bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Zicronapine open-label lead-in 10 mg daily; Zicronapine 10 mg daily; Zicronapine 20 mg once weekly; Zicronapine 30 mg once weekly; Zicronapine 45 mg once weekly
Intervention description: Encapsulated tablet ,10 mg, once daily, open-label; Encapsulated tablet, 10 mg, once daily, double-blind; Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind; Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind; Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Antipsychotic; Zicronapine; Lu 31-310

Summary:

      The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics
      of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of
             Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)

          -  A score of <=4 (moderately ill) on Clinical Global Impression - Severity of Illness
             (CGI-S) scale

          -  A total score >=60 on Positive and Negative Syndrome Scale (PANSS)

          -  A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)

        Exclusion Criteria:

          -  Acute exacerbation requiring hospitalization within the last 3 months OR requiring
             change of antipsychotic medication within the last 4 weeks

          -  Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR
             within the last 3 months

          -  Significant risk of harming himself/herself or others

          -  Positive serology for hepatitis A, B, C, or HIV

          -  Present condition that might compromise liver function

          -  Medical or neurological disorder or treatment that could interfere with study
             treatment or compliance

          -  Previous exposure to zicronapine

        Other inclusion and exclusion criteria may apply.
Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium
Condition: Delirium; Agitation
MeSH terms: Delirium; Psychomotor Agitation
Intervention: Dexmedetomidine; Standard of Care
Intervention description: dexmedetomidine infusion titrated to effect; Standard of care per treating physician preference
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Delirium; Agitation; Sedation; Dexmedetomidine; Surgical

Summary:

      The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect -
      a sedative) is effective for the treatment of acute delirium
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults admitted to our surgical ICU who do not have any exclusion criteria

          -  Eligibility for treatment- Development of delirium as defined

        Exclusion Criteria:

          -  Acute MI (myocardial infarction),

          -  Trauma <24 hours,

          -  Head injury,

          -  Multiple organ failure,

          -  EF (ejection fraction) < 30%,

          -  History of hypersensitivity to alpha2 agonist,

          -  History of seizures, MAP (mean arterial pressure) <60 mm of Hg,

          -  Dysrhythmias a/with bradycardia (HR (heart rate) <50),

          -  Need for vasopressors,

          -  Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous
             Hemofiltration) or liver disease.

          -  Women of child bearing age who do not have a documented negative pregnancy test and/or
             who do not actively use contraception. (Documented negative pregnancy test will be a
             urine pregnancy test obtained on this admission)
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Gemcitabine
Intervention description: 150 mg po daily; As prescribed
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared
      with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced
      non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po
      daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine
      monotherapy. The anticipated time on study treatment is until disease progression, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable
             disease ;

          -  ECOG PS 2;

          -  adequate organ function.

        Exclusion Criteria:

          -  prior chemotherapy or systemic anti-tumor therapy;

          -  hypersensitivity to erlotinib;

          -  any condition contraindicating the use of the study medication and/or impairing the
             interpretation of results and/or leading to treatment-related complications.
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MEDI9929; Placebo
Intervention description: Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.; Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  AD meeting Hanifin and Rajka criteria

          -  Age 18-75 years inclusive at screening

          -  Atopic dermatitis that affects greater than/equal to 10% body surface area

          -  Moderate to severe AD

          -  Effective birth control in line with protocol details

        Exclusion Criteria:

          -  Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis

          -  Hepatitis B, C or HIV

          -  Pregnant or breastfeeding

          -  History of anaphylaxis following any biologic therapy

          -  History of clinically significant infections within 4 weeks prior to Visit 3

          -  Diagnosis of helminth parasitic infection within 6 months to screening

          -  History of Cancer except basal cell

          -  Receipt of any marketed or investigational biologic agent within 4 months to visit 3

          -  Any clinically relevant abnormal finding

          -  Major surgery within 8 weeks prior to Visit 1
A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: PF-03654746; Placebo capsules; PF-03654746
Intervention description: Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21; Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.; Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether PF-03654746 is effective in the treatment
      of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized,
      double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment
      with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg),
      and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants
      will be required to washout of prior ADHD medication before entering the study. Participants
      will be required to come to the site for 10 visits over approximately a 10-week period.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical
        assessment and interview.

        Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity
        Disorder, based on clinical assessment and interview.

        Female subjects must be of non-childbearing potential.

        Exclusion Criteria:

        Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
        gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic
        disease.

        Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder
        (with the exception of social or specific phobia), or substance abuse or dependence in the
        past 6 months.

        Current episode of Major Depression or episode within the last 6 months.
Tiotropium Respimat Pharmacokinetic Study in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium medium; Tiotropium low; Tiotropium high; Tiotropium 18mcg; Tiotropium placebo
Intervention description: Tiotropium inhalation solution medium dose; Tiotropium inhalation solution low dose; Tiotropium inhalation solution high dose; Tiotropium inhalation powder 18mcg; Placebo inhalation solution
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 154.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is compare the effect of different doses of tiotropium delivered by
      the HandiHaler and Respimat device on lung function. Additionally, the study will investigate
      the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile
      shows what happens to the medication in the body over a period of hours and provides
      information on potential effects of the medication.
    

Eligibility criteria:

        Inclusion criteria:

          1. All patient must sign an informed consent consistent with IInternational Conference on
             Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior
             to any study-related procedures, including medication washout and restrictions.

          2. Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease
             (COPD)

          3. Current or ex-smokers (smoking history of at least 10 pack years)

          4. Able to perform lung function tests

          5. Able to use study inhalers

        Exclusion criteria:

          1. Significant diseases other than COPD

          2. Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia,
             hospitalisation for cardiac failure.

          3. Malignancy requiring resection, radiation therapy or chemotherapy within the last 5
             years

          4. History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or
             clinically evident bronchiectasis 5 Active tuberculosis

        6. History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a
        pulmonary rehabilitation program or current participation which will not be continued 9.
        Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational
        drugs, restrictions on the use of some respiratory medications during the study period.

        11. Current participation in another clinical trial 12. Pregnant or nursing women 13. Women
        of childbearing potential not using a highly effective method of contraception (e.g:
        implants, injectable, oral contraceptives)
ToRsemide for pOstpartum HYpertension
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia; Hypertension
Intervention: Torsemide; Placebo
Intervention MeSH terms: Torsemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preeclampsia, puerperium

Summary:

      Currently there is no intervention to prevent persistent postpartum hypertension in
      preeclamptic women. Physiologically, the use of a pharmacokinetically predictable
      loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated
      secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the
      incidence of persistent postpartum hypertension in preeclamptic women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women at ≥ 18 years of age

          -  Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:

          -  Preeclampsia

          -  Preeclampsia with severe features

          -  Preeclampsia superimposed to chronic hypertension

        Exclusion Criteria:

          -  Chronic hypertension without superimposed preeclampsia

          -  Gestational hypertension

          -  Urine output < 30 cc/h at time of randomization

          -  Heart failure or pulmonary edema

          -  Hypersensitivity to Torsemide or sulfonylureas

          -  Hypokalemia (serum potassium < 3 mEq/L)

          -  Preexisting diuretic use within 24 hours prior to randomization
Prevention of Acute Kidney Injury in Cardiac Surgery Patients
Condition: Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Intervention: 0.9% Sodium Chloride (Placebo); Sodium Bicarbonate
Intervention description: 0.9% Sodium Chloride (placebo) will infuse at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.; Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac surgery; Sodium bicarbonate; Acute kidney injury; Saline

Summary:

      Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in
      serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients
      following cardiac surgery, and at least 50% of patients with underlying renal insufficiency.
      Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of
      developing post-operative AKI. The purpose of the current study is to determine if
      intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is
      effective at preventing post-operative AKI in patients with baseline kidney insufficiency and
      who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that
      an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in
      reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative
      glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass

          -  baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in
             Renal Disease equation

        Exclusion Criteria:

          -  cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose
             inotropes or the need for intra-aortic balloon pump)

          -  end-stage kidney disease requiring dialysis

          -  received an infusion of sodium bicarbonate on the same day as cardiac surgery
Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC) in Patients With Stable Type 2 Diabetes and Hypertension
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: IW-1973; Placebo
Intervention description: Oral Tablet; Oral Tablet
Intervention MeSH terms: Praliciguat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-Blind
Enrollment: 26.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD)
      effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2
      weeks to patients with stable type 2 diabetes mellitus and hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is ambulatory male or female

          -  Patient's body mass index score is > 20 and < 40 kg/m^2 at the Screening Visit

          -  Women of childbearing potential must have a negative pregnancy test at the time of
             screening and check-in and must agree to use protocol-specified contraception
             throughout the duration of the study

          -  Patient's health is stable with no clinically significant findings on physical
             examination

          -  Patient has type 2 (ie, adult onset) diabetes mellitus diagnosed by a physician or
             nurse practitioner > 6 months before the Screening Visit, is on a stable glycemic
             control medication, and protocol specified hemoglobin (Hb)A1c values at the Screening
             Visit

          -  Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months
             before the Screening Visit, and blood pressure (BP) within the protocol's acceptable
             range

          -  Patients must be on a stable regimen for hypertension control that includes an
             angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB),
             stable for 28 days

          -  Other inclusion criteria per protocol

        Exclusion Criteria:

          -  Patient has a clinically significant active or unstable medical condition that, in the
             opinion of the Investigator, would preclude trial participation

          -  Patient is on medication(s) that, when co-administered with a sGC stimulator, could
             increase the risk of hypotension

          -  Patient has evidence of severe or active end-organ damage

          -  Patient is an active smoker or has used any nicotine-containing products (cigarettes,
             e-cigarettes, vape pens, cigars, chewing tobacco, gum, patches) during the 6 months
             before Check-in. Use of nicotine is excluded during the study until after the End of
             Trial Visit.

          -  Other exclusion criteria per protocol
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
Condition: Hepatitis C; Liver Disease
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases
Intervention: Alisporivir; Ribavirin
Intervention description: ALV 100 and 200 mg soft gel capsules administered orally; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C genotype 2; Chronic hepatitis C genotype 3; Cyclophilin inhibitor; Interferon intolerant

Summary:

      The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus
      (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving
      different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks
      treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed
      interferon therapy or were intolerant or unable to take interferon.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed

          2. Participants with HCV genotype 2 or 3 infection who have previously failed interferon
             therapy or are intolerant or unable to take interferon

          3. Males or females aged ≥18 years

          4. Diagnosed Chronic hepatitis C virus infection

        Exclusion criteria:

          1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of that medication before enrollment

          2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes

          3. Hepatitis B surface antigen (HBsAg) positive

          4. Human immunodeficiency virus (HIV) positive

        Other protocol-defined inclusion/exclusion criteria apply.