bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study of AZD4041 in Healthy Participants
Condition: Opioid Use Disorder (OUD)
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple
      ascending doses (MAD) study in healthy male and female adult participants.

      The study will include up to 48 participants (12 participants per cohort) who will be
      randomized 9:3 to active drug or placebo. Each cohort will receive AZD4041 or placebo in a
      MAD study.

      A sequential cohort MAD design will be employed to assure that higher doses are administered
      to healthy participants only after lower doses have demonstrated an acceptable safety
      profile.

      The total study duration will be up to 59 days (including Screening) per participant.
    


Intervention name(s): AZD4041; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive oral solution of AZD4041 as stated in arm description.; Participants will receive oral solution of placebo as stated in arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For each cohort, 9 participants will be randomly assigned to receive AZD4041 and 3 participants will be assigned to receive placebo. Within each cohort, 2 participants will be randomized initially to AZD4041 or placebo (1:1 ratio) to allow a sentinel dosing approach. Providing no clinically significant issues have been noted after the first 3 doses of the initial 2 (sentinel) participants in a cohort and provided the Day 3 safety laboratory tests for the 2 participants have been reviewed, the remaining 10 participants will be randomized to AZD4041 or placebo in an 8:2 ratio. All participants will receive either AZD4041 or placebo administered once daily for 14 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Effects of Differential Organ Growth Rates
Condition: Resting Energy Expenditure
Study type: Observational

Summary: 
      Young children have a high resting energy expenditure (REE) relative to their body weight and
      metabolically active compartment, fat-free mass (FFM). Both body weight and FFM are, however,
      metabolically heterogeneous and include organs and tissues varying widely in specific
      metabolic rate (i.e., organ REE/kg/d). One prevailing hypothesis is that most, if not all, of
      the higher REE observed in young animals and children compared to adults can be accounted for
      by a larger proportion of high metabolic rate components such as brain, liver, and heart..
    

Detailed description: 
      FFM was the traditional and only means of adjusting REE for between-individual differences in
      metabolically active tissue components. The investigators seek to improve the understanding
      of variation in REE by developing new and improved rapid magnetic resonance imaging (MRI)
      methods of quantifying some of the major heat producing organs and tissues in children and
      adults. The long-term aim is to provide an improved understanding of human energy
      requirements. Specifically, the investigators propose to test whether: 1) a portion of the
      elevated daily REE adjusted for FFM observed in young children (Tanner Stage 1) could be
      accounted for by the relative fractions of body mass as high metabolic activity tissues
      (heart, liver, kidney, brain) and low metabolic activity tissues (skeletal muscle, adipose
      tissue), 2) a portion of the age-related decline in daily REE adjusted for FFM observed in
      children could be accounted for by changes in the relative fractions of body mass as high and
      low metabolic rate tissues during growth.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be healthy African-American, Asian (Chinese, Korean, Japanese), and Caucasian
        pre-pubertal females and males (ages 7-11 years) at baseline. Lean (Body mass index (BMI) <
        85th by age and sex) and obese (BMI > 95th percentile by age and sex.
      
Keywords: Fat-free mass; Tanner stage 1; Pre-pubertal
Work Ability in Young Adult Cancer Survivors
Condition: Cancer Survivor
Study type: Observational

Summary: 
      To document levels of labor force participation, occupation, educational attainment, and
      financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.
    

Detailed description: 
      This observational, cross-sectional study will recruit 220 analyzable YA survivors through
      the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP)
      Research Base (WF NCORP RB). Data will be collected using a web-based interface and will
      capture physical, psychosocial and cognitive late effects; work ability; work-related
      outcomes, including labor force participation, occupation, work place characteristics, and
      educational attainment; survivor characteristics; and cancer diagnosis/treatment information
      (from clinical records). We will evaluate the relationships among these measures using the
      theoretical framework to guide statistical analysis.
    

Intervention name(s): Cognitive Assessment; Questionnaire Administration
Intervention type(s): Procedure; Other
Intervention description(s): Complete CogState; Complete Self-Report Questionnaire
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the immediate effects of diaphragmatic release
      techniques on posterior chain flexibility and lumbar spine amplitude. Respiratory muscle
      strength and chest cavity mobility in healthy women.
    

Detailed description: 
      The aim of this study was to evaluate the immediate effects of diaphragmatic release
      techniques on posterior chain flexibility and lumbar spine amplitude; Respiratory muscle
      strength and chest cavity mobility in healthy women. This is an intervention study with a
      randomized controlled trial design. The randomized study in two groups, the Intervention
      Group in which two diaphragmatic release techniques were performed and the Control Group
      where two placebo techniques were applied in 75 participants between 18 and 35 years of age.
      For intragroup analysis the paired Student t test was used, comparing the outcomes before and
      after the intervention and for intergroup analysis the independent Student t test.
    

Intervention name(s): Diaphragm lift; Relaxation of the diaphragm pillars
Intervention type(s): Procedure; Procedure
Intervention description(s): The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice; Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute
Other intervention name(s): Diaphragmatic release 1; Diaphragmatic release 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample was randomly divided by electronic draw in two groups, the intervention group (GI), where two techniques were performed, one for diaphragmatic release and another for relaxation of the diaphragm pillars. In the control group (CG) the same techniques were applied, but in a placebo form.
Masking: Single (Participant)
Primary purpose: Treatment
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500
      mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under
      fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B
      (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at
      least 7 days and not more than 14 days. The total duration of study for each subject will be
      approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a
      single center.
    


Intervention name(s): GR37547 tablet; Ciprofloxacin reference tablet
Intervention type(s): Drug; Drug
Intervention description(s): A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed "GSK500"on lower side.; A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water. Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500" marked on upper side and "BAYER" on lower side.
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment: Subjects will receive treatment in one of the two sequences; Treatment A (GR37547 tablet) followed by Treatment B (ciprofloxacin reference tablet) or vice versa separated by a washout period of at least 7 days and not more than 14 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GR37547; Cross-over; Bioequivalence; Ciprofloxacin
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
Condition: Infection, Human Immunodeficiency Virus I
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 48-week study to collect information on the safety and activity of an
      investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
    

Detailed description: 
      A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate
      the safety, tolerability, pharmacokinetics and antiviral activity of GW433908/Ritonavir BID
      when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18
      years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to <6 years old
    

Intervention name(s): LEXIVA (GW433908); Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Fosamprenavir suspension or tablet bid; Ritonavir solution bid
Other intervention name(s): LEXIVA (GW433908)
Intervention MeSH terms: Ritonavir; Fosamprenavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antiretroviral therapy; pediatrics; AGENERASE; amprenavir; fosamprenavir; HIV Infection; ritonavir; protease inhibitor; LEXIVA
Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Study is conducted to evaluate safety and efficacy in patients with osteoarthritis
    

Detailed description: 
      Osteoarthritis is the most common disorders of the joints, which gives a page more than 10%
      of the world population aged over 45 years (Woolf A. D., Pfleger B., Bergman S., 2009). The
      main clinical manifestations of the disease are pain in the joints and a violation of their
      functions. Therefore, one of the first tasks in the therapeutic program, these patients will
      decrease and possible pain relief. Nesteroi dnye anti-inflammatory drugs (NSAIDs) are the
      main group of medicines drugs used in medical practice in lech th Research Institute of pain
      in patients with lesions of the musculoskeletal system. The basis of the therapeutic effect
      of the second of these drugs is the suppression of the activity of Fe p IU NTA cyclooxygenase
      (COX). Prichё m, the suppression of the activity of COX-2 isoenzyme involved in the synthesis
      of prostaglandins, induce the development of pain and PLAYBACK tion and provides
      anti-inflammatory effects of NSAIDs. B Blocking out of the enzyme COX-1, which controls the
      synthesis of prostaglandins, have cited a protective properties, leading to side effects of
      NSAIDs These so called nye formed the basis for the creation of new NSAIDs that can
      selectively inhibit COX-2 and m and mally affect COX. - 1.

      Nimesulide is a selective inhibitor of cyclooxygenase -2 vnym with Sat and anced analgesic
      and anti-inflammatory effect, but also has antibradikinin, antihistamine and antioxidant
      activity of Stu(Nasonov EL, 1999, 2001).
    

Intervention name(s): NISE
Intervention type(s): Drug
Intervention description(s): Nise 200mg Max per day in 2 divided doses
Other intervention name(s): Nimesulide
Intervention MeSH terms: Nimesulide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean
Condition: Orotracheal Intubation
Study type: Observational

Summary: 
      Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper
      management.

      Several methods to evaluate the anatomical structures has been used during preoperative
      period for airway assessment.

      Evaluation methods are such as the Mallampati classification, mouth opening, thyromental
      distance and sternocostal distance.

      the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper
      lip by the lower incisor.

      The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT)
      in Korean compared to Modified Mallampati classification(MMT).
    


Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients undergoing general anesthesia with orotracheal intubation
      
Keywords: ULBT, diffficult laryngoscopy, Predictive Value of Tests
Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib
Condition: Arthritis; Bleeding Ulcer
MeSH terms: Arthritis; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of Esomeparzole with Placebo in the
      Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor
    

Detailed description: 
      Among patients with previous ulcer bleeding, neither nonsteroidal anti-inflammatory drugs
      (NSAIDs) plus a proton pump inhibitor (PPI) nor a cyclooxygenase (COX)-2 inhibitor adequately
      prevents recurrent ulcer bleeding.

      The aim is to investigate whether adding a PPI to a COX-2 inhibitor is superior to a COX-2
      inhibitor alone for the prevention of recurrent ulcer bleeding in high-risk patients.

      Patients with arthritis who presented with NSAID-induced ulcer bleeding were eligible if they
      had healed ulcers on follow-up endoscopy; were H. pylori negative or eradicated; and required
      regular NSAIDs. After the ulcers had healed, all patients received celecoxib 200 mg b.i.d.
      They were randomly assigned to esomeprazole 20 mg b.i.d. or its placebo for 12 months. The
      primary endpoint was recurrent ulcer bleeding.

      Results Intention-to-treat analysis included 273 patients (137 received esomeprazole and 136
      received placebo). Recurrent ulcer bleeding occurred in none receiving esomeprazole and 8
      patients receiving placebo. The 12-month cumulative incidence of recurrent bleeding was 0% in
      the esomeprazole group and 8.9% in the placebo group (difference, 8.9 percentage points; 95%
      confidence interval for the difference, 4.1 to 13.7; P=0.0004). During follow-up, 16.1% of
      patients in the esomeprazole group and 15.4% in the placebo group used low-dose aspirin.
      Among patients who did not use aspirin, the cumulative incidence of recurrent ulcer bleeding
      was 0% in the esomeprazole group and 7.1% in the placebo group (difference, 7.1 percentage
      points; 95% confidence interval, 2.4 to 11.8; P=0.004).

      Conclusion Among patients with arthritis who have previous NSAID-induced ulcer bleeding,
      adding a PPI to a COX-2 inhibitor is superior to a COX-2 inhibitor alone for the prevention
      of recurrent ulcer bleeding.
    

Intervention name(s): celecoxib, esomeprazole
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: celecoxib; oesomeprazole; arthritis; ulcer bleeding
Nitric Oxide Administration for Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This research project is an open-label, randomized study for the use of Nitric Oxide in
      pediatric patients with acute respiratory distress syndrome (ARDS). The study examines
      whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of
      oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal
      of the study is to evaluate whether the order of NO therapy will have any effect on response,
      and evaluate the characteristics of patients who respond to NO compared to those who do not.
    

Detailed description: 
      At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of
      microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its
      treatment. NO may be primarily useful in improving matching of ventilation and perfusion in
      the lung. The aims of the study are to attempt to show that NO will improve oxygenation as
      evidenced by improvement in PaO2/FiO2. Secondary aims are to see if the improvement in
      oxygenation allows there to be decreased time on FiO2>0.60, evaluate whether the order of NO
      therapy will have any effect on response, and evaluate the characteristics of patients who
      respond to NO compared to those who do not.

      Subjects will be randomized to receive either nitric oxide first (nitric oxide for the first
      4 hours, then no intervention/no nitric oxide for the next 4 hours) or delayed treatment with
      nitric oxide (no intervention/no nitric oxide for the first 4 hours, then nitric oxide for
      the next 4 hours)..

      Blood gases were monitored once an hour during study participation (total of 8 hours). Final
      PaO2/FiO2 levels will be compared after 8 hours of study treatment in each group.
    

Intervention name(s): Nitric Oxide; No Intervention
Intervention type(s): Drug; Other
Intervention description(s): Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.; Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.
Other intervention name(s): Inhaled Nitric Oxide
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Respiratory Distress Syndrome; ARDS; Nitric Oxide
Botulinum Toxin for the Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Depression is frequently accompanied by a specific sad facial expression. This expression is
      in part mediated by the same muscle activity that produces frown lines. Based on the
      assumption that there is a positive feedback between depressed mood and the correspondent
      facial muscle activity (facial feedback) the investigators will conduct a randomized
      controlled pilot study in which the investigators will apply a classical cosmetic treatment
      of frown lines with injections of botulinum toxin to depressed patients who did not
      sufficiently respond to antidepressant medication. The investigators hypothesize that this
      treatment will contribute to the amelioration of depressive symptoms in these patients. This
      hypothesis is supported by a previous open case series in which remission of depression was
      reported after such treatment (Finzi and Wasserman, 2006).
    


Intervention name(s): clostridium botulinum toxin type A neurotoxin complex; 0.9% NaCl solution
Intervention type(s): Drug; Other
Intervention description(s): A total of 20-50 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected at four to six sites in the glabella region according to standard protocols of cosmetic botulinum toxin applications.; 0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.
Other intervention name(s): Vistabel; Botox Cosmetic; Botox; NaCl 0.9% B. Braun
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; depressive; botulinum; botox