bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a phase I, open label, two arm, fixed sequence crossover study to
      investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of
      GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration.
      Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50
      mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600
      mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7
      days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14
      days. Serial PK sampling will be completed following the last dose of each treatment. Safety
      and tolerability will be assessed throughout the study through assessment of adverse events
      (AEs), and clinical laboratory tests.

      This study will be conducted at one center in the US with healthy adult male and female
      subjects.
    


Intervention name(s): GSK1349572; Rifampin; Rifabutin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1349572 is an experimental drug for the treatment of HIV. GSK1349572 is in the integrase inhibitor class. It is not yet approved by the FDA.; Rifampin is approved by the FDA for the treatment of tuberculosis.; Rifabutin is approved by the FDA for the treatment of tuberculosis.
Other intervention name(s): RIFADIN. RIFADIN is a trademark of Sanofi-Aventis; MYCOBUTIN. MYCOBUTIN is a trademark of Pfizer
Intervention MeSH terms: Rifampin; Rifabutin; Dolutegravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1349572; pharmacokinetics; dolutegravir; integrase; rifabutin; rifampin
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to characterize the safety, and efficacy of
      Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a
      continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational
      age.
    


Intervention name(s): Dexmedetomidine; Midazolam; Fentanyl; Morphine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine; Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Condition: Onychomycosis
MeSH terms: Mycoses; Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in
      patients with mild-to-moderate fungal infection of the toe nail.
    

Detailed description: 
      This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy
      of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe
      nail.
    

Intervention name(s): NVXT Solution; Vehicle of test product
Intervention type(s): Drug; Drug
Intervention description(s): NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.; Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Other intervention name(s): NVXT; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of oral lenvatinib in
      participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant
      differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified
      by Histology.
    

Detailed description: 
      This study contained 3 Phases: the Pretreatment Phase, the Treatment Phase, and the Extension
      Phase. The Pretreatment Phase lasted no longer than 28 days. Informed consent was obtained
      and protocol eligibility and disease characteristics were established prior to treatment. The
      Treatment Phase consisted of a Treatment Period and a Follow-up Period. The Treatment Period
      of the Treatment Phase began at the time that the first participant began study drug
      administration and ended at the time when all participants enrolled completed 8 cycles of
      treatment or discontinued study treatment prior to the eighth cycle (ie, time of data cutoff
      for the primary study analysis [Primary Completion Date]). All participants then entered the
      Extension Phase. The Extension Phase consisted of a Treatment Period and a Follow-up Period.
      The Extension Phase began immediately after the Treatment Phase ended and included all
      participants that were either still receiving treatment or in follow-up. The time of data
      cutoff for the primary study analysis occurred when all subjects in the study completed 8
      cycles of treatment or discontinued study treatment prior to the eighth cycle.
    

Intervention name(s): Lenvatinib (DTC Cohort); Lenvatinib (MTC Cohort)
Intervention type(s): Drug; Drug
Intervention description(s): 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.; 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.
Other intervention name(s): E7080, LENVIMA; E7080, LENVIMA
Intervention MeSH terms: Lenvatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thyroid Cancer
Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Between 30% and 40% of patients with colorectal cancer develop metastatic disease
      intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy
      but requires resection of all lesions larger than 2mm.

      Indocyanine green has an affinity for tumor tissues and the interest of its use has been
      demonstrated for the detection of sentinel lymph node and some liver surgeries.

      The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been
      evaluated.

      This study aims to evaluate the diagnostic performance of fluorescence in the detection of
      malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological
      analysis.
    


Intervention name(s): indocyanine green
Intervention type(s): Drug
Intervention description(s): intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection
        +/- Chemotherapy Hyperthermic Intraperitoneal
      
Keywords: colorectal cancer metastatic; indocyanine green
Mindfulness Training in Healthy Older Veterans
Condition: Aging
Study type: Interventional

Summary: 
      Evidence shows the positive effects of Brain Health & Wellness classes in younger
      individuals. The proposed study investigates the usefulness of these classes in older
      Veterans aged 50-85. We hope to show that such classes can lead to improvements in both
      thinking skills as well as stress levels.
    

Detailed description: 
      The expansion of the aging Veteran population, in addition to the frequent presence of
      comorbidities (e.g., PTSD and TBI) that exacerbate age-associated cognitive and health
      declines, has generated substantial interest in interventions that promote brain health in
      older Veterans. A growing body of evidence shows the positive effects of Brain Health &
      Wellness classes on brain health in younger and middle-aged adults, thus training might be
      able to enhance brain health in older Veterans and offset age-related declines. Such training
      holds particular promise in enhancing areas of cognition that are especially susceptible to
      aging processes (e.g. attention and executive control), potentially through multiple
      mechanistic pathways. It is in many respects a cognitive exercise and may strengthen neural
      networks involved in such processes. Additionally, there is evidence for further facilitating
      brain health in other ways related to, for instance, altering the stress response. Currently,
      there is little information regarding the potential brain health benefits in older adults. As
      a first step to understanding these potential beneficial effects in Veterans, the aim of the
      proposed pilot study is to evaluate the acceptability, feasibility and potential efficacy of
      two Brain Health & Wellness classes in healthy older Veterans through a randomized,
      controlled trial.
    

Intervention name(s): Mindfulness-based Stress Reduction; Brain Health
Intervention type(s): Behavioral; Behavioral
Intervention description(s): mindfulness/meditation/movement training; Brain Health Education
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mindfulness; aging; Veterans
CARES: A Mobile Health Program for Alcohol Risk Reduction
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      In this fast-track STTR, Phase 1 will develop and test a mobile phone app among 40 adult
      community college students. The app is designed to reduce risky drinking behaviors and
      improve user safety. In Phase 2 the app ("CARES") will be tested with 200 adult community
      college students who drink alcohol. Participants will be randomly assigned to the "CARES" app
      or an alcohol education control condition and will use the app for 12 weeks. Six month
      outcomes will assess changes in drinking related behaviors.
    

Detailed description: 
      This STTR builds on our successful pilot that developed a text message-delivered alcohol
      intervention for, and in collaboration with CCS. Phase I will develop and test a smart phone
      application (the "Cares" app) incorporating the text message program with additional features
      and functionality requested by students in the pilot trial (Aim 1.1). After obtaining user
      feedback (Aim 1.2) programming will be completed in both iOS and Android languages. To ensure
      that the College Alcohol Risk Education System (CARES) is well positioned to get into the
      community college marketplace, it is critical to demonstrate efficacy. Phase 2 will conduct
      an efficacy trial of CARES compared to a competing alcohol education program that would be
      feasible for most community colleges to adopt, thus providing a real-world comparison with
      data suitable to support future efforts toward commercialization. This study will also
      identify the types of individuals for whom CARES is more/less effective and identify how it
      might be improved.
    

Intervention name(s): CARES mobile smart phone app; Check Your Drinking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CARES smart phone mobile app contains a number of features to support safety while drinking and reduced alcohol consumption plus regular test messages for personal support; Check Your Drinking is an online alcohol assessment that provides normative feedback on the user's drinking habits relative to his/her peers. Alcohol interventions that provide normative feedback are rated by the NIAAA Alcohol Intervention Matrix as effective and low cost, and with few administrative or structural barriers to implementation thus making it suitable for community colleges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Effect Of Myofascial Release Technique On Respiratory Parameters in Subjects With Short Hamstring Muscle
Condition: Hamstring Contractures
MeSH terms: Contracture
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of myofascial release technique on rib
      cage mobility, respiratory function, respiratory muscle strength and endurance in patients
      with hamstring muscle shortness.
    

Detailed description: 
      Hamstring flexibility is important to maintain activities such as walking and running in
      daily life. Hamstring muscle shortness, commonly seen in the community, is a risk factor for
      many musculoskeletal pathologies. Clinical observations have shown that the shortness of the
      Hamstring muscle causes spinal malalignment. This deterioration of the spine alignment may
      adversely affect the rib cage expansion. Moreover, considering that the optimal length of the
      muscles provides optimal contraction, it was found that the spinal malalignment adversely
      affected the effective contraction of the diaphragm by changing the position of diaphragm. A
      different view is that, because the fascia functions as a single tissue surrounding the
      entire body, a restriction in the hamstring muscle can also cause a restriction in distal
      muscles such as diaphragm through the fascia.

      There are many treatment methods used to increase the flexibility of the hamstring muscle.
      One of these methods is the myofascial release technique. In this technique, which targets
      both muscle and fascia, applying light and prolonged pressure provides the myo-fascial
      complex to reach its optimal length, resulting in the optimal function of the muscle. In our
      best knowledge, no study has evaluated the effect of myofascial release technique on
      respiratory parameters in patients with hamstring muscle shortness.
    

Intervention name(s): Myofascial Release Technique; Sham-Ultrasound
Intervention type(s): Other; Other
Intervention description(s): Myofascial release technique will bi applied bottom of the feet, back of the legs and hamstrings in both extremities. The practitioner will decide how long she should stay in a region according to the feeling of releasing in the tissue. The technique will be applied to a region at least 3 times.; Sham-ultrasound will be applied to back of legs and thighs in both extremities without pressure and all parameters of the ultrasound device except the timer will be closed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hamstring Muscle; Hamstring Shortness; Hamstring Stiffness; Myofascial Release Technique; Respiratory Functions; Respiratory Muscle Strength; Respiratory Muscle Endurance
Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Although post-op renal function decrease is determined by serum creatinine, serum creatinine
      has disadvantages that it increases a long time after renal function decrease and it has
      various increasing time based on the level of renal function. Neutrophil
      Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage
      occurring from post-op cardiac surgery, being critical patients and contrast medium use is
      already proven.

      But NGAL's usefulness for renal function after non-cardiac surgery is not proven and
      especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal
      disease patients is not proven.Therefore, the investigators will study about renal function
      decrease after non-cardiac surgery with NGAL and serum creatinine.
    


Intervention name(s): The level of NGAL after pre op,post op 4hr, post op 12hr
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        43 patients who had non-cardiac surgery in Seoul Paik Hospital.
Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Condition: Healthy Subjects
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The aim of this study is to simulate the orthopedic treatment called Morton's extension on
      non-deformed patients to check the effects on each metatarsal head on its static footprint.
    

Detailed description: 
      The objective of this study is to perform an assimilation of the orthopedic treatment called
      morton extension on non-deformed patients to verify the effects on each metatarsal head on
      its static footprint, specifically the mean pressures and before and after the application of
      the morton extension.
    

Intervention name(s): Morton extension
Intervention type(s): Other
Intervention description(s): A Morton extension with a height of 5 mm was insert from the proximal area of the first metatarsal head to the base of the proximal phalanx of the Hallux of the subjects' bare feet using a paper bandage. The material, shape, size, and thickness of the Morton Extension were the same.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metatarsalgia; foot; orthopedics
Bismuth for PCAB-based H. Pylori Eradication
Condition: H. Pylori Infection
Study type: Observational

Summary: 
      Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically
      available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in
      the gastric acid secretion of parietal cells. The mechanism of action is different from that
      of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid
      inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In
      Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those
      using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.

      Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and
      infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and
      cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication
      rate by 30%-40% in resistant H. pylori strains.
    

Detailed description: 
      The investigators aim to evaluate the success rate and adverse drug events of bismuth added
      to PCAB-based triple therapy as a first-line regimen for H. pylori infection.
    

Intervention name(s): H. pylori eradication
Intervention type(s): Drug
Intervention description(s): PPIs-based Antimicrobial agents for H. pylori eradication
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        H. pylori-infected patients
Supermicrosurgical LVA for Lymphedema Treatment
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and
      side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and
      disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of
      the LVs and the RVs, and the relative distance between them. Most published literatures have
      focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in
      LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow.
      Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this
      study, we aimed to establish the basis of selecting the proper anastomotic orientation, based
      on the size and comparative size discrepancy between LV and RV. To the best of our knowledge,
      this is the first report to focus on this subject.
    


Intervention name(s): LVEEA; LVESA; LVSEA
Intervention type(s): Other; Other; Other
Intervention description(s): lymphaticovenous end-to-end; lymphaticovenous end-to-side; lymphaticovenous side-to-end
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective observational study was approved by the institutional review board in
        our hospital. From March 2016 to October 2018, 100 patients with 103 lymphedematous lower
        limbs (International Society of Lymphology stage I-III) were included. All the patients
        underwent supermicrosurgical LVA performed by a single surgeon using a high-power
        microscope.
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to
      baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.
    


Intervention name(s): quetiapine fumarate; SSRI/Clomipramine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate; Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder (OCD)