bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
Condition: Neoplasms; Neoplasm Metastasis; Melanoma; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms
MeSH terms: Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: LY3009120 capsule
Intervention description: Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to see how safe the investigational drug known as LY3009120
      is and whether it will work to help people with advanced cancer or cancer that has spread to
      other parts of the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced or metastatic cancer

          -  Other available therapies have failed to cure the cancer

          -  The cancer that has no proven effective therapy

          -  The cancer can be biopsied (depending on the tumor type and/or the dose of drug
             received, tumor biopsies may be required)

          -  Able to swallow capsules

        Exclusion Criteria:

          -  Have active cancer in the brain or spinal cord

          -  Have an active infection of any kind (fungal, viral, or bacterial)

          -  Have a cancer of the blood

          -  Are pregnant or breastfeeding

          -  Have some types of eye problems or impairments
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
Condition: COVID 19
MeSH terms: COVID-19
Intervention: Ivermectin (IVM)
Intervention description: Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Intervention MeSH terms: Ivermectin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group
      to Hydroxychloroquin (HCQ) + azithromycin (AZT)
    

Eligibility criteria:

        Inclusion Criteria:

        -1. Patients with age above 18 years and any gender with definite Dx of covid19 and
        pneumonia in the ward according to the clinical, laboratory, and imaging criteria.

        2. Understands and agrees to comply with planned study procedures.

        Exclusion Criteria:

          1. Patients with hypersensitivity or severe adverse effects to Ivermectin

          2. Renal impairment

          3. Hepatic impairment.

          4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c)

          5. Breast feeding.

          6. Patient with covid 19 positive and mild no pneumonia

          7. Children under the age of five or those who weigh less than 15 kilograms
Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Condition: Healthy
Intervention: Mirasol System for Whole Blood.
Intervention description: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: red blood cells; transfusion; recovery; feasibility; white blood cell inactivation

Summary:

      Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from
      Mirasol-treated whole blood
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adults who meet AABB (formerly known as the American Association of Blood
             Banks) criteria for whole blood donation

          -  females incapable of becoming pregnant

          -  males agreeing to use contraception during trial

        Exclusion Criteria:

          -  pregnancy or nursing

          -  abnormal medical history (bleeding disorders, anemia, myocardial ischemia,
             uncontrolled hypertension, heart disease, epilepsy)

          -  major surgery

          -  use of drugs affecting coagulation or RBC function

          -  recent participation in other trials which may confound results
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
Condition: Obesity
MeSH terms: Obesity
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a study of tirzepatide in participants with obesity. The main purpose is to learn
      more about how tirzepatide affects the number of calories participants burn and the amount of
      food they eat. The study lasted for 28 weeks and will include about 21 visits to the study
      center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive

          -  Have a stable body weight in the past 1 month prior to screening

          -  Willing and agreeable to commit to the duration of the study and undergo study
             procedures as instructed by the clinic staff

        Exclusion Criteria:

          -  Have undergone gastric bypass or bariatric surgery

          -  Have a diagnosis of type 2 diabetes

          -  Have a history or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological or neurological disorders capable of
             significantly altering the absorption, metabolism or elimination of drugs; of
             constituting a risk when taking the study drug; or of interfering with the
             interpretation of data

          -  Have received prescription drugs or over the counter drugs that promote weight loss in
             the past 6 months prior to screening

          -  Have any lifetime history of a suicide attempt

          -  Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening

          -  Positive responses to selected items on the Columbia Suicide Severity Rating Scale
             (C-SSRS)
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
Condition: Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: RP6530
Intervention description: Tablet starting at 200 mg
Intervention MeSH terms: Tenalisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; PTCL; RP6530

Summary:

      The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K
      delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)

          -  Refractory to or relapsed after at least 1 prior treatment line.

          -  ECOG performance status ≤2

          -  Patients must be ≥18 years of age

          -  Able to give a written informed consent.

        Exclusion Criteria:

          -  Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks

          -  Patients with HBV, HCV or HIV infection

          -  Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or
             any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus),
             AKT or BTK Inhibitor (including Ibrutinib) in last 6 months

          -  Patients on immunosuppressive therapy including systemic corticosteroids.

          -  Patients with known history of liver disorders.

          -  Patients with uncontrolled Diabetes Type I or Type II

          -  Any severe and/or uncontrolled medical conditions or other conditions that could
             affect their participation in the study.

          -  Women who are pregnant or lactating.
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
Condition: Healthy Adult Male
Intervention: OPC-34712
Intervention MeSH terms: Brexpiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The ratios of the geometric means of the ODT formulation to those of the reference
      formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of
      brexpiprazole (OPC-34712)).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of providing written informed consent prior to initiation of any trial-related
             procedures, and able, in the opinion of the investigator, to comply with all
             requirements of the trial

        Exclusion Criteria:

          -  Clinically significant abnormality at the time of screening (eg, significant deviation
             from reference ranges) or in medical history that, in the opinion of investigator or
             sponsor may place the subject at risk or interfere with outcome variables, including
             drug absorption, distribution, metabolism, and excretion

          -  History of serious mental disorder

          -  History of drug or alcohol abuse within 2 years prior to screening

          -  History of any significant drug allergy

          -  Use of an investigational drug within 120 days prior to the first dosing of trial drug

          -  Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to
             screening

          -  Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange
             products, starfruit, or starfruit products within 72 hours prior to dosing

          -  Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or
             St. John's Wort within 14 days prior to the first dosing of trial drug, or of
             antibiotics within 30 days prior to the first dosing of trial drug

          -  History of major surgery of the digestive tract (excluding appendectomy)

          -  Any subject who, in the opinion of the investigator, should not participate in the
             trial
CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos
Condition: Caregiver Burnout
MeSH terms: Dementia; Caregiver Burden
Intervention: CuidaTXT
Intervention description: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: This intervention, CuidaTXT [Spanish for self-care and texting], will be available in English and Spanish, incorporate two-way messaging and will tailor text messages to the preferences of Latino caregivers. CuidaTXT will be multicomponent and based on the Stress Process Framework as supported by evidence. The intervention will incorporate social support and coping components including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dementia; Caregiver; mHealth; Stress; Latino; Disparities

Summary:

      Latino families with dementia experience substantial disparities in access to caregiver
      support compared to their non-Latino white peers, putting them at an increased risk for
      negative emotional, physical and financial outcomes. This R21 will address this research gap
      by 1) Developing a culturally and linguistically appropriate text message intervention for
      caregiver support among Latino family caregivers of individuals with dementia and 2) Testing
      the feasibility and acceptability of CuidaTXT, a multicomponent text message caregiver
      support intervention culturally and linguistically tailored for the Latino community.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Spanish and English-speaking individuals

          -  Over the age of 18

          -  Identify as Latino

          -  Report providing hands-on care for a relative who has been given a clinical or
             research dementia diagnosis

          -  Care recipient has an AD-8 screening score greater than or equal to 2, indicating
             cognitive impairment

          -  Self-report being able to read and write

          -  Self-report owning a cell phone with a flat fee and use it at least weekly for texting

        Exclusion Criteria:

        -
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to learn more about the safety and side effects of
      tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also
      measure how much tirzepatide gets into the bloodstream and how long it takes the body to
      remove it. The study will last about six or eight months for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are
             stable on a single oral antihyperglycemic medication (OAM), metformin, acarbose, or
             sulphonylureas only (other types of OAM [dipeptidyl peptidase IV inhibitors,
             sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones] are not allowed in
             this study), for at least 3 months

          -  Have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²),
             inclusive

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus

          -  Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to Visit 1

          -  Have a history of heart block or PR interval greater than (>)220 milliseconds (msec)
             or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the
             opinion of the investigator, increases the risks associated with participating in the
             study

          -  Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or a GI
             disease that impacts gastric emptying or could be aggravated by glucagon-like
             peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have known allergies to tirzepatide, GLP-1 analogs, or related compounds or any
             components of the formulation
Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps
Condition: Sinusitis; Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: Verapamil Hydrochloride Intranasal
Intervention description: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Intervention MeSH terms: Verapamil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce
      inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is
      characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial
      of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this
      study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP. The study was
      initially approved as a Phase Ib/II, but only the Phase Ib portion was completed as part of
      this protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the Mass Eye and Ear Sinus Center

          -  Age 18-80 yrs old

          -  Diagnosed with Chronic Rhinosinusitis with Nasal Polyps according to the EPOS 2012
             consensus criteria

          -  Post-operative with a Lund-Kennedy Poly score of <4

          -  Baseline SNOT-22 Score ≥ 30

        Exclusion Criteria:

          -  Patients with the following comorbidities:

          -  GI Hypomotility

          -  Heart Failure

          -  Liver Failure

          -  Kidney Disease

          -  Muscular Dystrophy

          -  Pregnant or Nursing Females

          -  Steroid Dependency

          -  Hypertrophic Cardiomyopathy

          -  Any Atrial or Ventricular arrhythmia (ie. Atrial fibrillation, atrial flutter, etc..)

          -  Resting Heart Rate less than 60 beats per minute

          -  Baseline Systolic Blood Pressure less than 110 mmHg

          -  Baseline Diastolic Blood Pressure less than 70 mmHg

          -  Baseline Mean Arterial Pressure Less than 60 mmHg

          -  PR interval less than 0.12 seconds

          -  Patients taking the following medications:

          -  Aspirin

          -  Beta-blockers

          -  Cimetidine(Tagamet)

          -  Clarithromycin(Biaxin)

          -  Cyclosporin

          -  Digoxin

          -  Disopyramide(Norpace)

          -  Diuretics

          -  Erythromycin

          -  Flecainide

          -  HIV Protease Inhibitors(Indinavir, Nelfinavir, Ritonavir)

          -  Quinidine

          -  Lithium

          -  Pioglitazone

          -  Rifampin

          -  St Johns Wort

          -  Patients with cardiac or conduction abnormality picked up by screening EKG

          -  Post-op patients with surgery within 3 months prior to enrollment.
Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks
Condition: Marijuana Use Disorder
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Inactive Marijuana (0% THC); Low THC marijuana (1.8 %THC); High THC marijuana (3.9% THC)
Intervention description: Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.; Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.; Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
Intervention MeSH terms: Dronabinol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind, placebo-controlled
Enrollment: 36.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cannabinoids; Risk taking; Decision making

Summary:

      The purpose of this study is to investigate the effects of smoked marijuana on both risk
      taking and decision making tasks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current marijuana use

          -  21-45 years of age

          -  Practicing an effective form of birth control

          -  Not seeking treatment for marijuana use

        Exclusion Criteria:

          -  Current, repeated illicit drug use other than marijuana

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
             hypertension)

          -  Laboratory tests outside normal limits that are clinically unacceptable to the study
             physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)

          -  Significant adverse reaction to marijuana

          -  Current parole or probation

          -  Pregnancy or current lactation

          -  Recent history of significant violent behavior

          -  Major current Axis I psychopathology (e.g., mood disorder with functional impairment
             or suicide risk, anxiety disorder, schizophrenia

          -  History of heart disease

          -  Current use of any over-the-counter or prescription medication from which the
             volunteer cannot be withdrawn