bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of Range and Schedule of rPA Doses
Condition: Prevention of Bacillus Anthracis (Anthrax) Infection
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose ranging study comparing different vaccine schedules of rPA vaccine for
      anthrax. Safety and the capability to induce an immune response will be evaluated.
    

Detailed description: 
      Anthrax is a zoonotic disease, occurring in wild and domestic mammals, caused by the spore
      forming bacterium Bacillus anthracis. Anthrax occurs in humans when they are exposed to
      infected animals, tissue from infected animals or when they are directly exposed to B.
      anthracis or its spores. In the USA, the annual incidence of human anthrax has declined.
      However, in the USA, shortly after September 11th 2001, there were 22 cases (18 confirmed) of
      inhaled and cutaneous anthrax infections that were related to contaminated mail. This is a
      double blind, parallel-group, dose ranging study of rPA anthrax vaccine. The subjects will be
      blinded as to which dose of rPA vaccine is administered. The primary objectives of this
      clinical trial are 1.) To evaluate the safety and tolerability associated with different
      primary immunization doses and schedules of rPA vaccine to enable determination of the
      optimum dose for future clinical trials and 2.) To evaluate the immunogenicity of different
      primary immunization doses and schedules of rPA vaccine to enable determination of the
      optimum schedule for future clinical trials.
    

Intervention name(s): rPA vaccine containing alhydrogel
Intervention type(s): Biological
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Anthrax vaccine
Individualized Therapy For Asthma in Toddlers
Condition: Asthma; Wheezing
MeSH terms: Asthma; Respiratory Sounds
Study type: Interventional
Phase: Phase 3

Summary: 
      The INFANT study will test whether, in preschool children 12-59 months of age with persistent
      asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control:

        1. Daily inhaled corticosteroid (ICS) treatment,

        2. Daily leukotriene receptor antagonist (LTRA) treatment, and

        3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
    

Detailed description: 
      INFANT is a double-blind, randomized clinical trial in which all participants will receive
      each of the three therapies for 16 weeks by means of a cross-over study design. INFANT aims
      to determine whether individual children respond better to one treatment than another and, if
      so, whether those children can be identified by phenotypic characteristics or selected
      biomarkers. In this regard the INFANT study is expected to address critical gaps in current
      asthma management guidelines. Ultimately, the findings from this study are expected to help
      clarify treatment modalities for this population of young preschool children who are
      extremely difficult to treat.
    

Intervention name(s): daily fluticasone propionate; Montelukast; as-needed fluticasone propionate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily; Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening; Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Intervention MeSH terms: Fluticasone; Xhance; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Wheezing; Fluticasone; Montelukast; Preschool-age
A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when
      administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose
      (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate
      safety of ABT-263 monotherapy (Arm C).
    


Intervention name(s): ABT-263; erlotinib; irinotecan (3-week schedule); irinotecan (weekly schedule)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABT-263 is taken orally.
Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed.; 150 mg of erlotinib is taken orally once daily.; 180 mg/m2 over 90 minutes, irinotecan will be given by intravenous infusion on Day 1 of each 21 day cycle.
Note - The dose and schedule is subject to change based on the toxicities observed.; 75 mg/m2 over 45 minutes, irinotecan will be given by intravenous infusion on Days 1 and 8 of each 21 day cycle.
Note - The dose and schedule is subject to change based on the toxicities observed.
Intervention MeSH terms: Irinotecan; Erlotinib Hydrochloride; Navitoclax
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Exercise With Low Intensity and Longer Duration Versus High Intensity Interval Training
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare exercise at 70% of maximal heart rate were total
      energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate.
      Since 70% of maximal heart rate is well above the minimum threshold for improvements in
      maximal oxygen uptake it should be suited to investigate the effect of duration.
    


Intervention name(s): endurance exercise of different duration and intensity
Intervention type(s): Other
Intervention description(s): Two interventions are compared with aerobic capacity as the main outcome. one group exercise at 70% of maximal heart rate for 90 minutes 3 times per week. group two exercise performe10 minutes warm up at 70% of maximal heart rate 4 x 4 minutes intervals at 90-95% of maximal heart rate with 3 minutes active pause at 70% of maximal heart rate in between, and finally 5 minutes cooling down at 70 % of maximal heart rate.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: aerobic capacity; maximal oxygen uptake; aerobic endurance; work economy; lactate threshold; endurance training; exercise intensity
Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments
Condition: Ability, Spatial
Study type: Interventional

Summary: 
      A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand
      hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing
      impaired participants. These sound changing principles are enabled by respective hearing
      instrument technologies and hearing instrument algorithms. The aim of the study is to
      investigate and assess strengths and weaknesses of these novel sound changing principles in
      terms of hearing performance to determine their application in hearing instruments (Phase of
      development). Both, objective laboratory measurements as well as subjective evaluations in
      real life environment will be carried out. This will be a controlled, single blinded and
      randomised active comparator clinical evaluation which will be conducted mono centric at the
      University Hospital of Zürich.
    


Intervention name(s): several virtual 3-D complex audio environments
Intervention type(s): Procedure
Intervention description(s): The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.
Intervention model: Single Group Assignment
Intervention model description: a group of normal-hearing volunteers
Masking: None (Open Label)
Primary purpose: Other
Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.
Condition: Esophageal Anastomotic Leak; Tissue Pressure of Oxygen
MeSH terms: Esophageal Neoplasms; Anastomotic Leak
Study type: Interventional

Summary: 
      This study is a randomized clinical trial to clarify if preoperative embolization of gastric
      arteries can reduce the incidence of oesophagogastric leakage after an esophagectomy for
      esophageal cancer comparing an experimental group vs control group.
    

Detailed description: 
      In patients with infracarinal esophageal carcinoma, the surgery is a complex procedure and
      with a high morbidity. It consists of a subtotal esophagectomy with tubular gastroplasty and
      cervical esophagogastric anastomosis. The most important complication is the anastomotic
      leakage with a high mortality. Among the possible causes of anastomotic leakage an important
      factor is the impaired microcirculation in the anastomotic region after the partial
      devascularization of the stomach during the surgery. There are several experimental studies
      about the different techniques to improve this vascularization and their effects on mucosal
      oxygenation. There are several methods currently used for assessing tissue oxygenation. The
      polarographic partial pressure of oxygen (pO2) electrode has been considered as the 'gold
      standard' for measuring oxygen tension. This is the reason why tissue pressure of oxygen
      (PtiO2) will be measured by Licox® (Integra Neuroscience) system in two groups. There aren't
      prospective randomized controlled trials to answer these questions. For this reason the
      investigators propose to perform a prospective randomized controlled trial in patients
      underwent on this surgery, comparing two groups: one of them will be carried out a
      preoperative arterial embolization (PAE), and the other one will be operated directly, to
      demonstrate if the ischemic conditioning by PAE can reduce the incidence of anastomotic
      esophagogastric leakage and improve the gastric conduit oxygenation.
    

Intervention name(s): Preoperative Arterial Embolization
Intervention type(s): Procedure
Intervention description(s): PAE will be performed by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery.
An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. Embolization by coils of the left gastric artery, splenic artery and the right gastric artery is realized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of the Metabolism of Danicopan in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover,
      relative bioavailability, and food-effect study comparing different formulations of danicopan
      in healthy adult participants.
    

Detailed description: 
      For both parts of this study, on Day 1 of each period, participants will receive a single
      oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2)
      under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the
      tablet formulation under fed conditions.
    

Intervention name(s): Danicopan: Powder-In-Capsule 1; Danicopan: Powder-In-Capsule 2; Danicopan: Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Danicopan (200 milligrams) will be administered orally on Day 1.; Danicopan (200 milligrams) will be administered orally on Day 1.; Danicopan (200 milligrams) will be administered orally on Day 1.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ALXN2040; ACH-0144471 (formerly); ALXN2040; ACH-0144471 (formerly)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tablet; Capsule; Danicopan; Bioavailability; Factor D Inhibitor; Food Effect
A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the pharmacokinetics (what the body does to the
      medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single
      oral dose of 100 micrograms under fasted conditions in healthy male participants.
    

Detailed description: 
      This is a phase I, open-label (all people know the identity of the intervention) and
      parallel-group (each group of patients will be treated at the same time), randomized (the
      study medication is assigned by chance) study in healthy male participants, to investigate
      the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or
      JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first
      dose of study medication), a treatment phase, and a follow up phase. In the treatment phase,
      participants will be divided into 3 treatment groups with 6 participants each, to receive a
      single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an
      overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical
      laboratory tests, physical examination, vital signs and electrocardiogram will be monitored
      throughout the study. The total duration of the study will be approximately 4 weeks.
    

Intervention name(s): JNJ-42396302; JNJ-42692507; JNJ-53773187
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.; A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.; A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42396302; JNJ-42692507; JNJ-53773187; Pharmacokinetics
Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine the effectiveness of two psychological
      techniques in chronic low back pain patients treated in hospital pain clinics. The techniques
      are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a
      multiple site project in which patients come from 16 different pain clinics throughout Spain.
      The control group is formed by patients under usual medical treatment at pain clinics. The
      two intervention groups also receive usual medical treatment at pain clinics plus one
      psychological therapy treatment. The sample size is 330 subjects.
    


Intervention name(s): Cognitive Behavioral Treatment; Mindfulness Based Stress Reduction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral treatment to reduce pain in chronic back pain patients; Behavioral treatment to reduce pain in chronic back pain patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: chronic low back pain; cognitive-behavioral therapy; Mindful Based Stress Reduction; pain clinics; anxiety; quality of life; chronic pain
Fecal Microbiota Transplantation After HSCT
Condition: Bone Marrow Transplantation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study is studying an intervention called fecal microbiota transplantation
      (FMT). Patients who are scheduled to undergo Hematopoietic Stem Cell Transplantation are
      invited to take part in this clinical trial to undergo empiric FMT soon after hematopoietic
      engraftment. The primary endpoint will be to assess the feasibility of FMT in this population
      and to assess safety.
    

Detailed description: 
      The microbiome (spectrum of bacteria in a patient's gut) is thought to play a role in helping
      to shape one's immune system given its direct contact with normal cells in our intestine.
      Recent studies have suggested that a microbiome with very few bacteria (low diversity) seems
      to be bad for health and a high-diversity microbiome (many different species) appears to be
      good. This appears to be true even for patients after HSCT where low diversity microbiome
      status has correlated with infections, GVHD and overall survival.

      Fecal microbiota transplantation (FMT) is routinely performed for an infection caused by
      Clostridium difficile but is not yet approved by the FDA as a treatment for any disease. FMT
      restores a high diversity microbiome. It is hoped that through FMT, overall outcomes after
      HSCT can potentially be improved.

      FMT will be performed in the first 3 weeks after recovery of white blood cells after HSCT.
      The source of FMT will be from healthy 3rd party donors. FMT will be performed through the
      ingestion of 30 capsules over 2 consecutive days.
    

Intervention name(s): Fecal Microbiota Transplantation (FMT)
Intervention type(s): Biological
Intervention description(s): FMT will be given through the ingestion of 30 capsules (15 capsules daily x 2 consecutive days)
Other intervention name(s): FMT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem cell transplant; fecal microbiota transplantation
Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients
Condition: Erosive Reflux Disease; Non-erosive Reflux Disease; Functional Heartburn
MeSH terms: Gastroesophageal Reflux; Heartburn
Study type: Observational

Summary: 
      Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease
      (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that
      depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses
      to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still
      remain controversial. Therefore, the aims of this study were to investigate the efficacy of
      PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic
      GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS),
      Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and
      depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final
        diagnosis could be erosive reflux disease(ERD), non-erosive reflux disease (NERD) and even
        functional heartburn (FH).
      
Keywords: Erosive reflux disease (ERD); Non-erosive reflux disease (NERD); Functional heartburn (FH)
A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK189254 is a highly potent histamine 3 (H3) receptor antagonist which has demonstrated
      efficacy in the reduction of mechanical hyperalgesia and allodynia in the chronic
      constriction injury pre-clinical model of neuropathic pain (NP). The mechanism of action of
      GSK 189254 in the pain model is hypothesised to be via enhanced release of monoamines in the
      central nervous system (CNS). A similar mechanism of action has also been shown for
      duloxetine. In this phase I study, the safety and efficacy of GSK189254 will be investigated
      in the electrical hyperalgesia (EH) model in healthy volunteers to build confidence that the
      preclinical efficacy demonstrated by this compound will translate into patients.

      This study will be conducted as a double-blind, double-dummy, placebo-controlled, incomplete
      block, two period crossover study. Up to 40 healthy male or female volunteers, aged 18-45
      years old, will be randomised into the study in order to achieve 32 evaluable subjects.
      Subjects will undergo two 3-week treatment periods and will be randomised to receive placebo
      and either GSK189254 (up to 100µg once daily) or duloxetine (up to 60mg daily). There will be
      a one week washout between treatment periods. The effects of repeated oral dosing of
      GSK189254 and duloxetine on secondary hyperalgesia in the EH model will be determined.
      Subject: GSK189254, Neuropathic pain (NP), H3 antagonist, duloxetine, Electrical
      hyperalgesia, Phase I, Healthy volunteers, Double blind, Safety, tolerability.
    


Intervention name(s): Duloxetine; GSK189254; GSK189254 Placebo; Duloxetine Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be receive hard gelatin capsules of Duloxetine at 30mg once daily for one week and 60mg once daily for the second week in Treatment Arm B.; Subjects will receive film coated tablet of GSK189254 at 50 mcg once daily for a one week and 100 mcg once daily for the second week in Treatment Arm A.; Subjects will receive Placebo matching GSK189254 for 3 weeks in each period.; Subjects will receive Placebo matching Duloxetine for 3 weeks in each period.
Other intervention name(s): Duloxetine
Intervention MeSH terms: Niacinamide; Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Duloxetine; GSK189254; Healthy volunteers; Phase I.; Electrical hyperalgesia model
Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
Condition: Diabetes Mellitus Type 2
MeSH terms: Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety, tolerability and pharmacokinetics of multiple
      oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight
      and obese subjects.
    


Intervention name(s): PF-05175157; Midazolam; Placebo; Midazolam
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): 200 mg tablet administered twice per day for 14 days; 2mg administered as single doses on Days 0 and 11; Placebo administered twice per day for 14 days; 2mg administered as single doses on Days 0 and 11
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science