bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
Condition: Various Advanced Cancer
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor
      size in subjects with metastatic or unresectable bladder cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of metastatic or surgically unresectable transitional cell carcinoma of the
             urothelium involving the bladder,urethra,ureter or renal pelvis

          -  Measurable disease by CT or MRI

          -  Progression or recurrence after treatment

          -  i) With at least 1 platinum-containing chemotherapy regimen for metastatic or
             surgically unresectable locally advanced urothelial cancer, or

          -  ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a
             platinum agent in the setting of cystectomy for localized muscle-invasive urothelial
             cancer

          -  Subject that have received more than 2 prior lines of chemotherapy must not have liver
             metastases

          -  Tumor tissues (archived or new biopsy) must be provided for biomarker analysis

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

        Exclusion Criteria:

          -  Subjects with active cancer that has spread to the central nervous system

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured

          -  Subject with active, known or suspected autoimmune disease

          -  Subjects with a condition requiring systemic treatment with either corticosteroids
             (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
             day of study drug administration

          -  Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic
             T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody
             or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

        Exclusion laboratory criteria:

          -  Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
             ribonucleic acid (HCV antibody) indicating acute or chronic infection

          -  Known history of testing positive for human Immunodeficiency virus (HIV) or known
             acquired Immunodeficiency syndrome (AIDS)

        Other protocol-defined inclusion/exclusion criteria apply
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Condition: Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Intervention: sodium bicarbonate buffered lidocaine; Non-buffered lidocaine
Intervention description: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for
      their cervical block will experience less injection pain than women who receive plain
      lidocaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  antecedent biopsy read as

               -  cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer

               -  adenocarcinoma in situ

               -  persistent CIN 1

          -  antecedent pap read as

               -  high grade squamous intraepithelial lesion

               -  atypical glandular cells

               -  persistent low grade squamous intraepithelial lesion

        Exclusion Criteria:

          -  anatomy unsuitable for safe office loop excision based on operator judgement

          -  inability to tolerate procedure under local anesthesia

          -  pregnancy

          -  age less than 18 years

          -  inability to understand spoken or written English

          -  refusal of consent

          -  prisoner

          -  mental incapacity

          -  anticoagulant or antiplatelet therapy, or known bleeding diathesis

          -  use of analgesics other than over the counter medications(OTC meds include NSAIDS or
             Tylenol) within 7 days of scheduled LEEP
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
Condition: HIV-1-infection
Intervention: Doravirine; Descovy
Intervention description: Doravirine 100 mg tablet; Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Intervention MeSH terms: Emtricitabine tenofovir alafenamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patients with Doravirine administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC) and administered orally once daily.
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Doravirine

Summary:

      This study aims to evaluate the ability of Doravirine to penetrate the genital tract and
      suppress viral replication and provide evidence for the use of Doravirine as part of
      treatment strategies as prevention.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.

          2. Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine
             or abacavir/lamivudine, plus an non-nucleoside reverse transcriptase inhibitor, a
             boosted protease inhibitor or an integrase inhibitor, continuously for at least 3
             consecutive months preceding the screening visit.

          3. Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.

          4. Signed and dated written informed consent prior to inclusion.

          5. Female Subjects of Childbearing Potential must agree to utilize a highly effective
             method of contraception during heterosexual intercourse from the screening visit
             throughout the duration of the study.

        Exclusion Criteria:

          1. Severe hepatic impairment (Child-Pugh Class C)

          2. Ongoing malignancy

          3. Active opportunistic infection

          4. Resistance to any of the antiretroviral (ARV) included in the study or history of
             virologic failure with risk of resistance selection to any of the study drugs.

          5. Any verified Grade 4 laboratory abnormality

          6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN

          7. Severe renal impairment (Estimated creatinine filtration rate <50mL/min).

          8. Females who are pregnant (as confirmed by positive serum pregnancy test) or
             breastfeeding.
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
Condition: Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Infarction
Intervention: Short Tirofiban; Eptifibatide; Long Tirofiban
Intervention description: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.; 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.; 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
Intervention MeSH terms: Tirofiban; Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 535.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a
      shortened infusion duration compared to label-dosing eptifibatide in patients undergoing
      percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of
      death, PCI-related myocardial infarction, urgent target vessel revascularization or
      in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever
      comes first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years of age

          -  Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures
             such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one
             or more native coronary target lesions

          -  Written informed consent

        Exclusion Criteria:

          -  Primary PCI for STEMI as index procedure

          -  Prior STEMI within 48 hours before randomization

          -  Prior PCI within 30 days before randomization

          -  Planned staged PCI within the subsequent 24 hours after index PCI

          -  Use of abciximab within 7 days before randomization

          -  Use of tirofiban or eptifibatide within 12 hours before randomization

          -  Use of low-molecular weight heparin within 12 hours before randomization

          -  Use of bivalirudin within 12 hours before randomization
A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: BAY94-9343 (Anetumab ravtansine)
Intervention description: BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
Intervention MeSH terms: Maytansine; Tubulin Modulators; Anetumab ravtansine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumors; Mesothelin; Mesothelioma

Summary:

      The purpose of this study is to enable patients with solid tumors, who received anetumab
      ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective
      study has been closed. The patients will be observed to collect information on how safe and
      efficient the drug is.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants ongoing in an applicable Bayer-sponsored anetumab ravtansine parent study
             at the time of its planned study closure.

          -  For on-treatment participants: participant is eligible to receive the next dose of
             study intervention per the parent study protocol.

          -  For on-treatment participants: any ongoing adverse events that require temporary
             treatment interruption must be resolved to baseline grade or assessed as stable and
             not requiring further treatment interruption. For applicable studies: should treatment
             be permanently interrupted in the parent study, participants may be enrolled in the
             follow-up portion of the rollover study.

        Exclusion Criteria:

          -  For on-treatment participants: a positive serum pregnancy test.

          -  For on-treatment participants: use of one or more of the prohibited medications listed
             in the respective parent study protocol.

          -  Participants who are receiving standard-of-care agent(s) but not anetumab ravtansine
             in the parent study, and are able to receive standard-of-care agent outside of the
             clinical study.
Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Condition: Graves Disease
MeSH terms: Graves Disease
Intervention: 1α-D3; Placebos
Intervention description: patients were given PTU and 1α-D3; patients were given PTU and placebos
Intervention MeSH terms: Alfacalcidol; Dihydroxycholecalciferols
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vitamin D; graves' disease; dendritic cells

Summary:

      Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating
      autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in
      healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro
      1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral
      1α-D3 on DC maturation in GD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Graves' disease and still have not gone into remission

          -  Willing to participate in the research

        Exclusion Criteria:

          -  Pregnant patient

          -  Suffered from severe liver disease

          -  Suffered from severe kidney disease

          -  Taking vitamin D substitution therapy

          -  Suffered from another autoimmune disease

          -  Suffered from malignancy
Cangrelor Prasugrel Transition Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Cangrelor; Prasugrel
Intervention description: Cangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8; Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Intervention MeSH terms: Prasugrel Hydrochloride; Cangrelor
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CAD

Summary:

      To demonstrate that patients treated with cangrelor can be directly switched to oral
      prasugrel and that patients treated with prasugrel can be switched to cangrelor without a
      significant decrease in the extent of inhibition of platelet aggregation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. greater than / equal to 18 and less than 75 years of age

          2. stable coronary artery disease defined by the following criteria

               1. Previous myocardial infarction defined by admission to the hospital with
                  elevation of markers of injury or the presence of pathologic Q waves on at least
                  2 contiguous electrocardiogram (ECG) leads.

                  OR

               2. Previous revascularization by percutaneous coronary intervention (PCI) or
                  coronary artery bypass graft (CABG).

                  AND

               3. Treatment with aspirin (ASA) 81 mg daily.
ALS Reversals - Lunasin Regimen
Condition: ALS (Amyotrophic Lateral Sclerosis)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Lunasin Regimen; Historical control
Intervention description: LunaRich X Capsules, Reliv Now, ProVantage; Matched historical controls will be identified from the PatientsLikeMe database.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial
      utilizing a historical control group. Participants will receive a Lunasin regimen and will be
      asked to register for an account of PatientsLikeMe website, where after the initial in-clinic
      visit, they will be asked to enter specific data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged at least 18 years.

          -  Sporadic or familial ALS diagnosed as possible, laboratory-supported probable,
             probable, or definite as defined by revised El Escorial criteria.

          -  Patient is able to understand and express informed consent (in the opinion of the site
             investigator).

          -  Patient has access to the Internet on a desktop computer, laptop, or tablet and has a
             working email address.

          -  Patient or caregiver is willing and able to use a computer and enter data on a secure
             website.

          -  Patient is able to read and write English.

          -  Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile,
             or using adequate birth control methods) for the duration of the study and three
             months after study completion. Adequate contraception includes: abstinence, hormonal
             contraception (oral contraception, implanted contraception, injected contraception or
             other hormonal contraception, for example patch or contraceptive ring), intrauterine
             device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide,
             or another adequate method.

        Exclusion Criteria:

          -  Patient is taking other experimental treatments for ALS.

          -  Prior side effects from Lunasin.

          -  Known soy allergy.

          -  Patient has a medical or psychiatric illness that could in the investigator's opinion
             interfere with the patient's ability to participate in this study.

          -  Pregnant women or women currently breastfeeding.
Safety and Effectiveness of D-serine in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: D-serine; D-serine; D-serine; D-serine
Intervention description: D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Negative symptoms; NMDA; Glutamate; Glycine

Summary:

      This study will determine whether increasing D-serine within the body will improve negative
      symptoms and cognitive impairments in people with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Structured Clinical Interview for DSM-III-R diagnosis of schizophrenia or
             schizoaffective disorder

          -  PANSS 3 factor negative symptom inclusion score greater than 20 prior to study entry

          -  PANSS total score between 60 and 110

          -  Simpson-Angus Scale total score of 12 or less

          -  Calgary Depression Inventory total score of 10 and suicide score less than 2

          -  No change in Clinical Global Impressions (CGI) Scale score prior to study entry

          -  Chlorpromazine (CPZ) equivalent of 1500 or less

          -  Willing to use an effective form of birth control throughout the study if sexually
             active

        Exclusion Criteria:

          -  High extrapyramidal symptom (EPS) levels

          -  Began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry

          -  Taking investigational medication within 2 weeks of study entry

          -  Contraindication to study medication

          -  Serious or unstable medical illness

          -  Pregnant or breastfeeding

          -  Alcohol or drug abuse within 6 months of study entry

          -  Diagnosed with neurodegenerative disease or a seizure disorder

          -  History of a kidney impairment

          -  Currently taking clozapine

          -  Currently taking more than two antipsychotic medications

          -  Currently taking stimulants or cholinesterase inhibitors
PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: PF-06651600; Placebo
Intervention description: 50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD; tablet, dosed as 4 tablets QD or 1 tablet QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: alopecia totalis; alopecia universalis; hair loss; alopecia; JAK; ritlecitinib; PF-06651600; double-blind; placebo-controlled; phase 2a

Summary:

      This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the
      safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp
      hair loss due to Alopecia Areata (AA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.

          -  At least 25% hair loss due to alopecia areata

          -  Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)

          -  Must have a normal neurological exam; can have a stable unilateral median neuropathy
             or ulnar neuropathy

          -  Signed informed consent

          -  Stable regimen for other medications before and during the study

        Exclusion Criteria:

          -  Other significant medical conditions

          -  Occupational or recreational noise exposure

          -  History of peripheral neuropathy or first degree relative with a hereditary peripheral
             neuropathy

          -  HbA1c > or = 7.5% at Screening

          -  Recurrent or disseminated Herpes Zoster

          -  Active or chronic infection; or infection requiring hospitalization or IV
             antimicrobials within 6 months

          -  Active or latent (insufficiently treated) Hepatitis

          -  Active or latent (insufficiently treated) TB

          -  Concomitant medications associated with peripheral neurologic or hearing loss

          -  Protocol specific laboratory abnormalities