bioihbjkbjnl/mcl2 huggingface dataset:
Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous
      beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C
      cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze
      cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P.
      aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes,
      such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli
      Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-betalactamase (VIM), and
      class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D
      carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
    

Detailed description: 
      The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and
      Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum
      beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats [CDC, 2019]. Consistent
      with the global nature of these resistant bacteria, the World Health Organization (WHO) has
      designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant
      Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for
      which new agents are critically needed [WHO, 2017]. Qpex Biopharma is developing a fixed
      combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor,
      QPX7728.
    

Intervention name(s): QPX7728; QPX2014
Intervention type(s): Drug; Drug
Intervention description(s): beta lactamase inhibitor; antibiotic
Other intervention name(s): IV; IV
Intervention MeSH terms: QPX7728
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Single-Dose, Drug-Drug Interaction Study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: beta-lactam antibiotic
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
Condition: Untreated T-cell Angioimmunoblastic Lymphoma
MeSH terms: Lymphoma; Immunoblastic Lymphadenopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and
      rituximab in patients aged 60 to 80 years with previously untreated AIL.
    

Detailed description: 
      This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy
      and the safety of a front-line treatment combining CHOP regimen and rituximab in patients
      aged 60 to 80 years with previously untreated AIL.

      It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis
      performed every 5 patients (based on triangular test).

      The duration of the treatment period is approximately 25 weeks and patients are followed
      until Death.

      The total Duration of the study is expected to be 2.5 years.
    

Intervention name(s): Rituximab; Prednisone; Doxorubicine; Cyclophosphamide; Vincristine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 375 mg/m2 D1; 40 mg/m2 D1 to D5; 50 mg/m2 D1; 750 mg/m2 D1; 1,4 mg/m2 D1
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T-cell angioimmunoblastic lymphoma; Rituximab
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and reactogenicity of various
      formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult
      volunteers following the 0, 1, 6 months schedule
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Engerix™-B; HBV-MPL vaccine (208129); Hepatitis B vaccine, experimental formulation
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis B; Engerix™-B; Recombinant hepatitis B vaccine
Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia
Condition: Biliary Atresia, Kasai Portoenterostomy Status
MeSH terms: Biliary Atresia
Study type: Interventional
Phase: Phase 4

Summary: 
      In this clinical study, meloxicam will be used to the patients who are older than 2 years and
      underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the
      medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver
      stiffness scores will be compared before and after the medication of meloxicam, and the roll
      of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their
      hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug,
      meloxicam is safe medicine which is used to treat pain or inflammation caused by
      osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old.
      It may also be used for purposes not listed in the medication guide. It will be taken once a
      daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group).
      After 6 months of medication, the maintenance will be decided by the comparison of liver
      stiffness score before and after the intervention.
    


Intervention name(s): Meloxicam
Intervention type(s): Drug
Intervention description(s): The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.
Intervention MeSH terms: Meloxicam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Body Cooling in Hyperthermic Males and Females
Condition: Cryotherapy Effect
Study type: Interventional

Summary: 
      Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military
      soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C
      with the presence of central nervous dysfunction (altered mental status). The gold standard
      method of care for EHS is immediate onsite whole body cooling using cold-water immersion
      (cooling rates >0.15°C•min-1), which is reported to have the highest cooling rate. In the
      treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to
      minimize the time above the critical threshold of body temperature at 40°C to less than 30
      minutes for the best chance of survival and to minimize the severity of prognosis. However,
      in situations where cold water immersion is not feasible (in certain military, firefighter,
      or other remote settings), other cooling modalities must be available that have a cooling
      capacity similar to that of cold-water immersion. In this proposed study, we aim to compare
      the cooling rates of the Polar Breeze® (developed by Polar Breeze ®, Clearwater, FL),
      cold-water immersion (the current gold standard for EHS treatment), and passive cooling in
      individuals with exercise-induced hyperthermia
    


Intervention name(s): Thermal Rehabilitation Machine; Cold Water Immersion
Intervention type(s): Device; Other
Intervention description(s): The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air; Whole-body immersion in cold water.
Other intervention name(s): Polar Breeze
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete three trials under three different body cooling conditions/interventions; passive cooling using the body's natural body cooling mechanisms, body cooling using cold water immersion, and cooling using the investigational thermal rehab machine.
Masking: None (Open Label)
Primary purpose: Other
Smoking, Stress & Allopregnanolone Response
Condition: Smoking Cessation
Study type: Observational

Summary: 
      This study aims to characterize the effect of smoking on stress-induced allopregnanolone
      (ALLO) response in women by menstrual phase. The investigators hypothesize that women who
      smoke will have a blunted ALLO response to stress.
    

Detailed description: 
      Cigarette smoking persists as the leading cause of preventable morbidity and mortality. Thus,
      finding ways to maximize quitting behavior is critical. Women have a more difficult time
      achieving smoking abstinence than men. The risk for smoking relapse appears to vary by
      menstrual phase such that the follicular phase is associated with greater risk compared to
      the luteal phase. Women are also more likely to smoke in response to stressful stimuli than
      men. Allopregnanolone (ALLO) is a stress-reducing neuroactive steroid that is primarily
      metabolized from the sex hormone progesterone and, therefore, varies by menstrual phase in
      women. Recent preclinical literature has indicated that ALLO may protect against drug abuse
      behaviors. Unfortunately, ALLO remains largely unexplored in clinical samples containing
      women.

      In this study we aim to characterize the effect of smoking on stress-induced ALLO response in
      women by menstrual phase. To achieve this goal, we will recruit a sample of premenopausal
      women who smoke (n=30) and do not smoke (n=30) to participate in a controlled cross-over
      study. All participants will complete two four-hour lab sessions timed to occur in the
      Follicular (F; low ALLO) and Luteal (L; high ALLO) menstrual phases. Each lab session will
      contain an acute stressor along with a timed series of assessments including blood samples
      (for ALLO measurement) and self-report of mood and perceived stress.
    

Intervention name(s): F phase lab session; L phase lab session
Intervention type(s): Behavioral; Behavioral
Intervention description(s): F phase sessions will occur three to seven days post the onset of menses. It will include blood draws, an acute stressor and completion of questionnaires.; L phase sessions will occur six to ten days prior to the onset of the next expected menses. It will include blood draws, an acute stressor and completion of questionnaires.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 18 and 40 who either smoke or do not smoke.
      
Keywords: smoking cessation; smoking abstinence; allopregnanolone
If Different Types of Periampullary Diverticula Affect ERCP Cannulation?
Condition: Intubation;Difficult
MeSH terms: Diverticulum; Diverticular Diseases
Study type: Observational

Summary: 
      To study the influence of different types of periampullary diverticulum(PAD) on ERCP
      difficult cannulation and postoperative complications.
    

Detailed description: 
      Periampullary diverticula (PAD) are extraluminal out-pouching of the duodenum mucosa often
      occurring within a radius of 2-3 cm from the ampulla of Vater or hepatopancreatic ampulla.
      More PAD cases have been identified over recent years, and it's generally believed that up to
      27% of elderly cases may have PAD. Several classifications of PAD have been proposed, and the
      most commonly used distinguishes intraluminal and extraluminal diverticula. Recent studies
      suggest that PAD is a risk factor for the development of bile duct diseases, and it may cause
      endoscopic retrograde cholangiopancreatography (ERCP) procedures to fail, but some other
      studies have come to the opposite conclusion.

      During ERCP procedures, the investigators found that different types of PAD seem to have some
      differences in the size of the diverticulum, difficulty in intubation, and complications. The
      investigators plan to this retrospectively study collecting 4 years of cases to evaluate the
      clinical features of different types of PAD in terms of difficult cannulation and
      complications.
    

Intervention name(s): Routine ERCP
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        18-90 years old patients with ERCP indications
      
Keywords: ERCP; periampullary diverticula; difficulty cannulation; complication; biliary disorder
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
Condition: Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Study type: Interventional

Summary: 
      This study is a post market clinical follow up study performed to confirm the performance of
      BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in
      a controlled desaturation study over a range between 80% and 100% peripheral oxygen
      saturation (SpO2).

      The study will be performed on a group of healthy volunteers in a controlled clinical
      setting.
    

Detailed description: 
      This study is a post market clinical follow up study performed to confirm the performance of
      BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment
      (Nellcor™ Bedside Respiratory Patient Monitoring System model PM1000N, Covidien LLC, USA) in
      a controlled desaturation study over a range between 80% and 100% SpO2.

      The study will be performed on a group of healthy volunteers in a controlled clinical
      setting. Due to the use of a controlled desaturation protocol foreseen by the standard ISO
      80601-2-61:2017, this study is classified as an interventional post-market clinical study in
      accordance with Annex I of EN ISO 14155:2020.
    

Intervention name(s): Controlled desaturation study
Intervention type(s): Other
Intervention description(s): Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is planned to assess the safety, tolerability and pharmacokinetic profile
      of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare
      the safety, tolerability and pharmacokinetic data with the data observed in similar studies
      conducted in India.
    


Intervention name(s): WCK 2349 Oral; Placebo Oral
Intervention type(s): Drug; Other
Intervention description(s): 1 dose given orally twice daily at 12 hourly interval for five days.; Subjects will receive matching placebo
Intervention MeSH terms: Levonadifloxacin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasonic Stimulation for Patients With Major Deperessive Disorder - Exploratory Clinical Trial
Condition: Major Depressive Disorder(MDD)
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The non-invasive type ultrasonography system is applied to patients with major depressive
      disorder to evaluate their effectiveness and safety. Brain Computer Tomography(CT) and
      Magnetic Resonance Image(MRI) are taken to induce images before transcranial low intensity
      focused ultrasonic stimulation.

      Through random extraction, the group is divided into treatment group and placebo group. The
      treatment is started by targeting left Dorsolateral prefrontal cortex(DLPFC) region according
      to assigned groups. As for women, considering mood change during menstrual cycle, the
      treatment is taken place 1 week after the menstruation has initiated. The treatment group and
      the placebo group will be treated three times a week for two weeks.

      To evaluate clinical symptoms, Quick Inventory of Depressive Symptomatology-Self Report,
      Scale for Suicidal Ideation, state-trait anxiety scale, frontal lobe management function
      test, memory test, and continuous performance test are performed before, during, and after
      treatment. For the assessment of side effects, Systematic Asseseement for Treatment Emergent
      Events-General Inquiry(SAFTEE) are conducted for treatment presentation events every week
      during the treatment implementation period and every two weeks after the treatment is
      completed.
    


Intervention name(s): Active stimulation group Sham stimluation group
Intervention type(s): Procedure
Intervention description(s): Participants are randomly assigned to either treatment group or sham group for application of transcranial low intensity focused ultrasound stimulation. For sham group, transducer is surrounded by rubber band in order to block the transmission of ultrasonic wave.
Before initiating transcranial low intensity focused ultrasonic stimulation, in order to identify anatomical structure of the brain, Brain Magnetic Resonance Image(MRI) and Computer Tomography(CT) will be taken. For image coordination, multi-modal stick(fiducial marker, PinPoint) will be attached to the participant.
With acquired brain images of the participant, researchers identify participant's dorsolateral prefrontal cortex(DLPFC) region, and design focused ultrasound focus targeting, image-guidance method.
The treatment is started by targeting left DLPFC region according to assigned groups. Both the treatment and sham group will be under procedure for 2 weeks, 3 times a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Anterior Cruciate Ligament; Injury
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different soft tissue allografts, double bundle
      tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn
      anterior cruciate ligament (ACL) of the knee.
    


Intervention name(s): ACL reconstruction
Intervention type(s): Procedure
Intervention description(s): Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anterior cruciate ligament tear; ACL; ligament; knee; allograft
A Pilot Monocenter Study to Assess Cellular and Soluble Biomarkers in Nasal Secretions
Condition: Seasonal Allergic Rhinitis; Healthy Subjects
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and
      cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions.
      The evaluation of these inflammatory biomarkers is of great interest as this could lead to a
      concept of measuring the efficacy of anti-allergic treatments by assessing the changes in
      nasal biomarkers after allergen challenge. To use this model as an assessment of
      pharmacodynamics it is crucial to evaluate the specificity and reproducibility of cellular
      and cytokine levels in the nasal secretions after allergen provocations.

      In a 2 part repeated measurement design 20 patients with allergic rhinitis and 20 healthy
      subjects will undergo two 4-hour pollen exposures in an interval of 21 days.

      The aim of this study is to explore the cellular and cytokine levels this allergen challenge
      will induce in nasal secretions and to assess if an increase in those inflammatory biomarkers
      is specific to the patient subgroup and whether the results are reproducible after the second
      allergen challenge.
    


Intervention name(s): allergen challenge (grass pollen), nasal lavage
Intervention type(s): Procedure
Time perspective: Other
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
Condition: Tattoo Removal
Study type: Interventional

Summary: 
      The purpose of this study is to compare the investigational medical grade laser device to a
      marketed medical grade laser device for effectiveness in lightening or clearing unwanted
      tattoos. This study will also compare any side effects from treatment with the devices.
    

Detailed description: 
      This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the
      abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower
      buttocks).

      The objective of this study is to evaluate the thermal and histological changes observed in
      the subcutaneous tissue following RF exposure.
    

Intervention name(s): Picosecond Q-switched Laser Treatment; Nanosecond Q-switched Laser Treatment
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tattoo Removal; Q-switched laser; Nd:YAG laser; Nanosecond laser; Picosecond laser; Laser therapy; Tattoo; pulsed-laser; laser treatment; remove tattoo; tattoo clearing; tattoo lightening; tattoo lighten
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic
      studies, with assessment of the following parameters:

        -  Injecting the desired volume of rhBMP-2/CPM within the defect

        -  Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence
           of rhBMP-2/CPM.
    


Intervention name(s): rhBMP-2/CPM
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: osteoarthritis; deformity of knee