bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel
Intervention description: Rapastinel pre-filled syringes for IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive
      to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Screening

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Screening

          -  Lifetime history of meeting DSM-5 criteria for:

          -  Schizophrenia spectrum or other psychotic disorder

          -  Bipolar or related disorder

          -  Major neurocognitive disorder

          -  Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  Dissociative disorder

          -  Posttraumatic stress disorder

          -  MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Corticosteroids for Children With Febrile Urinary Tract Infections
Condition: Acute Urinary Tract Infection; Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Placebo; Dexamethasone
Intervention description: Twice daily for 3 days; 0.15 mg/kg/dose twice daily for 3 days
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 546.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Renal scarring; Dexamethasone; Child; Corticosteroids; Pediatric; Urinary tract infection; Escherichia Coli Urinary Tract Infection

Summary:

      In this study the investigators will determine whether corticosteroids given at the time of
      urinary tract infection help prevent permanent damage to the kidneys.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 2 months to 6 years

          -  Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged
             specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged
             specimen or ≥1+ leukocyte esterase (LE) on dipstick

          -  Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the
             body either at home or at doctor's office within 24 hours of diagnosis

        Exclusion Criteria:

          -  Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;

          -  Planned admission to intensive care unit;

          -  Known bacteremia;

          -  Previous protocol defined UTI;

          -  Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral
             valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic
             bladder, pelvic or fused kidney);

          -  Congenital/acquired immunodeficiency;

          -  Bag urine collection

          -  Chronic diseases that could potentially interfere with response to therapy, such as
             chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease),
             liver/kidney failure;

          -  Allergy to dexamethasone

          -  Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)

          -  Systemic use of corticosteroids or other immunomodulating agents within 14 days of
             enrollment

          -  History of Kawasaki disease

          -  Sickle cell disease (not trait)
A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
Condition: Actinic Keratosis; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Keratosis, Actinic; Keratosis
Intervention: ingenol disoxate gel 0.018%; ingenol disoxate gel 0.037%; Vehicle gel
Intervention description: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.; Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.; Vehicle to ingenol disoxate gel with no active ingredient
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 563.0
Sex: All
Healthy volunteers: No

Summary:

      One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of
      progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000
      AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and
      the disease is chronic the cumulative risk for a patient can be substantial.

      In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the
      incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients
      over a period of 2 years, so that the total follow-up time for each patient will be 3 years
      and 2 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent has been obtained.

          -  The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196
             and has been evaluated at the end of follow-up visit (month 14) of that trial.

        Exclusion Criteria:

          -  The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the
             selected treatment area .

          -  The subject is enrolled in any other interventional clinical trial.

        For subjects where there is a gap between end of follow-up visit (month 14) in one of the
        trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:

          -  The subject has been treated with ingenol mebutate or ingenol disoxate in the selected
             treatment area after end of follow-up visit (month 14) in one of the trials
             LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.

          -  The subject has been enrolled in any other interventional clinical trial after end of
             follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196
             and until participation in the current trial.
Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Condition: Bipolar Disorder; Substance Use Disorder
MeSH terms: Substance-Related Disorders; Bipolar Disorder
Intervention: Icariin
Intervention description: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is being done to see if icariin will help with depression in patients with bipolar
      disorder and alcohol or cocaine use disorders. The pills used in this study contain 20%
      icariin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current BPD I, II or NOS and cocaine or alcohol use disorder with HAMD score of ≥ 15

          -  Cocaine or alcohol use with 5 days of initiating study drug

          -  Men and women

          -  Age 18-70 years

        Exclusion Criteria:

          -  Psychotic features

          -  Non-English speakers

          -  Treatment resistant depression defined as failure of a trial of antidepressants (≥ 4
             weeks at a therapeutic dose) in current episode

          -  Major medical condition including heart, lung, liver or renal disease, cancer,
             neurological or immunological conditions

          -  Vulnerable populations including prisoners, cognitively impaired individuals, and
             pregnant or nursing women

          -  Prior side effects or allergic reactions to icariin-containing preparations

          -  Change in psychotropic medications within 14 days of study entry

          -  Current suicidal ideation (plan and intent), a suicide attempt within the past 12
             months or history of > 1 lifetime suicide attempt
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Istradefylline 40 mg; Istradefylline 20 mg; Placebo
Intervention description: Istradefylline 40 mg and placebo; Istradefylline 20 mg and placebo; Placebo
Intervention MeSH terms: Istradefylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 613.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Moderate to Severe Parkinson's Disease

Summary:

      This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in
      patients with moderate to severe Parkinson's Disease. While on this study, participants will
      continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or
      Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be
      randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per
      day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate
      the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as
      improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in
      this group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 years of age or older.

          -  UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD

          -  PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.

          -  On levodopa therapy for at least 1 year with beneficial clinical response at the
             baseline visit

          -  Taking at least 400mg levodopa combination daily and on stable regimen of any other
             anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization

          -  Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization

          -  Documented end-of-dose wearing-off and levodopa-induced dyskinesia

          -  Have an average of two hours of OFF time per day

        Exclusion Criteria:

          -  Subjects on apomorphine and/or dopamine receptor antagonists or direct
             gastrointestinal levodopa infusion.

          -  Subject who have had neurosurgical operation for PD

          -  Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers

          -  Subjects who smoke > 5 cigarettes/day
Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: ruxolitinib; Vehicle
Intervention description: ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 458.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: INCB018424

Summary:

      The purpose of this study is to evaluate the duration of response following withdrawal of
      ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued
      use of ruxolitinib cream in participants who have completed either Study NCT04052425 or
      NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream
      BID for the previous 28 to 52 weeks depending on their initial randomization in the parent
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB
             18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with
             vitiligo.

          -  Currently tolerating ruxolitinib cream in the parent study and no safety concerns per
             investigators judgment.

          -  Has demonstrated compliance, as assessed by the investigator, with the parent study
             protocol requirements.

          -  Willingness and ability to comply with scheduled visits, treatment plans, and any
             other study procedures indicated in this protocol.

          -  Male and female participants must be willing to take appropriate contraceptive
             measures to avoid pregnancy or fathering a child.

          -  Ability to comprehend and willingness to sign an ICF or written informed consent of
             the parent(s) or legal guardian and written assent from the participant when possible.

        Exclusion Criteria:

          -  Has been permanently discontinued from study treatment in the parent study for any
             reason.

          -  Participants with an uncontrolled intercurrent illness or any concurrent condition
             that, in the investigator's opinion, would jeopardize the safety of the participant or
             compliance with the Protocol.

          -  Pregnant or breastfeeding woman.

          -  Participants who live with anyone participating in any current Incyte-sponsored
             ruxolitinib cream study.
A Phase III Study of NK105 in Patients With Breast Cancer
Condition: Breast Cancer Nos Metastatic Recurrent
MeSH terms: Breast Neoplasms
Intervention: NK105; Paclitaxel
Intervention description: IV, Weekly; IV, Weekly
Intervention MeSH terms: Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: Female
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: NK105, Paclitaxel, Breast cancer, Micelle

Summary:

      To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to
      paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent
      breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent of the patient signed by herself.

          -  Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.

          -  Aged 20 to 74 at the time of informed consent.

        Exclusion Criteria:

          -  Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent
             breast cancer.
Safety Study of SPARC1104
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: SPARC1104 modified dose regimen I; SPARC1104 modified dose regimen II; SPARC1104 modified dose regimen III
Intervention description: Subjects who exited study CLR_09_21; Subjects who received prior treatment regimen I; Subjects who received no prior treatment regimen
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: spasticity

Summary:

      Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
    

Eligibility criteria:

        -  Willingness to participate and give written informed consent

          -  Men and women ≥ 18 years of age

          -  Sexually active women who are of child bearing potential will practice an acceptable
             method of birth control for the duration of the trial as judged by the investigator.
             Examples of acceptable contraception are: condoms, foams, jellies, diaphragm,
             intrauterine device, oral or long-acting injected contraceptives, bilateral tubal
             ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable
             of initiating conception. The practice of contraception must have started at least 3
             months prior to trial entry.

          -  If female, negative pregnancy test result at Screening

          -  Diagnosed with MS and a known history of spasticity

          -  Meet one of the following criteria o Subjects who completed the double-blind
             randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol
             violation
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Condition: Cholestasis
MeSH terms: Cholestasis
Intervention: multicomponent lipid emulsion; pure soybean oil lipid emulsion
Intervention description: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.; Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 30 Weeks
Healthy volunteers: No
Keywords: preterm; parenteral nutrition; cholestasis; fish oil

Summary:

      The purpose of this study is to compare the effects of a multicomponent lipid emulsion
      containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil
      with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis,
      infant growth, infant morbidity and the biochemical assessment of liver enzymes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inborn infants with a gestational age of less than 30 weeks

          -  Who required parenteral nutrition for at least 7 days

        Exclusion Criteria:

          -  Evidence of congenital infection

          -  Perinatal asphyxia

          -  Congenital anomalies

          -  Severe IVH

          -  Thrombocytopenia

          -  Shock or circulation failure

          -  Renal or hepatic disorders.
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
Condition: Helicobacter Pylori
MeSH terms: Infections
Intervention: Vonoprazan; Amoxicillin; Clarithromycin; Bismuth Potassium citrate; Esomeprazole
Intervention description: Vonoprazan Tablets; Amoxicillin Capsules; Clarithromycin Tablets; Bismuth Potassium citrate; Esomeprazole Tablets
Intervention MeSH terms: Amoxicillin; Clarithromycin; Potassium Citrate; Esomeprazole; Bismuth
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 510.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication
      with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all
      HP-positive participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Helicobacter pylori (HP)-positive participants as determined by ^13C-urea breath test
        (^13C-UBT) at the start of the study (Visit 1 [screening]) and who require HP eradication
        in Physician judgment.

        Exclusion Criteria:

          1. Participant had any of the following conditions at the start of the study (Visit 1,
             screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or
             duodenal ulcer (DU) characterized by defective mucos with white coating (with or
             without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion
             (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis,
             gastric or duodenal erosion are permitted to participate.

          2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those
             with a history of gastric acid hypersecretion.

          3. Participant has a history of malignancy or was treated for malignancy within 5 years
             before the start of the screening visit (the participant may be included in the study
             if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).

          4. Participant has a known acquired immunodeficiency syndrome or hepatitis infection,
             including hepatitis virus carriers (hepatitis B surface antigen [HBsAg] or hepatitis C
             virus [HCV]- antibody-positive).