bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: BIC; F/TAF; DTG; BIC Placebo; DTG Placebo; B/F/TAF
Intervention description: 75 mg tablet administered orally once daily; 200/25 mg FDC tablet administered orally once daily; 50 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily; 50/200/25 mg FDC tablet administered orally once daily
Intervention MeSH terms: Dolutegravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult; HIV; naive

Summary:

      This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) +
      emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir
      (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also
      evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)

          -  Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

          -  Screening genotype report provided by Gilead Sciences must show sensitivity to
             tenofovir (TFV) and emtricitabine (FTC)

          -  Adequate renal function as measured by estimated glomerular filtration rate ≥ 70
             mL/min according to the Cockcroft-Gault formula

          -  CD4+ cell count ≥ 200 cells/µL at screening

        Key Exclusion Criteria:

          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening as
             defined in the study protocol

          -  Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post
             exposure prophylaxis (PEP)

          -  Chronic hepatitis B virus (HBV) infection

          -  Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but
             have a documented negative HCV RNA, are eligible)

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to baseline

          -  Participation in any other clinical trial without prior approval from the sponsor is
             prohibited while participating in this trial

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-195,543; celecoxib; Methotrexate
Intervention description: CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.; Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.; Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
Intervention MeSH terms: Celecoxib; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in
      subjects with rheumatoid arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of RA based upon the American college of Rheumatology 1987 revised
             criteria

          -  Active disease at Screening

          -  Stable dose of methotrexate between 10-25 mg/week oral or parenteral

        Exclusion Criteria:

          -  A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in
             the opinion of the Investigator, would interfere with disease activity assessments

          -  A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors,
             opiates, aspirin or sulfonamides
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Condition: COVID-19 Pulmonary Complications; COVID-19
MeSH terms: COVID-19
Intervention: Zanubrutinib; Supportive Care; Placebo
Intervention description: 320 mg (4 x 80 mg) capsules administered orally once daily; Supportive care treatment was selected and administered as deemed appropriate by the study investigator; Placebo to match zanubrutinib
Intervention MeSH terms: Zanubrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Corona Virus; COVID-19

Summary:

      The primary objective of this study was to evaluate if the addition of zanubrutinib to
      supportive care increases the respiratory failure-free survival rate at Day 28 in
      participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not
      receiving mechanical ventilation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Hospitalization for COVID-19 infection

          2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
             polymerase chain reaction (PCR)

          3. Participant requires supplemental oxygen for pulmonary distress related to COVID-19
             infection, and has been on supplemental oxygen for no more than 96 hours from time of
             screening

        Key Exclusion Criteria:

          1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease or
             ulcerative colitis, or partial or complete bowel obstruction

          2. On a Bruton's tyrosine kinase (BTK) inhibitor

          3. Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20
             monoclonal antibody treatment

          4. Participants with prior of current hematologic malignancy or solid tumor malignancy
             with treatment within 6 months prior to study entry

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS
Intervention description: twice daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      An open label, safety study to assess the potential for adrenal suppression following maximal
      use treatment with DSXS administered twice daily for 28 days in patients with moderate to
      severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age
             with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA
             affected

          2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline
             for the overall disease severity.

          3. Results from a cortisol response test that are considered normal and show no evidence
             of any abnormal HPA function or adrenal response

        Exclusion Criteria:

          1. Patients under 2 years of age.

          2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4
             (severe) at baseline.

          3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e.,
             erythrodermic, exfoliative or pustular psoriasis).

          4. Results from a cortisol response test that show evidence of any abnormal HPA function
             or adrenal response
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: DUR-928
Intervention description: oral suspension daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a research trial testing DUR-928 (an experimental medication). The purpose of the
      trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary
      Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Verified diagnosis of primary sclerosing cholangitis (PSC) for at least 12 months,
             with or without inflammatory bowel disease (IBD).

          -  Serum alkaline phosphatase (ALP) ≥ 1.5 times ULN and with no >15% fluctuation in the
             past 3 months.

          -  In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be
             stable for at least 3 months and at a dose not greater than 20 mg/kg/day.

          -  Subjects of childbearing potential must agree to use a medically acceptable method of
             contraceptive to prevent pregnancy in the subject and/or the partner for the duration
             of their participation in the trial up to 2 months after the last study drug dosing.

        Exclusion Criteria:

          -  Presence of documented secondary sclerosing cholangitis or small duct PSC

          -  Bacterial cholangitis within 30 days prior to Screening

          -  Presence of percutaneous drain or endoscopic bile duct stent

          -  History of, or suspicion of cholangiocarcinoma.

          -  Prior liver transplantation, or currently listed for liver transplantation

          -  Presence of other concomitant liver diseases

          -  Moderate to Severe active IBD or flare in colitis activity within the last 3 months

          -  Any severe and/or untreated concomitant cardiovascular, renal, endocrine or
             psychiatric disorder

          -  Any active malignant disease (within 3 years), other than non-melanomatous skin cancer

          -  Human immunodeficiency virus (HIV) infection

          -  Existing or intended pregnancy, or breast feeding

          -  Has received medication from another clinical trial within the past 30 days
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: placebo; Pregabalin; Pregabalin; Pregabalin; Pregabalin; Pregabalin
Intervention description: Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks; 50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks; 100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks; 150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks; 300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks; 450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pregabalin, RLS, efficacy, safety

Summary:

      To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe idiopathic RLS

          -  symptoms occur predominantly in the evening

          -  symptoms interfere with sleep onset or maintenance

        Exclusion Criteria:

          -  Any secondary RLS

          -  require treatment for daytime RLS symptoms

          -  symptomatic neuropathies
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: AIN457 (secukinumab); Placebo
Intervention description: Secukinumab intravenous injection; Placebo intravenous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Secukinumab; Therapeutic Uses; Respiratory; Lung; Pulmonary; inhaled; corticosteroids

Summary:

      This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial
      asthma that is poorly controlled with the current standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with asthma >1 year duration diagnosed according to the GINA guidelines
             (GINA 2010).

          -  Daily treatment with > 1000μg beclomethasone dipropionate or equivalent, plus a long
             acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4
             weeks prior to screening.

          -  Asthma which is not adequately controlled on current treatment

          -  Peripheral blood eosinophil count < 400/μl at screening

        Exclusion Criteria:

          -  Women of child-bearing potential unwilling to use effective contraception during the
             study and for 16 weeks after stopping treatment.

          -  Use of other investigational drugs at the time of screening, or within 30 days of
             screening.

          -  Smokers
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Intervention: deep needling; Lactulose; shallow needling
Intervention description: Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain.
Once a day, five times a week, four weeks.; 20-30ml, once a day before breakfast, for the whole study except the run-in period; Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.
Intervention MeSH terms: Lactulose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 475.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acupuncture; Functional constipation

Summary:

      The purpose of this study is to re-evaluate the therapeutic superiority and safety of
      acupuncture treatment using high quality and large sampled clinical research. The
      investigators want to provide a preferred treatment protocol, which is effective, safe, and
      easy to use in clinical practice. This research also clarifies that the insertion depth is a
      key factor in the therapeutic effect of acupuncture. The results of the study will help
      promote the development of the standardization of acupuncture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meeting the diagnosis of Rome III criteria;

          -  aged from 18 to 75 years old;

          -  no use of medicine for constipation about 2 weeks before the enrollment, no
             acupuncture treatment for constipation in the previous 3 months, and never joined any
             other trial in progress in the previous 3 months;

          -  volunteered to join this trial and signed the informed consent form

        Exclusion Criteria:

          -  irritable bowel syndrome, organic constipation or secondary constipation caused by
             endocrine, metabolic, nervous, postoperative diseases, or by drugs;

          -  constipation with serious cardiovascular, hepatic or renal diseases, cognitive
             dysfunction, aphasia, mental disorders, or illness which affects the cooperation for
             examination and treatment;

          -  women in gestation or lactation period;

          -  abdominal aortic aneurysm or hepatosplenomegaly, etc.;

          -  blood coagulation disorders or using anticoagulants regularly such as Warfarin and
             Heparin;

          -  cardiac pacemaker carrier.
Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Intervention: cetuximab, cisplatin; cisplatin
Intervention description: Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m^2) followed by weekly doses of 250 mg/m^2. All doses will be given by intravenous (IV) infusion.
Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.
Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent.; Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.
Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles.
Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent.
Intervention MeSH terms: Cisplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; breast; metastatic; triple negative

Summary:

      The primary objective of this study is to determine whether overall response to cetuximab
      combined with cisplatin is better than overall response to cisplatin alone together with
      showing that the overall response for cetuximab and cisplatin was above a pre-specified
      threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

      The secondary objective of this study is to compare the differences between the two treatment
      groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival
      (OS), Time to Response (TTR) and Safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)

          -  Estrogen Receptor [ER] negative, PgR negative and HER2 less than 3+ expression by
             immunohistochemistry (IHC)

          -  No more than 1 prior chemotherapy received for treating this metastatic breast cancer

          -  No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or
             metastatic setting)

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Prior platinum agent

          -  Prior mitomycin

          -  Known history of brain metastases

          -  Other protocol-defined exclusion criteria may apply
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.; Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
Intervention description: Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.; Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 40 Months
Maximum age: 62 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Pre-school; Meningococcal disease; Prevention; Vaccination

Summary:

      The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of
      this extension study will be to explore antibody persistence at approximately 40 months of
      age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV
      NZ administered to subjects at approximately 40 months of age. Antibody persistence will be
      subsequently measured at 18-20 months after these booster doses when the subjects are 60
      months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be
      recruited in the study to serve as a baseline comparator for assessing antibody persistence
      at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.
      Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if
      they have not already received these vaccines prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 40 to 44-months-old children, who participated and completed the study V72P6
             (NCT00381615; follow-on subjects)

          -  Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

        Exclusion Criteria:

          -  Previous ascertained or suspected disease caused by N. meningitidis

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component

          -  Any serious chronic or progressive disease

          -  Known or suspected impairment/alteration of the immune system

          -  Receipt of, or intent to immunize with another vaccine, within 30 days prior and after
             vaccination with the investigational vaccines (within 14 days for licensed flu
             vaccines)