bioihbjkbjnl/mcl2 huggingface dataset:
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: BTRX-246040 oral capsule(s); Placebo oral capsule(s)
Intervention description: BTRX-246040 administered once daily to patients with MDD for 8 weeks; administered once daily to patients with MDD for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Anhedonia; antidepressant; Nociceptin; NOPR

Summary:

      This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of
      up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of MDD as defined by DSM-5 criteria and have had at least 1
             prior major depressive episode in the past 10 years

          -  Patients must present with a new current episode of MDD and the duration of the
             current episode must be at least 4 weeks but not longer than 18 months.

          -  At Visit 1 (screening) and Visit 2 (baseline), patients must have clinically
             significant depressive symptoms defined by tandem (investigator- and
             computer-administered) Montgomery-Asberg Depression Rating Scale (MADRS) total scores
             ≥ 26 with a difference of ≤ 7 points between the Investigator- and
             computer-administered MADRS total scores

          -  Patients must have a CGI-S score ≥ 4 at Visit 2 (baseline).

        Exclusion Criteria:

          -  Patients who present with any current DSM-5 disorder other than MDD which is the focus
             of treatment.

          -  Patients who are homicidal in the opinion of the Investigator or are at suicidal risk
             (any suicide attempts within 12 months prior to Visit 1 [screening] or any suicidal
             intent, including a plan, within 3 months prior to Visit 1 [screening]; C-SSRS answer
             of "YES" on item 4 or 5 [suicidal ideation]; Investigator- or computer-administered
             MADRS score of ≥ 5 on item 10 [suicidal thoughts]; by Investigator clinical
             evaluation).

          -  Patients cannot have any history of substance or alcohol use disorder within 12 months
             prior to Visit 1 (screening) per DSM-5 criteria

          -  Patients must not have a clinically significant comorbid disease.
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Condition: Parenteral Nutrition Associated Liver Disease PNALD; Cholestasis
MeSH terms: Liver Diseases; Cholestasis
Intervention: Omegaven™
Intervention description: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: PN; parenteral nutrition; fat emulsions; omega-6 fatty acid; liver disease; fatty acid deficiency

Summary:

      The purpose of this study is to determine if established parenteral nutrition (PN) associated
      liver disease can be reversed or its progression halted by using a parenteral fat emulsion
      prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and
      bilirubin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be enrolled in the Intestinal Rehabilitation Program at the University
             of Nebraska Medical Center, AND:

          -  Be unable to meet nutritional needs solely by enteral nutrition and be expected to
             require PN for at least another 30 days

          -  Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as
             defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not
             necessary for treatment

          -  Signed patient informed consent

        Exclusion Criteria:

          -  Parent or guardian or child unwilling to provide consent or assent

          -  Inability or unwillingness on the part of parent/guardian or child to follow clinical
             recommendations of the Intestinal Rehabilitation Program

          -  Allergies or clinical conditions precluding safe use of Omegaven™
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Condition: Muscle Cramps; Cirrhosis
MeSH terms: Muscle Cramp; Liver Cirrhosis; Spasm; Fibrosis
Intervention: Baclofen
Intervention MeSH terms: Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and efficacy of the medication Baclofen
      for treatment of muscle cramps in patients with cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cirrhosis

          -  Presence of muscle cramps on a regular basis

        Exclusion Criteria:

          -  Allergy or hypersensitivity to Baclofen

          -  Active or untreated Portosystemic encephalopathy

          -  Active alcohol or substance abuse

          -  Age less than 18

          -  Pregnancy

          -  Concomitant use of narcotic pain medication, other muscle relaxer, or other
             anti-spastic agent

          -  Concomitant use of Tricyclic Antidepressant due to drug interaction

          -  History of chronic kidney disease defined by GFR < 30 (using MDRD equation)

          -  Subject is institutionalized or a prisoner

          -  Inability or unwillingness to give informed consent

          -  Expected lifespan less than 3 months

          -  Severe or poorly controlled coexisting medical conditions or other significant issues
             as determined by the principal investigator to hinder the ability to adhere to study
             protocols
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Condition: Peritoneal Neoplasms; Intestinal Obstruction; Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms; Intestinal Obstruction
Intervention: Octreotide LAR; Octreotide (Immediate release); methylprednisolone; Placebo
Intervention description: Octreotide long-acting release (LAR) 30 mg intramuscular injection.; Immediate-release Octreotide supplied in 100 µg/mL ampules.; methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).; Physiologic saline solution
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Octreotide; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bowel obstruction,; peritoneal carcinomatosis; Octreotide; inoperable

Summary:

      To evaluate in combination with corticosteroid and local standard medical care the efficacy
      and safety of long-acting octreotide compared to placebo for the treatment of symptoms of
      inoperable bowel obstruction in patients with peritoneal carcinomatosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptoms and signs of inoperable bowel obstruction confirmed by a
             surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);

          -  Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery,
             imaging and/or cytology);

          -  No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the
             previous 2 weeks ;

          -  No chemotherapy in the previous week;

          -  No radio or chemotherapy planned at the inclusion and within the two weeks following
             inclusion

          -  Authorized concomitant treatments for local standard medical care : antiemetics,
             antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor,
             analgesics; nasogastric tube

        Exclusion Criteria:

          -  Abnormal coagulation (prothrombin time < 60%, platelets < 50x10^9/L).

          -  Non authorized concomitant treatments :

               1. Anticholinergics such as scopolamine

               2. Other somatostatin analogues

        Other protocol-defined inclusion/exclusion criteria may apply
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Condition: Childhood Cancer; Central Venous Catheters; Deep Vein Thrombosis; Catheter-related Infection; Catheter-related Occlusion
MeSH terms: Catheter-Related Infections; Thrombosis; Venous Thrombosis
Intervention: Enoxaparin
Intervention description: Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children >2 months and 1.5 mg/kg every 12 hours for infants <2 months. Duration of treatment is 6 weeks.
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Childhood Cancer; Central Venous Catheter; Deep Vein Thrombosis; Catheter-related Infection; Catheter-related Occlusion

Summary:

      The primary hypothesis of this study is that occult catheter-related DVT in children with
      cancer is common and directly contributes to development of serious catheter complications,
      specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly,
      anticoagulant treatment of clinically silent (occult) DVT will reduce rates of
      catheter-related infection and occlusion, delays in therapy and need for catheter
      replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of cancer

          2. Age ≤ 18 years

          3. First tunneled central venous catheter (implanted port or external) inserted in the
             upper venous system (subclavian, brachiocephalic, or jugular vein) within the previous
             2 weeks

          4. Catheter expected to be in place for duration of chemotherapy (≥ 3 months)

          5. History of no more than one catheter complication (occlusion or infection)

        Exclusion Criteria:

          1. Prior history of DVT

          2. Currently receiving an anticoagulant or anti-platelet agents on a daily basis

          3. Diagnosis of high grade malignant brain tumor or metastasis to the brain

          4. Clinical signs/symptoms of DVT

          5. Clinical signs/symptoms of Pulmonary embolism

          6. Renal failure

          7. Recent major hemorrhage
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QMF149 Twisthaler®; Mometasone Twisthaler®
Intervention description: Once daily via multi-dose dry-powder inhaler; Once daily via multi-dose dry-powder inhaler
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2283.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Asthma; LABA; Safety

Summary:

      Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose
      combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an
      inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The
      objective of this safety trial was to assess the effect of treatment on the incidence of
      serious asthma exacerbations, defined as asthma related hospitalization and/or intubation
      and/or death. This was an event driven trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a documented diagnosis of persistent asthma and who were currently
             treated with or qualified for treatment with both ICS and long-acting beta2-agonist
             (LABA) combination

          -  Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥
             12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist
             (SABA)

          -  Patients with an FEV1 ≥ 50% of predicted normal

        Exclusion Criteria:

          -  Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)

          -  Patients who had an asthma attack/exacerbation requiring hospitalization/emergency
             room visit or respiratory tract infection within 1 month prior to randomization

          -  Patients who had ever required ventilator support for respiratory failure

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Patients with concomitant pulmonary disease

          -  Patients with certain cardiovascular co-morbid conditions

          -  Patients with any significant medical condition that might compromise patient safety,
             interfere with evaluation or preclude completion of the study

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Condition: Raynaud Disease
MeSH terms: Raynaud Disease
Intervention: Ginkgo biloba extract EGb 761
Intervention description: daily Ginkgo biloba extract EGb 761
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Raynaud´s phenomenon; Vasospastic attacks; Ginkgo biloba

Summary:

      The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with
      the primary Raynaud phenomenon, with regards to the frequency, duration and severity of
      vasospastic attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary Raynaud´s phenomenon

          -  History of episodic digital or toe pallor

          -  Duration of Raynaud´s phenomenon at least 2 years

          -  Suffering form regular occuring attacks prior to enrolment

        Exclusion Criteria:

          -  Secondary Raynaud´s phenomenon

          -  Connective tissue disease

          -  Large vessel disease

          -  Cryoglobulinemia, cold agglutinins disease, thrombocytosis

          -  Concomitant pharmacological treatment with effects on the vasculature

          -  Pregnancy or lactation

          -  Severe internal or systemic disease
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: MenACWY-CRM conjugate vaccine, adjuvanted; MenACWY polysaccharide vaccine; MenACWY-CRM conjugate vaccine, unadjuvanted
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 623.0
Sex: All
Minimum age: 12 Months
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningitis; children; vaccine

Summary:

      To compare the functional immune response 28 days after administration of one dose of Men
      ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY
      polysaccharide (PS) vaccine
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy 12-<60 month old children;

        Exclusion Criteria:

          -  subjects who have previously received any meningococcal vaccine

          -  subjects with any serious acute or chronic progressive disease
Exploratory Study of OPC-12759 Ophthalmic Suspension
Condition: Keratoconjunctival Epithelial Disorder
Intervention: OPC-12759 ophthalmic suspension; Sodium hyaluronate ophthalmic solution
Intervention description: OPC-12759 ophthalmic suspension 2%; Sodium hyaluronate ophthalmic solution 0.1%
Intervention MeSH terms: Rebamipide; Ophthalmic Solutions; Hyaluronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for
      patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also,
      safety of OPC-12759 is to be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent
             epithelial defect

          2. Fluorescein corneal staining score of 3 or higher

        Exclusion Criteria:

          1. Active ocular infection

          2. Vernal keratoconjunctivitis

          3. Recurrent corneal erosion

          4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or
             conjunctiva

          5. Subjects who cannot discontinue or anticipate use of eye drops except for limited
             concomitant ones during the study. Soft-santear is allowed during the screening
             period.

          6. Anticipated use of contact lens during the study.

          7. Insertion of punctal plug or fall out of punctal plug within 3 months

          8. Subjects who are judged by the investigator to be ineligible for the study because of
             a past or concurrent systemic disease.

          9. Receipt of any investigational product within 4 months.
Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo
Intervention description: Alirocumab two SC injections in the abdomen only.; Placebo two SC injections in the abdomen only.
Intervention MeSH terms: Alirocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in
      participants diagnosed with heterozygous familial hypercholesterolemia (heFH)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must meet the World Health Organization criteria for heFH

          2. Participants must be on a stable statin dose, with or without ezetimibe, for at least
             6 weeks before screening

          3. Serum LDL-C levels ≥ 100 mg/dL at screening

          4. Willing to follow the NCEP ATPIII TLC diet, or an equivalent diet plan, starting at
             screening and continuing until the last study visit

          5. A negative urine/serum pregnancy test at each screening visit and start of the study,
             for women of childbearing potential

        Key Exclusion Criteria:

          1. Participants with homozygous FH (clinically or by previous genotyping)

          2. Use of a medication (other than a statin or EZE) to alter serum lipids within 42 days
             (6 weeks) before screening including, but not limited to:

               -  Fibrates

               -  Niacin (>500 mg/day)

               -  Omega-3 fatty acids (>1000 mg/day of DHA/EPA)

               -  Bile acid resins

          3. Use of nutraceuticals or OTC medications that may alter lipid levels that are not
             stable for at least 6 weeks before screening and are not planned to remain constant
             throughout the study. Examples include:

               -  Omega-3 fatty acids (≤1000 mg/day of DHA/EPA)

               -  Niacin (≤500 mg/day)

               -  Plant stanols, such as found in Benecol, flax seed oil, psyllium

               -  Red yeast rice

          4. Disorders known to influence lipid levels, such as nephrotic syndrome, significant
             liver disease, Cushing's disease, untreated hypothyroidism (patients on stable thyroid
             replacement for at least 12 weeks before the full screening visit, who are
             metabolically euthyroid by thyroid-stimulating hormone (TSH) testing are allowed)

          5. Use of thyroid medications (except for replacement therapy which has been stable for
             at least 12 weeks before the full screening visit)

          6. Fasting serum TG >350 mg/dL screening

          7. LDL apheresis within 12 months before screening
Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: TBL 12
Intervention description: TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asymptomatic

Summary:

      Purpose:

      The purpose of this study is to see if TBL 12, which is a blend of Sea Cucumber, Sea Sponge,
      Shark Fin, and Sea Urchin (animals that live in the Pacific Ocean) as well as Sargassum (a
      plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple
      myeloma and to see what the side effects are.

      Eligibility:

      Several criteria must be met to be eligible for this study, including but not limited to the
      following:

        -  a diagnosis of asymptomatic multiple myeloma

        -  adequate cardiac, liver and kidney function

        -  age 18 and older
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma

          -  Measurable disease

          -  For non-secretors, measurable protein by Freelite or plasmacytoma

          -  Asymptomatic disease

        Exclusion Criteria:

          -  POEMS syndrome

          -  Plasma cell leukemia

          -  Receiving steroids greater than the equivalent of 10 mg prednisone

          -  Infection not controlled by antibiotics

          -  HIV infection

          -  Known active hepatitis B or C