bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of TD-9855 to Treat Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TD-9855 Group 1; TD-9855 Group 2; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibromyalgia

Summary:

      The purpose of this study study is to determine whether TD-9855 is effective in treating
      patients with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)

               -  Informed consent

               -  18 to 65 years of age

               -  Discontinue therapy with adrenergic-acting drugs, and certain other medications

                    -  Only acetaminophen or NSAID as rescue pain medication

                    -  No narcotic pain meds or benzodiazepines

                    -  Only non-benzodiazepines as rescue hypnotics

        Exclusion Criteria:

          -  Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II
             disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric
             Interview (MINI)

          -  Major depression at screening by MINI when unable to be washed out of MDD meds
             (investigator or provider's judgment)

          -  Risk of suicide (investigator opinion and/or C-SSRS)

          -  Recent history of substance or alcohol abuse

          -  BMI <18 or ≥45

          -  Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history
             of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or
             orthostatic tachycardia; untreated sleep apnea

          -  Abnormal lab values (liver, kidney, thyroid, and others)
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: 10% VDA-1102; 20% VDA-1102
Intervention description: 200 mg twice-daily for 12 weeks; 200 mg once-daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 3-part, open-label, multi-center study
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratosis; efficacy; safety; VDA-1102

Summary:

      This is a Phase 2 clinical study in patients with actinic keratosis involving daily
      application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84
      days). This study has no placebo and the subjects enrolled in the study will know exactly
      what they are receiving. The objectives of the study are to evaluate the safety and benefit
      of these two strengths.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

        Exclusion Criteria:

          -  Subject has no clinically significant findings at Baseline

          -  Subject is unable to demonstrate adequate precision applying the study drug to the
             Treatment Field at Baseline

          -  Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric,
             social problem

          -  Subject has at any time been given a diagnosis or treatment associated with
             immunosuppression

          -  Subject has received VDA-1102 in the past
Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy
Condition: Breast Cancer
Intervention: Glutamine; Placebo
Intervention description: Oral glutamine for subjects undergoing breast conserving therapy; For subjects undergoing breast conserving therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast

Summary:

      This study is a single-centered, double-blind, two-arm randomized study to determine if oral
      glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving
      Therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject have been diagnosed with Stage I or II invasive breast cancer

          -  Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast
             Conserving Therapy (BCT)

          -  Subject is eligible for APBI based on American Society of Therapeutic Radiation
             Oncology (ASTRO) criteria

          -  Subject is 18 years of age or older

          -  Subject is female

        Exclusion Criteria:

          -  History of uncontrolled, clinically significant lung, heart, endocrine, liver, or
             renal disease

          -  Subject has been diagnosed with any other cancer

          -  Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN),
             glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)

          -  Subject has history of collagen vascular disease

          -  Subject has been diagnosed with Diabetes mellitus I or II

          -  Subject has had any prior breast radiation

          -  Subject is pregnant or breastfeeding
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Condition: Congenital Fibrinogen Deficiency; Afibrinogenemia
MeSH terms: Afibrinogenemia
Intervention: Octafibrin; Haemocomplettan® P or RiaSTAPTM
Intervention description: Octafibrin was supplied as a powder for reconstitution with water for injection.; Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy
      and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital
      fibrinogen deficiency
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 12 years.

          -  Documented congenital fibrinogen deficiency (afibrinogenemia).

        Exclusion Criteria:

          -  Life expectancy > 6 month.

          -  Bleeding disorder other than congenital fibrinogen deficiency.

          -  Presence or history of hypersensitivity to study medication.

          -  Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior
             to enrollment.

          -  Presence or history of arterial thrombosis with 1 year prior to enrollment.

          -  Hypersensitivity to human plasma products.

          -  Acute bleeding.

          -  Pregnant or currently breast-feeding women.

          -  Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery
             (if available).

          -  Blood or plasma donation in the 3 months prior to enrollment.

          -  Human immunodeficiency virus (HIV) positive with a viral load > 200 particles/µl or >
             400000 copies/mL.

          -  End-stage liver disease.

          -  History of oesophageal varicose bleeding.
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
Condition: Genital Warts; Perianal Warts
MeSH terms: Warts; Condylomata Acuminata
Intervention: NVN1000 8% Gel; NVN1000 16%; Vehicle; NVN1000 24%
Intervention description: once and twice daily; once daily; placebo comparator; once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: genital warts; perianal warts

Summary:

      A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study
      Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External
      Genital Warts and Perianal Warts
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 2 but not more than 20 genital/perianal warts with a maximum total wart
             surface area no more than 1% body surface area

          -  If a woman of child-bearing potential, have a negative pregnancy test and use
             effective contraception

          -  If currently receiving wart treatment, be willing to stop all treatment for 28 days
             prior to randomization and during the study

        Exclusion Criteria:

          -  Immunocompromised patients including those with HIV, receiving radiation, or drugs
             that suppress the immune system

          -  Pregnant, planning to become pregnant, or nursing

          -  History of cancer (including cervical cancer) within 5 years, with exception of
             non-melanoma skin cancer in non-genital skin

          -  Recent history of other genital skin infections

          -  Active HSV and frequent HSV recurrences unless receiving suppression therapy

          -  Have hemoglobin < 10 G/dl or methemoglobin > 3%

          -  Known allergy to any component of the gel including excipients

          -  Previously participated in any study with NVN1000 or SB204
The Effect of Thiamine vs. Placebo on VO2 in Critical Illness
Condition: Critically Ill; Respiratory Failure
MeSH terms: Respiratory Insufficiency; Critical Illness
Intervention: Thiamine
Intervention description: 200 mg IV thiamine
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VO2, critically ill, oxygen consumption

Summary:

      The objective of this study is to determine the effect of thiamine therapy on oxygen
      consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before
      and after thiamine or placebo administration in patients admitted to the ICU and requiring
      mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on
      the metabolic profile of the patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (age > 18 yrs) admitted to an ICU

          2. Mechanically ventilated for an acute illness, with stable respiratory status (no
             changes in ventilator settings in the 3 hours prior to enrollment)

          3. Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by
             Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.

          4. Upper central venous line in place

        Exclusion Criteria:

          1. Unstable ventilator settings during measurement of VO2

          2. Temperature >100.5

          3. FIO2>60%

          4. Endotracheal cuff leak, chest tube, or other evident source of air leak

          5. Positive end expiratory pressure > 12cmH2O

          6. Intravenous thiamine supplementation within 2 weeks of enrollment, or oral
             supplementation more than that found in a multivitamin.

          7. Protected populations (pregnant woman, prisoners, cognitively impaired)
Naltrexone for Individuals of East Asian Descent
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Naltrexone; Placebo
Intervention description: Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors; Sugar pill, matched to the active study medication in capsule size and color
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: alcohol use disorder; naltrexone; Asian American; pharmacogenetics; OPRM1 gene

Summary:

      This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene
      on biobehavioral and neural markers of response to naltrexone in individuals of East Asian
      descent, an ethnic group most likely to express the positive predictive allele.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current (i.e., past month) alcohol dependence

          -  East Asian ethnicity (i.e., Chinese, Korean, or Japanese)

          -  Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to
             allow for balanced groups on all three genotypes (AA, AG, GG)

        Exclusion Criteria:

          -  lifetime DSM-IV of drug dependence (other than alcohol or nicotine)

          -  current use of psychoactive drugs as determined by self-reports and verified using
             toxicology testing

          -  lifetime diagnosis of bipolar disorder or any psychotic disorder

          -  contraindications to an MRI scan (including left handedness)
Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma (PTCL); Cutaneous T-cell Lymphoma (CTCL)
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Selinexor
Intervention description: 20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (Protocol V.3.0).
20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (Protocol V.<3.0).
Number of Cycles: up to 12 but there is no maximal duration for treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTCL; CTCL; Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma; Karyopharm; KPT-330; Selinexor

Summary:

      This is a single-arm, multi-center, open-label phase 2 study of the SINE™ compound selinexor
      given orally to patients with relapsed or refractory PTCL or CTCL.

      Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility
      criteria and have none of the exclusion criteria will be enrolled to receive selinexor until
      either disease progression or intolerance has occurred.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG performance status of ≤2.

          -  Relapsed or refractory disease to at least one prior systemic regimen.

          -  Measurable disease: according to International Working Group (IWG) guidelines for all
             patients with PTCL and according to CTCL Response in Skin consensus criteria for all
             patients with CTCL.

          -  Objective, documented evidence of disease progression on study entry.

        Exclusion Criteria:

          -  Known active central nervous system (CNS) lymphoma.

          -  Active graft-versus-host disease after allogeneic stem cell transplantation. At least
             4 months must have elapsed since completion of allogeneic stem cell transplantation.

          -  Unable to swallow tablets or malabsorption syndrome, disease significantly affecting
             gastrointestinal function.
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Condition: Total Parenteral Nutrition-induced Cholestasis
MeSH terms: Cholestasis
Intervention: Omegaven®
Intervention description: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 4 Weeks
Maximum age: 18 Years
Healthy volunteers: No
Keywords: PNALD; Cholestasis; Omegaven®; Short Bowel Syndrome

Summary:

      The purpose of this study is to determine whether the omega-3 fatty acid emulsion
      (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is
      effective in treating parenteral nutrition associated liver disease (PNALD) in children.

      The study hypothesis is that Omegaven® can be safely provided to children who are dependent
      on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until
      the child can take adequate nutrition by mouth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 0-18 years of age

          -  Patients will be PN-dependent and expected to continue PN for at least 30 days

          -  Patients considered eligible for study participation must have PN-associated liver
             diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1
             antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for
             treatment

          -  Direct bilirubin > 2.0 mg/dl

          -  Signed patient informed consent

          -  Signed patient assent where applicable.

        Exclusion Criteria:

          -  Pregnancy

          -  Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1
             antitrypsin deficiency)

          -  Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites

          -  The patient is allergic to eggs/shellfish

          -  The patient has a severe hemorrhagic disorder

          -  The patient is enrolled in any other clinical trial involving an investigational agent
             (unless approved by the designated physicians on the multidisciplinary team)

          -  The parent or guardian or child unwilling to provide consent or assent.
A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Condition: Rhinovirus
MeSH terms: Infections; Asthma
Intervention: BTA798; Placebo
Intervention description: BTA798 twice daily; Placebo twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Human rhinovirus; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen

Summary:

      This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on

        -  shortening the length and reducing the symptoms of human rhinovirus infection (also
           known as the common cold),

        -  controlling asthma symptoms, and

        -  lowering the risk of asthma symptoms worsening in subjects with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18-70 years

          -  Diagnosis of asthma consistent with Global Initiative for Asthma (GINA) steps 1 to 3

          -  Presumptive human rhinovirus infection

        Exclusion Criteria:

          -  Current severe asthma exacerbation

          -  Severe asthma, GINA steps 4 or higher

          -  Uncontrolled or clinically significant medical condition, disease or event which could
             impact subject safety and/or study evaluations and/or compliance to the protocol

          -  Current smoker, ex-smoker of <1 year, or history of smoking >/=10 pack years.
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: dorzolamide-timolol-brimonidine
Intervention description: Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma; Ocular hypertension; POAG; Treatment

Summary:

      To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects of either sex and any race with open-angle glaucoma or ocular
             hypertension;

          -  Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).

        Exclusion Criteria:

          -  Clinically relevant ophthalmic or systemic conditions may be excluded.