bioihbjkbjnl/mcl2 huggingface dataset:
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: LAT8881; Placebo
Intervention description: Two 30 mg capsules of LAT8881; Two capsules of placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomised, placebo controlled, double blind, crossover proof of concept study to
      investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females aged 18 to 75 years at the time of consent

          2. Diagnosis of episodic migraine headache at least 12 months ago with or without aura as
             defined in International Classification of Headache-3

          3. Onset of migraine headache before age 50

          4. Medical history of 2 - 8 migraine headache attacks per month for the previous 12
             months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie,
             rapidly-escalating)

          5. Minimum 48 hours on average between migraine headache attacks

          6. Acute headache medication on ≤ 14 days/month in the 3 months prior to screening

          7. Willing and able to comply with all study procedures including completion of a
             headache diary and a migraine diary on the day of a migraine headache

        Exclusion Criteria:

          1. Unable to distinguish migraine from other primary headache conditions

          2. Average of 15 or more headache (migraine or nonmigraine) days per month or history of
             more than 25% of headaches occurring at time of wakening (wake up headaches)

          3. History of aura lasting more than 60 minutes

          4. History of vomiting within 2 hours of onset of a migraine headache in more than 25% of
             migraine headaches

          5. Medication overuse headache, defined as:

               1. use of opioids, triptans or ergot alkaloids or any combination of these
                  medications for treatment of headaches 10 or more days per month during the 90
                  days prior to screening OR

               2. Non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics for treatment
                  of headaches on more than 14 days per month during the 90 days prior to screening

          6. Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension
             headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or
             treatment resistant atypical migraine

          7. Hospital admission for status intractable migraine or medication overuse headache
             within 6 months of screening
A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
Condition: Subjects Referred to CT-examination of the Abdomen
Intervention: Lumentin® 44; Diluted Omnipaque®; Movprep®
Intervention description: Contrast agent; Contrast agent; Contrast agent
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to
      either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in
      contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining)
      will be compared by the three contrast agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender at least 18 years at the time of signing the informed
             consent.

          -  Having a clinical indication for CT-examination of the abdomen

        Exclusion Criteria:

          -  IV administration of iodine is contraindicated

          -  Known allergy to egg albumen

          -  Clinical suspicion, according to medical record, of fistula formation and/or leakage

          -  Referral indication of small bowel disease(s)

          -  Having known manifest thyrotoxicosis

          -  Having known phenylketonuria

          -  Having known Glucose-6-phosphatase deficiency
Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: BMS-955176; Atazanavir (ATV); Ritonavir (RTV); Dolutegravir (DTG); Tenofovir (TDF)
Intervention description: HIV Maturation Inhibitor; Atazanavir; Ritonavir; Dolutegravir; Tenofovir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Dolutegravir; BMS-955176
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether the combination of BMS-955176 with
      atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious,
      safe, and well-tolerated in HIV-1 infected treatment experienced adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant women, at least 18 years of age

          -  Antiretroviral treatment-experienced, defined as having documented evidence of having
             failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or
             without documented resistance)

          -  CD4+ T-cell count > 50 cells/mm3

          -  Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV,
             FC < 2.2; DTG; TDF)

        Exclusion Criteria:

          -  Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens

          -  Resistance or partial resistance to any study drug determined by tests at Screening

          -  Historical or documented genotypic and/or phenotypic drug resistance testing showing
             certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs

          -  Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)

          -  Blood tests that indicate normal liver function

          -  Hemoglobin < 8.0 g/dL, Platelets < 50,000 cells/mm3
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
Condition: Heart Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure; Ventricular Dysfunction, Left; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Finerenone (BAY94-8862); Placebo; Inspra (eplerenone)
Intervention MeSH terms: Eplerenone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1066.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Decompensation

Summary:

      To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was
      safe and can help the well-being of patients with worsening chronic heart failure and either
      type II diabetes with or without chronic kidney disease or kidney disease alone. These
      treatment doses were compared to eplerenone, another marketed drug approved to treat heart
      failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 years and older. The lower age limit may be higher if legally
             required in the participating country

          -  Women of childbearing potential can only be included in the study if a pregnancy test
             is negative and if they agree to use adequate contraception when sexually active

          -  Subjects with worsening chronic heart failure requiring emergency presentation to
             hospital and treatment with intravenous diuretics at hospital

          -  Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non
             ischemic, New York Heart Association (NYHA) functional class II-IV

          -  Subjects with type 2 diabetes mellitus and / or

          -  Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of
             Diet in Renal Disease Study Group) at screening

          -  Left ventricular ejection fraction (LVEF) </= 40%

          -  Blood potassium </= 5.0 mmol/L at screening

          -  Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the
             screening visit

        Exclusion Criteria:

          -  Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute
             myocarditis

          -  Acute coronary syndrome (ACS) in last 30 days prior to screening

          -  Cardiogenic shock

          -  Valvular heart disease requiring surgical intervention during the course of the study

          -  Stroke or transient ischemic cerebral attack in the last 3 months prior to the
             screening visit

          -  Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin
             inhibitor, or potassium-sparing diuretic
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: SGX942; Placebo
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:

      To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment
      for the treatment of head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is
             planned to receive a standard course of concomitant CRT.

          -  Patients who have received surgery are eligible if surgery is performed within 6 weeks
             prior to study initiation.

          -  Planned to receive standard cisplatin chemotherapy administered either weekly or every
             third week.

          -  Must be able to read and understand informed consent

          -  Adequate birth control methods for the duration of the study

        Exclusion Criteria:

          -  Current mucositis.

          -  Prior radiation to the head and neck.

          -  Chemotherapy treatment within the previous 12 months.

          -  Tumors of the lips, sinuses, salivary glands or nasopharynx.

          -  Unknown primary tumor.

          -  Stage 4c metastases.

          -  Evidence of significant hepatic, hematologic, or immunologic disease.

          -  Women who are pregnant or breast-feeding.
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Placebo; Dexpramipexole 50 mg/day; Dexpramipexole 150 mg/day; Dexpramipexole 300 mg/day
Intervention description: Placebo: 2 tablets taken orally twice daily; Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily; Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily; Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
Intervention MeSH terms: Pramipexole
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: Matching placebo during Part 1 and Part 2 placebo washout.
Enrollment: 194.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig; Lou Gehrig's; Lou Gehrig's disease; Motor Neuron Disease; Nervous System Diseases; KNS-760704; BIIB050

Summary:

      This was a 2-part study of dexpramipexole in patients with ALS.

      Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety,
      tolerability, and clinical effects of oral administration of 3 dosage levels of
      dexpramipexole vs. placebo for 12 weeks.

      Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the
      safety, tolerability, and clinical effects of oral administration of 2 dosage levels of
      dexpramipexole for up to 72 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible,
             laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS
             according to the World Federation of Neurology El Escorial criteria

          -  Patients with ALS symptom onset < 24 months from randomization

          -  Patients with upright vital capacity (VC) > 65% of predicted for age, height, and
             gender

        Exclusion Criteria:

          -  Patients in whom causes of neuromuscular weakness other than ALS have not been
             excluded

          -  Patients without clinical evidence of upper motor neuron dysfunction

          -  Patients with clinically suspected ALS according to the World Federation of Neurology
             El Escorial criteria

          -  Patients with prior exposure to KNS-760704 or the R(+) enantiomer of pramipexole
             (i.e., R(+)-pramipexole)

          -  Patients taking other investigational agents (including lithium) within 30 days of
             randomization or during the study
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands
Condition: Platysmal Bands
Intervention: AbobotulinumtoxinA dose 1; Placebo; AbobotulinumtoxinA dose 2; AbobotulinumtoxinA dose 3
Intervention description: Treatment of platysmal bands; Treatment of platysmal bands; Treatment of platysmal bands; Treatment of platysmal bands
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the
      treatment of platysmal bands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe platysmal bands at maximum contraction as assessed by the
             Investigator using a photographic scale

          -  Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the
             subject using a photographic scale

        Exclusion Criteria:

          -  Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or
             chest within 12 months prior to study treatment
Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Mometasone Furoate; Placebo
Intervention description: inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks; placebo training inhaler with the same instructions as the experimental group.
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: 54.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Pain Crisis; Painful Crisis; Sickle Pain

Summary:

      The proposed research is designed to test the global hypothesis that inhaled corticosteroids
      (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in
      adults with Sickle Cell Disease (SCD) who wheeze, but do not meet criteria for a diagnosis of
      asthma. The specific aims of this proposal are 1) Conduct a feasibility study - a randomized
      controlled trial of ICS for adults with SCD who do not meet criteria for a diagnosis of
      asthma but report recurrent cough or wheezing, 2) Measure the effects of ICS on biological
      correlates of pulmonary inflammation (as determined by exhaled nitric oxide) and vascular
      injury (as determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian
      adaptive clinical trial design for therapeutic trials in SCD in preparation for designing a
      definitive trial of ICS. These aims have the potential to 1) change the standard of care for
      individuals with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis
      of non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability of
      innovative clinical trial designs to overcome the challenges that have hindered therapeutic
      innovation for SCD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 15 or older

          -  Sever SCD phenotypes (Hb SS and Sβthalassemia0)

          -  A positive response to cough/wheeze questions

        Exclusion Criteria:

          -  Patient carries a physician diagnosis of asthma

          -  Patient is prescribed asthma medications

          -  Patient is currently having a painful crisis (as defined by validated pain diary
             questions)

          -  Patient has acute respiratory symptoms

          -  Known hypersensitivity to milk proteins

          -  Meets criteria for our operational diagnosis of asthma

          -  More than 15 ED visits for pain over the preceding 12 months

          -  Admitted or discharged from the hospital for SCD pain within the last 7 days
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Naproxen Sodium (Aleve, BAY117031); Acetaminophen ER; Celecoxib; Placebo
Intervention description: 660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A); 3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B); 200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C); Over-encapsulation capsule, 4 days, oral (Treatment D)
Intervention MeSH terms: Acetaminophen; Celecoxib; Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that
      frequently affects several joints such as knee, hip, spine and hands.This placebo-controlled
      clinical trial assessed the effects of naproxen sodium, acetaminophen and celecoxib on
      stiffness in subjects with osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 40 and 80 years

          -  Body Mass Index (BMI) between 18 and <40 kg/m^2

          -  Unilateral or bilateral osteoarthritis of the knee

          -  Diagnostic quality radiography of the target knee performed no more than 1 year prior
             to baseline showing evidence of osteoarthritis (OA) with Kellgren and Lawrence grade
             of II or III

          -  Joint Stiffness Severity score ≥3.0 on a 0-10 numerical rating scale (NRS) at
             screening

        Exclusion Criteria:

          -  History of underlying inflammatory arthropathy, rheumatoid arthritis or fibromyalgia

          -  History of or scheduled for target knee replacement surgery

          -  Recent injury in target knee (past 4 months)
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
Condition: Advanced or Metastatic Solid Tumors; FGFR Mutations; FGFR Translocations
MeSH terms: Neoplasms
Intervention: Pemigatinib
Intervention description: Pemigatinib administered orally once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced solid tumor; metastatic solid tumor; FGFR inhibitor; FGFR mutation; FGFR translocation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of pemigatinib in
      participants with previously treated locally advanced/metastatic or surgically unresectable
      solid tumors harboring activating FGFR mutations or translocations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed solid tumor malignancy that is advanced or
             metastatic (Stage IIIB or IV) or is surgically unresectable.

          -  Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain
             tumors).

          -  Documentation of an FGFR1-3 gene mutation or translocation.

          -  Objective disease progression after at least 1 prior therapy.

          -  Not eligible or able to participate in any other Incyte-sponsored clinical trial.

        Exclusion Criteria:

          -  Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.

          -  Prior receipt of a selective FGFR inhibitor.

          -  Current evidence of clinically significant corneal or retinal disorder.

          -  History of calcium and phosphate hemostasis disorder or systemic mineral imbalance
             with ectopic calcification of soft tissues.