bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Condition: Acute Unilateral Vestibulopathy (AUV)
Intervention: SENS-111 100mg; SENS-111 200mg; Placebo Oral Tablet
Intervention description: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.; SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.; Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute unilateral vestibulopathy, AUV

Summary:

      A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and
      safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4
      days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
    

Eligibility criteria:

        Inclusion criteria includes, but is not limited to:

        * Subject has a diagnosis of definite Acute Unilateral Vestibulopathy

        Exclusion criteria includes, but is not limited to:

          -  Acute continuous vertigo lasting more than 72 hours prior to randomization

          -  History of acute or chronic vestibular diseases

          -  History of prior acute central vestibular lesion

          -  Acute or chronic disease of middle ear
Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm
MeSH terms: Lymphoma; Neoplasms
Intervention: Palbociclib
Intervention description: Given PO
Intervention MeSH terms: Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose
      cancer has genetic changes called CCND1, 2, or 3 amplification. Palbociclib blocks proteins
      called CDK4 and CDK6, which may stop cancer cell growth when CCND1, 2, or 3 amplifications
      are present. Researchers hope to learn if palbociclib will shrink this type of cancer or stop
      its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must have amplification of CCND1, 2, or 3, or another aberration, as
             determined via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

        Exclusion Criteria:

          -  Patients must not have known hypersensitivity to palbociclib or compounds of similar
             chemical or biologic composition

          -  Patients must not have breast cancer, mantle cell lymphoma or myeloma

          -  Patients with known or symptoms of left ventricular dysfunction will be excluded

          -  Patients must not have had prior treatment with palbociclib, ribociclib, abemaciclib
             or any other CDK4/6 inhibitors

          -  Patients must not be using drugs or foods that are known potent CYP3A4 inhibitors or
             inducers, or are CYP3A4 substrates with narrow therapeutic indices
Efficacy and Safety of AQX-1125 in Unstable COPD
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: AQX-1125; Placebo
Intervention description: Synthetic SHIP1 activator; Placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Exacerbation of COPD; Unstable COPD

Summary:

      The primary objective of this study is to evaluate the effect of 12 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo in subjects following exacerbations
      of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology
      2-containing Inositol-5'-Phosphatase 1) pathway.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥40 years at screening

          2. History of COPD for at least 18 months prior to screening, characterised by excessive
             sputum production

          3. Chronic productive cough for at least 3 months in each of the 2 years prior to
             screening (if other causes of productive cough have been excluded) and/or an
             exacerbation of COPD with predominantly bronchitic symptoms at enrolment

          4. At least 2 documented exacerbations during the last 18 months prior to screening.

          5. Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3
             days) been discharged from hospital due to an acute exacerbation of COPD

          6. Ability to perform pulmonary function testing and with documented fixed airway
             obstruction determined by an FEV1 /FVC [forced vital capacity] ratio
             (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within
             the 6 months prior to Visit 1.

          7. Former smoker or current smoker, both with a smoking history of at least 10 pack years

        Exclusion Criteria:

          1. Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or
             significant non-CF bronchiectasis)

          2. Known alpha-1-antitrypsin deficiency

          3. Treatment with roflumilast or theophylline within 1 month prior to screening

          4. Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior
             to screening including the presence of any new radiological infiltrate on CXR within
             the previous two weeks

          5. Hospitalisation for more than 7 days for current acute exacerbation, or the
             requirement for intubation during hospitalisation

          6. For outpatients, prior medical history indicating that previous exacerbations required
             >3 weeks to stabilise
Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Condition: Atrial Fibrillation; Heart Valve Diseases; Venous Thrombosis
MeSH terms: Atrial Fibrillation; Thrombosis; Venous Thrombosis; Heart Valve Diseases
Intervention: Dosing warfarin every 12 weeks, sham INRs 2 out of 3 times
Intervention description: Warfarin is dosed according to INR to maintain INR 2.0-3.0 or for mechanical mitral valves or mechanical aortic valves with atrial fibrillation INR 2.5-3.5
Intervention MeSH terms: Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: warfarin; prothrombin time; monitoring

Summary:

      Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation)
      have a high risk of blood clot formation. Such clots can result in a stroke. The patients are
      treated with warfarin - a "blood thinner" - to prevent these complications. The treatment has
      to be monitored with a blood test called Prothrombin time (PT) every 1-4 weeks. The dose of
      warfarin has to be changed whenever the PT result is outside of the treatment range. If the
      result is too low there is an increased risk of blood clots. If, instead, the result is too
      high there is a risk of bleeding. One third of the patients have very stable PT results and
      hardly ever have to change the dose.

      The investigators hypothesis is that these patients can go less often, e.g. every 12 weeks,
      for the blood tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients on long-term warfarin (for prophylaxis of arterial embolism in patients with
             atrial fibrillation or mechanical heart valve replacement, or secondary prophylaxis
             after VTE) with a target INR of 2.0-3.0 or 2.5-3.5,

          -  Anticoagulant therapy managed by the clinic (HHS - General Hospital) for at least 6
             months prior to enrolment, and

          -  Maintenance dose of warfarin unchanged for the previous 6 months or longer.

        Exclusion Criteria:

          -  Age <18 years,

          -  Life expectancy of less than 1 year,

          -  Attending physician believes the patient is not suitable for the study (e.g.
             psychiatric disorder, history of non-compliance),

          -  Geographic inaccessibility or

          -  Failure to obtain written consent.
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Condition: Hodgkin Lymphoma; Lymphoma, Large B-Cell, Diffuse; Post-transplant Lymphoproliferative Disorder
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoproliferative Disorders
Intervention: baltaleucel-T
Intervention description: Autologous EBV-specific T cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epstein-Barr Virus; DLBCL; PTLD; EBV; CIVIC; HL; T cell

Summary:

      To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the
      treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and
      Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The study will include three primary cohorts, with any of the following EBV+ diseases:

             Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous
             transplantation following salvage therapy OR 2) relapse following autologous
             transplantation.

             Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.

             Cohort C - PTLD, rituximab treatment failure.

          2. Presence of active lymphoma or active PTLD, based on imaging performed within the
             previous 3 months.

          3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.

          4. Absolute lymphocyte count (ALC) >500/µL

          5. Male or female ≥ 12 years of age

          6. Weight ≥ 35 kg

          7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky
             score ≥ 60, as age appropriate

          8. Able to understand and comply with the requirements of the study and to provide
             written informed consent or age appropriate assent for pediatric patients.

        Exclusion Criteria:

          1. Known central nervous system (CNS) lymphoma

          2. Primary refractory HL or DLBCL

          3. Bulky disease

          4. Relapse or progression following previous autologous EBV specific T cell treatment.

          5. Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of
             alternative corticosteroid within 10 days prior to obtaining 200 mL starting material

          6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus
             (HTLV).

          7. Patient is pregnant or lactating

          8. Systemic fungal, bacterial, viral or other infection that is not controlled

          9. Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)

         10. Known history of primary immunodeficiency
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
Condition: Disseminated Intravascular Coagulation
MeSH terms: Sepsis; Disseminated Intravascular Coagulation
Intervention: Antithrombin alfa (INN name); Control (Standard treatment)
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DIC associated with severe sepsis

Summary:

      The primary objective of the study is to explore the efficacy and safety of ATryn®
      (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC)
      associated with severe sepsis, when administered by continuous intravenous (IV) infusion over
      five days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent has been obtained from the patient or his/her legally
             acceptable representative

          -  Severe sepsis

          -  Disseminated intravascular coagulation
Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Condition: Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma
MeSH terms: Adenocarcinoma; Uterine Neoplasms; Hyperplasia
Intervention: Megestrol acetate and metformin; Megestrol acetate
Intervention description: Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.; Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.
Intervention MeSH terms: Metformin; Megestrol; Megestrol Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma; Conservative Medication

Summary:

      The purpose of this study is to see if megestrol acetate plus metformin will be more
      effective in returning the endometrial tissue to a normal state than megestrol acetate alone
      in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between the ages of 18-45 years old

          -  Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon
             D&C or hysteroscopy

               -  OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low
                  tumor grade), based upon D&C or hysteroscopy, and three MRI parameters shows
                  there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes

          -  Have a desire for remaining reproductive function or uterus

          -  Need to be able to undergo correlative treatment and follow-up

        Exclusion Criteria:

          -  Have a history of serious liver or renal dysfunction

          -  Have a confirmed diagnosis of malignant tumor in genital system

          -  Have taken oral contraceptive or other medicine for the treatment of endometrial
             hyperplasia in the past 6 months

          -  Ask for removal of the uterus or other conservative treatment

          -  serum CA-125 > 35 Um/L
GB001 in Adult Subjects With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: GB001; Placebo
Intervention description: film-coated oral tablet; film-coated oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: GB001; eosinophilic asthma; moderate asthma; severe asthma

Summary:

      A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate
      the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance
      therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect
      to asthma worsening at the end of 24 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  A diagnosis of asthma by a physician at least 12 months before Screening Visit.

          -  Treated with medium or high dose inhaled corticosteroid (ICS) plus additional
             controller for at least 12 months prior to Screening Visit. Subjects must maintain a
             stable ICS dose regimen during the 4 weeks prior to the Screening Visit.

          -  Forced Expiratory Volume in 1 second (FEV1) of ≤ 85% of predicted normal

          -  Demonstrated reversibility of at least 12% in FEV1

          -  Evidence of uncontrolled asthma

          -  Eosinophilic asthma

          -  No changes in ICS dose and compliant with standard of care asthma therapy during
             run-in period.

        Exclusion Criteria

          -  Current smokers (any substance)

          -  Serious co-morbidities

          -  Fridericia's correction QT factor (QTcF) ≥450 msec (male) or ≥470 msec (female)

          -  Use of other investigational drugs within 30 days, or within 5 half-lives, whichever
             is longer, prior to Screening Visit

          -  Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal
             antibodies for asthma

          -  Pregnant or breastfeeding

        Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Condition: Chronic Rhinitis
MeSH terms: Rhinitis
Intervention: Placebo; Guaifenesin
Intervention description: Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID.; Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of
      oral guaifenesin for the therapy of Chronic Rhinitis (CRS) in 36 children between the ages of
      7 and 18 years. The study investigates the effectiveness of guaifenesin in the relief of
      nasal symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to
      nasal airway volume, and biophysical properties of nasal secretion. The investigators
      hypothesize that Guaifenesin use over a period of 14 days improves subjective nasal
      complaints in pediatric patients with chronic rhinitis and nasal congestion, as measured by
      the SN-5 survey compared to use of placebo. There will be an observed improvement in nasal
      volume and cross-sectional area following use of guaifenesin, and nasal secretions will have
      more favorable mucociliary and sneeze clearability compared to use of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal
             stuffiness for at least 3 month duration.

        Exclusion Criteria:

          -  Children with immunodeficiency, cystic fibrosis, acute or subacute symptoms, signs of
             bacterial infection, and/or those who are unable to cooperate with testing will be
             excluded. Children with documented use of the study medication in the month before
             evaluation and during period of symptoms will also be excluded.