bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
Condition: Alcoholism; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Alcoholism; Alcohol Abstinence
Intervention: Quetiapine XR; Placebo.
Intervention description: Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.; Inactive or inert pill which will be used as a comparator.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcoholism; Insomnia; Quetiapine; Seroquel

Summary:

      The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in
      improving the sleep in recovering alcohol dependent subjects.
    

Eligibility criteria:

        Inclusion Criteria: subjects between the ages of 18-65 years, with a DSM-IV diagnosis of
        current alcohol dependence (past year), can speak, understand, and print in English, and is
        capable of giving written informed consent

        Exclusion Criteria: Positive urine drug screen for opioids, cocaine, or amphetamine
        (excluding THC), dependence on other drugs excluding alcohol/nicotine/cannabis over the
        past year, unstable psychiatric, medical disorders, cataracts [posterior capsular/ nuclear
        (grade NS3 or more), currently on any maintenance psychotropic medications affecting sleep,
        currently pregnant, nursing, or not using a reliable method of contraception; history of
        hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment,
        severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Condition: Aspergillosis; Invasive Fungal Infection
MeSH terms: Mycoses; Aspergillosis; Invasive Fungal Infections
Intervention: Isavuconazole; Voriconazole
Intervention description: Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).; Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Intervention MeSH terms: Voriconazole; Isavuconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 527.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Invasive fungal disease; BAL8557; Isavuconazole; ASP9766; Filamentous fungi; Phase III; Aspergillus species

Summary:

      The purpose of this study is to compare the efficacy and safety of isavuconazole versus
      voriconazole in the treatment of patients with invasive aspergillosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have proven, probable or possible invasive fungal disease caused by
             Aspergillus species or other filamentous fungi

          -  Female patients must be non-lactating and at no risk for pregnancy

        Exclusion Criteria:

          -  Patients with invasive fungal infections other than Aspergillus species or other
             filamentous fungi

          -  Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction

          -  Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary
             aspergillosis

          -  Patients who have received more than 4 days of systemic antifungal therapy other than
             fluconazole within the 7 days prior to the first administration of study medication

          -  Patients previously enrolled in a Phase III study with isavuconazole

          -  Patients with a body weight </= 40 kg
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: OPC-1085EL ophthalmic solution; Carteolol long-acting ophthalmic solution
Intervention MeSH terms: Carteolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 193.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic
      solution in comparison with carteolol long-acting ophthalmic solution in subjects who are
      insufficiently responsive to carteolol long-acting ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular
             hypertension

        Exclusion Criteria:

          -  Subjects with ocular conditions as defined by the protocol
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
Condition: Nail Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab; Placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Nail Psoriasis; Plaque Psoriasis

Summary:

      This study is being conducted to assess the safety and efficacy of adalimumab in participants
      with nail psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail
             Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail
             mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0.

          -  Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a
             Nail Psoriasis Pain Numeric Rating Scale (NRS) score of >3.

          -  Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a
             PGA of Skin Psoriasis of at least moderate.

          -  Subject must have discontinued use of all systemic therapies for the treatment of
             psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior
             to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0.

          -  Target fingernail must have mNAPSI score of ≥ 8.

          -  Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease
             duration of at least 6 months).

        Exclusion Criteria:

          -  Prior adalimumab therapy.

          -  Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or
             viral) that may interfere with evaluation of skin or fingernail psoriasis.

          -  Recent infection requiring treatment.

          -  Significant medical events or conditions that may put patients at risk for
             participation, including recent history of drug or alcohol abuse.

          -  Female subjects who are pregnant or breast-feeding or considering becoming pregnant
             during the study.

          -  History of cancer, except successfully treated skin cancer.
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: ALD403 (Eptinezumab); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1121.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of
      migraine headache in chronic migraineurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 65 years of age, inclusive, who were diagnosed with
             migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months
             before screening.

          -  During the 28 day screening period, subjects must adequately complete the headache
             eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must
             be migraine days.

          -  Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

        Exclusion Criteria:

          -  Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low
             back pain, complex regional pain syndrome).

          -  Psychiatric conditions that are uncontrolled and/or untreated, including conditions
             that are not controlled for a minimum of 6 months prior to screening. Patients with a
             lifetime history of psychosis, mania, or dementia are excluded.

          -  Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons
             requiring injections within 4 months prior to screening and during the screening
             period.

          -  History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, or sporadic and familial hemiplegic migraine.

          -  Receipt of any monoclonal antibody treatment (within or outside a clinical trial)
             within 6 months before screening.

          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
Condition: Hemispatial Neglect
MeSH terms: Perceptual Disorders
Intervention: Mirror therapy; Control group
Intervention description: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.; The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemispatial neglect, Stroke

Summary:

      Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the
      environment contra lateral to a cerebral lesion, can be a major source of functional handicap
      after stroke. The currently available treatments for unilateral neglect are scanning
      training, visual cuing approaches, limb activation strategies, visual imagery, tactile
      stimulation, prisms and sustained attention training.Mirror therapy improves the hand
      function in sub-acute stroke.

      Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke
      patients with unilateral neglect.
    

Eligibility criteria:

        Inclusion Criteria: 1.All stroke patients with parietal lobe and thalamic lesions 2. Stroke
        duration: within 48 hours 3. Patients willing to participate in the study 4. MRI/ CT scan
        showing parietal lobe and thalamic lesion 5. Patients with upper limb weakness

        Exclusion Criteria:

          1. Stroke duration more than 1 yr

          2. Glasgow Coma Scale (GCS) of less than 7

          3. Uncooperative patients
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine transdermal patch; Buprenorphine transdermal patch; Buprenorphine transdermal patch
Intervention description: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear; Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 290.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Opioid; Transdermal

Summary:

      The purpose of the extension phase is to evaluate the long-term safety and tolerability of
      buprenorphine transdermal system (BTDS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of
             the double-blind phase on study drug, or who discontinued study drug due to lack of
             therapeutic effect in the double-blind phase, but still completed all visits of the
             double-blind phase off study drug, are eligible to enroll in the extension phase.

        Exclusion Criteria:

          -  Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of
             their current stable nonopioid analgesic regimen.

          -  Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an
             every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase
             should be discontinued from the study.

        Refer to core study for additional inclusion/exclusion information.
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Brexpiprazole (OPC-34712); Aripiprazole; Placebo
Intervention description: Once-daily, tablets; Once-daily, tablets; Once-daily, tablets
Intervention MeSH terms: Aripiprazole; Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety & efficacy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 316.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Brexpiprazole; Schizophrenia; Adolescent

Summary:

      To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of
      adolescents with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline
             visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and
             confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to
             screening.

          -  PANSS score >= 80, inclusive, at screening and baseline

        Exclusion Criteria:

          -  Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary
             focus of treatment within 3 months of screening.

          -  Subjects with a clinical presentation or history that is consistent with delirium,
             dementia, amnesia or other cognitive disorders

          -  Subjects who have been hospitalized > 21 days for a current exacerbation of
             schizophrenia at the time of baseline.

          -  Any neurological disorder other than Tourette's Syndrome

          -  Subjects at significant risk of committing violent acts, serious self-harm or suicide
             based on history

          -  Subjects with epilepsy, a history of seizures, severe head trauma or stroke

          -  Subjects who test positive for drugs of abuse at screening
Hepatitis B Challenge Dose in Adults (V232-059-10)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Modified Process Hepatitis B Vaccine
Intervention description: Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years
      following completion of a primary series with a hepatitis B vaccine (Base Study V232-059,
      NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In general good health based on a medical history.

          -  Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at
             least 2 years prior to enrollment in this study.

        Exclusion Criteria:

          -  Known history of previous Hepatitis B infection.

          -  History of vaccination with any Hepatitis B vaccine within the last 2 years.

          -  History of febrile illness.

          -  Known or suspected hypersensitivity to any component of HBVaxPro.

          -  Receipt of medication / vaccine that may interfere with study assessments.

          -  Known or suspected immune impairment.

          -  Pregnant women and nursing mothers.
Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin detemir; NPH insulin; insulin aspart
Intervention description: Treat-to-target, dose titration, s.c. (under the skin) injection; Treat-to-target, dose titration, s.c. (under the skin) injection; Treat-to-target, dose titration, s.c. (under the skin) injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 470.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of
      this trial is to compare the effect and safety on blood glucose control in pregnant women
      with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH
      insulin) given as long-acting insulin in combination with a short-acting insulin (insulin
      aspart).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes treated with insulin for at least 12 months

          -  Planning to become pregnant and have a screening HbA1c (glycosylated haemoglobin)
             lesser than or equal to 9.0%, or

          -  Pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when
             joining the trial and a HbA1c lesser than or equal to 8.0% when pregnancy is confirmed

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to the trial product(s) or related products

          -  Untreated hyperthyroidism or hypothyroidism

          -  Known or suspected abuse of alcohol or narcotics

          -  Cardiac problems

          -  Impaired kidney function

          -  History of severe hyperemesis gravidarum

          -  Treatment with in-vitro fertilisation or other medical infertility treatment

          -  Impaired liver function

          -  Uncontrolled hypertension

          -  Proliferative retinopathy or maculopathy requiring acute treatment

          -  Known to be HIV (human immunodeficiency virus) positive, Hepatitis B or Hepatitis C
             positive

          -  Any concomitant medication contraindicated in pregnancy
Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
Condition: Glaucoma, Neovascular
MeSH terms: Glaucoma; Glaucoma, Neovascular
Intervention: Aflibercept (Eylea, BAY 86-5321); Sham Injection
Intervention description: After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.; After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of the administration of aflibercept by intravitreal
      injection in comparison to sham to control intraocular pressure in patients with neovascular
      glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese men and women aged 20 years or older,

          -  Patients diagnosed as having Neovascular glaucoma (NVG) with neovascularization in the
             anterior segment (both iris and anterior chamber angle),

          -  Patients with Intraocular pressure (IOP) higher than 25 mmHg in the study eye due to
             anterior segment (both iris and anterior chamber angle) neovascularization.

        Exclusion Criteria:

          -  Patients with angle-closure due to conditions other than Neovascular glaucoma

          -  Patients with a known or suspected ocular or peri-ocular infection,

          -  Patients with severe intraocular inflammation in the study eye,

          -  Women who are pregnant, suspected of being pregnant or lactating,

          -  Patients with known allergy to aflibercept.