cyrilzakka/clinical-trials huggingface dataset:
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

People with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (Nite2Day+). Participants will complete a baseline survey online, using a mobile application, or paper/pencil. Once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive Nite2Day+ or Standard Care. Nite2Day+ will include activities during and after inpatient treatment. During inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. After inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. Three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. Participants randomized to Nite2Day+ will be given the option to complete an exit interview to provide feedback on the Nite2Day+ program. Participants randomized to Standard Care will only complete the four surveys. All participants will continue to receive their usual medical care. The total study duration is about 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, \>18 years old
2. Initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome
3. \>7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)
4. \>8 on the Insomnia Severity Index with timeframe adjusted to be "past 7 days"
5. Ability to speak and read English, and intact hearing and vision

Exclusion Criteria:

1. Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam \<25
2. Serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider
3. Expected survival of \<6 months
The Effects of Red Spinach Extract Supplementation on Isometric Strength, Resistance Exercise and Cognitive Performance

Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects. Red spinach extract has been shown to be beneficial in exercise performance, albeit mostly in aerobic exercise. In a previous study in our lab, we found that dietary nitrate consumption resulted in significantly greater isometric force production in teenage males. However, currently there is little know regarding the effects of dietary nitrate supplementation on isometric strength, resistance exercise and cognitive performance.

This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical and cognitive performance during and following anaerobic exercise.

Eligibility Criteria:
Inclusion Criteria:

* 18-34 years old Participants must have at least 1 year of resistance training experience.
* Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
* Are free of musculoskeletal injuries
* Are not taking medications that may interfere with study measurements

Exclusion Criteria:

* Participants that cannot take either the RSE or placebo supplement will be excluded, as this will be a double-blind study.
* Furthermore, participants that cannot participate in pre- and post-research testing, and/or those that cannot commit to regular training sessions will be excluded.
* Inability to perform physical exercise (determined by health and activity questionnaire)
* Taking any other nutritional supplement or performance enhancing drug.
* Any chronic illness that causes continuous medical care
Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs

The overall objective of this project is to identify clinical and genetic risk factors for Atypical Femur Fractures (AFFs) in Anti-resorptive therapy (ART) users by conducting a case control study of 330 cases of AFFs and 660 controls without AFFs matched for age, sex, race and duration of ART.

Antiresorptive therapy (ART) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. However, their long-term use has been associated with rare but serious atypical femur fractures (AFFs). Fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. The investigators propose to compare 330 cases of people with AFFs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of ART and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 AFF patients and not present in 100 control subjects. This study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.

Eligibility Criteria:
Inclusion Criteria:

* Cases: Have experienced a confirmed, documented Atypical femur fracture
* Controls: currently on anti-resorptive therapy, matches AFF case by age, race and length of ART use

Exclusion Criteria:

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US Guided WALLANT vs CPB Block for Clavicle Surgery

The clavicle is frequently fractured bone. regional anesthesia (RA) for clavicle surgery is always challenging due t complex innervation from the two plexuses (cervical and brachial). various RA techniques described for clavicle surgery include plexus blocks, fascial plane blocks,and truncal blocks.

Clavipectoral Fascial Plane Block (CPB) is most commonly used as an anesthesia and postoperative analgesia technique to clavicle surgery.

This study is deigned to evaluate the feasibility of wide awake local anesthesia no tourniquet (WALANT) technique as a sole anesthesia in clavicle surgery, clavipectoral (CVP) fascia plane block + superficial cervical plexus plane block (CPB) as a sole anesthesia technique in clavicle surgery by using intraoperative verbal rating score (VRS) to determine how many patients need analgesia, sedation or convert to general anesthesia (GA), and postoperative assessment of patient satisfaction and 24 hour postoperative opioid consumption.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists (ASA) 1,2
* Unilateral clavicle fracture.

Exclusion Criteria:

* psychologically unstable patient.
* uncooperative patient.
* patient refusal to be awake during surgery.
* allergy.
* infection at site of infection.
First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-MAB
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* History of significant cardiac disease
* History of myelodysplastic syndrome (MDS) or AML
* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
* If female, is pregnant or breastfeeding
Vulvar Scarring Grading Scale for Lichen Sclerosus

The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).

Utilizing the vulvar disorders registry, protocol #STU00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar LS population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of Northwestern Medicine (NM). These photographs will be used to develop a vulvar scarring grading scale for LS. The objective measurement of scarring severity in LS deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. The development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. Further, objective grading of scarring would also provide the opportunity to search for potential correlation between QoL scores and severity of clinical states in scarring dermatoses.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen at Northwestern Medicine Department of Dermatology and/or Department of Obstetrics and Gynecology, who were seen by Dr. Bethanee Schlosser, and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination.
* Patients with histologically confirmed vulvar LS.

Exclusion Criteria:

* Patients who refuse complete mucocutaneous examination.
* Patients who refuse recommended diagnostic procedures.
* Pregnant women or prisoners.
A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants

The purpose of this study is to test the safety of mRNA-0184 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs.
* Body weight within 50 to 100 kilograms (kg) (inclusive) and body mass index within 18 to 32 kg/square meter (m\^2) (inclusive) at Screening.
* Participant who could become pregnant must meet conditions as defined in the protocol.

Exclusion Criteria:

* History of any clinically significant disease or disorder, including bleeding disorders and wound healing disorders, which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
* Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study drug (mRNA-0184).
* Any clinically significant abnormalities in clinical laboratory results at Screening. Repeat assessments are allowed at the Investigator's discretion if a false positive is suspected.
* Clinically significant abnormal findings in vital signs at Screening.
* Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
* Use of any prescribed medication or over-the-counter (OTC) medication that may have an impact on the interpretation of study analyses in the opinion of the Investigator during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of the study drug. Such prescribed or OTC medications are also not permitted during participation in the study. Hormonal contraception is permitted.
* Participation in another clinical study of another drug product (DP) within 30 days before Screening or within 5 terminal half-lives of the DP, whichever is longer.
Training and Detraining Effects of a Physical Activity Program Implemented Through Mobile Applications in Adolescents.

The use of mobile applications to promote the practice of physical activity has begun to be used in the adolescent population in recent years. This has made it possible to carry out interventions inside and outside the educational setting, the latter being the ones that have brought the greatest benefits. Thus, it has been observed that the promotion of the use of mobile applications in out-of-school hours from the subject of physical education has reported significant benefits on body composition and fitness in the adolescent population. However, there is no known research that has analyzed whether the effect achieved with mobile applications when their use is mandatory disappears when they are no longer promoted from the physical education subject. Therefore, this project goes further and tries to find out whether after the ten-week period of mandatory use of the applications, adolescents continue to use the applications autonomously and the beneficial effects achieved are maintained or disappear due to the lack of use.

For this purpose, a 10-week intervention was planned in which the adolescents used the mobile applications. Prior to the start of the intervention, the adolescents' body composition and fitness (pre) were measured. At the end of the intervention of mandatory use of the mobile applications, the adolescents were measured again (post). And after the post measurement, the adolescents were left for 10 weeks during which they could use the applications autonomously. A third measurement of the adolescents was performed after this 10-week period (post 2).

The aim of this project was to find out the effects of stopping the use of the mobile fitness apps on body composition and fitness of the adolescents.


Eligibility Criteria:
Inclusion Criteria:

* enrollment in one of the selected educational centers.
* age comprised between 12-16 years old.
* completion of all questionnaires and physical tests during the three measurement periods (T1, T2 and T3).
* attending the kinanthropometric and body composition measurement periods.
* absence of any pathology or injury that would hinder participation in the tests or measurements conducted.

Exclusion Criteria:

* missing more than 20% of the compulsory physical education sessions throughout the academic year.
* lack of mobile phone.
* failure to meet the minimum mandatory weekly distance requirement in the App group when app usage was obligatory.
* changing schools or class group during the course of the intervention.
* starting or ending any form of physical activity during the intervention that could alter the level of physical activity practiced for reasons unrelated to the study.
* having presented any illness during the follow-up period that would have prevented them from engaging in their usual physical activity.
A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma

This open-label single-arm study will evaluate the effect of RO5185426 \[RG7204; PLEXXIKON: PLX4032\] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1, patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426 twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21 to 25, patients will receive RO5185426. Assessments will be made at regular intervals during the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426) until the development of progressive disease or unacceptable toxicity. Target sample size \<50.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient \>/= 18 years of age
* Malignant melanoma (Stage IV, AJCC)
* Patients who are treatment-naive or have received prior systemic treatments for metastatic melanoma. Time elapsed between previous treatment for metastatic disease and first administration of study drug must be at least 28 days
* Positive tested for BRAF mutation
* Patients must not be poor metabolizers of CYP450 enzymes 2C9, 2C19, or 2D6 as determined by genotyping
* Measurable disease by RECIST criteria
* Negative pregnancy test; for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

* Active CNS lesions on CT/MRI within 28 days prior to enrollment
* History of known spinal cord compression, or carcinomatous meningitis
* Severe cardiovascular disease within 6 months prior to study
Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent (TARGET-AC)

Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm, non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a "real world, all comers" study.

Primary objective: to compare the MicroPort Medical (Group) Co., Ltd Firehawk™cobalt chromium coronary stent ( rapamycin target eluting ) system with abluminal grooves containing a biodegradable polymer with the Abbott XIENCE family EES (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.

Eligibility Criteria:
Inclusion Criteria:

* Minimal age 18 years
* Symptomatic coronary artery disease
* Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
* Presence of one or more coronary artery stenosis \>50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
* Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
* Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent

Exclusion Criteria:

* Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
* Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Sirolimus, Everolimus, or contrast material
* Participating in other trial before reaching primary endpoint
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Eligible cohort entry dates:

The degarelix indication for treatment of prostate cancer was approved by the FDA on Dec 24, 2008. Leuprolide was initially approved for the same indication prior to Dec 24, 2008.

IBM MarketScan: Dec 24, 2008 - December 31, 2018 (end of available data) Optum CDM: Dec 24, 2008 - June 30, 2020 (end of available data) CMS Diabetes: Dec 24, 2008 - Dec 31, 2017 (end of available data)

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Pre-existing ASCVD (confirmed diagnosis, documented) according to a least 1 of the following criteria:
* Previous MI \>= 30 days before randomization
* Previous revascularization procedure \>= 30 days before randomization
* Coronary artery: stent placement/balloon angioplasty or coronary artery bypass graft surgery
* Carotid artery: stent placement/balloon angioplasty or endarterectomy surgery
* Iliac, femoral, popliteal arteries: stent placement/balloon angioplasty or vascular bypass surgery

Exclusion Criteria:

* Treatment naivety (ADT)
* Previous or current hormonal management of prostate cancer including surgical castration, any hormonal manipulation, or any previous neoadjuvant/adjuvant hormonal therapy, unless treatment was terminated more than 12 months prior to enrollment
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Uncontrolled hypertension
* A history of congenital long QT syndrome or risk factors for Torsade de pointes ventricular arrhythmias
* MI; stroke; or coronary, carotid, or peripheral artery revascularization