bioihbjkbjnl/mcl2 huggingface dataset:
Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)
Condition: Familial Partial Lipodystrophy
MeSH terms: Lipodystrophy, Familial Partial; Lipodystrophy
Intervention: AKCEA-ANGPTL3-LRx
Intervention description: AKCEA-ANGPTL3-LRx solution for SC injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lipodystrophy; Lipodystrophy, Familial Partial; Lipid Metabolism Disorders; Dyslipidemias; Kobberling-Dunnigan syndrome (type 1 and 2); Lipoatrophic Diabetes

Summary:

      This is a single-center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for
      reduction of fasting triglycerides in participants with familial partial lipodystrophy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must give written informed consent to participate in the study.

          -  Clinical diagnosis of familial partial lipodystrophy plus diagnosis of type 2 diabetes
             mellitus and hypertriglyceridemia.

          -  Diagnosis of diabetes mellitus, made at least 6 months prior to the Screening with
             hemoglobin A1c (HbA1c) ≥ 7% to ≤ 12% at Screening and on anti-diabetic therapy as
             defined in study protocol.

          -  Hypertriglyceridemia as defined by fasting triglycerides (TG) levels ≥ 500 milligrams
             per deciliter (mg/dL) at both Screening and Qualification visits. Participants with
             the clinical diagnosis of FPL and with fasting TG levels ≥ 200 (≥ 2.26 millimoles per
             liter [mmol/L]) to < 500 mg/dL (≥ 5.7 mmol/L) who meet the genetic or family history
             criteria for study inclusion may be further screened and enrolled in the study.

          -  Presence of hepatosteatosis (fatty liver), as evidenced by a Screening magnetic
             resonance imaging (MRI) indicating a hepatic fat fraction (HFF) ≥ 6.4%.

        Key Exclusion Criteria:

          -  Diagnosis of generalized lipodystrophy.

          -  Diagnosis of acquired partial lipodystrophy (APL).

          -  Acute pancreatitis within 4 weeks of Screening.

          -  Acute coronary syndrome within 6 months of Screening.

          -  Major surgery within 3 months of Screening.

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study.
Market Potential of Carbon Dioxide Nasal Spray
Condition: Nasal Congestion
Intervention: Carbon Dioxide
Intervention description: Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Carbon Dioxide, Allergy symptoms

Summary:

      Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues
      and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic
      rhinitis have shown that nasally administered CO2 may provide relief of the associated
      symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration,
      and may persist for four to six hours.

      This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as
      evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who
      qualify and choose to participate in the clinical study will be administered nasal CO2 under
      medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for
      self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and
      completion of assessment questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant who demonstrate understanding of, and willingness to participate in the
             study

          -  Aged at least 18 years.

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions.

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee

          -  Participant has perception of Nasal Breathing score ≤70 mm (Visual Analogue Scale) on
             the evaluation day

          -  Females of childbearing potential who are, in the opinion of the investigator,
             practising a reliable method of contraception.

        Exclusion Criteria:

          -  Women who are known to be pregnant or who have a positive pregnancy test, or who are
             intending to become pregnant over the duration of the study.

          -  Women who are breast-feeding.

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients.

          -  Participation in another clinical study or receipt of an investigational drug within
             30 days of the screening visit.

          -  Recent history (within the last 2 years) of alcohol or other substance abuse.

          -  Medical history of significant respiratory impairment.

          -  No history of product purchase for treatment of nasal congestion
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Condition: Hepatobiliary Disorders; Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Liver Diseases
Intervention: Semaglutide; Placebo
Intervention description: Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg); Once daily administration subcutaneously ( s.c., under the skin)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
      daily versus placebo in subjects with non-alcoholic steatohepatitis
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial except for protocol described
        pre-screening activities which require a separate informed consent. - Male or female, aged
        18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive))
        at the time of signing informed consent - Local histological diagnosis of NASH followed by
        histological confirmation of NASH based on central pathologist evaluation of a liver biopsy
        obtained up to 21 weeks before screening - Histologic evidence of NASH based on central
        pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH
        fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central
        pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20
        g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed
        by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type
        1 diabetes according to medical records - HbA1c above 10% at screening - History or
        presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at
        screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary
        thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤
        25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or
        intends to become pregnant or is of childbearing potential and not using an adequate
        contraceptive method (adequate contraceptive measures as required by local regulation or
        practice)
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Plecanatide; Placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 428.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in
      patients with IBS-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18-75, inclusive

          -  Body Mass Index = 18-35 kg/m2, inclusive

          -  Meets modified Rome III criteria for irritable bowel syndrome with constipation which
             includes abdominal pain or discomfort for at least 3 days/month in the last 3 months
             with symptom onset for at least 6 months.

          -  Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.

          -  Hard or lumpy stools ≥ 25 % of defecations

          -  Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2
             week pre-treatment period

          -  Patient is willing to discontinue use of supplemental fiber, laxatives, prescription
             and nonprescription medications, herbal or dietary supplements intended to treat
             constipation during the screening, pre-treatment, treatment and 2-week post-treatment
             periods

          -  Willing to maintain a stable diet during the study.

          -  Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered
             into the study.

        Exclusion Criteria:

          -  Loose stool (mushy) or watery stool in the absence of any laxative or prohibited
             medicine for > 25% of BMs during the 3 months prior to screening visit OR during the
             14 day pre-treatment period

          -  Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or
             diarrhea and normal cycling) IBS.

          -  Active peptic ulcer disease not adequately treated or not stable

          -  History of cathartic colon, laxative, enema abuse, or ischemic colitis.

          -  Fecal impaction within 3 months of screening

          -  Patient has had /has any: structural abnormality of the GI tract or gastric bypass
             surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis,
             diverticulitis, anal fissures or any disease or condition that can affect GI motility
             or defecation or can be associated with abdominal pain

          -  Unexplained and clinically significant "alarm symptoms" including lower GI bleeding,
             iron-deficiency anemia, weight loss or systemic signs of infection or colitis.

          -  Major surgery within 60 days of screening.
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Condition: Acute Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Intervention: LME636 60 mg/mL ophthalmic solution; Dexamethasone 0.1% ophthalmic solution; LME636 Vehicle
Intervention description: Inactive ingredients used for masking purposes
Intervention MeSH terms: Dexamethasone; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute anterior uveitis; LME636

Summary:

      The purpose of the study is to determine whether topical ocular administration of LME636 60
      mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC)
      associated with acute anterior uveitis (AAU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent.

          -  Diagnosis of non-infectious AAU in at least 1 eye.

          -  Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature
             (SUN) in at least one eye.

          -  Able to communicate well with the Investigator, to understand and comply with the
             requirements of the study.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of child-bearing potential unwilling to use effective contraception methods as
             defined in the protocol.

          -  AC cell score of 4+ (SUN) or hypopyon.

          -  Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.

          -  Presence of intermediate-, posterior-, or panuveitis in either eye.

          -  Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as
             described in the protocol.

          -  Recurrent corneal abrasion or ulceration in either eye (past or present).

          -  Tuberculosis (past or present).

          -  Other protocol-specified exclusion criteria may apply.
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Placebo; Cariprazine
Intervention description: Placebo was supplied in capsules.; Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 584.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar I disorder; Bipolar depression; Depression; Bipolar disorder

Summary:

      The objective of this study was to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of participants with bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have provided informed consent prior to any study specific
             procedures.

          -  Participants currently meeting the Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder
             as confirmed by the Structured Clinical Interview (SCID) with a current with a current
             major depressive episode of at least 4 weeks and not exceeding 12 months in duration.

          -  Participants with normal physical examination, laboratory, vital signs, and/or
             echocardiogram (ECG).

          -  Verified previous manic or mixed episode.

          -  Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.

          -  Participants with a HAMD-17 item 1 score ≥ 2.

          -  Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

        Exclusion Criteria:

          -  Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
             disorder that was the primary focus of treatment within the previous 6 months.

          -  Women who are pregnant or breast feeding

          -  Participants with Young Mania Rating Scale (YMRS) total score > 10

          -  Participants who have dementia, mental retardation, schizophrenia/schizoaffective
             disorder.
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
Condition: Severe Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-547; Placebo
Intervention description: Administered as intravenous infusion.; Administered as intravenous infusion.
Intervention MeSH terms: Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
      the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants
      diagnosed with severe postpartum depression.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant either must have ceased lactating at Screening; or if still lactating at
             Screening, must have already fully and permanently weaned their infant(s) from
             breastmilk; or if still actively breastfeeding at Screening, must agree to cease
             giving breastmilk to their infant(s) prior to receiving study drug.

          -  Participant had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).

          -  Participant was less than or equal to (<=) six months postpartum.

          -  Participant must be amenable to intravenous therapy.

        Key Exclusion Criteria:

          -  Active psychosis.

          -  Attempted suicide associated with index case of postpartum depression.

          -  Medical history of seizures.

          -  Medical history of bipolar disorder.

        Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion
        criteria may apply.
Zaleplon in HIV Patients With Depression
Condition: HIV/AIDS; Clinical Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Zaleplon
Intervention description: non-benzodiazepine hypnotic agent
Intervention MeSH terms: Zaleplon
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Insomnia; Zaleplon

Summary:

      In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for
      comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep
      measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive
             HIV

          2. Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance
             with DSM-IV criteria, and receiving pharmacologic treatment.

          3. Subject has obtained some subjective benefit from current antidepressant therapy and
             is agreeable to remain on the same medication for the course of this study

          4. Current symptoms of insomnia as determined by a total score of at least 2 on items 4,
             5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset
             latency of at least 1 hour, 3 or more times per week))

          5. Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll
             any patients who might require weaning off of sedative hypnotic medications in order
             to be eligible for the study)

          6. Ability to understand the requirements of the study and provide informed consent

        Exclusion Criteria:

          1. Significant chronic, systemic illness or significant neurologic disorder, including
             traumatic brain injury

          2. Clinically significant history of liver disease

          3. Psychiatrically unstable patients in the clinical judgment of the investigator as
             indicated by current acute suicidality, current homicidal thoughts, or current
             psychosis

          4. Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness

          5. History of substance abuse or dependence over the past 6 months

          6. Currently taking medication to assist with sleep (e.g.,
             Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam,
             Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon,
             Sonata/Zaleplon, Melatonin, Unisom, Benadryl).

          7. Pregnant