bioihbjkbjnl/mcl2 huggingface dataset:
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Placebo
Intervention description: Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.; Matching placebo to be given orally, in capsule form, once daily.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 734.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER
      relative to placebo in the prevention of depression relapse in patients with major depressive
      disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 4 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  any manic or hypomanic episode

               -  schizophrenia or any other psychotic disorder

               -  obsessive-compulsive disorder

          -  Patients who are considered a suicide risk
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta
Intervention description: Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm study will assess the efficacy and safety of monthly administration of
      intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of
      hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine
      clinical practice in Hungary. Participants currently receiving maintenance treatment with
      intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the
      starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been
      receiving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (≥) 18 years of age

          -  Chronic renal anemia

          -  Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin
             therapy during previous month

          -  Regular long-term hemodialysis therapy with the same mode of dialysis for the previous
             3 months

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months

          -  Poorly controlled hypertension

          -  Significant acute or chronic bleeding
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Factor XIII Deficiency
Intervention: catridecacog
Intervention description: Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The aim of the trial is to
      investigate the safety of monthly replacement therapy of recombinant factor XIII in patients
      with congenital FXIII deficiency. The trial continues until the product is commercially
      available, but an interim assessment will take place when all subjects have completed 52
      weeks in the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For subjects who participated in F13CD-1725:

          -  Previous participation (means up to and inclusive Visit 16, (End of Trial)) in
             F13CD-1725

          -  For all other subjects:

          -  Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at
             screening visit or documented results from previously performed genotyping)

          -  Body weight at least 20 kg

        Exclusion Criteria:

          -  Known neutralizing antibodies (inhibitors) towards FXIII

          -  Any known congenital or acquired coagulation disorder other than congenital FXIII
             deficiency

          -  Platelet count (thrombocytes) of less than 50 × 109/L. For subjects who participated
             in F13CD-1725 platelet count from visit 15 in F13CD-1725 must be used for evaluation.

          -  Females of childbearing potential who are pregnant, breastfeeding or are not using
             adequate contraceptive methods
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: 1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in
      patients with Major Depressive Disorder (MDD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is judged to benefit from adjunctive treatment with brexpiprazole
             according to the clinical opinion of the investigator.

          -  The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or
             NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.

          -  The patient agrees to protocol-defined use of effective contraception.

        Exclusion Criteria:

          -  The patient has a disease or takes medication that could, in the investigator's
             opinion, interfere with the assessments of safety, tolerability, or efficacy, or
             interfere with the conduct or interpretation of the study.

          -  The patient has been diagnosed with a psychiatric disorder other than MDD during the
             lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.

          -  The patient, in the opinion of the investigator or according to C-SSRS, is at
             significant risk of suicide.

          -  The patient has any relevant medical history or current presence of systemic disease.

          -  The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's
             opinion, clinically significant.

          -  The patient has a moderate or severe ongoing adverse event related to study medication
             from the lead-in studies considered of potential safety risk by the investigator.

          -  The patient is, in the investigator's opinion, unlikely to comply with the protocol or
             is unsuitable for any reason.

        Other inclusion and exclusion criteria may apply.
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Condition: Bipolar I Disorder
Intervention: Inhaled Placebo; Inhaled loxapine 5 mg; Inhaled loxapine 10 mg
Intervention description: Inhaled loxapine Placebo, may repeat after 2 hours x 2; Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2; Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
Intervention MeSH terms: Loxapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar 1 disorder,; agitation,; acute,; treatment

Summary:

      Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in
      bipolar 1 disorder patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients with bipolar 1 disorder and acute agitation

        Exclusion Criteria:

          -  Agitation caused primarily by acute intoxication

          -  History of drug or alcohol dependence

          -  Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug
             administration
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Condition: Genital Psoriasis; Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: genital

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug
      ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at
             least 6 months before baseline.

          -  Have moderate-to-severe psoriasis in the genital area at screening and baseline.

          -  Have plaque psoriasis in a nongenital area at screening and baseline.

          -  Have failed to respond to, or are intolerant of, at least 1 topical therapy used for
             treatment of psoriasis affecting the genital area.

          -  Must agree to use reliable method of birth control, which could include abstinence,
             during the study and for at least 12 weeks following the last dose of study drug.

        Exclusion Criteria:

          -  Pustular, erythrodermic, and/or guttate forms of psoriasis.

          -  History of drug-induced psoriasis.

          -  Have recently received certain treatments for psoriasis (in particular, within the
             past 4 weeks but the restriction can go up to 12 months for some treatments).

          -  Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug
             with a similar mode of action.

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to baseline and during the study.

          -  Are currently enrolled in any other clinical trial involving an investigational
             product.

          -  Serious disorder or illness other than plaque psoriasis.

          -  Active or history of malignant disease within 5 years prior to baseline.

          -  Serious infection within the last 3 months.

          -  Have received a live vaccine within 3 months of baseline or plan to do so during the
             study.

          -  Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.

          -  Pregnant or breastfeeding (lactating) women.
Open Label Study Telmisartan and Amlodipine in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: telmisartan/amlodipine 40/5 mg fixed combination; telmisartan/amlodipine 80/5 mg fixed combination
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Enrollment: 976.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to assess the efficacy and safety of the fixed dose
      combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5
      mg (T80/A5) during long-term open-label treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. patients aged at least 18 years

          2. diagnosis of essential hypertension and blood pressure not adequately controlled
             before enrolment in the preceding trial.

          3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of
             the preceding trial.

        Exclusion Criteria:

          1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or
             are not practising acceptable means of birth control or do not plan to continue using
             acceptable means of birth control throughout the study

          2. development of any medical condition in the preceding trial that in the investigator's
             opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg
             or Telmisartan 80 mg/Amlodipine 5 mg

          3. discontinuation from the preceding trial because of any adverse event or any other
             reason

          4. known or suspected secondary hypertension

          5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood
             Pressure => 120 mmHg at any visit
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: NT0102; Placebo
Intervention description: NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.; Matching ODT placebo was given once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to
      evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit
      Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory
      classroom study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently being treated for ADHD

        Exclusion Criteria:

          -  Other psychiatric diagnoses

          -  Significant cognitive impairment

          -  Chronic medical illnesses

          -  Structural cardiac defects

          -  Significant abnormal lab tests

          -  Taking disallowed medications

          -  Positive drug test
Clinical Trial in Females With Female Pattern Hair Loss
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: 5% Minoxidil; 2% Minoxidil
Intervention description: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks; one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
Intervention MeSH terms: Minoxidil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 322.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Female Pattern Baldness

Summary:

      This is a year-long clinical trial to evaluate the effectiveness and safety in women with
      Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation
      applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

      This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to
      evaluate if there is a change in the number of hairs in the area being examined after using
      the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).

      This trial will determine if the benefit of using either study product outweighs the risks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females, age 18 or older in general good health

          -  exhibits female pattern hair loss

          -  signs and dates an informed consent document

          -  agrees to use an adequate method of birth control; if of childbearing potential

          -  shows a negative urine pregnancy test at Screening Visit

          -  is willing to maintain the same hair style, hair color, and hair regimen throughout
             the study

          -  is willing and able to comply with scheduled visits, treatment plan, laboratory tests
             and other trial procedures

        Exclusion Criteria:

          -  hypersensitivity to the study product, or any ingredients of the study product

          -  known allergy to hair dye, or hair dye components

          -  clinically relevant history of hypotension

          -  untreated or uncontrolled hypertension

          -  pregnant, planning a pregnancy or nursing a child

          -  history of hair transplants

          -  currently use hair weaves or non-breathable wigs

          -  dermatologic disorders of the scalp that require chronic use of medication for control

          -  other types or history of hair loss

          -  enrolled in any other investigational medication (drug) study currently, or within the
             last 6 months
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: octreotide capsules; Matching placebo
Intervention description: octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration); Matching placebo capsules
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA

Summary:

      Octreotide capsule is a novel, orally-administered formulation of the commercially-available
      injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated
      maintenance of biochemical response up to 13 months in the majority of patients with
      acromegaly previously managed with somatostatin analog injections (reference below).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented evidence of active acromegaly

          -  Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least
             6 months with a stable dose for at least the last three months of therapy

          -  Biochemically controlled

        Exclusion Criteria:

          -  Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as
             indicated in the label

          -  Pituitary surgery within six months

          -  Conventional or stereotactic pituitary radiotherapy any time in the past

          -  Patients who previously participated in CH-ACM-01 or OOC-ACM-302

          -  Any clinically significant uncontrolled concomitant disease

          -  Symptomatic cholelithiasis

          -  Pegvisomant, within 24 weeks

          -  Dopamine agonists, within 12 weeks

          -  Pasireotide, within 24 weeks
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: RVT-101 35 mg tablets
Intervention description: once daily, oral tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1099.0
Sex: All
Minimum age: 50 Years
Maximum age: 86 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; RVT-101; donepezil

Summary:

      This 12-month open-label study will provide further information regarding the long-term
      safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who
      have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind
      study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed last on-treatment visit of the lead-in study RVT-101-3001

        Exclusion Criteria:

          -  Any clinically relevant concomitant disease, which, in the opinion of the
             investigator, makes the subject unsuitable for inclusion in the study.
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
Condition: Plaque Psoriasis; Psoriatic Arthritis; Pustular Psoriasis (Excluding a Localized); Psoriatic Erythroderma
MeSH terms: Arthritis, Psoriatic; Psoriasis; Dermatitis, Exfoliative
Intervention: TA-650
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Infliximab; REMICADE; TA-650; psoriasis

Summary:

      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650
      at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the
      treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but
      decreased thereafter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have already been diagnosed as having plaque psoriasis, psoriatic
             arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.

          -  Patients in whom effect of the treatment was confirmed for a certain period after the
             start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased
             thereafter.

        Exclusion Criteria:

          -  Patients who have guttate psoriasis.

          -  Patients who have drug-induced psoriasis

          -  Patients who have previously used any other biological products than infliximab.

          -  Patients who have a concomitant diagnosis, or a history within 6 months prior to
             provisional enrollment, of serious infections that need hospitalization.

          -  Patients who have a concomitant diagnosis, or a history within 6 months prior to
             provisional enrollment, of opportunistic infections

          -  Female patients who are pregnant, breast-feeding, or possibly pregnant.