bioihbjkbjnl/mcl2 huggingface dataset:
Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients
Condition: Hand Injuries; Edema Arm
MeSH terms: Hand Injuries
Study type: Observational

Summary: 
      This study determined the intra-rater and inter-rater reliability of the Figure-of-Eight
      method on healthy hands, and compared the figure-of-eight measurements to the gold standard
      volumetric measurements. Part B of the study conducted in a clinic, assessed the intra-rater
      reliability and inter-rater reliability on both hands of patients with hand injuries.
    

Detailed description: 
      Edema is the retention of fluid in the intracellular spaces, which is common in inflammatory
      condition such as traumatic injury and post surgical conditions. Edema in the hand and wrist
      can result in detrimental physiological changes which decrease the range of motion of joint
      and limit the overall functional capacity and dexterity of the hand. The gold standard
      Volumetric measurements are reliable for measuring edema changes in upper extremity. Using
      volumeters can be cumbersome in a busy clinic. Figure-of-eight measurements using a tape
      measure on the wrist and hand is an easy way to measure edema and can capture the
      accumulation in the dorsal hand that circumferential tape measurements do not capture. This
      study was performed in two parts. Part A determined the intra-rater and inter-rater
      reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight
      measurements to the gold standard volumetric measurements. No study other study has compared
      right and left hands. Part B of the study was conducted in a clinic to assess the intra-rater
      reliability and inter-rater reliability on both hands of patients with hand injuries.
    

Intervention name(s): Figure-of-eight tape measure measurements on both hands; Volumeter measurements
Intervention type(s): Other; Other
Intervention description(s): Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.; Volumeter measurements to uninjured participants had 3 measurements taken of each hand.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Part A: Thirty healthy participants (10 men and 20 women) were recruited from the student
        population at a university.

        Part B: 17 participants with upper extremity injury (4 men & 13 women)
      
Keywords: reliability; edema; physical therapy; occupational therapy; figure-of-eight
A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately
      150 subjects with acne vulgaris in Phase 2.
    

Detailed description: 
      Phase 1/2 study enrolling up to 60 healthy volunteers followed by approximately 150 subjects
      with acne vulgaris. Data from Phase 1 stage will be reviewed before progressing to Phase 2.

      Phase 1 is an open label study to determine safety, tolerability of XPF-005 topical gel and
      exposure of XEN801 (active ingredient). Up to 5 cohorts of 12 healthy volunteers will each
      receive different dose volumes of XPF-005 gel or Placebo gel on their face and back for 14 or
      21 days. Safety assessments are completed and PK samples are collected at study visits.

      Phase 2 is a randomized, double-blind, vehicle-controlled, parallel-group study to determine
      safety, tolerability, efficacy of XPF-005 topical gel and exposure of XEN801 (active
      ingredient). Approximately 150 subjects with acne vulgaris will apply XPF-005 or matching
      placebo gel on their face for 12 weeks. Safety and efficacy assessments are completed and PK
      samples are collected at study visits.

      Safety assessments include local skin tolerability assessments, vital signs, physical
      examination, 12-lead ECG, safety laboratory blood and urine and adverse event reporting.

      Efficacy assessments include acne lesion counts and Investigator's Global Assessment (IGA).
    

Intervention name(s): XPF-005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall primary objective of this study is to test the hypothesis that, compared with
      placebo,administration of atomoxetine will result in an improved work productivity.
    


Intervention name(s): Atomoxetine Hydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin
      (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin)
      of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be
      observed.
    


Intervention name(s): liraglutide; placebo; liraglutide; placebo; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Liraglutide for s.c. injection once daily: dose step 1 (9 subjects); Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects); Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects); Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects); Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects); Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery
Condition: Other Peripheral Nerve Disease
MeSH terms: Nervous System Diseases; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Several reports have compared the duration of action of levobupivacaine and ropivacaine as
      local anesthetic. The most widely used method for sensory function evaluation is though means
      of a pinprick test. The investigators want to use the novel method of Quantitative Sensory
      Testing to better evaluate the anesthetic activity. This method used hot and cold sensation
      to assess small nerve fiber function. The investigators will assess the duration of action of
      different drugs when used in an inter scalene nerve block in patients scheduled for shoulder
      surgery.
    

Detailed description: 
      This study aims to compare the length of the analgesic effect of different local anesthesic
      solutions, used in an interscalene nerve block. This will be objectified by measuring the
      changes in small nerve functioning, using quantative sensory testing. Based on the results of
      a previous study, the investigators reduce the dose of the administered local anesthetic,
      expecting a similar length of action using these smaller doses.
    

Intervention name(s): Ropivacaine 0.75%; Levobupivacaine 0.5%; Levobupivacaine 0.5% + epinephrin 1/200000
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block; The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block; The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block
Other intervention name(s): Naropin; Chirocaine; Chirocaine
Intervention MeSH terms: Epinephrine; Ropivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral nerve block
Effectiveness of Nefopam for Thermoregulation During Surgery
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic
      hypothermia
    

Detailed description: 
      Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory
      defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal
      centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without
      sedation, making it an ideal candidate to counteract thermoregulatory shivering.

      Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized,
      double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples
      with non-linear mixed effect modelling. A two compartment mammillary model independent of
      covariates was found to describe the data best and could be implemented to drive automated
      pumps, achieving and maintaining a desired plasma concentration.
    

Intervention name(s): Nefopam Low dose; Nefopam High dose
Intervention type(s): Drug; Drug
Intervention description(s): Continuous intravenous infusion at 0.5 mg/ml for three hours.; Continuous intravenous infusion at 1.0 mg/ml for three hours.
Other intervention name(s): Low; High
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Volunteers given two doses of nefopam in a crossover protocol.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nefopam; Pharmacokinetics; Shivering,; Thermoregulation; Anesthesia
PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers
Condition: Effect of Drugs; Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and
      Lansoprazole DR Capsules in healthy Chinese volunteers.
    

Detailed description: 
      This is a randomized, open Label, parallel, single and multiple doses designed clinical
      trial. This study will determine the pharmacokinetics (PK), pharmacodynaimcs (PD) and safety
      after oral administration of an investigational Lansoprazole Capsules in healthy Chinese
      volunteers.

      This study will enroll 24 healthy adults with 12 cases in each group (male : female=1:1).
    

Intervention name(s): Lansoprazole Capsules
Intervention type(s): Drug
Intervention description(s): 24 healthy volunteers will be recruited and randomized into 2 groups (12 for each). During the study session, subjects will receive T drug in group A or R drug in group B for 7 days in fasted condition.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Condition: Perfusion; Complications
MeSH terms: Paraplegia
Study type: Interventional

Summary: 
      Preconditioning of regional skin is known to reduce post surgery complications due to
      increased perfusion and better skin condition. The aim of this study is to prove that local
      heating through a standardized device in patients with spinal cord injury induces no burnings
      or other relevant side effects. The investigators expect an increased regional perfusion,
      temperature and redness.
    


Intervention name(s): HydroSun; Hilotherm
Intervention type(s): Device; Device
Intervention description(s): a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp; a skin area of the lower limb will be treated three times with heat applied by a sleeve
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Complete paraplegia
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicide; Suicidal Ideation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses
      of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive
      placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD)
      including suicidal ideation in participants 12 to less than 18 years of age who are assessed
      to be at imminent risk for suicide.
    

Detailed description: 
      This study will enroll participants with major depressive disorder (MDD) presenting with
      suicidal ideation who are assessed to be at imminent risk for suicide. The study will be
      conducted in 4 phases: a screening evaluation performed within 48 hours prior to Day 1
      intranasal dose; a 25-day double-blind treatment phase (Days 1-25); an 8-week initial
      post-treatment phase (Days 25-81); and a subsequent phase to complete a full 6-month
      post-treatment follow-up (Days 81-200). Efficacy, safety, pharmacokinetic, biomarker, and
      pharmacogenomic evaluations will be performed in the study at defined schedule. The duration
      of the participant's participation will be approximately 29 weeks. If you or a loved one are
      having thoughts of suicide, please seek immediate medical help. Go to the emergency room or
      call the National Suicide Prevention Lifeline at 1-800-273-8255.
    

Intervention name(s): Intranasal Placebo; Midazolam Placebo Solution; Midazolam; Esketamine; Esketamine; Esketamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive placebo as intranasal dose to match intranasal esketamine.; Participants will receive placebo as oral dose to match midazolam drug.; Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.; Participants will receive esketamine at a dose of 28 mg as intranasal solution.; Participants will receive esketamine at a dose of 56 mg as intranasal solution.; Participants will receive esketamine at a dose of 84 mg as intranasal solution.
Intervention MeSH terms: Midazolam; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on
           Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with
           omeprazole 80 mg/day compared to given alone in healthy male and female subjects

      Secondary Objective:

        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when
           clopidogrel is given either alone or concomitantly with omeprazole
    

Detailed description: 
      The total study duration per subjects is 8 - 9 weeks broken down as follows:

        -  Screening: 2 to 21 days before the first dosing

        -  Period clopidogrel/placebo: 7 days including 5 days treatment

        -  Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment

        -  Washout between periods: at least 14 days after last dosing with respect to clopidogrel
           treatment

        -  End of study: 7 to 10 days after the last dosing
    

Intervention name(s): clopidogrel; placebo; omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: matching tablet
Route of administration: oral; Pharmaceutical form: delayed-release capsule
Route of administration:oral
Other intervention name(s): SR25990
Intervention MeSH terms: Omeprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
Condition: Covid-19; Deconditioning
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of this study is to investigate the feasibility (safety, adherence) and initial
      efficacy (physical function and patient reported outcomes) of a multicomponent
      tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized
      due to COVID-19.
    

Detailed description: 
      The aim of this study is to investigate the feasibility and initial efficacy of a
      multicomponent tele-rehabilitation program during COVID-19 recovery. The tele-rehabilitation
      program will include biobehavioral training and high intensity exercise facilitated through
      an online application ('Platform'). Initial efficacy will be assessed primarily by
      performance on the 30" Chair Stand Test and secondarily through other physical function tests
      and patient reported outcome measures.

      This study will advance the feasibility of tele-rehabilitation as a more generally useful
      intervention in patients lacking access (distance, availability, mobility) to standard
      rehabilitative services and could transform the way in which acute rehabilitation and
      post-hospital care is delivered for all patients.
    

Intervention name(s): Biobehavioral Tele-rehabilitation Sessions
Intervention type(s): Behavioral
Intervention description(s): Biobehavioral tele-rehabilitation sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tele-rehabilitation; High Intensity; Biobehavioral; Activity Self-Monitoring; Physical Functional Performance
Histology of SMA-001 in the Abdomen
Condition: Abdominoplasty; Medical Aesthetics
Study type: Interventional

Summary: 
      Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal
      filler to fill wrinkles and folds. This study is designed to collect short-term visual,
      photographic, and histological and safety data on small aliquots of the product as part of
      device development. It is an open label study involving up to three investigational sites and
      a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler
      will serve as a control device. Briefly, the investigational product and the control device
      will be injected into the abdomen of patients intending to undergo abdominoplasty at a later
      date. The patients will be followed for 30 days post injection through visual observation. At
      30 days post injection, the injected gel and associated tissue will be removed via biopsy
      during the abdominoplasty surgery and histology slides created for analysis.
    


Intervention name(s): SMA-001
Intervention type(s): Device
Intervention description(s): Intra-dermal injection of SMA-001 and control device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment
Condition: Aortic Aneurysm, Abdominal
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational [Patient Registry]

Summary: 
      The study of demographics and risk factors for abdominal aortic aneurysms, allows to
      individualize treatment approaches.

      Determining of the results of treatment of patients who requires a late open conversion after
      EVAR will allow to develop the surgical approach and the selection of the optimal type of
      surgical treatment.

      Determination of genetic polymorphisms will reduce the number of postoperative complications
      by predicting of possible complications in the long term period.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients wit infrarenal Aortic Aneurysms
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus)
      vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving
      placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      Sep 2007.
    

Detailed description: 
      This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects
      at the discretion of the investigator.

      One complimentary dose of Rotarix will be administered to all infants enrolled in this study
      (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the
      placebo group for participation in the study.

      The study will be conducted in a double-blind manner with respect to Rotarix and placebo
      administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that
      within each pair of twins, one subject will receive the Rotarix vaccine and one subject will
      receive the placebo.

      The study will be open label with respect to administration of the Rotarix vaccine dose given
      at Visit 3 to all subjects in each group who are aged less than 6 months.
    

Intervention name(s): Rotarix; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two-dose oral vaccination.; Two-dose oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Transmission; Gastroenteritis; Shedding; rotavirus; HRV vaccine