cyrilzakka/clinical-trials huggingface dataset:
Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program.

In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to:

Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months.

Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns).

This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.


Eligibility Criteria:
* Assigned female at birth and currently identify as female
* Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
* BMI=25-50kg/m2
* 18-70 years old
* Interested in losing weight
* Regular internet and e-mail access
* No significant weight loss within past 6 months (\>5%)
* Fluent in English
* Able to participate in moderate physical activity
* Not currently enrolled in a weight loss program
* Not currently taking weight-loss medication
* Not currently pregnant or trying to get pregnant
* Participated in a previous Phase of this study
* Reports a serious mental/physical health condition that would increase potential risks of treatment to the participant (e.g., active symptoms of psychosis, suicidality, mania, alcohol/substance use, or a medical condition that is serious, active, unstable, and degenerative (e.g., CHF)).
Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)

Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Category 4-high-grade intraepithelial neoplasia
* Ages 18 or older
* signed Informed Consent Form
* signed Health Insurance Portability and Accountability Act (HIPAA) Authorization Form

Exclusion Criteria:

* Clinically relevant data suggesting an unknown disease and requiring further evaluation by the Primary Investigator.
* Patients with renal failure or organ transplants.
* Patients who have known allergic reactions to Proton Pump Inhibitors (PPI).
* Participation in another study that would interfere with study endpoints within 30 days prior to screening.
* Previous enrollment into the current study.
* Patient is the Investigator, his family member or employee at the investigational site.
* Patient known or suspected to be involved in alcohol or drug abuse.
* Known or suspected history of non-compliance with medications.
* Inability to follow the procedures of the study (e.g., due to language problems, psychological disorders)
* Patients receiving prohibited concomitant medications including PPIs, H2-blockers, sucralfate, misoprostol.
* Patients receiving prohibited concomitant medications including clopidogrel, ketoconazole, digoxin, diazepam, warfarin, phenytoin, emtricitabine/nelfinavir/tenofovir, atazanavir, citalopram, emtricitabine/rilpivirine/tenofovir, rilpivirine, nelfinavir, tricyclic antidepressants, baclofen, tacrolimus, cyclosporine, cilostazol, disulfiram, methotrexate, voriconazole.
* Pregnancy or intention to become pregnant during the course of study, breast feeding, or unwillingness to use a highly effective means of contraception (oral contraception or intrauterine device).
* Prescription Non-steroidal anti-inflammatory Drug (NSAID) or aspirin use: The patient must be able to stop these meds 1 week prior to screening and during treatment.
* History of upper gastrointestinal surgery, Zollinger-Ellison syndrome, esophageal stricture, peptic stricture, duodenal and ⁄ or gastric ulcer, esophageal motility disorders, Inflammatory Bowel Disease (IBD), AIDS, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, liver disease, active malignant disease, Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy, functional bowel disorder or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time.
* Subject unable or unwilling to fully complete all stages of the study.
* Unable to sign informed consent or inability to give fully informed consent due to language problems, psychological disorder or mental deficiency.
Relationships Between Anterior and Condylar Guidance - Comparison by CBCT and Electronic Axiography

The aim of the following study was to investigate the existence of a statistically significant correlation between the incisal features (incisal guidance angle, interincisal angle, overbite, overjet), temporomandibular joint (TMJ) morphology and its function. The hypothesis was:

I. The protrusive movement of the mandible does correlate with the TMJ anatomy. II. The protrusive movement of the mandible does not correlate with the incisal features.

III. The position and relationship of upper and lower permanent incisors do not have a direct and significant effect on the TMJ morphology in young adults.

The study was based on anatomical and functional measurements of the parameters within the masticatory system. The study group was composed in a way that all the participants (age 20-24) had the temporomandibular joints fully developed and at the same time not yet modified by adaptive processes.

Eligibility Criteria:
Inclusion Criteria:

* 20-24 years old

Exclusion Criteria:

* history of trauma, orthodontic treatment or temporomandibular disorders
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study

Informed by a previous trial in general cancer patients, the investigators aim to conduct a multi-centre Phase III explanatory RCT to demonstrate a significant impact of PTSD Coach on levels of anxiety in head and neck cancer (HNC) patients, including saliva and hair cortisol as bio-immunological indicators for stress. However, prior to proposing a larger trial requiring 267 patients, the investigators aim to demonstrate feasibility of recruitment and compliance with protocol procedures in a Phase II Pilot of 60 newly diagnosed HNC patients. The EG will receive PTSD Coach + usual care, compared to two control groups (UC and AC). AC will be comprised of a game app (e.g., Tetris, Candy Crush, or Solitaire) and will be structurally equivalent to the EG to control for distraction (attention on something pleasant or a task) and the human factor involved in usage prompting (i.e., same exposure time + contacts with personnel), since either distraction or the human contact with staff may, alone, lower anxiety. From a resource allocation perspective, it is important to know if the positive effects of PTSD Coach are due to the intervention itself or to the use of an app and its usage prompting. The investigators believe that PTSD Coach will be even more effective at reducing anxiety in HNC patients, as it teaches specific CBT techniques and uses psychoeducation already found to be more effective than distraction alone.

See above

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed with HNC (all HNC sites; TNM classification system); first occurrence, progression or recurrence \<4 weeks at referral.
2. Willing to complete PTSD Coach or game app within 3 weeks as they await treatment onset.
3. \>18 years old
4. Alert and capable of giving free and informed consent according to referring clinician.

Exclusion Criteria:

1. Karnofsky Performance Status (KPS) score \< 60 (rated by referring oncologists/nurses or Research Coordinator) or expected survival \<6 months according to clinical judgment of physicians and/or nurses.
2. Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI) suicide item.
3. Known diagnosis of schizophrenia or schizoaffective disorder.
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers

The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy female patients of non-childbearing potential or male patients as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
* Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive
* This study permits the re-enrollment of a patient that has discontinued the study as a pre-treatment failure (i.e. patient has not been randomized / has not been treated). If re-enrolled, the patient must be re-consented

Exclusion Criteria:

* Women who are of childbearing potential, lactating or breastfeeding
* Any significant acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
* Patients with history of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
* Patients with any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening
* Patients who have received any live vaccines within 1 month of study drug administration, or who plan to have a live vaccine at any time during the study, including during the follow up period
* Positive test for tuberculosis at screening
* Past or current history of neurologic disorders, Guillain-Barré Syndrome, central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesia's (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities

Other protocol defined inclusion/exclusion criteria could apply
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

The purpose of this study is to determine the efficacy of blood restriction therapy by comparing increase in muscle mass and strength in patients that receive blood restriction therapy to patients who receive a placebo.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I-II
* Diagnosed with patellofemoral pain syndrome

Exclusion Criteria:

* Patients with confirmed radiographic evidence explaining knee pain
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients with impaired circulation, peripheral vascular compromise, Previous revascularization of the extremity, or severe hypertension
* Patients with Sickle cell anemia or venous thromboembolism
* Patients with Sickle cell anemia or venous thromboembolism
* Patients with cancer or Lymphectomies
* Patients with increased intracranial pressure
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.

This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable malignancy of the extrahepatic bile duct

Exclusion Criteria:

* Age below 21 years
* Pregnancy
* Active alcohol or drug abuse
* Simultaneously participating in another investigational drug or device study.
* Allergy to stainless steel or nitinol
* Active cholangitis
* Brachytherapy
* Unable or unwilling to comply with follow up
Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).

Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years old;
* Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
* DVT with thrombosis involving iliac vein, femoral vein popliteal vein and calf vein;
* Informed consent signed by patients.

Exclusion Criteria:

* Patients with the previous history of the same side of lower-limb DVT;
* Patients with plasma Creatinine level greater than 180umol/L;
* Patients who are contraindicated to thrombolysis;
* Patients with inferior vena cava thrombosis;
* Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
* Patients who have participated in a clinical trial in the past three months;
* Women during pregnancy and lactation
* Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<2 years);
* Patients with autoimmune thrombopathy
* Patients who are unable or unwilling to participate in the study.
Effectiveness of a Mindfulness Based Diet Program on Weight Loss

Meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . Mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining long-term eating habits and appetite regulation.In the light of this information, in this study, it is aimed to observe the effect of mindfulness approach on body weight and eating behaviours.

The use of minfulness based programs for body weight control and stress management is increasing. One of the main reasons for this situation is that individuals care more about the diet and body weidght as a result of the increase in health concerns and stress. In addition, such cognitive support programs in the diet process provide a more comfortable and stress-free continuation of the diet. Based on the above-mentioned information; in this study, it is aimed to determine the effect of mindfulness based diet intervention on weight loss and eating behaviuors.

Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 2 groups: mindfulness group (15) and control group . Food consumption records, anthropometric measurements and eating behaviours scale of all individuals will record at the beginning and end of the study. In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20-65
* Being obese (BMI≥30 kg/m2)
* Volunteering to participate in research

Exclusion Criteria:

* Being pregnant/lactating
* Having a psychological problem
* Being on a followed diet program
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.


Eligibility Criteria:
Inclusion Criteria:

For T2DM Cohort only:

* Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2.
* A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening
* Current stable treatment (at least 3 months) for diabetes
* Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%.
* For women of childbearing potential, agreement to remain abstinent or use reliable contraception during treatment period and for at least 42 days after last dose of study drug
* For men, agreement to remain abstinent or use reliable contraception and agree to refrain from donating sperm
* For NAFLD cohort only:
* BMI ≥ 25 kg/m2 and ≤ 40 kg/m2
* At screening, confirmed liver fat by ultrasound OR calculated Liver Fat ≥ 10% using variables from the NAFLD liver fat score
* Hepatic steatosis on magnetic resonance imaging (MRI; ≥ 10% average liver proton density fat fraction \[PDFF\]) prior to randomization.

Exclusion Criteria:

* Pregnant, lactating, or intending to become pregnant within 42 days after the last dose of study drug is administered
* Suspected or confirmed diagnosis of Type 1 diabetes
* Significant cardiac disease
* Any psychiatric illness that increases the risk of participation in the study
* History of severe allergic, anaphylactic, or other hypersensitivity reactions, or severe systemic bacterial, fungal, or parasitic infections
* Poor peripheral venous access
* Received blood products within 2 months before dosing
* Donation or loss of blood within 30-56 days prior to study drug administration
* Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
* Liver enzymes greater than acceptable limits
* History of eating disorders or surgical procedures for weight loss
* Active participation in a structured weight loss or dietary program
* Treatment with investigational therapy or exposure to any biological therapy
* Illicit drug use, marijuana use, or alcohol abuse
* Current use of more than one pack of cigarettes a day or equivalent nicotine- containing products
* Any serious medical condition or abnormality in clinical laboratory tests
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.

Primary Aims:

1. To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer.
2. To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data.

Secondary Aims:

1. To evaluate the correlation between imaging findings and disease progression.
2. To evaluate the correlation between ctDNA and disease progression.
3. To develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.

Outline:

Participants will be recruited to participate in the registry during a regularly scheduled clinic visit with their treating oncologist, and consented to participate at this time. At each evaluation time point, participants will have a blood draw performed. Participants will be followed until loss to follow up, death, or withdrawal from the registry.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is allowed.
2. Age \>=18 years
3. Any receptor subtype.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Stage I-III breast cancer.
2. Lack of lobular histology on tumor biopsy.
3. Other active cancer (prior treated cancer with no current evidence of disease is allowed).