Smoker
* Alcoholic
* Under medication
* History of chronic disease
* Use of denture cream
* Vegetarian
* Food allergy
The Effect of Breastfeeding Training Given to Mothers With Vaginal Birth by Motivational Interview Technique

This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial.

The study will be conducted as a single-blind, randomized controlled trial with 80 mothers who gave birth vaginally. In the experimental group, just before discharge from the hospital (within the last 4 hours before discharge), on the 2nd-5th, 13th-17th, 30th-42nd days after birth. Breastfeeding training based on motivational interviewing technique will be given 4 times in total. The control group will continue to receive the current standard care and service of the relevant hospital and other postpartum health institutions.

Hypotheses of the Research

1. The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the mother's breastfeeding motivation.

   are there?(H1)
2. Breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique has no effect on increasing the mother's breastfeeding self-efficacy.

   Does it have any effect?(H2)
3. The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the level of mother-infant attachment.

are there?(H3)

Eligibility Criteria:
Inclusion Criteria:

Maternal criteria;

* Agreeing to participate in the research
* Being 20 years or older
* Having had a vaginal birth
* being primiparous
* Being at least a primary school graduate
* Ability to speak Turkish
* Not having any condition that would prevent communication
* No medical breast problem

Criteria for the baby;

* Being born at term (38-41 gestational weeks)
* There is no congenital anomaly such as cleft palate or lip of the newborn that may prevent sucking.
* Birth weight over 2500 grams

Exclusion Criteria:

Maternal criteria;

* Having a chronic disease that prevents breastfeeding
* Having major breast problems that will prevent breastfeeding
* The mother has a diagnosed psychiatric disease
* Having 2 or more live newborns in this birth

Criteria for the baby;

* Premature birth (37th gestational week and before)
* Having a congenital disease
* Being in the risk group/being diagnosed with a disease in the newborn screening program
Plan of the Day Radiotherapy

The study objectives are to improve the treatment of LACC patients and to increase knowledge of the potential benefit of the plan-of-the-day concept on side effects during and after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cervical cancer eligible for definitve radiochemotherapy
* FIGO stage IB1-IVa
* Over 18 years
* Speaks and understands Norwegian or English.
* ECOG 0-2
* Histology: Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
* Ability to understand and fill in patient questionnaires, and willing to sign a written informed consent
* Large movers (LM), fundus movement ≥2,5 cm.

Exclusion Criteria:

* Evidence of distant metastasis. Suspicious paraaortic lymphnodes below the renal vessels is allowed if they are covered by the radiation field
* Patients with previous surgery for their cervical cancer
* Uncontrolled intercurrent somatic illness.
* Psychiatric illness /social situations limiting study compliance
* Prior radiotherapy to the pelvis
* Patients who are pregnant or breastfeeding is excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants
* Patients under current treatment for other invasive s except non-melanoma skin cancers
* Nephrostomy
* Patients with inflammatory bowel disease
Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants

Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which has been rarely achieved. High intensities of noise have several negative effects on preterm newborns. Also, they are exposed to either continuous bright light continuous near darkness or unstructured combination of the two during their hospitalizations. The investigators primary objective is to determine the impact of reduced noise levels and cycled light on growth parameters and visual development in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* \<37 gestational weeks preterm infants and \>1250g birth weight

Exclusion Criteria:

* Major congenital anomaly and infection prior to enrolment
* Infants with surgical issues
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV

The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.

This study prioritizes comparisons involving two-dose regimens recently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE) and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21. Furthermore, the study will provide data on the comparative humoral immunogenicity of various schedules to inform polio immunization policy for the post-eradication era.

The study population will include infants in Dominican Republic and Panama. Absence of wild and circulating vaccine derived polioviruses along with the lack of regular Supplementary Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic setting to study polio vaccine immunogenicity.

Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses.

A total of 773 infants will be enrolled and distributed into 4 groups, according to a randomization scheme. During the study period, infants will be administered other concomitant vaccines according to the national schedules of the participating countries, but the effect, if any, of the concomitant administration on IPV immunogenicity will not be assessed.

Optimum immunogenicity expected from the dose(s) of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule are optimal for the post-eradication era after the global cessation of Oral Polio Vaccine (OPV) use.

Eligibility Criteria:
Inclusion Criteria:

1. Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.
2. Healthy, as assessed from medical history and physical examination by a study physician,
3. Written informed consent obtained from parents or legal representatives who have been properly informed about the study and are able to comply with planned study procedures.

Exclusion Criteria:

1. Vaccinated with any poliovirus vaccine prior to inclusion,
2. A household contact with OPV vaccination history in the past 4 weeks,
3. HIV infection or pharmacologic immunosuppression,
4. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),
5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections,
6. Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be a contraindication for vaccination,
7. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).