cyrilzakka/clinical-trials huggingface dataset:
Leader Partner Interactions

Obesity is often cited as being inversely related with socioeconomic status (SES), although the mechanisms linking social status with obesity are not well understood. Dietary restraint, physical activity, and social mobility have been proposed as possible mechanisms. Although there is some evidence of SES variation in the proposed mechanisms, evidence is mixed and mostly observational. The purpose of this research is to determine if one's social position influences eating behaviors. This study will attempt to determine this using a randomized, 2 parallel arm trial to determine the effects that social hierarchy positioning has on energy intake. To prevent compromise in the integrity of data, the investigators will detail the exact treatment condition (i.e., social positioning) after the data collection period.

Based on findings from previous animal and large clinical observational studies, there are two complementary hypotheses tested in this study. First, it is hypothesized that being in a lower social position affects one's perception of food availability by making the future availability of food seem less certain. This uncertainty will lead to increased food consumption. Second, it is hypothesized that being in a position of power will lower one's food consumption, as previous research has found that individuals in power tend to east less in groups. Understanding how social position influences food intake could help improve weight loss/maintenance interventions by identifying unexpected factors that could limit the intervention's effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Male and female college student between the ages of 19 and 25

Exclusion Criteria:

* Those with food allergies
* Pregnant individuals
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).


Eligibility Criteria:
Inclusion Criteria

* Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
* Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
* Participant must have documented response of PR or VGPR at time of consent.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
* Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

Exclusion Criteria

* Participant with known central nervous system involvement with myeloma.
* Participant has non-secretory MM.
* Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
* Participant has history of primary immunodeficiency.
* Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Wholegrain Cereal Diet and Insulin Sensitivity

A diet with the multiple beneficial characteristics of whole grains and, more in general, of "healthy cereals" favorably influences glucose and insulin metabolism in subjects with metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a diet containing "healthy cereals" versus a control diet, on glucose and insulin metabolism in subjects with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:

  1. waist circumference \>102 for men and 88 for women,
  2. fasting total serum triacyglycerol concentration \>1.7 mmol/L,
  3. fasting HDL cholesterol \<1.0 mmol/L for men or \<1.3 mmol/L for women,
  4. IFG (plasma glucose between 6.1 and 6.9 mmol/L) or
  5. blood pressure \>130/85 mmHg or use of blood pressure medication
* Hypertension in stable control (BP \<135/80 mmHg) by means of drugs, which will not be allowed to be changed during the study
* Absence of main cardiovascular events (IMA, Ictus)

Exclusion Criteria:

* Diabetes mellitus diagnosed according to history of diabetes or blood glucose ≥ 200 mg/dL (11.1 mmol/L) 2 hours after a 75 g Oral glucose tolerance test (OGTT) to be performed during the run-in period in all the subjects
* Any drug able to influence glucose and lipid metabolism (hypolipidemic drugs, cholesterol lowering foodstuffs, anti-inflammatory drugs)
* Renal failure (serum creatinine \> 1.5 mg/dL) and liver failure (ALT/AST\> 2 times above normal values)
* Anemia (Hb \< 12g/dl) or any other chronic disease
Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality

This study will assess the impact of a school-based water, sanitation, and hygiene management intervention on toilet use and pupil handwashing in the Philippines.


Eligibility Criteria:
Inclusion Criteria:

* Attending study school on day of observation

Exclusion Criteria:

* No predefined exclusion criteria since individual-level data is not recorded.
CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors

To assess the efficacy of systemic corticosteroids alone as first-line treatment of Churg-Strauss syndrome without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse

All patients initially treated with systemic corticosteroids alone: optional IV methylprednisolone pulse (15 mg/kg) at treatment start followed by oral prednisone (1 mg/kg/day) according to a tapering schedule. Treating physicians allowed to treat minor relapses with corticosteroids without referring the patient for randomization, as long as the prednisone dose did not exceed 0.5 mg/kg for 1 month.

Patients in whom prednisone doses could not be tapered below 20 mg, those who failed to enter remission and those who relapsed were randomized to receive either 6 months of oral azathioprine (2mg/kg/day) or 6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month)

Eligibility Criteria:
Inclusion Criteria:

* Men and women with newly diagnosed Churg-Strauss syndrome;
* absence of poor prognostic factors as defined by the five-factor score (serum creatinine \> 140 μmol/l or 1.58 mg/dl, proteinuria \> 1 g/day, severe gastrointestinal tract involvement, specific cardiomyopathy and/or central nervous system involvement;
* written informed consent.

Exclusion Criteria:

* age \< 15 years, previously treated Churg-Strauss syndrome;
* history of cancer;
* pregnant or breast-feeding women;
* psychiatric disorders that might compromise compliance with therapy;
* contraindication to study drug;
* other ongoing therapeutic trial;
* concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone

The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* Is 18-65 years of age
* Has static and dynamic forehead/glabellar wrinkles
* Has willingness and the ability to understand and provide informed consent and communicate with the investigator

Exclusion Criteria:

* Pregnant or lactating
* Has received the following treatments in the forehead or glabellar region:

  * botulinum toxin injections in the past 6 months
  * ablative laser procedure in the past 6 months
  * radiofrequency device treatment in the past 6 months
  * ultrasound device treatment in the past 6 months
  * medium to deep chemical peel in the past 6 months
  * temporary soft tissue augmentation material in the past year
  * semi-permanent soft tissue augmentation material in the past 2 years
  * permanent soft tissue augmentation material
* Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
* Is planning to use tretinoin or retinoic acid in the next 6 months
* Has an active infection in the forehead or glabellar region (excluding mild acne)
* Is allergic to cow's-milk protein
* Is allergic to albumin
* Taking aminoglycoside
* Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
* Is currently using anticoagulation therapy
* Has a history of bleeding disorders
* Is unable to understand the protocol or to give informed consent
* Has a mental illness
Measuring Real Time Decision-Making About Ultraviolet Radiation (UVR) Protection

The purpose of this study is to understand how people make decisions about sun protection. This study is important in helping to protect against sun exposure, since it is a main risk factor for melanoma. The investigators would like to understand the decisions people make about sun protection so that they can improve their ability to help individuals who may be at risk for melanoma.


Eligibility Criteria:
Inclusion Criteria:

* A first-degree biological relative (a child, sibling or parent) as per self report of an MSKCC follow-up surgical patient diagnosed with melanoma as per pathology report or clinician's judgment;
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
* 18 years of age or older;
* For Phase I only: FDRs who live within a 50 mile radius of MSKCC to make it feasible for Ms. Shuk to be able to arrive at each person's home for the in-home interview without the cost being prohibitive;
* For Phase I only: Can recall a period when s/he was out in the sun for at least one hour on a sunny day this past summer 2009.
* For Phase I only: Can recall a separate period when s/he was out in the sun for at least one hour on a sunny day this past summer 2009, but s/he was in a different location from the period referenced above.
* For Phase II only: FDRs who self-report at least 1 consecutive hour in the morning (dawn to 12:30pm) and 1 consecutive hour in the afternoon (12:30-5pm) of daily (weekend and weekday) outdoor activities on the screening questionnaire

Exclusion Criteria:

* First-degree relatives of melanoma patients who report never using UVR protection;
* Patient's who provide consent for Phase I will not be eligible for Phase II.
* Any first-degree relative of a melanoma patient who already has a first-degree relative who consented to the study;
* Unable to provide informed consent.
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain

The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia

Fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points. It is multisystem disease characterized by sleep disturbance and fatigue. It affect 5% of the world population. The incidence is higher in women than in men. And the age is between 30 and 35 years old.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with fibromyalgia
* Ages ranges between 30 - 45 years old
* Body mass index \< 35 kg/m2
* All are medically stable

Exclusion Criteria:

* specific cervical and lumbar pain
* Smokers
* Pregnant women
* Medically unstable
* Postmenopausal women
Positive Activities for Asian American Cancer Patients and Caregivers

Positive Activities for Asian American Cancer Patients and Caregivers

Primary Objectives:

The overall objective of this project is to design and test the feasibility of two positive activities, household contribution and outside contribution, to increase quality of life in AA cancer patients.

Secondary Objectives:

Aim 1: To assess the acceptability and feasibility of household and outside contribution positive activities for AAs through a mixed qualitative and exploratory quantitative investigation.

Aim 2: To use the qualitative and quantitative data from Aim 1, in collaboration with the mentorship team, AA community members, and clinicians, to develop one or both positive activity intervention(s) (i.e., household or outside contribution) specifically for AA cancer patients.

Eligibility Criteria:
Inclusion criteria for patients will be:

* self-identifies as AA,
* males or females ages 25-75 years
* within 1 year of any cancer diagnosis
* actively undergoing systemic therapy (e.g., chemotherapy, radiation)
* able to identify a caregiver (e.g., spouse) who lives in the same household and consents to participate in the study,
* able to read, write, and speak English (i.e., English proficient; EP),
* access to internet, computer/phone, and web browser.

Exclusion criteria for patients will be:

* life expectancy less than 6 months in the opinion of the primary physician,
* inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
* major thought disorder (e.g., schizophrenia or bipolar \[patient records or

Inclusion criteria for caregivers will be:

* identifies as AA,
* patient considers them to be caregiver, -
* EP,
* access to computer/phone, internet, and web browser.

Exclusion criteria for caregivers will be:

* unwilling or unable to participate in the study for any reason,
* under the age of 18.
Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia

The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia

Myopic pediatric prevalence rate come to increase rapidly globally. This is a clinical trial to explore the safety and effectiveness of SAT-001(as a Software as Medical Device) developed for the treatment of myopia through suppressing the progress myopia

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patient age 5 to 12 years old at the Screening Visit
2. Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)

   1. Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye
   2. Astigmatism of 1.50 D or less in each eye
   3. Anisometropia of less than 1.00 D
3. The age of birth over 38 weeks
4. Over 2500g of birth weight
5. Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
6. Intraocular pressure 21 mmHg or less in each eye at the Screening Visit

Exclusion Criteria:

1. Administration of anti-muscarine drugs within 1 month before screening visit
2. Current or previous use of multi-focal lenses
3. Planning to use or having used Orthokeratology lenses (Ortho-K lenses), Rigid Gas Permeable (RGP) lenses, and other contact lenses to reduce the progression of myopia
4. History of atropine use for treatment of myopia within 1 month before screening visit
5. Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit
6. History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision)
7. History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery)
8. Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD)
9. Down's syndrome or cerebral palsy
10. Participation in another clinical trial within 6 months before screening visit
11. History of growth hormone treatment within 1 month before screening visit
12. Medically clear to have abnormal range of intellectual development
13. Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease
14. Currently taking or having taken antihistamines (tablets, nasal spray, eye drops, etc.) or psychiatric drugs (antidepressants, anti-anxiety medications, etc.) within 30 days before screening visit
15. History of injections with histamine release and cholinergic effect within 30 days before screening visit
16. Incongruent to participate in this study at the discretion of the investigator
Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with the diagnosis of chronic periodontitis
* presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph \[IOPA\])
* interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion Criteria:

* Subjects, with the diagnosis of aggressive periodontitis,
* with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
* insufficient platelet count (\< 200,000/mm3),
* pregnancy / lactation
* use of any form of tobacco
* unacceptable oral hygiene (if plaque index \[PI\] (Silness \& Loe 1964) \>1.5) after the reevaluation of phase I therapy
* teeth with furcation defects
* non-vital
* mobility of tooth ≥ Grade II
Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique

The purpose of the study is to create MR images using an investigative technique called pulse sequences with new computer software programs. The sequence will allow us to image vessels without injecting contrast agents.

The t-SLIP Investigational Study Sequences are designed to compare t-SLIP to standard MR contrast enhanced imaging techniques to establish the diagnosic benefits of t-SLIP compared to contrast enhanced MR techniques. The t-SLIP Investigational Study Sequences will be used for vascular MRI Imaging including, but no limited to, MRA of the renal, mesenteric, abdominal aortic, iliac and femoral arteries. We will be targeting all adult patients undergoing standard body MRA examinations without anesthesia.

The time spatial labeling inversion pulse (t-SLIP) technique is used for non contrast enhanced MR angiography imaging. It produces bright blood spin labeling images by using a single acquisition with a combination of a spatially nonselective inversion pulse and a spatially selective inversion pulse. The nonselective pulse inverts the magnetization of the entire imaging area. The spatially selective pulse, applied upstream of the arteries of interest, reverts those protons to full magnetization. A pre defined time delay between tagging and imaging allows the tagged spins to reach the imaging region and suppresses background tissue within the imaging region to some extent.

Eligibility Criteria:
Inclusion Criteria:

* All patients that are considered candidates and scheduled for standard contrast enhanced MRA can be included in the study.

Exclusion Criteria:

* Patients that can not undergo standard MRA
Beetroot Juice Resistance Training Older Adults

The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program with protein supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide own transportation to study testing visits and intervention
* Able to read and write in English
* Nondiabetic, i.e. fasting glucose \< 126 mg/dl
* Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program)
* Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months.

Exclusion Criteria:

* Smoking or use of chewing tobacco
* Involved in another intervention research study
* Diabetic (type 1 or 2)
* Atrophic gastritis
* Hypo- or hyperthyroidism
* Gout or history of kidney stones
* History of hypotension
* Premenopausal (women)
* Aversion to study-related testing procedures
* Allergy/sensitivity/aversion to beetroot beverages or protein supplement
* Medical conditions with contraindications for engaging in resistance training program or taking the protein supplement
* Systemic, uncontrolled diseases (diabetes, recent (last 6 months) or current treatment of cancer, thyroid disorders, cardiovascular disease, COPD, or inflammatory bowel diseases)
* Use of any of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, or medications for hypothyroidism
* Potential inability to complete the tasks required for the protocol as well as conditions that may interfere with interpretation of results including: inability to ambulate, severe congestive heart failure or severe cardiovascular disease, neoplasm for practical and neurophysiologic reasons
* Individuals with contraindications for performing a graded exercise test or have medical contraindications for participating in a scheduled exercise training program
* Individuals more than 300 pounds or less than 125 pounds due to DEXA weight limits and possibility of exceeding recommended daily nitrate dose of 7 mg/kg body weight, respectively.