bioihbjkbjnl/mcl2 huggingface dataset:
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: PF-06651600; PF-06700841; Placebo
Intervention description: 200 mg QD during induction and 50 mg QD during Maintenance; 60 mg QD during induction and 30 mg QD during maintenance; Placebo
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model description: The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Phase 2; randomized; double-blind; placebo; alopecia areata; safety; efficacy; JAK; janus kinase; moderate; severe

Summary:

      This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an
      extension period. The study will have a maximum duration of approximately 113 weeks. This
      includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday
      (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind)
      Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension
      Period and a 4 week Follow up Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 75 years of age, inclusive, at time of informed
             consent.

          -  Must have moderate to severe alopecia areata:

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)

          -  Have received any of the following treatment regiments specified in the timeframes
             outlined below:

        Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
        first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
        of first dose of study drug: Participation in other studies involving investigational
        drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
        attenuated live vaccine.

        Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
        (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
        booth/parlor.

        Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal
        medications with unknown properties or known beneficial effects for AA.
Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Condition: Stage III Gastric Cancer; Stage IV Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: bryostatin 1; cisplatin; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Correlative studies
Intervention MeSH terms: Bryostatin 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients
      who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different
      ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase
      the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining
      cisplatin with bryostatin 1 may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic or unresectable carcinoma of the stomach

          -  Measurable disease

          -  No brain metastasis

          -  Performance status - Karnofsky 70-100%

          -  More than 3 months

          -  WBC at least 3,000/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 g/dL

          -  No history of any bleeding disorders

          -  Bilirubin no greater than 1.5 mg/dL

          -  Transaminases no greater than 2 times normal

          -  Creatinine no greater than 1.5 mg/dL

          -  Creatinine clearance at least 60 mL/min

          -  No history of peptic ulceration or gastrointestinal bleeding

          -  No active infection

          -  No seizure disorder

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No other serious concurrent illness that would preclude study entry

          -  No medical, social, or psychological factors that would preclude study entry

          -  No prior chemotherapy

          -  No prior radiotherapy

          -  More than 4 weeks since prior major surgery

          -  Prior incomplete resection allowed

          -  No other prior antitumor treatment
Selinexor Treatment of Refractory Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Selinexor; Dexamethasone
Intervention description: Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.); 20 mg was given with each dose of Selinexor.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; Karyopharm; KPT-330; Selinexor; Refractory; Bortezomib; Carfilzomib; Lenalidomide; Pomalidomide; Dexamethasone; STORM; Daratumumab

Summary:

      This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus
      dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with
      penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).
    

Eligibility criteria:

        Inclusion Criteria:

        Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:

          1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by
             quantitative IgA

          2. Urinary M-protein excretion ≥ 200 mg/24 hours

          3. Free Light Chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal

          4. If serum protein electrophoresis is felt to be unreliable for routine M-protein
             measurement, then quantitative Ig levels by nephelometry or turbidimetry are
             acceptable

               -  Must have previously received ≥ 3 anti-MM regimens including: an alkylating
                  agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a
                  glucocorticoid. There is no upper limit on the number of prior therapies provided
                  that all other inclusion/exclusion criteria are met.

               -  MM refractory to previous treatment with one or more glucocorticoids, parenteral
                  PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or
                  pomalidomide), and the anti-CD38 mAb, daratumumab. Refractory is defined as ≤ 25%
                  response to therapy, or progression during therapy or progression within 60 days
                  after completion of therapy.

        Exclusion Criteria:

          -  Active smoldering MM.

          -  Active plasma cell leukemia.

          -  Documented systemic amyloid light chain amyloidosis.

          -  Active CNS MM.
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tesofensine/Metoprolol; Placebo
Intervention description: Tesofensine 0.5 mg + Metoprolol 100 mg
Intervention MeSH terms: Metoprolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2
      Diabetes Mellitus
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females

          2. Confirmed diagnosis of T2DM

          3. 18-70 years of age

          4. HbA1c ≥7.0%

        Exclusion Criteria:

          1. Hypersensitivity to tesofensine/metoprolol

          2. Heart failure class II or greater according to the New York Heart Association (NYHA)
             or decompensated heart failure

          3. History of myocardial infarction or stroke within 12 months prior to enrolment

          4. History of coronary revascularisation or angioplasty in the last 12 months prior to
             enrolment

          5. Patients reporting angina in the last 6 months prior to enrolment

          6. Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs

          7. Any clinically significant cardiac arrhythmia
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Levetiracetam
Intervention description: Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Child; Levetiracetam; Keppra®; Infusion; Intravenous

Summary:

      Keppra injection is approved in the US as adjunctive therapy in the treatment of partial
      onset seizures in adults with epilepsy. The objective of the current study is to assess the
      safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 4 and 16 years of age, inclusive

          -  The subject suffers from epilepsy (except status epilepticus)

          -  The subject is requiring levetiracetam IV treatment in place of oral therapy for a
             short period of time

        Exclusion Criteria:

          -  The subject has difficult venous accessibility

          -  History of status epilepticus during the 3 months prior to visit 1.

          -  The subject is taking felbamate at visit 1 or has been taking it in the past.
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)
Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: 5-Azacytidine; Ara-C; Valproic Acid (VPA)
Intervention description: 75 mg/m^2 daily for 7 days (days 1-7) via subcutaneous injection.; 20 mg twice daily via subcutaneous injection for 10 days.; 50 mg/m^2 orally daily days 1-7.
Intervention MeSH terms: Cytarabine; Azacitidine; Valproic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; AML; Myelodysplastic Syndrome; Leukemia; MDS; Azacytidine; 5-Azacytidine; 5-aza; Vidaza; 5-AZC; AZA-CR; Ladakamycin; Ara-C; Cytarabine; Cytosar; DepoCyt; Cytosine arabinosine hydrochloride; Valproic Acid; VPA; Depakene

Summary:

      Primary Objective:

      1. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces
      longer event free survival time in patients age > or = 60 years with untreated Acute Myeloid
      Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for,
      or not placed on, studies of new agents.

      Secondary Objective:

      1. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts
      predicts response to either therapy or whether the ability of the 5 azacytidine + valproic
      acid combination to induce demethylation or acetylation parallels response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have untreated AML, or untreated MDS with > 10% blasts in marrow or
             blood.

          2. They must be at least age 60.

          3. They must either have a serum creatinine > 1.9 mg/ml, a serum bilirubin > 1.9 mg/ml,
             or a Zubrod performance status of 3 or 4.

          4. Alternatively, they must not be candidates for protocols of higher priority.

          5. They must provide written consent.

        Exclusion Criteria:

        1) Must not have the cytogenetic abnormalities inv (16), t (16;16) t (8;21), or t (15;17).
        The relatively good prognoses of patients with these findings do not warrant use of 5
        azacytidine, + valproic acid or low-dose ara-C (LDAC).
A Rollover Protocol of Dacomitinib For Patients In Japan
Condition: NSCLC
Intervention: Dacomitinib
Intervention description: Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study to permit continued access to dacomitinib for patients who
      participated in other dacomitinib monotherapy treatment protocols in Japan and have the
      potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who received dacomitinib on another clinical trial in Japan

          -  Evidence of a personally signed and dated informed consent document

        Exclusion Criteria:

          -  Patients who meet one or more study withdrawal criteria on the prior study

          -  Participation in other studies involving other investigational drug(s) during study
             participation
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
Condition: Hypertension, Pulmonary; Ventricular Dysfunction, Left
MeSH terms: Hypertension, Pulmonary; Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Riociguat (Adempas, BAY63-2521); Placebo
Intervention description: 1 mg single oral dose; Single oral dose
Intervention MeSH terms: Riociguat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Hypertension; Left ventricular dysfunction

Summary:

      The aim of this study is to assess whether oral Riociguat affects the left ventricular
      contractility and relaxation in patients with pulmonary hypertension associated with left
      ventricular systolic dysfunction
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with symptomatic pulmonary hypertension due to left
             ventricular systolic dysfunction despite standard heart failure therapy

        Exclusion Criteria:

          -  Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
Condition: Neuroendocrine Carcinoma of the Lung and Thymus
MeSH terms: Carcinoma; Carcinoma, Neuroendocrine; Lung Neoplasms
Intervention: Pasireotide LAR; Everolimus; Pasireotide LAR and Everolimus Combination
Intervention description: 60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1; 10 mg tables administered orally once a day; Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
Intervention MeSH terms: Everolimus; Pasireotide; Somatostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus,adult,SOM230,carcinoma,lung cancer,

Summary:

      This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR
      alone or in combination in adult patients with advanced (unresectable or metastatic)
      neuroendocrine carcinoma of the lung and thymus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmed advanced well differentiated typical and atypical carcinoid
             tumors of the lung or thymus

          -  Patients of all treatment lines including naive patients could have been enrolled

          -  At least one measurable lesion of disease on CT scan or MRI

          -  Radiological documentation of disease progression within 12 months prior to
             randomization

          -  Adequate liver, renal and bone marrow function

          -  WHO Performance Status 0-2

        Exclusion Criteria:

          -  Poorly differentiated neuroendocrine carcinoma

          -  Non-neuroendocrine thymoma

          -  Patients with severe functional disease who required symptomatic treatment with
             somatostatin analogs

          -  Prior therapy with mTOR inhibitors

          -  History of liver disease

          -  Baseline QTcF> 470 msec

          -  Uncontrolled diabetes mellitus despite adequate therapy
Study of Magnetic Fields for Treatment of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: The Resonator; The Resonator control
Intervention description: active magnetic field therapy; inactive magnetic field therapy with placebo fields
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if low level magnetic fields may help to relieve
      symptoms of Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  idiopathic PD with motor fluctuations of at least 3-4 hours daily., Subject on
             levodopa, subject is ambulatory, maintain regular med schedule, willing and able to
             abstain from new PD treatments, Able to demonstrate correct completion of PD diaries,
             non-demented, adequate contraceptive measures, capable of giving full written consent.

        Exclusion Criteria:

          -  any factors that will prevent subject from completing full course of therapy with the
             resonator, any factors preventing subject from attending clinic in the "off" state,
             atypical parkinsonism, no active brain tumors, strokes, hydrocephalus, any other
             neurologic or non-neurologic disorder which might affect the symptomatic expression of
             pts. parkinsonism, suffers from chronic pain, no meds that may produce parkinsonism,
             no psychiatric disturbance, Epilepsy, HIV, Cancer, History of ECT, Diabetic
             Neuropathy, Uncontrolled HTN, Advanced Pulmonary Disease, Known heart conditions such
             as cardiac arrythmias, previous PD surgical interventions, prosthetics comprised of
             ferrous metals, pacemakers, DBS, Uncontrolled, unstable or untreated medical
             illnesses, Consumption of more than 21 alcoholic drinks per week, Pregnant, breast
             feeding, developmental disability