cyrilzakka/clinical-trials huggingface dataset:
Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation

Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.

In the proposed study the investigators will execute a pilot randomized controlled trial to identify whether medically tailored meals (MTM, Group 1, N=20) and/or Noom®, a mobile application (Group 2, N=20) are associated with greater treatment adherence and satisfaction than usual care (Group 3, N=20) after GLP-1 Receptor Agonist cessation. The investigators will enroll adults 18 and older that have lost more than 10% of their bodyweight taking GLP-1 Receptor Agonist and ceased treatment within the past 30-days. For four-months, Group 1 will receive 40 MTM per month, Group 2 will receive a Noom® subscription, and Group 3 will receive lifestyle counseling per standard of care.

Eligibility Criteria:
Inclusion criteria:

* 18 years of age or older;
* ability to read, write, and speak English;
* ability to provide informed consent;
* greater than 10% GLP-1 Receptor Agonist induced weight loss
* less than 30-days since GLP-1 Receptor Agonist cessation;
* willing to participate.

Exclusion criteria:

* major psychiatric illness or substance misuse that could impair ability to participate;
* presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder);
* participation in a study or program involving medically tailored meals or Noom® within the past 12-months.
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant.

This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant.

The Phase II portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer.

Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer were planned to be enrolled.

On 31-May-2016 Novartis's made the decision decision to not open the Phase II portion of the study, for business reasons. Sufficient data had already been collected and no additional data for the triplet combinations was needed. As a result, the Phase II portion of the trial was not opened.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer
* Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting (Phase Ib)
* Unlimited number of lines of endocrine therapy and one line of cytotoxic chemotherapy in the metastatic setting (Phase II)

Exclusion Criteria:

* HER2-overexpression in the patient's tumor tissue
* Inadequate bone marrow function or evidence of end-organ damage
* Severe or uncontrolled medical issues
* Diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply
Analgesic Comparison of PENG/LFCN to FICB for Total Hip Arthroplasty

This study compares 2 commonly used interventions (regional pain blocks) used in hip arthroplasty for pain control. One of the interventions is newer and not widely established.

This study will compare the FICB to the PENG/LFCN blocks. Patient reported pain scores on a verbal numeric rating scale will be utilized and recorded in the PACU and postoperatively at 3, 6, 12, 18, 24, 36 and 48 hours after patient arrival in the PACU. Additionally, opioid consumption will be converted to morphine milliequivalents and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility criteria for the study were: age 40-80, Physical Status I-III, BMI less than 40 kg/m2, ability to read and speak English, able to sign their own consent form and undergoing elective primary total hip arthroplasty.

Exclusion Criteria:

* Patients were excluded if they were chronically prescribed opioids for a condition unrelated to their surgical hip pain, were deemed Physical Status 4 or higher, had an ongoing coagulopathy, had any infection near the site of injection, had an allergy to local anesthetics, deemed to have diabetic neuropathy, deemed to have a contraindication to spinal anesthesia or were unable to report their pain scores reliably (as in severe dementia or similar).
Energy Specific Far Infrared Radiation Treatment for Hyperparathyroidism

A study to determine the possibility of using far infrared radiation to treat Hyperparathyroidism.

Overactive parathyroid glands secrete an excess of parathyroid hormones, resulting in increased levels of calcium in the blood stream, which can lead to weakening of the bones and to kidney stones.

We are postulating that the non-invasive energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to stop the over secretion of the parathyroid hormones and normalize the body's metabolic functions.

Eligibility Criteria:
Inclusion Criteria:

* Persons with parathyroid disease

Exclusion Criteria:

* None
The Fast-track Centre for Hip and Knee Replacement Database

This is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 Danish dedicated arthroplasty departments from all five health regions in Denmark. The registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. Follow-up is based on electronical medical records by dedicated nurses with physician backup and includes Clavien-Dindo and Comprehensive Complication Index scoring. All patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. Finally, a machine-learning algorithm for identification of "high-risk" patients based on he preoperative data is included.

The study registry is intended for further detailed research on postoperative morbidity, feasibility and safety of day surgery and functional outcomes after fast-track hip and knee replacement in 8 dedicated Danish arthroplasty wards across all five health care regions in Denmark. The work is a continuation of the Lundbeck Foundation Centre Database on Hip and Knee Replacement also registered in ClinicalTrials but ceased enrolling in august 2017.

The aim of the registry is to provide standardized and comprehensive information on preoperative patient characteristics and postoperative complications, patient reported outcome measures and health-care utilization in fast-track hip and knee replacement within a socialized health-care system. Each department have dedicated research personel assuring registration and follow-up supervised by a datamanager, and with database-support from the Danish health Region of Southern Denmark.

All departments have similar established fast-track protocols as standard of care, but with focus on dividing patients into day-surgery, main fast-track group and high-risk cohorts.

Preoperative data includes information on prescribed medication, Clinical Frailty Score using CFS v.1, evaluation of Pain Catastrophizing Scale as well as laboratory testing of hemoglobin, kidney function, Hb1Ac in diabetics and C-reactive protein level. On the basis of the collected preoperative data a machine-learning algorithm for identifying the "high-risk" patients is being refined and with planned induction in the database.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* non-malignant surgery
* danish social security number
* elective procedure

Exclusion Criteria:

* unwilling to provide informed consent
Preserving Function Among Disability Applicants

To test the hypothesis that veterans counseled around managing their benefits will work more and have a better quality of life than those receiving non-specific counseling.

The aim is to develop and test the efficacy of Benefits Counseling to improve quality of life among veterans who apply for VA benefits. Benefits Counseling involves providing claimants information about rehabilitation and work-related activities, benefits determination and management, and available substance abuse treatment . Benefits Counseling is designed to increase motivation to be active and promote engagement in substance abuse treatment. After enrolling 15 participants in an open-label pilot phase, 300 veterans who are not receiving benefits and are applying to VBA for disability benefits will be randomly assigned to Benefits Counseling or the control condition, VA Orientation, and both groups will be followed for one year.

The primary outcome measures will be observer-rated and self-rated quality of life. Secondary outcome measures will include substance use and treatment utilization.

Eligibility Criteria:
Inclusion Criteria:

1. Applying for VA service connection and not currently receiving VBA benefits.
2. Veterans who have been rated 0% service-connected but do not receive financial benefits are eligible to participate.
3. Able to provide valid consent
4. Age 18-65
5. Expresses willingness to discuss benefits with a counselor
6. Anticipates difficulty working

Exclusion Criteria:

1. Already receiving VA payments
2. Already receiving SSI or SSDI
3. Has a conservator
Effect of Acute Physical Exercise on Memory

An increasing amount of studies show the beneficial effect of regular exercise on cognitive and brain functions and especially in the memory domain. Yet little is known of what happens within an acute bout of exercise and whether it would also yield cognitive effects. The literature clearly shows that molecules such as brain derived neurotrophic factor (BDNF) and endocannabinoids (mainly anandamide, AEA) are heavily involved in neural plasticity mechanisms and increase when we exercise hinting at possible mechanisms underlying memory improvement after exercise.

This protocol assesses the effects of acute exercise on associative and motor sequence memory, their underlying neural activations (measured using fMRI) and blood biomarkers (BDNF and AEA). A related aim is to assess the effect of exercise intensity, therefore three exercising conditions (rest, moderate intensity and high intensity) were included. Finally, a 3-month delayed retest visit is also realized to assess effects of acute exercise on long-term memory consolidation.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Right-handed,
* Exercising regularly (at least twice per week).
* VO2max comprised between 40ml/kg/min and 65ml/kg/min.

Exclusion Criteria:

- Psychiatric and neurological history
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD

This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists. The trial will be designed as a randomized controlled trial, randomizing patients to immediately starting the program as well as a 6 month delayed start. The intervention would leverage an existing clinical comprehensive MS wellness program at the Corinne Dickinson for Multiple Sclerosis (MS) at Mount Sinai Medical Center. The primary endpoint of this study would be evaluating quality of life, as assessed by MS-Quality of Life -54.

This pilot will aim to recruit 20 patients. Participants will be randomized into one of two arms: the trial group will begin wellness program services and behavioral interventions immediately; the control group will participate in other educational activities, and begin wellness program services and behavioral interventions 6 months after randomization. The wellness intervention will include dietary, physical therapy, social work, and nurse practitioner evaluations, as well as behavioral counseling to implement recommendations. All participants will complete assessments, with patient-reported outcome surveys and objective assessments at baseline, 12 weeks, and 6 months for the core study. Participants will also be offered the option of continuing into a one year extension study, wherein one additional wellness intervention and bimonthly behavioral counseling sessions will be offered until 12 months on study. Study assessments will be completed at 12 months and 18 months to assess sustainability of the program. Assessments will include subjective reports of quality of life as pertaining to living with their disease, mobility, vision, exercise, diet, as well as objective measures of motor and vision function.

Eligibility Criteria:
Inclusion criteria:

* Adults (age ≥18) with NMOSD diagnosed with 2015 NMOSD clinical criteria.
* All EDSS scores will be considered in order to make the intervention accessible to all patients regardless of disability.
* All patients regardless of treatment type will be considered.

Exclusion criteria:

* Age\<18
* Inability to voluntarily provide consent for study participation
* Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention.
* Any patients with a relapse within 30 days of randomization or any patients with medical restrictions on physical activity will be excluded.
* Any patients who begin stimulants and/or dalfampridine between enrollment and randomization will be excluded.
Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.

Eligibility Criteria:
Inclusion Criteria:

* Age greater to or equal to 55 years
* Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram
* Patients with acute cortical infarction with the presence of intracranial occlusion (preferably)
* Modified Rankin Scale (mRS) lower to 4

Exclusion Criteria:

* Diagnosis of lacunar infarction or transient ischemic attack (TIA)
* Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic)
* Use of pacemakers
* Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center)
* Unwillingness to the use of cardiac monitoring wearable devices
* Not understanding study procedures
Multidisciplinary Intervention In Chronic GVHD

This research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, Horizons Program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).

This randomized research study is being conducted to see if the Horizons Program compared to usual care is manageable and effective at improving understanding of chronic GVHD and treatment, coping, and quality of life.

Randomization means that participants will be put into one of two groups by chance:

* Horizons Program

  --Individuals who receive the Horizons Program will attend 8 weekly 90-minute group sessions using a secure TeleHealth videoconferencing system
* Usual care --Individuals who receive usual care will also receive an educational booklet.

The research study procedures include:

* screening for eligibility
* a brief test of videoconferencing software
* completion of three study assessments (after signing consent but before randomization and at 8 weeks and 16 weeks after the start of the Horizons Program)
* Individuals who receive usual care will also receive an educational booklet. It is anticipated 80 people will take part in this research study.

The MGH BMT Survivorship Program is supporting this research study by providing funding for this project.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥ 21 years) who underwent allogeneic HCT
* have moderate to severe chronic GVHD
* are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
* have the ability to participate in an English language group intervention

Exclusion Criteria:

* Patients with comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
* Vulnerable patients, defined here as prisoners and pregnant women, will not be included in the intervention
Cross Sectional Analysis of Healthcare for Psoriasis in 4 European Countries

Analysis of barriers in psoriasis care from the patient's and the physician's perspective and generation of scientific data on the quality of health care in Denmark, Poland, Spain, and Germany

Cross-sectional, non-interventional study on healthcare for psoriasis in patients and their treating physicians. Clinical data on severity as well as subjective estimates on disease burden, quality of life etc. will be collected. Data collection is planned at multiple, representative sites in fourEuropean countries with different healthcare systems with the aim to identify system-dependent and -independent barriers in guideline-compliant psoriasis care.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed psoriasis vulgaris
* age ≥ 18
* written informed consent

Exclusion Criteria:

* lack of mental, physical or linguistic ability to participate in a questionnaire survey
Physical Exercise for Men With Andropause

The aim of this study is to analyze the impact of physical exercise through a protocol of concurrent training in the psychological, physical, hormonal and sexual aspects in middle aged men with androgen deficiency in the aging male (ADAM). The study design with randomized clinical trial, comprising men in middle age (40 to 59 years) with ADAM, should be divided into two groups: 1) Control group (CG); 2) Experimental group (EG). Information related to sociodemographic and clinical profile will be collected; Psychological aspects (depressive and anxiety symptoms - Hospital Anxiety and Depression Scale ; stress - Perceived Stress Scale); Physical acpects (IMC; Percentage of body fat; Abdominal obesity - waist circumference in cm; Muscle strength - Biodex System 4 PRO isokinetic dynamometer; cardiorespiratory Fitness - Cycle-ergometer - CASE ECG Stress Testing System, General Electric Medical Systems, Milwaukee, WI); Hormonal aspects (total and free testosterone - blood collection); Sexual Aspect (Sexual satisfaction- International Index of Erectile Function); DAEM (scale of symptoms of aging). Apply a physical exercise protocol using the functional training method over a six-month period. All information will be collected before and after the intervention period. For statistical analysis, use the SPSS statistical package, version 20.0. (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.

In this protocol the participants will perform aerobic and resistance training according to published evidence for middle-aged men; Characterized as concurrent training.

The protocol will last six months and will be divided into two quarters. In the first trimester, initial 30 minutes will be assigned to resistance training, followed by 30 minutes of aerobic training; Already in the second trimester will be 20 initial minutes for the aerobic training and later 40 minutes for the resistance training; Aiming to obtain benefits in the levels of muscular strength, aerobic capacity, body composition, besides positive results in relation to the hormonal adaptations of testosterone, as well as in the psychological well being of the participants.

Classes will occur at a frequency of three times weekly, lasting 60 minutes a session.

For the elaboration of this protocol will be followed the guidelines of the American College of Sports Medicine of resistance training for healthy adults The aerobic training of this protocol will follow the American College of Sports Medicine's prescription prescription guidelines for the health of healthy adult subjects,

Eligibility Criteria:
Inclusion Criteria:

* men presenting ADAM according to their responses on the Aging Male Symptoms Scale and testosterone levels \<220 pmol/l

Exclusion Criteria:

* history of neurological or musculoskeletal diseases or who have prostate cancer will be excluded, as also those who have been submitted toresistance and/or aerobic in the three months prior to data collection
Improving Hypertension Control

* The overall hypothesis for the project is that racial health disparities will be reduced by improving hypertension control in African Americans.
* This will be accomplished through the development, implementation, and evaluation of a cost-effective hypertension control strategy based on the involvement of a community health worker.


Eligibility Criteria:
Inclusion Criteria:

* African Americans with uncontrolled hypertension, followed at Progressive Community Health Centers