bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Placebo; Curcumin
Intervention description: daily placebo for 6 weeks; 500 mg BID
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Chemotherapy; Radiotherapy; NF-kB; DNA Binding; Curcumin; IL-6; TNF; sTNFR2; IL-1-ra; Fatigue; Cytokine

Summary:

      The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding
      and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer
      after having completed chemotherapy. Patients who have received prior chemotherapy will be
      eligible, because we have found that this enriched population is at particular risk for
      exhibiting increased NF-kB DNA binding and IL-6 following XRT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female breast cancer patients over the age of 18 will be recruited for this study.
             Patients enrolled in the study will meet standard criteria for whole breast XRT.

        Exclusion Criteria:

          -  Subjects will be excluded for a number of medical conditions that are
             contraindications to XRT and/or might confound the relationship among fatigue, and
             inflammation, including pregnancy, major psychiatric disorders, autoimmune or
             inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C),
             neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal
             disease (as determined by medical history, physical examination and laboratory
             testing). Subjects with a history of a major psychiatric disorder including
             Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence
             within the past 1 year (as determined by standardized psychiatric interview) will be
             excluded. Subjects taking drugs known to affect the immune system (e.g.
             glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or
             other natural products with one week of starting medications, excluding vitamins and
             calcium supplementation or at the discretion of the attending physician, will be
             excluded. Patients who have evidence of infection as determined by history, physical
             exam or laboratory testing (complete blood count and urinalysis) at baseline will be
             excluded. In addition, patients who develop evidence of infection (as determined by
             history, physical exam or laboratory testing) during the study will be discontinued
             from the study.
Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Lubiprostone; Placebo
Intervention description: 8 mcg administered orally twice daily (BID); Matching placebo, 0 mcg administered orally twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Care provider and outcomes assessor were also blinded
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III
             Diagnostic Questionnaire for Adult Functional GI Disorders.

          -  Subject Screening diary entries must show an average worst abdominal pain in the past
             24 hours score of at least 4 on a 11-point scale.

          -  Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs),
             serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
             inhibitors if taking antidepressants.

        Exclusion Criteria:

          -  Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation
             (IBS-C), according to Rome III Criteria.

          -  Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or
             defecation.

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication.
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Condition: Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Intervention: CC-90001; Placebo
Intervention description: oral; oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Alcoholic Steatohepatitis; NASH; Non-Alcoholic Fatty Liver; Liver Fibrosis; CC-90001

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational,
      dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with
      placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver
      fibrosis.

      This study is designed to assess response to treatment on measures of fibrosis and other
      efficacy parameters. It will also assess dose response and overall safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence
             of Stage 2, Stage 3 fibrosis based of the non-alcoholic steatohepatitis (NASH)
             Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty
             liver disease (NAFLD) Activity Score (NAS) of 4 or higher

        Exclusion Criteria:

        - Key Exclusion Criteria

          1. History or evidence of decompensated liver disease,

          2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic
             steatohepatitis (NASH).

          3. Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening.

          4. History or positive screen for human immunodeficiency virus (HIV) infection or
             congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies
             (eg, common variable immunodeficiency [CVID]).

          5. History of hepatitis B and/or hepatitis C.

          6. History of malignancy within the last 5 years (exceptions: excised and cured
             basal/squamous cell skin carcinomas and cervical carcinoma in situ).

          7. Pregnancy or lactation.
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Fludarabine; Rituximab
Intervention description: 150 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles; 12.5 mg/m^2 IV on Days 1-3 of every 28-day cycle for 6 cycles; 375 mg/m^2 IV Day 0 of Cycle 1, 500 mg/m^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will assess the safety and efficacy of low dose fludarabine
      and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as
      primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia.
      Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2
      intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5
      mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6).
      Anticipated time on study treatment is 6 months, with a 30-month follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 65 years of age

          -  Previously untreated B-cell chronic lymphocytic leukemia (CLL)

          -  Binet stage C or active Binet stage A and B disease

        Exclusion Criteria:

          -  Prior treatment for CLL

          -  CLL with transformation (Richter's syndrome)

          -  Suspected or known central nervous system (CNS) involvement of CLL

          -  Impaired renal or hepatic function

          -  Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B
             Virus (HBV) surface antigen positive, or any active or uncontrolled infections

          -  Patients with anti-HBV core antibodies (past infection with HBV) but who are negative
             for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or
             negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain
             reaction (PCR) analysis

          -  Concomitant diseases requiring chronic steroid administration

          -  Active second malignancy within the 2 years prior to study (except for non-melanoma
             skin cancer and in situ cervix or breast or prostate carcinoma)

          -  Eastern Cooperative Oncology Group (ECOG) performance status >/= 3
Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Condition: Thalassemia; Iron Overload
MeSH terms: Thalassemia; Iron Overload
Intervention: Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)
Intervention description: All subjects will be given Deferasirox 20-30 mg/kg for 7 days per week. All subject will be given Deferoxamine 50 mg/kg for 3-7 days per week. The number of days for Deferoxamine will be determined by liver iron concentration at baseline.
Intervention MeSH terms: Deferasirox; Deferoxamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: Thalassemia; Chelation; Iron Overload; Thalassemia patients with Iron overload

Summary:

      This is a pilot study looking at the safety and efficacy of giving combination chelation with
      deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in
      decreasing overall iron in patients with thalassemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Transfusion Dependent Thalassemia

          -  If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented
             endocrinopathy or cardiac finding

          -  Older than 8 years

        Exclusion Criteria:

          -  Participating on another interventional clinical trial
Paracervical Block During Office Hysteroscopy
Condition: Paracervical Block
Intervention: Lidocaine paracervical block; Normal Saline
Intervention description: 5cc 1% lidocaine injection in each paracervical region; 5cc Normal Saline injection in each paracervical region
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hysteroscopy; Pain medication; Lidocaine; Office Procedures

Summary:

      The purpose of this study is to determine the effectiveness of paracervical block for pain
      relief in office hysteroscopy - particularly with the placement of the Essure device.
      Subjects will be randomized to receive either paracervical block or saline, and will have
      pain assessments performed throughout the procedure. Subjects and physicians will be blinded
      to group assignments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women eligible and scheduled for office hysteroscopic placement of essure devices

        Exclusion Criteria:

          -  Planned secondary procedures

          -  Lidocaine allergy

          -  Repeat procedures
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-121; TEZ; VX-561; TEZ/IVA; IVA; Placebo
Intervention description: Tablets for oral administration.; TEZ tablet for oral administration.; Tablets for oral administration.; Fixed-dose combination tablets for oral administration.; Tablets for oral administration.; Placebos matched to VX-121, TEZ, and VX-561 for oral administration.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121
      combination therapy in subjects with cystic fibrosis (CF).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Part 1: Heterozygous for F508del and an MF mutation (F/MF)

          -  Part 2: Homozygous for F508del (F/F)

          -  FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height

        Key Exclusion Criteria:

          -  History of clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  History of solid organ or hematological transplantation

        Other protocol-defined Inclusion/Exclusion criteria may apply
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: RPC1063
Intervention MeSH terms: Ozanimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Crohn's disease (CD) confirmed by endoscopy and histology

          -  Active disease as evaluated by Crohn's Disease Activity Index Score and Simple
             Endoscopic Score for CD

          -  Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic
             therapy

        Key Exclusion Criteria:

          -  Diagnosis of ulcerative colitis or indeterminate colitis

          -  Known strictures/stenosis leading to symptoms of obstruction

          -  Current stoma or need for ileostomy or colostomy

          -  Clinically relevant cardiovascular conditions or other relevant diseases that could
             impact the implementation or interpretation of the trial, or put the patient at risk

          -  History of uveitis or known macular edema

          -  History of colonic dysplasia
Phase II Study of HMPL-004 in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: HMPL-004; Placebo
Intervention description: HMPL-004 1200 mg/d; Placebo 1200 mg/d
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy
      and safety of HMPL-004 in patients with active moderate Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or
             histologically), with a CDAI of 220-400 at baseline screen

        Exclusion Criteria:

          -  They have received anti-TNF-α antibody within 3 months of starting study medication,
             or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of
             starting study medication
Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Thymic peptides
Intervention description: 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A participant-level comparison based on registry data from the Hospital de Santa Bárbara Integrado will be performed after propensity score matching.
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: SARS-CoV-2 Infection; COVID-19 Pandemic; 2019 Novel Coronavirus Disease; Thymic peptides; Thymus gland; Peptides; Honduras; Coronavirus Disease 2019; Coronavirus Disease-19; COVID-19 Virus Infection; 2019-nCoV Disease; 2019-nCoV Infection

Summary:

      This is a single-arm, open-label, phase II clinical study to evaluate the safety and efficacy
      of thymic peptides in the treatment of hospitalized COVID-19 patients in Honduras.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed case of COVID-19 by viral nucleic acid (RNA) detection, viral antigen
             detection, or detection of antibodies to the virus.

          -  Participants that require hospitalization under Honduran Ministry of Health Guidelines
             for Clinical Management of COVID-19 Adult Patients: Stage IIb, defined as a patient
             with or without risk factors that presents with warning signs (shortness of breath,
             tachypnea), and altered inflammatory parameters.

          -  Participants that present with at least one of the following: oxygen saturation level
             below 94 percent; complete blood count showing lymphopenia, neutrophilia, or both;
             positive C-reactive protein; chest radiography or CT scan with ground-glass opacities.

          -  Male or female at least 21 years old.

        Exclusion Criteria:

          -  COVID-19 patients that do not require hospitalization under Honduran Ministry of
             Health Guidelines for Clinical Management of COVID-19 Adult Patients: phase IA
             (asymptomatic), phase IB (mild symptoms without risk factors), or phase IC (mild
             symptoms with risk factors).

          -  Participants currently in other clinical trials evaluating experimental drugs.

          -  Known history of allergic reactions to thymic peptides or calf thymus acid lysate
             derivatives.

          -  Organ transplant recipients.

          -  Women who are pregnant or breast feeding.
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ORM-12741; ORM-12741; Placebo for ORM-12741
Intervention description: 60mg twice a day; 200mg twice a day; Placebo twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether ORM-12741 is safe and effective in the
      treatment of Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained from the patient and legally acceptable representative, if
             required

          -  Informed consent obtained from the caregiver

          -  Males and and females between 55-90 years

          -  Diagnosis of probable Alzheimer's disease, history of progressive cognitive
             deterioration

          -  Brain imaging consistent with Alzheimer's disease

          -  Mini-mental state examination score 12-21

          -  Treated with donepezil, rivastigmine or galantamine

          -  At least mild level of behavioral symptoms

        Exclusion Criteria:

          -  Other types of dementias

          -  Modified Hachinski Ischemia Score > 4

          -  Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a
             max of 3 nights/week) within 2 months

          -  Changes in antidepressant dosing within 2 months

          -  Use of other psychotropic agents

          -  Myocardial infarction within the past 2 years

          -  Malignancy within the past 5 years

          -  Suicidal ideation, risk of suicide

          -  History of alcoholism or drug abuse within 5 years

          -  Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal,
             neurological or psychiatric disorder or any other major concurrent illness

          -  Specific findings in brain imaging

          -  Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical
             examination; orthostatic hypotension

          -  Blood donation or participation in a drug study within 60 days

          -  Previous AD immunotherapy treatment

          -  Patient cannot complete the computerised cognitive training

          -  Patients who reside in a skilled nursing facility

          -  Patients who are not able to swallow capsules