bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Intervention: LAS100977 0.313 μg; LAS100977 0.625 μg; LAS100977 1.25 μg; LAS100977 2.5 μg; Salbutamol 400 μg; Salbutamol placebo; LAS100977 placebo
Intervention description: Dry powder inhalation, once-daily, single-dose; Dry powder inhalation, once-daily, single-dose; Dry powder inhalation, once-daily, single-dose; Dry powder inhalation, once-daily, single-dose; Pressurized inhalation suspension, once-daily, single-dose; Pressurized inhalation, once-daily; Dry powder inhalation, once-daily
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled
      LAS100977 QD in patients with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male and female patients aged 18-70 years (both included).

          2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for
             at least 6 months prior to screening.

          3. Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.

          4. FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline
             value after inhalation of 400µg (four inhalations) of salbutamol.

          5. Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1
             measured at screening prior to salbutamol inhalation.

          6. Patients on a stable dose and regimen

        Exclusion Criteria:

          1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history
             of more than 10 pack-years.

          2. Patients diagnosed with COPD.

          3. Recent Respiratory tract infections within 6 weeks before Screening Visit.

          4. Intubation (ever) or hospitalization for longer than 24 hours for the management of an
             asthma exacerbation within the preceding 6 weeks of the screening visit.

          5. Clinically significant respiratory conditions.

          6. Clinically significant cardiovascular conditions.

          7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to
             perform acceptable spirometry.

          8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination
             results at the screening evaluation that in the investigator's opinion, preclude study
             participation.

          9. Patients who intend to use any concomitant medication not permitted by this protocol
             or who have not undergone the required washout period for a particular prohibited
             medication.
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Kidney Failure, Chronic
Intervention: SOF/VEL
Intervention description: 400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate safety, efficacy, and tolerability of
      treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end
      stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or
             older who are on dialysis for ESRD, including adults with HIV co-infection if they are
             suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks
             prior to screening.

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Pamrevlumab; Placebo
Intervention description: Sterile liquid for injection; Sterile liquid for injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Proof-of-concept
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Severe Acute Respiratory Syndrome coronavirus; SARS-COV-2 infection

Summary:

      This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab
      when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed SARS-CoV-2 infection

          2. Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by
             at least one (or more) of the following criteria:

               -  Interstitial pneumonia on chest x-ray or high-resolution computed tomography
                  (findings of consolidation or ground glass opacities), OR

               -  Peripheral capillary oxygen saturation < 94% on room air, OR

               -  Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to
                  maintain SpO2

          3. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)
             use at time of randomization

          4. Not participating in another clinical trial for the treatment of COVID-19 disease
             through Day 28

        Exclusion Criteria:

          1. Female participants who are pregnant or nursing

          2. Participation in a clinical trial with another investigational drug for COVID-19
             disease

          3. Anticipated discharge from the hospital or transfer to another hospital or long-term
             care facility which is not a study site within 72 hours of randomization

          4. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
             monoclonal antibodies
Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Lidoderm (Lidocaine 5% Patch); Placebo Patch
Intervention description: Topical Patch; Topical Patch
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 169.0
Sex: All
Minimum age: 37 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Lidoderm; Lidocaine; Topical patch; Adjunct therapy

Summary:

      Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from
      their current analgesic regimen will participate in a pilot clinical trial to evaluate the
      effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee
      pain from OA.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee

          -  Body mass index (BMI) ≤40 kg/m2

          -  Symptomatic OA of the index knee diagnosed with a functional capacity of II or III
             according to ACR criteria classification Note: Patients with symptomatic contralateral
             knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed
             to participate.

          -  Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening
             and for the duration of the study

          -  Able and willing to complete all paper and e-diary assessments required by protocol

        Key Exclusion criteria:

          -  Pain in any joint other than the index joint that could interfere with the patient's
             assessment of pain in the index joint

          -  Compromised integrity of the intact, superficial skin layer

          -  A grade 1 or 4 Kellgren and Lawrence score on radiographic examination

          -  Recent injury to either knee causing pain and interference with daily activities (eg.
             walking)

          -  Recent surgery/procedure to either knee causing pain that could interfere with study
             assessments of pain, function, and QoL

          -  Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type,
             or any component of the product
N-acetylcysteine for Tobacco Use Disorder
Condition: Nicotine Dependence; Smoking
MeSH terms: Tobacco Use Disorder
Intervention: N-acetylcysteine (NAC); Placebo
Intervention description: NAC or matched placebo will be given to study participants for 8 weeks.; Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine; tobacco; smoking; cessation; N-acetylcysteine; NAC; pharmacotherapy; relapse; tobacco use disorder

Summary:

      The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to
      assist in initial cessation and/or relapse prevention in adult cigarette smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65

          2. Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in
             the past month or must meet the criteria for nicotine dependence

          3. Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale
             assessing readiness and interest in quitting (1=not at all ready/interested,
             10=extremely ready/interested)

          4. Willing to engage in a 3-day quit attempt as part of study procedures

          5. Willing to abstain from cannabis use during study procedures (since inhaled cannabis
             will affect breath carbon monoxide readings).

          6. If female, agreement to use birth control (any form) to avoid pregnancy during study
             procedures

        Exclusion Criteria:

          1. Any serious or unstable medical/psychiatric disorder (including severe substance use
             disorders, other than tobacco use disorder) in the past month that may interfere with
             study performance based on PI judgment

          2. Current pregnancy or breastfeeding

          3. Current use of medications with smoking cessation efficacy

          4. Known hypersensitivity to NAC

          5. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous
             if taken with NAC) within 14 days of study participation
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Cedirogant; Placebo
Intervention description: Capsule, Oral; Capsule, Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque Psoriasis; Cedirogant; ABBV-157

Summary:

      Psoriasis is a chronic disease characterized by marked inflammation and thickening of the
      skin that results in thick, scaly skin plaques. This study assessed how safe and effective
      cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe
      psoriasis. Efficacy and safety-related measurements assessed disease activity in participants
      with plaque psoriasis.

      Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic
      plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each
      group received a different treatment. There was a 1 in 4 chance that participants were
      assigned to placebo.

      Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.

      There may have been a higher burden for participants in this study compared to usual standard
      of care. Participants attended regular visits per routine clinical practice. The effect of
      the treatment was checked by medical assessments, checking for side effects, and
      questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

        - Participants with stable moderate to severe plaque psoriasis of at least 6 months
        duration and who are candidates for systemic therapy or phototherapy.

        Exclusion Criteria:

          -  Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab,
             ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab),
             or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.

          -  Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis
             or any other skin disease which may interfere with assessment of chronic plaque
             psoriasis.
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn
Intervention: Misoprostol
Intervention description: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.
Intervention MeSH terms: Methotrexate; Misoprostol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: unripe cervix

Summary:

      The goal of this study is to determine whether inducing labor with just one dose of
      misoprostol, followed by treatment with oxytocin, will still be effective enough to increase
      the chances of having a successful vaginal delivery as compared to using more than one dose
      of misoprostol, followed by treatment with oxytocin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any pregnant woman undergoing induction of labor

          -  Live singleton pregnancy ≥ 37 week gestation

          -  Bishop score < 6

          -  Category I fetal heart rate

        Exclusion Criteria:

          -  Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex
             presentation, umbilical cord prolapse, and active genital herpes infection.)

          -  Pregnancies complicated by major fetal anomalies

          -  Any contraindication to the use of misoprostol, including

          -  History of previous c-section or major uterine surgery

          -  Prior allergic reaction

          -  Category II or III fetal heart rate

          -  Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30
             minutes

          -  Estimated fetal weight < 10 percentile

          -  Premature rupture of membranes

          -  Age < 18 years old

          -  Women who do not have the capacity to consent
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Condition: Smoking Lapse Behavior
Intervention: varenicline; bupropion; Placebo
Intervention description: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).; 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).; Placebo
Intervention MeSH terms: Bupropion; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: smoking lapse behavior; smoking cessation; varenicline; bupropion; medication effect on smoking lapse behavior

Summary:

      The purpose of this study is to examine how smoking cessation medications (varenicline,
      bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in
      non-treatment seeking daily smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-55

          -  able to read and write in English

          -  Smokers

        Exclusion Criteria:

          -  any significant current medical or psychiatric conditions that would contraindicate
             smoking

          -  current Diagnostic and Statistical Manual IV abuse or dependence of other substances,
             other than nicotine dependence or alcohol abuse

          -  positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  women who are pregnant or nursing

          -  suicidal, homicidal, or evidence of current severe mental illness

          -  participants prescribed any psychotropic drug in the 30 days prior to study enrollment

          -  blood donation within the past 6 weeks

          -  individuals seeking treatment for smoking cessation or have attempted to quit smoking
             within the past 3 months

          -  specific exclusions for bupropion administration not already specified, including:
             have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia;
             previous hypersensitivity to bupropion; history of alcohol or drug dependence in the
             past year; history of seizure disorder of any etiology

          -  known allergy to varenicline or taking H2blockers

          -  participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current study
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Seletracetam (UCB44212)
Intervention description: Pharmaceutical form: oral capsules
Concentration: 2, 10 and 50 mg
Route of administration: oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial Onset Seizures; Seletracetam; Levetiracetam

Summary:

      This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects
      with focal epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)

          -  Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures
             whether or not secondarily generalized

          -  Subjects who have been treated for epilepsy for >= 6 months and are currently
             uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of
             levetiracetam (LEV)

          -  Female subjects without childbearing potential or those who are using an acceptable
             contraceptive method

        Exclusion Criteria:

          -  Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History
             of non-epileptic seizures

          -  Subjects on vigabatrin

          -  Subjects on felbamate, unless treatment has been continuous for >2 years

          -  Ongoing psychiatric disease other than mild controlled disorders

          -  Subjects with clinically significant organ dysfunction

          -  Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

          -  Pregnant or lactating women

          -  Use of benzodiazepines (for any indication) taken at a higher frequency than an
             average of once a week, unless counted as one of the concomitant Antiepileptic Drug
             (AEDs).
Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes
Condition: Diagnosis, Dual (Psychiatry)
MeSH terms: Disease
Intervention: Telephone Monitoring (TM) with Motivational Interviewing; Usual care
Intervention description: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.; All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research program will improve the care and treatment outcomes of dually diagnosed
      veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental
      health services. It will increase the use of substance abuse outpatient care and 12-step
      groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dually diagnosed veteran in VA inpatient psychiatry treatment

        Exclusion Criteria:

          -  Current diagnosis of schizophrenia or schizoaffective disorder

          -  too psychiatrically unstable or cognitively impaired to understand informed consent
             and other study procedures

          -  does not have ongoing telephone access