cyrilzakka/clinical-trials huggingface dataset:
Compassion Training and Pain

The purpose of this study is to determine whether compassion training will improve the physical and psychological well-being of patients with chronic pain. The investigators also want to determine whether any benefit of compassion training in the patients "spreads" to significant others with whom the patient has a close relationship.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18+ and chronic pain for \>6months
2. Pain over the last month
3. Ability to read, write, and converse in English
4. If being treated for pain condition, then stable treatment regimen.

For significant others:

1)18 years of age or older 2)Ability to read, write, and converse in English

Exclusion Criteria:

For patients and significant others:

1)Current or history of a psychological disorder that would interfere with study procedures, at the discretion of the researcher.

For patients only:

1. prior compassion meditation experience
2. on going legal action or disability claim
3. currently pregnant or planning to become pregnant
Respiratory Muscle Function in Untreated X-Linked Myotubular Myopathy (XLMTM)

This study is a longitudinal study evaluating the severity and progression of respiratory muscle function in patients with X-Linked Myotubular Myopathy (XLMTM) aged 0-14.

Subjects aged 0-7 will be evaluated every six months for a total of three evaluations (Baseline, Six-Month Visit, Twelve-Month Visit). Subjects aged 8-14 will be evaluated every twelve months for a total of two evaluations (Baseline, Twelve-Month Visit). Evaluations include medical history, physical exam, respiratory muscle tests, a qualitative interview related to the child's function and use of respiratory aids, and quality of life assessments.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have centronuclear myopathy resulting from an MTM1 genetic mutation.
* Patients who are between 0 and 14 years of age.

Exclusion Criteria:

* Patients without a confirmed genetic mutation.
* Patients unable to travel to the site for the study.
* Patients participating in an interventional treatment study for XLMTM at the time of enrollment.
* Patients who are unable to complete study procedures.
* Patients who have a condition that, in the opinion of the investigator, would make participation in this study unsafe.
Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors

Health information technology (HIT) has the potential to improve the quality, efficiency, consistency, and availability of cancer survivor care. PREVENT is a novel HIT tool designed by our team for adolescents (12-19 years). PREVENT aggregates and displays the American Heart Association's (AHA) Life Simple 7 cardiovascular health (CVH) risk factors and provides tailored, evidence-based, behavior change recommendations inclusive of community resources that are delivered to overweight/obese adolescents at the point-of-care to improve CVH. The investigators seek to expand this tool for patients beyond 19 years of age to increase this tool's reach to the entire adolescent and young adult (AYA) age range and then evaluate its effectiveness among AYA cancer survivors.


Eligibility Criteria:
Patient eligibility criteria

* Aged 20-39 years
* Prior diagnosis of pediatric cancer (diagnosed \<21 years of age).
* Not receiving active therapy for their cancer
* Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital, the St. Louis Children's Specialty Care Center, Siteman Cancer Center's Lifelong Outcomes Clinic at Siteman South County
* At risk for poor CVH (BMI ≥ 25 kg/m\^2)
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Provider eligibility criteria.

-All providers and clinic staff (physicians, nurses, clinic staff, clinic research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC or in the Siteman Cancer Center's Lifelong Outcomes Clinic at Siteman South County are eligible to participate.
Evaluation of a Health at Every Size vs a Behavioral Weight Loss Approach for Obese Women

For over four decades the medical literature has observed a relationship between obesity and poorer health outcomes. The causal mechanisms of these poorer outcomes however are unclear. One assumption that has been supported by correlational data is that increased weight is associated with increased cardiovascular disease (CVD) risk factors (i.e., hypertension, dyslipidemia, and type 2 diabetes). Consequently, obese people are routinely prescribed weight loss programs in order to prevent or control these conditions. Unfortunately, long term weight loss has been met with minimal success for the large majority of people. Furthermore, the data suggesting that weight loss leads to long term health benefits and decreased mortality is limited and contradictory. The purpose of the proposed project is to perform a randomized controlled pilot study comparing the effectiveness of two lifestyle interventions for preventing CVD risk factors (hypertension, dyslipidemia, and type 2 diabetes). The interventions are constitutionally similar; however, the treatment condition is a wellness-focused intervention that teaches healthy living without consideration of weight. The control condition is a traditional curriculum where the prescribed outcome is weight loss. The primary goals of both programs are to reduce hypertension and total cholesterol, and to enhance glucose control. Secondary outcomes of interest are psychological and behavioral in nature (e.g., self-esteem; depressed mood; anxiety; stress; quality of life; dietary habits; and physical activity). We will compare the trajectories of the CVD and psychological/behavioral risk factors for a total period of 24 months (including the time from baseline to the end of the 6-month intervention). Our objectives are to collect data to a) determine whether participants in both programs reduce CVD and psychological/behavioral risk factors at the completion of the 6-month program, and b) compare the persistency of health improvements and rate of relapse at the end of the 18-month follow-up period between the traditional weight loss intervention and the wellness-focused intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Women ages 30 to 45 years old (at intervention onset);
2. BMI between 30 and 45
3. Physically inactive
4. Practicing birth control if heterosexually active and pre-menopausal.
5. English speaking

Exclusion Criteria:

1. Current smoker
2. Use of medications known to affect weight/energy expenditure;
3. Pregnant, intending to get pregnant over next two years, or lactating;
4. Recent myocardial infarction (within 6 months);
5. Congestive heart failure
6. Active neoplasms
7. Type 1 and insulin-dependent Type 2 diabetes
8. Cerebrovascular disease
9. Renal disease
10. Cirrhosis
11. Bulimia nervosa
12. Alcohol and/or Substance Abuse
13. Major psychiatric disturbance (suicidality, psychosis, anti-social personality disorder, current manic episode)
14. Prior bariatric surgery
15. Plans to have bariatric surgery over next 2.5 years
IL-33, Endocan and Endothelial Cells

The study aims to investigate the inflammatory response of endothelial cells to various stimulations, in particular the production of IL33 and of endocan in response to allergens, agonists of microorganisms and pollutants.

For that purpose, this project attempts to set up a biological collection of lung and umbilical cord endothelial cells.

Lung endothelial cells are resected from a surgical specimen, resulting from a lung cancer surgery.

Umbilical cord-derived endothelial cells are taken from the umbilical cord collected during the delivery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* signed consent
* Pregnant woman for umbilical cord-derive-endothelial cells

Exclusion Criteria:

* Age \< 18 years
* Refusal to participate to the study
* Endothelial cord-drived endothelial cells :

  * significant materno-foetal disorder (for example: meconium-stained amniotic fluid, chorioamnionitis, placental thrombosis, eclampsia etc.)
  * infection for HIV, VHB, VHC
  * unknown status for HIV, VHB, VHC the day of the childbirth.
Virtual Reality in COPD Exacerbation

In addition to conventional pulmonary rehabilitation, virtual reality will be applied during the hospitalization period of individuals hospitalized for COPD exacerbation. It is aimed to get more efficiency from the interventions in this short time.

Subjects with COPD exacerbation will be divided two groups. Group-1 will exercise with a bicycle ergometer until fatigue in addition to pulmonary rehabilitation. Group-2 will do the same exercises. Subjects in Group-2 will use virtual reality simulation, which is designed as cycling in the forest while cycling. Treatment will continue until discharge. CAT score, mMRC dyspnea score, hospital anxiety and depression score and London chest daily living activity score will be examined before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are in COPD exacerbation period, FEV1 \<70%, GOLD 2-3 spirometric stage, Hodkinson mental test score \> 6 and who want to participate in the study voluntarily will be included in the study.

Exclusion Criteria:

* If there is respiratory disease considered more significant than COPD (bronchiectasis, lung cancer requiring active therapy, or asthma), Heart failure New York Heart Association (NYHA) stage 3-4, Significant hemoptysis, surgical or non-surgical lung volume in the past 6 months Individuals with reduction procedures, Lung transplantation or pneumonectomy surgery in the last 6 months, pulmonary embolism or pulmonary edema, acute myocardial infarction, acute heart failure, vertigo, epilepsy and visual impairment will be excluded from the study.
Total Knee Arthroplasty: Fast Track Protocol is the Future?

Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

The aim of this protocol is to compare standard care and fast track total knee arthroplasties. The fast track care consists of:

* preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
* antalgic protocol administered only orally
* early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position.

The standard care consists of usual antalgic and physiotherapy post-operative care:

* Antalgic protocol consist in intravenous drugs
* the first physiotherapy session is the day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty
* BMI \< 32
* Time up ang go test \</= 12 seconds
* American Society of Anesthesiologists physical status classification system (ASA) \</= 2
* preoperative hemoglobin (HB) \>13 g/dl
* patients eligible for spinal anesthesia
* presence of a care-giver

Exclusion Criteria:

* psychiatric diseases
* preoperative use of crutches
* ASA \> 3
* preoperative HB \< 13 g/dl
User Acceptability of a Device-Based Opioid Overdose Intervention

This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.

All opioid overdose related deaths can be prevented with the timely delivery of Naloxone. This study is a one-time, preliminary survey of participants with opioid use disorder to assess the need for, and community attitudes towards, a wearable device capable of autonomously detecting and responding to an opioid overdose. The results of this survey will be used to guide ongoing development of a de novo device. This study will be conducted over a 3 month period and survey participants from the Kensington Neighborhood in North Philadelphia.

Eligibility Criteria:
Inclusion Criteria:

* Have used opioids for more than 3 months or will be having surgery where opioids will be administered

  * Able to provide informed consent
  * Moderate to severe chronic pain treated with opioids or recreational use

Exclusion Criteria:

* Pregnancy
A Study of LY2409021 Formulations and the Effect of Food

The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.

The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.

There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy male or a healthy female who cannot become pregnant
* Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
* Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
* The veins must be suitable for easy blood collection
* Must be willing to be available for the whole study and be willing to follow study procedures

Exclusion Criteria:

* Were in another new drug or medical research study in the last 30 days
* Have previously taken part in this study or any other study with LY2409021
* Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
* Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
* Electrocardiogram (ECG) readings are not suitable for the study
* Are infected with hepatitis B
* Are infected with human immunodeficiency disease virus (HIV)
* Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
* Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
* Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
* Have a history of drug or alcohol abuse
* Have donated 450 milliliters (mL) or more of blood in the last 3 months
* Are unwilling or unable to comply with dietary requirements/restrictions during the study
* The study doctor thinks the participant should not participate for any other reasons
Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

* Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy.
* Secondary Objectives:

  * To assess the ability of lomustine to increase the CR rate.
  * To assess the ability of lomustine to increase the event-free survival.
  * To evaluate the toxicity and side-effects of lomustine.
  * To evaluate the feasibility of reduced conditioning allogeneic transplantation \*between 60 and 65 years old.
  * To evaluate prognostic factors.
  * To evaluate QOL in elderly.
* Study design: Parallel
* Study plan:

  * Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1.
  * Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine.
  * Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months.
  * Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).
* Number of subjects: 460

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.
* Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
* Performance status and Sorror score \< 3 .
* Signed and dated informed consent.

Exclusion Criteria:

* Acute promyelocytic leukemia.
* Patients with myeloproliferative syndromes prior to diagnosis of AML.
* Patients who previously had myelodysplastic syndrome.
* Positive serology for HIV.
* Patients with unfavourable cytogenetic
* Patients with an isolated medullary extra localization of their disease
90-Day Online Substance Use Program

Individuals indicating risky substance use are randomly assigned either to a three-month online intervention on the Workit Health platform or a waitlist/treatment as usual. Those randomized to treatment will report reduced consumption of alcohol and other drugs and higher quality of life at study conclusion.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of this research are adults who self-identify as wanting to change their relationship to alcohol or drugs, who report currently using alcohol or drugs, or having recently stopped, who have access to an internet-enabled device, who are not currently suffering from untreated acute medical or psychiatric conditions, who anticipate being able to access the intervention over a six-month period, and who are able to freely consent to participate by themselves.

Exclusion Criteria:

* Because the intervention is written for an adult audience, as well as the logistical challenges of having private access to an internet enabled device, this research is limited to participants over the age of 18.
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

The purpose of this study is to study the effect of duloxetine treatment on (1) cognitive functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering; (2) psychosocial functions, how someone interacts with his/her social environment; and (3) the relationship between these two functions, in people who have major depressive disorder, a severe form of depression.

People who have difficulties with concentration and/or cognition as part of their depression will be treated with duloxetine for 12 weeks and their cognitive performance will be assessed before and after treatment using cognitive tests. Eligible participants will have eight clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent
* Primary diagnosis of Major Depressive Disorder (MDD)
* Age 18-45
* Screening and baseline Hamilton Rating Scale for Depression (HRSD) 17-item score greater than or equal to 16 or Clinical Global Impression (CGI) score of at least 4
* Subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the Inventory for Depressive Symptomatology (IDS-C(30)) item addressing this symptom (#16: Concentration and Decision Making)

Exclusion Criteria:

* Presence of significant comorbid condition based on laboratory tests, physician information, or evidence at examination
* Patient report or evidence (based on physical examination or laboratory tests) of existing liver disease
* Presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of duloxetine
* Concomitant pharmacological or psychotherapeutic treatment including but not limited to antidepressants, anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with duloxetine, as determined by the study doctor
* Hospitalization for mental illness within the past year
* Not fluent in spoken and written English
* For women, currently pregnant, planning to become pregnant in the next year, or breastfeeding
Intuitive Eating for Disordered Eating

Purpose: Research on intuitive eating is growing, but there are few interventions demonstrating the effect of learning to eat intuitively for people with disordered eating. Young women in particular are at high-risk for developing disordered eating. This study aimed to test the outcomes of a novel intuitive eating intervention for young women with disordered eating.

Methods: This study is the first randomized controlled trial introducing intuitive eating to a sample of participants with disordered eating. Participants with current eating disorders were excluded from this study. Women (n=123) ages 18-30 with high levels of disordered eating participated in this study and were randomized to either a treatment (10-week web-based intervention) or control group (10-week waitlist).


Eligibility Criteria:
Inclusion Criteria:

* Female
* Between 18 and 30 years of age
* Located in the United States or Canada
* No eating disorder
* No previous participation in an intuitive eating intervention
* Score greater than or equal to 25 on the TFEQ-r18 at baseline

Exclusion Criteria:

* Gender not female
* Younger than 18 years of age
* Older than 30 years of age
* Located outside the United States or Canada
* Score less than 25 on the TFEQ-r18 at baseline
* Previously participated in an intuitive eating intervention
* Current eating disorder