bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Intervention: OnabotulinumtoxinA; Normal Saline
Intervention description: OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.; Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature
      ejaculation (PE) in male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of premature ejaculation

          -  Stable monogamous sexual relationship with female partner for at least 6 months, and
             intends to continue with the same partner for the duration of the study

          -  Participant has ability to follow study instructions and complete study assessment
             tools

        Exclusion Criteria:

          -  Premature ejaculation caused by medical or surgical issues, or is related to stress or
             other issues (eg, relationship problems)

          -  Pain with ejaculation

          -  Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or
             penile injections during the study

          -  Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or
             circumcision)

          -  Previous or current usage of botulinum toxin therapy of any serotype for any
             urological condition

          -  Use of botulinum toxin therapy of any serotype for any nonurological condition (eg,
             cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage
             during the study

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: modafinil 50mg; Placebo oral capsule
Intervention description: 1 capsule oral daily; 1 capsule oral daily
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled delayed start
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: freezing of gait

Summary:

      Freezing of gait is a late stage complication of Parkinson's disease in which patients note
      that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and
      the secondary complications that can result from falls such as fractures and
      hospitalizations. While levodopa can help freezing of gait in some patients, it does not help
      in all, and the dose needed to treat freezing may be limited by side effects of the
      medications. Currently there are no treatments targeted towards freezing of gait and the goal
      of this research is to see if Modafinil could be one such drug to help freezing of gait in
      Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic PD on UK brain bank criteria.

          -  Presence of FOG based on objective assessment by the movement disorders neurologist.

          -  FOG-Q score > 8.

          -  Stable PD therapy (including medications and stimulation) for a period of 3 months
             prior to trial enrollment.

          -  Age ≥ 50 years.

        Exclusion Criteria:

          -  Patients on antidopaminergic medications for a period of less than 1 year from date of
             enrollment.

          -  Patients who may require adjustment of their PD medications over the 6 month period of
             the trial.

          -  History of allergic reactions to Modafinil or armodafinil.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, mitral valve prolapse, left ventricular hypertrophy, chronic obstructive
             pulmonary disease or psychiatric illness/social situations that would limit compliance
             with study requirements.

          -  Individuals who are pregnant or breastfeeding

          -  Non-english speaking individuals who are unable to complete the questionnaires and
             other assessments in English and/or follow instructions in English.
A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Placebo; Brivaracetam
Intervention description: Daily oral dose of two equal intakes.; Daily oral dose of two equal intakes.
Intervention MeSH terms: Brivaracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-herpetic Neuralgia (PHN); Brivaracetam

Summary:

      Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic
      neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor
      down-titration.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Male/female subject aged 18 years or older.

          -  Pain present for at least 6 months after healing of the acute herpes zoster skin rash.

          -  Pain intensity score assessed on an 11-point numerical pain rating scale with a score
             of at least 4 at the screening visit and with an average weekly score of at least 4 on
             an 11-point numerical pain rating scale during baseline period.

        Exclusion Criteria:

          -  Subject getting any kind of psychological support to help cope with pain such as
             biofeedback or behavioral cognitive therapy.

          -  Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy
             for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation
             (TENS.

          -  Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or
             permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30
             days and/or are not stabilized prior to screening and/or are not expected to be kept
             stable during the study.

          -  Intake of more than two pain treatments at trial entry (screening visit) including
             Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or
             permitted opioid analgesics.

          -  Subject being treated with Carbamazepine for any indication.

          -  Known coexistent source of painful peripheral neuropathy or other systemic disease
             associated with a secondary painful neuropathy.

          -  Subject being treated in the four weeks prior to screening visit with 'strong' opioid
             analgesics.

        Exclusion Criteria:
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Condition: Internal Hemorrhoids
MeSH terms: Hemorrhoids
Intervention: Hydrocortisone Acetate Suppository, 25 mg (Nivagen); Placebo (Vehicle) Suppository (Nivagen)
Intervention description: One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).; One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the
      safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo
      suppositories in the treatment of symptomatic internal hemorrhoids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  internal hemorrhoids.

          -  hemorrhoidal bleeding.

          -  male or female aged 18 years and older.

          -  willing to forego the use of non-prescription (OTC) and prescription medication or
             procedures for the treatment of hemorrhoidal disease and/or pain for the duration of
             the study.

          -  agree to not change their diet during the study.

        Exclusion Criteria:

          -  external hemorrhoids.

          -  using other OTC or prescription medications for treatment of hemorrhoidal disease
             and/or pain.

          -  pregnant or nursing female.

          -  received systemic glucocorticoids within the last 2 months prior to starting study.

          -  participated in an investigational drug study within 30 days prior to baseline.
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: SAGE-217; 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: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      This is a two-part (open-label followed by double-blind) study evaluating the safety,
      tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with
      moderate to severe Major Depressive Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a diagnosis of Major Depressive Disorder that has been present for at
             least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I
             Disorders (SCID-I)

        Exclusion Criteria:

          -  Participant has a history of suicide attempt

          -  Participant has a history of treatment-resistant depression, defined as persistent
             depressive symptoms despite treatment with adequate doses of antidepressants from two
             different classes for an adequate amount of time

          -  Participant has active psychosis

          -  Participant has a medical history of seizures

          -  Participant has a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder
Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Oxytocin; Placebo
Intervention description: spinal injection of oxytocin; spinal injection of placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of intrathecal oxytocin on speed of
      reduction in pain for the first 60 days after hip surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for unilateral, primary total hip replacement

          -  American Society of Anesthesiologists physical status 1-3

        Exclusion Criteria:

          -  Pregnancy

          -  Currently Workman's Comp litigation related to hip replacement

          -  Taking greater than 100 milligrams of morphine (or equivalent)

          -  Suffering from a psychotic disorder or a recent psychiatric hospitalization
PF-06372865 in Subjects With Photosensitive Epilepsy
Condition: Reflex Epilepsy, Photosensitive
MeSH terms: Epilepsy; Epilepsy, Reflex
Intervention: PF-06372865; Placebo; Lorazepam
Intervention description: Single dose; Placebo for PF-06372865 and placebo for lorazepam; 2 mg single oral dose
Intervention MeSH terms: Lorazepam; PF-06372865
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      PF-06372865 in subjects with photosensitive epilepsy
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis and history of photoparoxysmal response on electroencephalogram (EEG) with
             or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2
             concomitant antiepileptic drugs.

          -  Subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks
             prior to Screening Visit.

          -  A minimum average standardized photosensitive range (SPR) across all screening
             timepoints of 4 in the most sensitive eye condition and a non-zero average in at least
             one other eye condition.

        Exclusion Criteria:

          -  Subjects with a history of status epilepticus.

          -  Subjects who have experienced a generalized tonic-clonic convulsion in the past 6
             months, at the time of the initial screening visit.
A Study To Monitor Long-Term Treatment With PF-00547659
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: PF-00547659
Intervention description: 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Active Crohn's disease; Anti-TNF Refractory; Immunosuppressant Refractory

Summary:

      This study provides open-label drug to eligible patients who have completed a prior study of
      PF-00547659. The primary endpoint for this study is long-term safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18 and 76 years of age.

          -  Subjects previously enrolled in study A7281006 who have completed the blinded 84 day
             (12 week) induction period or in study A7281008 who have completed Week 12 and have
             demonstrated a clinical response as defined by that protocol.

        Exclusion Criteria:

          -  Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have
             experienced serious event(s) related to the investigational product, an unstable
             medical condition, or any other reason, in the opinion of the investigator, would
             hinder entry or participation in this study.

          -  Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Inarigivir Soproxil; TAF
Intervention description: Administered orally once daily one hour before or one hour after a meal; Administered orally once daily with food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety and tolerability of the 12
      week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or
      commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB),
      to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF
      alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of
      12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB
      participants (Group 4).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Groups 1-3 and 5:

               -  Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment

          -  Group 4:

               -  HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.

               -  Have been on a commercially available HBV NUC treatment(s)

        Key Exclusion Criteria:

          -  Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or
             hepatitis D virus (HDV).

          -  Extensive bridging fibrosis or cirrhosis

          -  Evidence of hepatocellular carcinoma on imaging

          -  Any history of, or current evidence of, clinical hepatic decompensation (e.g.,
             ascites, encephalopathy or variceal hemorrhage).

          -  Chronic liver disease of a non-HBV etiology

          -  Current alcohol or substance abuse

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Condition: Contraception
MeSH terms: Uterine Hemorrhage
Intervention: Nomegestrol acetate (NOMAC); Etonogestrel (ENG); Ethinyl estradiol (EE); Estradiol (E2)
Intervention description: Daily release of 500, 700, or 900 μg.; Daily release of 75, 100, 120 or 125 μg; Daily release of 15 μg; Daily release of 300 μg
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 666.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial was to identify at least one next generation ring (NGR)
      that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of
      participants ovulation was observed in less than 15% of the participants at any time during
      the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as
      judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The
      primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and
      cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the
      incidence of BTB-S.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) ≥18 and ≤35

          -  Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3
             days permitted within this range

          -  Good physical and mental health

        Exclusion Criteria:

          -  Diabetes mellitus with vascular involvement

          -  Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis

          -  Severe dyslipoproteinemia

          -  Severe hypertension

          -  Presence or history of pancreatitis associated with severe hypertriglyceridaemia

          -  Presence or history of severe hepatic disease

          -  Undiagnosed vaginal bleeding

          -  Known or suspected pregnancy

          -  Participation in another investigational drug study within 30 days prior to screening
             visit

          -  History of malignancy ≤5 years, except for adequately treated basal cell or squamous
             cell skin cancer, or in situ cervical cancer

          -  Documented abnormal cervical smear result in 6 months prior to screening visit

          -  Sterilization using a fallopian tube occlusion device (e.g., Essure method)

          -  Sex hormone therapy within 2 months prior to screening visit for purpose other than
             contraception, or injectable hormonal contraception within 6 months prior to screening
Study of SCB01A in Patient With Head and Neck Cancer
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: SCB01A
Intervention description: This study is a single arm, open-label, Phase II trial
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Head and neck squamous cell carcinoma

Summary:

      To evaluate the safety and efficacy of SCB01A in head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed squamous cell carcinoma of head and neck

          2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic
             carcinoma, after previous treatment with platinum agent.

          3. At least one measurable tumor lesion according to RECIST

          4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status

          5. All eligible patients of childbearing potential have to use effective contraception

          6. Signed informed consent before enrolment

        Exclusion Criteria:

          1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents

          2. Severe pulmonary obstructive or restrictive disease

          3. Uncontrolled inflammatory disease

          4. Clinically significant cardiac disease

          5. Results of laboratory tests

          6. Pregnancy or nursing status

          7. Known hypersensitivity to any component of SCB01A

          8. History of exposure to SCB01A or its analogues

          9. History of malignancy other than head and neck cancer

         10. History of active or significant neurological disorder or psychiatric disorder

         11. Any other reason the investigator deems the patient to be unsuitable for the study