bioihbjkbjnl/mcl2 huggingface dataset:
Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Giving more than one chemotherapy drug (combination chemotherapy) together with radiation
      therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium
      together with radiation therapy followed by docetaxel works in treating patients with stage
      III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated
           with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by
           consolidation therapy with docetaxel.

      Secondary

        -  Assess the progression-free survival and overall survival.

        -  Assess the toxicity of this regimen.

      OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV
      over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of
      unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7.
      Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease
      receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for
      3 courses.

      After completion of study therapy, patients are followed at 1 month and periodically
      thereafter.

      PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
    

Intervention name(s): Cisplatin; Docetaxel; Pemetrexed disodium; Radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Other intervention name(s): Platin; Cisplatinum; Taxotere®; Alimta
Intervention MeSH terms: Docetaxel; Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
Safety of and Immune Response to a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and the immune responses to the HIV
      vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three
      HIV "passenger" genes encoded with the viral vector, MVA.
    


Intervention name(s): MVA-CMDR; Placebo; MVA-CMDR; Placebo; MVA-CMDR; MVA-CMDR
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 10^7 PFU IM, 1.0 mL; 1.0 mL IM; 10^6 PFU ID, 0.1 mL; 0.1 mL ID; 10^8 PFU IM, 1.0 mL; 10^7 PFD ID, 0.1 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: MVA vector; Immunogenicity; HIV vaccine; HIV preventative vaccine
Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
Condition: Hemodynamic Effects of Energy Drink; Electrocardiograph Effects of Energy Drinks
Study type: Interventional

Summary: 
      This study is designed as a safety assessment to determine the cardiac and hemodynamic
      effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and
      blood pressure measurements. It will evaluate the use of a consumer available product that is
      classified as a dietary supplement by the FDA.
    


Intervention name(s): Energy Drink; Active Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 16oz energy drinks - 2 consumed within 60 minutes; 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Energy Drink; Electrocardiograph; Hemodynamic
Influence of Using Physical Therapy Resources for Knee Osteoarthritis
Condition: Osteoarthritis; Physical Therapy Modalities
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis is a chronic, multifactorial characterization, which changes in bone
      alignment, cartilage and structures that provide joint stability appear to be strongly
      correlated with the origin of this disease.This project will aim to verify the effectiveness
      of interferential current, short wave and low level laser therapy on an exercise program for
      mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups:
      exercise group, exercise group + Ultrasound therapy, exercise group + interferential current,
      exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and
      after the trial protocol by the following instruments: Western Ontario and McMaster
      Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual
      Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the
      World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain
      scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical
      agents in an exercise program will provide an improvement in pain, mobility and knee function
      in individuals diagnosed with knee osteoarthritis.
    


Intervention name(s): exercise; interferential current; short-wave diathermy; Low level laser therapy; Ultrasound therapy
Intervention type(s): Other; Device; Device; Device; Device
Intervention description(s): exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.; The basic principle of Interferential Therapy (IFT) is to utilise the significant physiological effects of low frequency (<250pps) electrical stimulation of nerves without the associated painful and somewhat unpleasant side effects sometimes associated with low frequency stimulation; Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy; Laser treatment in which the energy output is low enough so that the temperature of the treated tissue does not rise above 98.6°F (36.5° C) or normal body temperature.; Ultrasound (US) is a form of mechanical energy, not electrical energy and therefore strictly speaking, not really electrotherapy at all but does fall into the Electro Physical Agents grouping.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sex/Gender Differences in Risk and Resilience to PTSD; Implication of Oxytocin
Condition: PTSD
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in
      men and women with and without PTSD who have experienced childhood trauma. The study will
      also compare the effects of oxytocin and placebo on amygdala response, and explore the
      interaction of oxytocin plasma levels and amygdala response in men and women with and without
      PTSD who have experienced childhood trauma.

      Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to
      resilient subjects, and no sex differences in the magnitude of the response will be found.

      Hypothesis 2A: In response to OT, women will exhibit a greater reduction in amygdala
      responding than men.

      Hypothesis 2B: In response to OT, women with PTSD will exhibit a greater reduction in
      amygdala responding compared to women without PTSD.

      Hypothesis 3A: Women with PTSD will have lower levels of plasma OT as compared to men with
      PTSD, and women and men without PTSD.

      Hypothesis 3B: Plasma OT levels will be inversely correlated with amygdala responding to
      fearful faces in women but not in men.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Pitocin; Saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult, male and female human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the
      corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic
      Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects in
      a randomized crossover study.

      The study was conducted with 32 healthy adult subjects. In each study period, a single 75 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 10 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Indomethacin Extended-Release Capsules USP 75 mg; Indomethacin Extended Release Capsules USP 75 mg
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg tablet once a day; 75 mg tablet once a day
Other intervention name(s): Test Product
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
Condition: Head Lice Infestation
MeSH terms: Lice Infestations; Parasitic Diseases; Mite Infestations
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of a single application
      of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.

      Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in
      Ha44 vehicle) under maximal use conditions.
    

Detailed description: 
      This is an open-label safety and pharmacokinetic (PK) study involving a single application of
      Ha44 Gel 0.74% administered under maximal use conditions.

      All participants must have an active head lice infestation (at least 3 live lice) and be 6
      months to 17 years of age. The study will enroll approximately 36 pediatric subjects between
      the ages of 6 months and 17 years.

      Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time
      points.

      More than one household member with an active lice infestation may participate in the study.
      Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1).
      All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and
      14. The maximum study duration for a subject is 16 days.
    

Intervention name(s): Ha44 Gel
Intervention type(s): Drug
Intervention description(s): Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
Other intervention name(s): Benzyl Alcohol
Intervention MeSH terms: Benzyl Alcohol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Topical treatment of Head Lice Infestation
Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of this study was to compare the relative bioavailability (rate and extent of
      absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with
      that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc.
      following a single oral dose in healthy adults under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Pramipexole Dihydrochloride; Pramipexole Dihydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 0.25 mg Tablet; 0.25 mg Tablet
Other intervention name(s): Mirapex®
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Metformin and Furosemide Drug-Drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of
      metformin and furosemide in healthy, adult male subjects.
    

Detailed description: 
      Leinurad is a weak in vitro inhibitor of the hepatic transporter OCT1 and the renal
      transporters OAT1 and OAT3 (OAT1/3). To assess the clinical relevance of these in vitro
      findings, this clinical study will evaluate the effect of lesinurad on the PK of metformin
      (OCT1 substrate) and furosemide (OAT1/3 substrate).
    

Intervention name(s): Lesinurad 400 mg; Metformin 850 mg; Furosemide 40 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Lesinurad; Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effects of different dietary calcium have on the
      pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during
      pregnancy will result in higher bone mass in the newborn.
    

Detailed description: 
      Osteoporosis in the adult remains a significant public health problem. One of the major
      causes of osteoporosis is the inadequate calcium intake during the pediatric age range of
      birth to 20 years of age. We believe that this low calcium may start at birth since the fetus
      is actively accumulating calcium during the last trimester of pregnancy. Adolescents
      generally have poor calcium intake. Our study is to compare the newborn bone mass from
      adolescent mothers who are taking the recommended calcium intake from dairy foods or
      non-dairy foods such as orange juice during pregnancy.
    

Intervention name(s): Orange juice plus calcium; Dairy products
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): > 1,200mg Ca (four glasses of orange juice plus calcium)per day; > 1,200mg Ca (by consuming milk, yogurt, and cheese)
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dairy; Calcium; Pregnancy; Fetus; Bone mineralization
Magnesium Supplementation in Type II Diabetes
Condition: Effect of Magnesium in Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium
      from organic magnesium citrate affects blood glucose control and insulin resistance within
      patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive
      transporting genes is affected .
    

Detailed description: 
      The examinations are carried out in 50 subjects aged 20-80 years with existing type 2
      diabetes (HbA1c> 6%). The target parameters are determined in the blood. Blood sampling takes
      place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood
      pressure is determined and general health condition of each subject is recorded by a
      standardized questionnaire (SF-36).
    

Intervention name(s): Magnesium citrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Magnesium citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Magnesium; Type II diabetes; magnesium-sensitive genes
Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg
           acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325
           mg acetaminophen formulation after a single dose and at steady state

        2. Subjects: Healthy subject

        3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate
           release treatment profiles at steady state.
    

Detailed description: 
      This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of
      immediate release treatment and sustained release treatment was designed to assess the
      pharmacokinetics after a 2-day repeated administration in which the steady state was
      achieved.
    

Intervention name(s): Tramadol HCI/Acetaminophen
Intervention type(s): Drug
Intervention description(s): Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.
Other intervention name(s): ULTRACET immediate release tablet; YJAT sustained release tablet
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Tramadol; Acetaminophen; Pharmacokinetics; Sustained release; Immediate release
Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants
Condition: Phobic Disorders
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Procedurally Virtual reality exposure therapy (VRET) is quite similar to models of extinction
      of conditioned fears. Recent advances in animal research have identified pharmacological
      agents that appear to both accelerate and consolidate extinction learning. One of these
      cognitive enhancers is Yohimbine. An interesting finding in animal literature is that the
      administration of Yohimbine during extinction trials accelerates fear reduction and may
      convert ineffective exposures in to successful ones. It is thought that the mechanism of
      enhanced emotional memory is through elevated norepinephrine in the prefrontal cortex.
      Therefore, we propose to extend these studies by combining VRET with Yohimbine. In this pilot
      study with a between groups design 20 participants with a fear of flying will be treated with
      VRET plus Yohimbine or VRET plus placebo. This between groups design was chosen to further
      characterize the differential within and between trial extinction. Outcome will be measured
      by self-report, behavioral, and psychophysiological assessments at pre- and post-treatment.
      In addition, we will examine extinction parameters during exposures.
    


Intervention name(s): Virtual Reality Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phobic Disorders (Fear of Flying); Virtual Reality Exposure Therapy; Fear extinction; Yohimbine
Post- Thoracotomy Paravertebral Block
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative pain is the most undesired consequence of surgery, and if not managed
      adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to
      reveal that postoperative pain is insufficiently managed throughout the first world, let
      alone in the Third World. An American survey over 20 years showed that only one in four
      patients had adequate relief of postoperative pain. This has led recovery room protocols to
      include pain as a fifth vital sign that needs to be addressed before patients are discharged
      to the ward
    

Detailed description: 
      This prospective, randomized, double-blinded, parallel assignment clinical trial will be done
      after receiving approval from the local ethics committee of the Faculty of Medicine, Assiut
      University. A written informed consent will be taken after discussing a detailed description
      of the study with the patients.

      Patients will be allocated randomly into two equal groups by computer programs and will be
      contained in sealed opaque envelopes.

      Patients will be premedicated with midazolam (0.1mg/kg), 30 min before the operation.
      Patients will be monitored with ECG, non-invasive blood pressure, heart rate, temperature,
      oxygen saturation, exhaled CO2 (end tidal capnography), and train of four. In both groups,
      general anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal
      intubation will be facilitated with cisatracurium 0.1 mg/kg. Anesthesia will be maintained
      with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose). Fentanyl (0.5mcg/kg) will be
      repeated if heart rate (HR) and/or mean arterial pressure (MAP) rise 20 % above baseline
      values. After the end of anesthesia induction and before surgical procedure Technique of
      ultrasound guided paravertebral block will be done in both groups.
    

Intervention name(s): Bupivacaine; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided paravertebral block with bupivacaine; Ultrasound guided paravertebral block with dexmedetomidine
Other intervention name(s): Marcaine; Precedex
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexmedetomidine; bupivacaine; Ultrasound guided paravertebral block; pain; post-thoracotomy