bioihbjkbjnl/mcl2 huggingface dataset:
Hyperbaric Oxygen Therapy for Lung Transplantation
Condition: Disorder Related to Lung Transplantation; Central Airway Stenosis; Airway Exudative Plaques; Airway Complications Post-Lung Transplantation
MeSH terms: Constriction, Pathologic
Intervention: Hyperbaric Oxygen Therapy; Endobronchial Biopsy of Airway Epithelium
Intervention description: 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at 2 ATA once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.; During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Hyperbaric Oxygen; Lung Transplantation; Central Airway Stenosis; Airway Exudative Plaques; Hyperbaric Oxygen Therapy; Post-Lung Transplantation; Airway Ischemia; Endobronchial Biopsy; Bronchoscopy

Summary:

      The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on
      airway complications in post-lung transplant recipients with evidence of restricted levels of
      blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in
      the early post-transplant period will be randomized to HBOT or usual care and followed
      clinically for 12 months following randomization. The investigators hypothesize that HBOT
      will decrease the number of airway complications in the treated subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-lung transplant patient

          -  Extensive exudative plaques at 1 month bronchoscopy

          -  No sign of airway improvement, or showing worsening of plaques at follow-up
             bronchoscopy 2-3 weeks after 1 month bronchoscopy.

        Exclusion Criteria:

          -  Use of mechanical ventilation with fraction of inspired oxygen(FiO2) greater than 40%

          -  Use of extracorporeal membrane oxygenation

          -  Use of inhaled nitric oxide

          -  Presence of pneumothorax

          -  Pregnancy

          -  Inability to provide informed consent
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Condition: Urinary Tract Cancer
MeSH terms: Urologic Neoplasms
Intervention: trastuzumab; gemcitabine; cisplatin
Intervention description: 4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression; 1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6; 70 mg/m2 i.v. on Day 2 of Cycles 1 through 6
Intervention MeSH terms: Gemcitabine; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous
      Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The
      anticipated time on study treatment is until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients with >=18 years of age;

          -  metastatic urothelial carcinoma;

          -  measurable metastases or local recurrent disease;

          -  no prior chemotherapy for metastatic disease;

          -  HER2 overexpression (IHC [2+] or [3+]).

        Exclusion Criteria:

          -  concomitant chemotherapy or immunotherapy;

          -  active or uncontrolled infection;

          -  solely CNS metastases;

          -  clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;

          -  co-existing malignancies diagnosed within last 5 years, except basal cell cancer or
             cervical cancer in situ.
11C-acetate for Treatment Response After Radiotherapy for HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: 11C-Acetate
Intervention description: The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).
There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      It is thought that PET of the abdomen with 11C Acetate will provide new information regarding
      whether or not patient's have benefited from radiotherapy. To test this theory, the project
      will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of
      treatment success.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 18 years of age

          -  Subject is willing to participate in the study and has signed the study informed
             consent

          -  Subject is available and willing to comply with the protocol evaluations

          -  Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if
             undergoing 90Y radioembolization

          -  Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic
             Body Radiation Therapy (SBRT)

          -  Under consideration for 90Y radioembolization or Stereotactic Body Radiation Therapy
             (SBRT)

        Exclusion Criteria:

          -  Pregnant or planning to become pregnant within the next 12 months or breast-feeding

          -  GFR < 45

          -  Life expectancy < 6 months

          -  Claustrophobic and cannot tolerate imaging procedures

          -  Weigh > 350 lb (upper weight limit of scanner beds)

          -  Special vulnerabilities (e.g. fetuses, neonatales, pregnant women, children,
             prisoners, institutionalized individuals).
Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Intervention: Olinciguat; Matching Placebo
Intervention description: oral tablet; oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives of this study are as follows:

      In participants with primary Type I or II achalasia, following a single 5-mg dose of
      olinciguat (IW-1701),

        -  To assess the safety and tolerability

        -  To determine the effects on measures of esophageal function by high-resolution impedance
           manometry (HRIM)

        -  To determine the pharmacokinetic (PK) parameters
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patient has a diagnosis of primary Type I or II achalasia.

          -  Patient has no contraindications to the performance of the baseline and postdose HRIM
             procedures per Investigator discretion.

        Key Exclusion Criteria:

          -  Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment
             with sclerosing agent.

          -  More than 1 pneumatic dilation procedure to a diameter of > 2 cm in their lifetime.

          -  Pneumatic dilation procedure to a diameter of > 2 cm within 1 year prior to
             randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.

          -  Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to
             randomization or more than 2 esophageal Botox injection procedures in their lifetime.

          -  Patients with malignant or premalignant esophageal lesions.

          -  Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72
             hours before check-in through discharge from the clinic.

        Other inclusion and exclusion criteria specified in the protocol.
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: secukinumab (AIN457); placebo
Intervention description: Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Matching placebo to AIN457 i.v. and to AIN457 s.c..
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA; secukinumab; AIN457; inflammatory joints; American College of Rheumatology; ACR

Summary:

      The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous
      (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo,
      followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite
      treatment with Methotrexate.
    

Eligibility criteria:

        Inclusion criteria:

          -  presence of RA classified by ACR 2010 revised criteria for at least 3 months before
             screening

          -  must have been taking MTX for at least 3 months before randomization and must
             currently be on a stable dose of MTX for at least 4 weeks before randomization.

          -  At Baseline: Disease activity criteria defined by >6 tender joints out of 68 and >6
             swollen joints out of 66 and with at least 1 of the following at screening: Anti-CCP
             antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following
             at screening: hsCRP ≥ 10 mg/L OR ESR ≥ 28

        Exclusion criteria:

          -  RA patients functional status class IV according to the ACR 1991 revised criteria

          -  Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
             or IL-17 receptor

          -  Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic
             agent (experimental or approved)

          -  Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or
             morphine)

          -  Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required
             for treatment of arthritis within 4 weeks before randomization

          -  Other protocol-defined inclusion/exclusion criteria may apply.
A Study of Ketamine in Patients With Treatment-resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: Placebo; Ketamine
Intervention description: Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.; Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Treatment-resistant depression; Ketamine

Summary:

      The purpose of this study is to explore the optimal dose frequency of ketamine in patients
      with treatment-resistant depression (TRD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be medically stable on the basis of clinical laboratory tests performed at screening

          -  Meet diagnostic criteria for recurrent major depressive disorder (MDD), without
             psychotic features

          -  Have a history of inadequate response, ie treatment was not successful, to at least 1
             antidepressant

          -  Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total
             score >= 40 at screening and predose at Day 1

          -  Inpatient or agreed to be admitted to the clinic on each dosing day

        Exclusion Criteria:

          -  Has uncontrolled hypertension

          -  Has a history of, or current signs and symptoms of diseases, infections or conditions
             that in the opinion of the investigator, would make participation not be in the best
             interest (eg, compromise the well-being) of the patient or that could prevent, limit,
             or confound the protocol-specified assessments

          -  Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients

          -  Is unable to read and understand the consent forms and patient reported outcomes,
             complete study-related procedures, and/or communicate with the study staff
A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659; TEZ/IVA; IVA; Placebo (matched to VX-659/TEZ/IVA); TEZ; VX-561; Placebo (matched to VX-659/TEZ/VX-561)
Intervention description: Tablet for oral administration.; TEZ/IVA fixed-dose combination tablet for oral administration.; Tablet for oral administration.; Placebo matched to VX-659 and TEZ/IVA.; Tablet for oral administration.; Tablet for oral administration.; Placebo matched to VX-659, TEZ and VX-561.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor
      (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the
      safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with
      cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane
      conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del
      mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or
      TEZ/IVA (F/MF genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Body weight ≥35 kg.

          -  Subjects must have an eligibleCFTR genotype.

               -  Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF)

               -  Part 2: Homozygous for F508del (F/F)

          -  FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height

        Key Exclusion Criteria:

          -  History of clinically significant cirrhosis with or without portal hypertension.

          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  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.
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: MB-6; Placebo
Intervention description: 6# TID with meal; 6# TID with meal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: MB-6; FOLFOX4; Metastatic Colorectal Cancer

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the
      preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in
      addition to standard chemotherapy in the treatment of patients with metastatic colorectal
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient with histologically confirmed colorectal cancer and/or clinical evidence of
             metastasis;

          2. At least one measurable lesion either by computer tomography (CT) scan or magnetic
             resonance imaging (MRI);

          3. Aged 20 years old or above;

          4. Eastern Cooperative Oncology Group (ECOG) performance status < 2;

          5. Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x
             109/L, platelets > 100 x 109/L);

          6. Adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit,
             creatinine < 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) < 2.5 x upper normal limit;

          7. Patients willing to participate in the trial and giving written informed consent.

        Exclusion Criteria:

          1. Pregnant or lactating patients;

          2. Patients (male or female) with reproductive potential not using adequate contraceptive
             measures;

          3. Patients with evidence of central nervous system metastasis;

          4. Subject with active infection which requires systemic treatment of antibiotic,
             antifungal, or antiviral agents

          5. Current history of chronic diarrhea;

          6. Other serious illness or medical conditions (e.g.: history of angina, myocardial
             infarction);

          7. History of second primary malignancies except for adequately treated basal cell
             carcinoma of the skin or carcinoma in situ of the cervix;

          8. Concurrent treatment with any other anticancer therapy;

          9. Patients with congestive heart failure (New York Heart Association Functional
             Classification III or IV), epilepsy, or other significant medical conditions as judged
             by the investigator;

         10. Patients treated with another investigational drug within 4 weeks of entry into this
             study.
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: AZD3355
Intervention MeSH terms: Lesogaberan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 244.0
Sex: All
Minimum age: 17 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Heartburn; Patient reported symptoms; Proton pump inhibitor

Summary:

      The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a
      Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients
      with an incomplete response to PPI treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent

          -  At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms

          -  Continuous treatment with Proton Pump Inhibitor (PPI)

          -  Ability to read and write

        Exclusion Criteria:

          -  Prior surgery of the upper gastrointestinal (GI) tract

          -  History of clinically significant diseases other than GERD

          -  Need for concomitant medication with drugs that may influence gastrointestinal
             symptoms
OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib
Intervention description: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: African Americans

Summary:

      This study determines tumor response rate, time to tumor progression and survival rate at 1
      year produced by OSI-774 in previously treated African American patients with nonsmall cell
      lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have histologically or cytologically confirmed stage IIIB or IV NSCLC treated
             with 1-2 platinum- or taxane-containing regimens

          -  Measurable disease

          -  May have had prior surgery & external beam radiation

          -  African American

          -  18 years or older

        Exclusion Criteria:

          -  Known brain mets

          -  Prior treatment with EGFR targeting therapies

          -  Pregnant/lactating women