bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: ATI-50002
Intervention description: ATI-50002 Topical Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female
      subjects with androgenetic alopecia.
    

Eligibility criteria:

        Inclusion Criteria:

        Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a
        clinical diagnosis of androgenetic alopecia.

        Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length
        on their balding spot.

        Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the
        center of the identified target area.

        Subjects must agree to maintain the same hair style and hair care regimen during the study.

        Exclusion Criteria:

        Females who are nursing, pregnant, or planning to become pregnant for the duration of the
        study and up to 30 days after the last application of study medication.

        Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss
        on the treatment area, due to disease, injury or medical therapy.

        Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history
        of skin disease on the scalp that in the opinion of the investigator would interfere with
        the study assessments or efficacy or safety.
Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
Condition: Metastatic Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: CS7017 tablets; Paclitaxel; Carboplatin; Placebo Tablets
Intervention description: CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months; Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks; IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks; Placebo tablets matching CS-7017 tablets
Intervention MeSH terms: Paclitaxel; Carboplatin; Efatutazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects
      with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in
      combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the
      study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin
      and paclitaxel to evaluate effectiveness and safety. The study will find out if adding
      CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in
      subjects with metastatic non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no
             significant pleural effusion or pleural involvement from the tumor

          -  Age greater than or equal to 18 years

          -  Adequate organ and bone marrow function

        Exclusion Criteria:

          -  Any prior systemic therapy for NSCLC

          -  Major surgical procedure or other investigational agents within 4 weeks before study
             enrollment

          -  Need for concomitant use of other thiazolidinediones during the study

          -  History of any of the following conditions within 6 months prior to initiating study
             treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or
             thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of
             cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease
             or partial bowel obstruction;

          -  Clinically active brain metastases, uncontrolled seizure disorder; spinal cord
             compression or carcinomatous meningitis
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Condition: Insulin; Exercise
Intervention: Placebo into the intranasal mucosa; 20 IU NovoLog Insulin aspart into the intranasal mucosa; 40 IU NovoLog Insulin aspart into the intranasal mucosa; 60 IU NovoLog Insulin aspart into the intranasal mucosa; 80 IU NovoLog Insulin aspart into the intranasal mucosa; 100 IU NovoLog Insulin aspart into the intranasal mucosa; 120 IU NovoLog Insulin aspart into the intranasal mucosa
Intervention description: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer; 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.
Masking: Double (Participant, Investigator)
Masking description: Double blind, placebo controlled trial
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intranasal Insulin; Cognition; Exercise; Physical Activity

Summary:

      To determine if physical activity engagement alters the dose-response profile and safety of
      administration of insulin into the intranasal mucosa.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must be over the age of 18..

          2. Participants must have normal or corrected-to-normal vision in order to complete the
             cognitive task.

        Exclusion Criteria:

          1. Lack of consent.

          2. Presence of any major neurological health issues, brain trauma, or concussion with
             loss of consciousness assessed through a health history and demographics
             questionnaire.

          3. Type I or Type II Diabetes

          4. Self-reported pregnancy

          5. Currently has any type of inflammation or blockage of the nasal passageways (i.e.
             allergies or a cold affecting the sinuses).
Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
Condition: Disorder of Oral Mucous Membrane
Intervention: EVPOME (autogenous ex vivo produced oral mucosa equivalent); POM (Palatal oral mucosa)
Intervention description: EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.; POM is a tissue graft harvested from the palate and surgically placed into the defect area
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dental implants; deficient keratinized oral mucosa

Summary:

      The purpose of this study is to improve the current standard of care of repairing mouth soft
      tissue defects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Deficient band (<3mm) of keratinized mucosa prior to or following dental implant
             placement

          -  Surgery to increase width of keratinized mucosa is clinically indicated or requested
             by the patient to facilitate oral hygiene procedures or to improve esthetics

          -  Patients in need of a graft of approximately 15 x 10 x 20 mm in dimension

        Exclusion Criteria:

          -  Subjects with potential medical complications such as evidence of clinically
             significant (as described by investigators) renal, hepatic, cardiac, endocrine,
             hematologic, autoimmune, or any systemic disease which may complication execution of
             the protocol and/or interpretation of results

          -  Current radiation therapy or history of radiation therapy treatment to the intraoral
             donor biopsy site or recipient site for graft placement

          -  Documented history of syphilis, HIV, Hepatitis B or C virus

          -  Pregnant women or women planning to become pregnant or unwilling to abstain or use
             double barrier contraceptives during the course of the study

          -  Smoking or use of tobacco products within 6 months prior to screening

          -  History of either alcohol or drug abuse

          -  Subjects taking medications that can result in gingival enlargement/overgrowth
             (Cyclosporine, Dilantin, calcium channel blockers)

          -  Current use of intravenous bisphosphonate or current oral bisphosphate use or a
             history of bisphosphonate use for over 5 years
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353; Placebo
Intervention description: Plasma kallikrein inhibitor
Intervention MeSH terms: Berotralstat
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in
      preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the
      study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks.
      Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to
      one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one
      of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in
      each treatment group, as well as a number of other clinical and pharmacologic outcomes, and
      the safety and tolerability of each dose of BCX7353 compared to placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of HAE type I or II

          -  Documented HAE attacks within a defined calendar period

          -  Access to acute attack medications

          -  Sexually active women of child-bearing potential and sexually active men must utilize
             effective contraception

        Key Exclusion Criteria:

          -  Women who are pregnant or breast-feeding

          -  Any clinical condition or medical history that would interfere with the subject's
             safety or ability to participate in the study

          -  Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks

          -  History of or current alcohol or drug abuse

          -  Infection with hepatitis B, hepatitis C or HIV

          -  Participation in any other investigational drug study currently or within the last 30
             days
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543; CTP-543 Matching Placebo
Intervention description: CTP-543 administered as 8 mg tablet.; Administered as tablets to aid treatment masking.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and tolerability of once-daily versus twice-daily
      dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definitive diagnosis of alopecia areata with a current episode lasting at least 6
             months and not exceeding 10 years at the time of Screening. Total disease duration
             greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Clinical lab results within the normal range

        Exclusion Criteria:

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or untreated actinic
             keratosis on the scalp.

          -  Treatment with systemic immunosuppressive medications or biologics.

          -  Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening
             or during the study
Evaluate SAGE-547 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Intervention: SAGE-547; Placebo
Intervention MeSH terms: Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,
      tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female
      participants with essential tremor in the upper limb.

      Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and
      effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who
      completed Stage 1 were invited to participate in Stage 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms
             clearly present in at least 1 upper limb; participant has had tremor present for at
             least 2 years prior to Screening

          -  Off medication, or on a stable dose of medication for their tremor for at least 28
             days prior to Screening

        Exclusion Criteria:

          -  Recent history or active clinically significant manifestations of metabolic, hepatic,
             renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal,
             dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological
             (other than essential tremor) disorders

          -  Medical history of seizures
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
Condition: Otomycosis
MeSH terms: Otomycosis
Intervention: 7-Day Miconazole Oil (Miconazole 2%); 14-Day Miconazole Oil (Miconazole 2%); 14-Day Placebo - Oil Vehicle
Intervention description: 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole); 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole); 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Intervention MeSH terms: Miconazole; Clotrimazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Subjects, investigators, and study staff will not be masked as to the treatment duration assigned to each subject (7 versus 14 days). For subjects receiving the 14-day treatment with study drug, the contents of the study drug (active versus placebo) will be masked to the subject, investigator, and study staff.
Enrollment: 65.0
Sex: All
Minimum age: 25 Months
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy and safety of active treatment
      (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole
      oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with
      fungal infection (otomycosis) of the external ear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Uncomplicated otomycosis of the external ear only, age more than 2 year

        Exclusion Criteria:

          -  Pregnancy

          -  Other dermatoses or conditions of the ear that may interfere with the evaluation of
             otomycosis, including concomitant otic infections (including bacterial infection) that
             require antimicrobial treatment, disease that has spread beyond the external ear(s),
             or pre-existing skin atrophy of the affected ear(s)

          -  Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated

          -  Previous surgery affecting the ear(s) that will be treated, except for prior
             tympanostomy tube(s) that had been removed and had completely healed

          -  Previous use of medicated treatments for otomycosis or participation in another
             investigational study within 28 days of study entry

          -  Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or
             immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3
             months of study entry

          -  Recurrent otomycosis that had been unresponsive to previous antifungal treatment

          -  Known hypersensitivity to any of the components in the test formulation
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Antidepressant + placebo; Antidepressant + cariprazine (0.1-0.3 mg/day); Antidepressant + cariprazine (1-2 mg/d)
Intervention description: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.; Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.; Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Adjunctive; Depression; Major Depressive Disorder (MDD)

Summary:

      This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on
      therapy to standard antidepressants in patients who did not respond to previous
      antidepressant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic
             features.

          -  Previous failure to respond to adequate trials of one or two ADTs with less than 50%
             reduction in depressive symptoms during the present episode.

        Exclusion Criteria:

          -  DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I
             disorder other than MDD that was the primary focus of treatment within 6 months before
             Visit 1
A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Condition: Congenital Ichthyosis
MeSH terms: Ichthyosis; Ichthyosis, Lamellar; Ichthyosiform Erythroderma, Congenital
Intervention: Isotretinoin; Vehicle
Intervention description: Topical Isotretinoin ointment; Topical Vehicle Ointment
Intervention MeSH terms: Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Parallel, Double-Blind, Vehicle-Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 34.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of two concentrations of
      topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1%
      isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis
      (CI), including recessive X-linked ichthyosis (RXLI) and autosomal recessive congenital
      ichthyosis-lamellar ichthyosis (ARCI-LI) subtypes.

      Funding Source FDA-OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female, 9 years of age or older at Visit 2 (Baseline)

          -  Subject has provided written informed consent

          -  Females of child bearing potential must be surgically sterile or agree to 2 forms of
             birth control

          -  Subject has clinical diagnosis of Congenital Ichthyosis with genetic confirmation of
             subtype

          -  Subject has between 10% and 90% total BSA affected by Congenital Ichthyosis

          -  Subject has at least 2 VIIS assessment areas with a scaling score of 3 or greater

        Exclusion Criteria:

          -  Subject has inflammatory skin diseases unrelated to ichthyosis

          -  Subject has used other prohibited topical treatments in the assessment areas within
             certain days from baseline

          -  Subject has used systemic retinoids within12 weeks of baseline

          -  Subject has untreated secondary infections

          -  Subject has lesions suspicious for skin cancer or untreated skin cancers