bioihbjkbjnl/mcl2 huggingface dataset:
Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: VAY736; Placebo; Standard of Care (SoC)
Intervention description: 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks; Placebo administered subcutaneously every 4 weeks for 48 weeks; Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: idiopathic pulmonary fibrosis; VAY736

Summary:

      The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736
      as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of definite or probable IPF within 5 years of the screening visit

          -  Forced Vital Capacity (FVC) 40-90% predicted (inclusive)

          -  Diffusing Capacity of the Lungs (DLCO), corrected for hemoglobin, 25-79% predicted
             (inclusive)

          -  Forced Expiratory Volume in first second (FEV1)/FVC >70%

          -  Unlikely to die from cause other than IPF within the next 3 years, in the opinion of
             the investigator

          -  Unlikely to undergo lung transplantation during this trial

        Exclusion Criteria:

          -  Emphysema > fibrosis on screening high-resolution computed tomography (must be
             confirmed by central reader)

          -  History of major organ, hematopoietic stem cell or bone marrow transplant

          -  Clinically diagnosed acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) or
             other significant clinical worsening within 3 months of randomization

          -  New York Heart Association (NYHA) class III/IV Congestive Heart Failure (CHF),
             Ejection Fraction (EF) <25%

          -  Current smoker

          -  Prior use of any B-cell depleting therapy (e.g., rituximab, ofatumumab, or other
             anti-CD20 mAb, anti-CD40, anti-CD19,anti-CD22 mAb, anti-CD52 mAb, or anti-BAFF mAb)
Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: NBI-98854; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will
      enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          5. Be in good general health

          6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine,
             phencyclidine, cocaine, or opiates, and a negative alcohol screen

          7. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a known history of substance dependence, substance (drug) or alcohol abuse

          7. Have a significant risk of suicidal or violent behavior

          8. Are currently pregnant or breastfeeding

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study

         11. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening
MP1032 Treatment in Patients With Moderate to Severe COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: MP1032; Placebo
Intervention description: Hard gelatin capsules for oral administration.; Placebo capsules matched to MP1032 for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; MP1032

Summary:

      The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of
      care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to
      severe coronavirus disease 2019 (COVID-19).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant is admitted to hospital and has a positive severe acute respiratory
             syndrome coronavirus type 2 (SARS-CoV-2) test by standard reverse
             transcription-polymerase chain reaction (RT-PCR) assay or equivalent test

          -  Participant has the presence of any symptom(s) suggestive of moderate or severe
             systemic illness with COVID-19

        Key Exclusion Criteria:

          -  Participant, in opinion of the investigator, is not likely to survive >=48 hours
             beyond Day 1

          -  Participant has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical
             COVID-19 on Day 1

          -  Participant has a documented medical history of infection with hepatitis A, B, C, or
             with human immunodeficiency virus (with a detectable viral load and CD4 count <500
             cells per micro liter), or a documented active infection with tuberculosis.

          -  The Participant has clinically significant electrocardiogram (ECG) abnormalities at
             screening

        Other protocol defined inclusion/exclusion criteria may apply
Inulin and S. Salivarius Reduce Halitosis
Condition: Halitosis; Tongue Diseases
MeSH terms: Tongue Diseases; Halitosis
Intervention: Inulin+SS; S salivarius; Placebo
Intervention description: Experimental treatment: A gum of inulin 1g plus Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days; Active comparator: A gum of Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days; Placebo 1 gum each 12 hours for 10 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Halitosis associated with tongue coating results from the production of volatile sulfur
      compounds by bacterial action. The use of prebiotics and probiotics might be useful in
      treating such condition. The aim of this study was to evaluate the effect of the prebiotic
      inulin combined with the probiotic Streptococcus salivarius (SS) on halitosis by coating.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients with halitosis by tongue coating;

          -  participants must accept to participate in the study;

          -  tongue coating identified by oral examination;

          -  halitosis must be confirmed by the organoleptic test.

        Exclusion Criteria:

          -  halitosis for other conditions, including periodontal diseases and non-oral
             conditions;

          -  use of antibiotics in the last 30 days;

          -  active smoking (>10 cigarettes/day);

          -  alcohol consumption (>2 drinks/day);

          -  report of pregnancy or breastfeeding;

          -  report of systemic diseases, including diabetes, kidney failure and hepatic cirrhosis.
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
Condition: Infertility
MeSH terms: Infertility
Intervention: FE 999049; Gonal - F
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 265.0
Sex: Female
Minimum age: 18 Years
Maximum age: 37 Years
Healthy volunteers: No

Summary:

      This trial investigates the effects of several doses of FE 999049 in women undergoing
      IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women diagnosed with tubal infertility, unexplained infertility, infertility related
             to endometriosis stage I/II or with partners diagnosed with male factor infertility

          -  Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm
             injection) treatment

          -  Women aged 18-37 years

          -  Women with body mass index (BMI) of 18.5-32.0 kg/m2

        Exclusion Criteria:

          -  Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis
             stage III/IV

          -  Women with history of recurrent miscarriage

          -  Women with contraindications to controlled ovarian stimulation with gonadotropins

          -  Women with three or more controlled ovarian stimulation cycles
The Study of AZD8529 for Smoking Cessation in Female Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: AZD8529
Intervention description: comparison of different dosages of drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 214.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; smoking cessation; cigarette

Summary:

      To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a female smoker between the ages of 18 to 75 years.

          -  Want to quit smoking.

          -  Be currently (last 30 days) smoking 10 or more cigarettes per day and report less than
             3 months of consecutive smoking abstinence during the past year.

          -  Be able, in the opinion of the site investigator (SI), to understand and follow all
             protocol-specified instructions and understand and provide written informed consent.

          -  Be willing to provide personal information for entry into a clinical trial registry.

          -  Agree to use and continue using at least one acceptable contraceptive method (oral
             contraceptives, IUDs, contraceptive implants under the skin, contraceptive rings or
             patches or injections, diaphragms with spermicide, condoms with spermicide, or
             abstinence) or, if not of childbearing potential, must fulfill one of the following
             criteria at screening: post-menopausal defined as amenorrhea for at least 12 months
             and with follicle stimulating hormone (FSH) levels in the laboratory defined
             post-menopausal range and/or documentation of irreversible surgical sterilization by
             hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation
             verified by the Site Investigator.

          -  Agree not to use any other smoking behavioral intervention (self-help or formal
             treatment), acupuncture, or other smoking cessation pharmacotherapy during the study.

          -  Agree to refrain from using dietary/herbal supplements other than vitamins and
             minerals for 7 days prior to receiving study drug and throughout the 13-week treatment
             period.

          -  Agree to attend all required clinic appointments (including 3 eye exams) during the
             course of the 19-week study.

        Exclusion Criteria:

          -  Please contact the site for more information
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Intervention: Cetuximab,Paclitaxel, Carboplatin
Intervention description: IV treatment for 6 weeks
Intervention MeSH terms: Paclitaxel; Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: esophageal cancer; gastroesophageal cancer; gastric cancer

Summary:

      Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction
      and Gastric Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are required to have pathologically confirmed adenocarcinoma or squamous cell
             carcinoma of the esophagus, gastroesophageal junction, or stomach.

          -  Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric
             lymphadenopathy.

          -  There must be no evidence of distant organ metastases.

          -  No prior radiation for gastric or esophageal cancer.

          -  Patients must be > 18 years of age, and nonpregnant

          -  Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper
             limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN.

          -  ECOG performance status 0-2.

          -  Patients must not have significant infection or other coexistent medical condition
             that would preclude protocol therapy.

          -  Female patients, must either be not of child bearing potential or have a negative
             pregnancy test within 7 days of starting study treatment. Patients are considered not
             of child bearing potential if they are surgically sterile (they have undergone a
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
             postmenopausal. Pregnant or lactating females are not eligible.

          -  All patients must sign informed consent

        Exclusion Criteria:

        Any of the following criteria will make the patient ineligible to participate in this
        study:

          -  Acute hepatitis or AIDS.

          -  Active or uncontrolled infection.

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
             congestive heart failure, and cardiomyopathy with decreased ejection fraction.

          -  Prior therapy which specifically and directly targets the EGFR pathway.

          -  Prior severe infusion reaction to a monoclonal antibody.

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agent(s).
Mechanisms of Refractory Hypertension (Reserpine)
Condition: Refractory Hypertension
MeSH terms: Hypertension
Intervention: Reserpine
Intervention description: Open label reserpine 0.1 mg pill orally
Intervention MeSH terms: Reserpine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, dose titration study
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; sympathetic tone; resperpine

Summary:

      The study is deigned to determine if refractory hypertension is attributable to heightened
      sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic
      agent, in patients failing other classes of antihypertensive agents.
    

Eligibility criteria:

        Inclusion Criteria:

        - adult with refractory hypertension defined as uncontrolled office blood pressure with use
        of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

        Exclusion Criteria:

          -  congestive heart failure (EF 40%)

          -  chronic kidney disease (GFR <40 ml/min/1.73 mm)

          -  stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months

          -  ongoing depression

          -  active peptic ulcer disease

          -  bradycardia <50 beats per minute

          -  2nd or 3rd degree heart block

          -  known intolerance of reserpine

          -  use of digoxin or tricycle antidepressants
Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: chemotherapy; porfimer sodium; immunohistochemistry staining method; laboratory biomarker analysis; spectroscopy; therapeutic conventional surgery
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
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
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; malignant pleural effusion

Summary:

      RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by
      tumor cells. The drug becomes active when it is exposed to light. When the drug is active,
      tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells
      that remain after surgery.

      PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy
      given during surgery works in treating patients with resectable non-small cell lung cancer
      that has spread to the pleura.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell lung cancer (NSCLC)

               -  Must have clinical and/or pathological evidence of pleural spread

               -  Primary tumor must be resectable as assessed by the attending thoracic surgeon

          -  Patients who have received or are currently receiving two-to-four courses of standard
             front-line chemotherapy are eligible

        PATIENT CHARACTERISTICS:

          -  Must be medically fit to tolerate surgery

          -  No CTCAE v3.0 grade III-IV elevations in liver transaminases

          -  Bilirubin ≤ 1.5 mg/dL

          -  No known HIV infection

          -  Not pregnant or nursing

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior treatment for NSCLC except pleurodesis or standard front-line chemotherapy

          -  No prior pemetrexed disodium chemotherapy

          -  No prior mantle radiotherapy

          -  No concurrent chemotherapy or radiotherapy during the active study treatment period

               -  Post-operative radiotherapy will be administered as clinically indicated
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Condition: NASH - Nonalcoholic Steatohepatitis; Fibrosis, Liver; NAFLD - Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Intervention: CRV431 75mg; Placebo (1 softgel); CRV431 225mg; Placebo (3 softgels)
Intervention description: 1 x 75mg softgel capsule; 1 x placebo softgel capsule; 3 x 75mg softgel capsule; 3 x placebo softgel capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, single-blind
Masking: Single (Participant)
Masking description: placebo-controlled
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Anti-fibrotic

Summary:

      This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431
      in presumed NASH F2/F3 subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between 18 and 75 years of age (inclusive).

          -  Capable of giving written informed consent and able to effectively communicate with
             the investigator and study personnel.

          -  Presumed F2/F3 NASH to include: AST >20 IU/L, Pro-C3 >15.5 ng/mL, enhanced liver
             fibrosis (ELF) score >9.8, and FibroScan >8.5 kPa values.

        Key Exclusion Criteria:

          -  Pregnant or breastfeeding or planning to become pregnant during the study period.

          -  Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.

          -  Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies
             (HCVAb) or human immunodeficiency virus antibodies (HIVAb).

          -  Well documented causes of chronic liver disease according to standard diagnostic
             procedures to include any history or presence of decompensated cirrhosis.

          -  Subjects with a platelet count <150,000/mL.

          -  Subjects with hemoglobin A1c(HbA1c) >9.5%.

          -  Weight loss of more than 5% within 3 months prior to randomization.

          -  Subjects with a blood pressure to include a systolic pressure >150 or a diastolic
             pressure >90.

          -  At Screening, an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 mL
             (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method)
             and/or a Kidney Disease Improving Global Outcomes (KDIGO) category of >G2.

          -  Subjects with a history of organ transplantation. Corneal transplantation will be
             allowed.