bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Condition: Scar Prevention
Intervention: EXC 001; Placebo
Intervention description: Multiple intradermal injections of EXC 001 and placebo; Multiple intradermal injections of EXC 001 and placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Scarring; Cicatrix; Fibrosis; Pathologic Process

Summary:

      This study will compare how well EXC 001 works to improve the appearance of scars in subjects
      undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001
      in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have previously had breast surgery resulting in unacceptable scars

          -  Subject has chosen to have the breast scars revised

          -  Subjects must not be pregnant or lactating

        Exclusion Criteria:

          -  Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or
             lactating

          -  Participation in another clinical trial within 30 days prior to the start of the study

          -  Any other condition or prior therapy, which, in the opinion of the PI, would make the
             subject unsuitable for this study
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo; CP-690,550; CP-690,550
Intervention description: oral tablets twice daily; oral tablets twice daily; oral tablets twice daily
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to
      severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is
      more effective than placebo (inactive drug).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between the ages of 18 and 75 years at screening (upper age
             limit will be 64 years in India and 65 years in the Netherlands).

          -  Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to
             screening.

          -  Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a
             baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

        Exclusion Criteria:

          -  Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings
             suggestive of UC.

          -  Subjects diagnosed with Crohn's disease but without previous exposure to treatment
             (i.e., treatment-naïve).

          -  Subjects receiving the following treatment for Crohn's disease:

          -  Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.

          -  Anti-TNFα therapy within 8 weeks prior to baseline.

          -  Interferon therapy within 8 weeks prior to baseline.

          -  Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.

          -  Intravenous corticosteroids within 2 weeks prior to baseline.
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Drug: GB-102; Aflibercept
Intervention description: Intravitreal injection of GB-102; Intravitreal injection of aflibercept (2 mg dose)
Intervention MeSH terms: Sunitinib; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-arm design
Masking: Single (Outcomes Assessor)
Masking description: Visual examiner-masked
Enrollment: 56.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration (AMD); Choroidal neovascularization

Summary:

      Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm
      design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels
      of GB-102 compared with aflibercept.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥ 50 years of age

          -  Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with
             at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth
             factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).

          -  Demonstrated response to prior anti-VEGF treatment since diagnosis

          -  Best-corrected visual acuity (BCVA) of 35 letters or better

        Exclusion Criteria:

          -  History, within 6 months prior to screening, of any of the following: myocardial
             infarction, any cardiac event requiring hospitalization, treatment for acute
             congestive heart failure, transient ischemic attack, or stroke

          -  Uncontrolled hypertension, diabetes mellitus or intraocular pressure (IOP)

          -  Chronic renal disease

          -  Abnormal liver function

          -  Women who are pregnant or lactating
Double-Blind Naltrexone in Compulsive Sexual Behavior
Condition: Compulsive Sexual Behavior
Intervention: Naltrexone; Sugar pill
Intervention description: daily; daily
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Impulse Control Disorder; Compulsive Sexual Behavior

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in
      compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will
      receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will
      be effective in reducing the urges to act out sexually in patients with compulsive sexual
      behavior. The proposed study will provide needed data on the treatment of a disabling
      disorder that currently lacks a clearly effective treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 21-75;

          2. current diagnosis of compulsive sexual behavior

        Exclusion Criteria:

          1. unstable medical illness or clinically significant abnormalities on prestudy
             laboratory tests or physical examination;

          2. history of seizures;

          3. myocardial infarction within 6 months;

          4. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          5. clinically significant suicidality;

          6. current or recent (past 1 month) DSM-IV substance abuse or dependence;

          7. illegal substance within 2 weeks of study initiation;

          8. initiation of psychotherapy or behavior therapy from a mental health professional
             within 3 months prior to study baseline;

          9. initiation of a psychotropic medication within 2 months prior to study inclusion;

         10. previous treatment with naltrexone; and

         11. treatment with investigational medication or depot neuroleptics within 3 months, with
             fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study
             baseline
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant
Condition: Single Umbilical Cord Blood Transplantation; Non-myeloablative Conditioning; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Intervention: HSC835
Intervention description: HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Healthy volunteers: No
Keywords: HSC835; single umbilical cord blood transplantation; non-myeloablative conditioning regimen; Umbilical cord blood; UCB transplantation

Summary:

      This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as
      measured by the absence of graft failure at day 42 in excess of that currently observed with
      double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA)
      conditioning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis that qualifies them for UCBT

          -  Adequate organ function

          -  Availability of eligible donor material

        Exclusion Criteria:

          -  Pregnancy or breastfeeding women and women of child-bearing potential unless two
             acceptable forms of contraception are being used

          -  Human immunodeficiency virus (HIV) infection

          -  Active infection
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
Condition: Venous Thrombosis; Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Intervention description: Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Embolism and Thrombosis; Pulmonary Embolism; Embolism; Venous Thrombosis; Thrombosis; Enzyme Inducers; CYP Inducers; Cohort Study; Pharmacologic Actions; Respiratory Tract Diseases; Lung Diseases; Vascular Diseases; Human Immunodeficiency Virus (HIV); Neurologic disease; Additional relevant MeSH terms:; Fibrin Modulating Agents; Anticoagulants; Therapeutic Uses; Hematologic Agents; Enzyme Inhibitors; Cardiovascular Diseases; Cardiovascular Agents

Summary:

      This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in
      patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who
      concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire
      3-month study duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism

          -  Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin,
             rifampicin/rifampin, and rifabutin)

        Exclusion Criteria:

          -  Legal lower age limitations (country specific)

          -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
             current episode of deep -vein thrombosis and/or pulmonary embolism

          -  Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or
             pulmonary embolism

          -  Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic
             ketoconazole)

          -  Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort
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:
Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
Condition: Osteoporosis Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Odanacatib; Vitamin D3; Calcium carbonate; Placebo
Intervention description: Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.; Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.; Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.; Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 287.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the dose-response on the percent change from baseline
      in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when
      odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52
      weeks to Japanese involutional osteoporosis participants. The study will also assess safety
      and tolerability of odanacatib (10, 25, and 50 mg) in these participants.

      The study will enroll approximately 280 participants and randomly assign them to 3 different
      doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium
      carbonate. The primary efficacy hypothesis is that a dose-response relationship on the
      percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50
      mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis
      participants. The primary safety hypothesis is that odanacatib will be safe and well
      tolerated over 52 weeks to involutional osteoporosis participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85

          -  Participant who has low bone mineral density

          -  Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the
             lumber spine and hip

          -  Participant is ambulatory (can walk)

        Exclusion Criteria:

          -  Participant has secondary osteoporosis or has a metabolic bone disorder other than
             osteoporosis or osteopenia

          -  Participant has received osteoporosis medications or other medications that affect
             bone

          -  Participant is already participating in another drug study
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: OPA-15406; Placebos
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1%
      OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

        Exclusion Criteria:

          -  Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a
             sudden intensification of atopic dermatitis.

          -  Subjects who have an active viral skin infection.

          -  Subjects with a current or history of malignancy.
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: MORAb-009 (Amatuximab); Pemetrexed; Cisplatin
Intervention description: MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.; Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles; Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research is being done to find out if pemetrexed and cisplatin work better when given
      together with an experimental drug called MORAb-009 in patients with malignant pleural
      mesothelioma.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following
             characteristics: unresectable disease (or otherwise not a candidate for curative
             surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.

          -  Measurable disease at Screening by computed tomography (CT)(or magnetic resonance
             imaging [MRI]).

          -  KPS of greater than or equal to 70% at Screening.

          -  Life expectancy of at least 3 months

        Primary Exclusion Criteria:

          -  Sarcomatous type of mesothelioma

          -  Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control
             (ie, non-curative intent) is permitted.

          -  Confirmed presence of CNS tumor involvement.

          -  Evidence of other active malignancy requiring treatment.
A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Bevacizumab; Dacarbazine
Intervention description: Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle.; Dacarbazine will be given as 800 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 28-day cycle.
Intervention MeSH terms: Bevacizumab; Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the preliminary anti-tumor activity and safety profile of a
      combination of bevacizumab and dacarbazine in participants with unresectable/metastatic
      melanoma not previously treated with chemotherapy for metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed cutaneous malignant melanoma

          -  Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease
             and/or extensive in transit recurrent disease

          -  Measurable and/or evaluable lesions according to RECIST

        Exclusion Criteria:

          -  Prior interferon alfa and/or cytokine therapy for metastatic disease

          -  Prior chemotherapy for metastatic disease

          -  Brain metastases

          -  Chronic daily treatment with high-dose aspirin (more than 325 milligrams per day)

          -  Other co-existing malignancies or malignancies diagnosed within the past 5 years with
             the exception of basal cell cancer or cervical cancer in situ
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost eye drops; placebo
Intervention description: 1 drop in each eye daily for 1 month; 1 drop in each eye daily for 1 month
Intervention MeSH terms: Bimatoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A one month study which will determine the safety and efficacy of bimatoprost eye drops in
      patients with glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic glaucoma or ocular hypertension

          -  IOP controlled on Xalatan

        Exclusion Criteria:

          -  Uncontrolled medical conditions

          -  Known hypersensitivity to study medications