bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)
Condition: -Unhealthy Children With a History of Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of
      the following treatment sequence A or B.
    

Detailed description: 
      Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A
      total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of
      the following treatment sequence: Sequence A (single dose of the liquid formulation on Study
      Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single
      dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on
      Study Day 30). Children will be followed for adverse events through 30 days after each
      injection of study drug and will have blood collected for determination of palivizumab
      concentrations in serum.
    

Intervention name(s): MEDI-493
Intervention type(s): Drug
Intervention description(s): Active Comparator
Other intervention name(s): Synagis
Intervention MeSH terms: Palivizumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immediate and Long-term Effects of an Adaptation of the "Balloon-blowing Exercise"
Condition: Healthy
Study type: Interventional

Summary: 
      Despite the literature evidence that the "balloon-blowing exercise" improves the pulmonary
      function as a long-term effect, this exercise has not yet been studied or tested
      experimentally, meaning that there are no specific and measurable results that attest the
      improvement on thoracoabdominal movement.
    


Intervention name(s): An adaptation of the "balloon-blowing" exercise; An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home
Intervention type(s): Procedure; Procedure
Intervention description(s): The participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds.; The participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds.
Other intervention name(s): Motor control exercise A; Motor control exercise B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single
      ascending IV doses of GMI-1271 in healthy adult subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single ascending IV dose study
      conducted at one study center in the United States (US). One (1) cohort of 12 subjects (6
      active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned
      for evaluation. Subjects will participate in only one cohort. Safety will be assessed
      throughout the study and serial blood samples and urine samples will be collected for the
      safety and PK assessment of GMI-1271.
    

Intervention name(s): GMI-1271; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: healthy volunteers, GMI-1271
Plantar Fascia Release With Magnetic Fascia Ball
Condition: Flexibility; Muscle Tightness
Study type: Interventional

Summary: 
      In this study, the effect of plantar fascia release with a magnetic fascial cork ball on
      hamstring and lumbar extensor muscle elasticity will be investigated.
    

Detailed description: 
      The use of tools such as foam rollers or massage balls to resolve myofascial tension is
      highly preferred by both therapists and patients. It is theorized that the sweeping pressure
      generated during rolling causes the fascia to stretch and increase the range of motion. In
      addition, the warming caused by the friction during rolling can dissolve the adhesions
      between the fascial layers and restore the elasticity of the myofascial tissues. In addition
      to similar mechanical effects, the use of cork balls with magnetic properties is becoming
      increasingly common. Studies have shown that static magnetic magnets reduce pain, increase
      microcirculation and oxygenation and cause changes in presynaptic membrane function. As far
      as we know, there is no study examining the myofascial relaxation effect of magnetic balls in
      the literature. Evaluating the clinical impact and efficacy of this device which allow the
      person to perform self-massage might contribute the current literature. This study was
      planned to evaluate the myofascial relaxation caused by two different fascial cork balls with
      and without magnetic properties.
    

Intervention name(s): Plantar fascia self massage with a magnetic fascia ball; Plantar fascia self massage with a non-magnetic fascia ball
Intervention type(s): Other; Other
Intervention description(s): Participants were asked to roll the magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.; Participants were asked to roll the non-magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; Hamstring Muscles; Magnets; Lumbar Fascia
Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess in healthy adult male subjects:

        -  The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899
           including two up titration steps.

        -  Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in
           plasma.

        -  Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin,
           biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21).

      To assess in overweight to obese T2DM mellitus patients:

        -  The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up
           titration steps.

        -  PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine.

        -  PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin
           panel (total and active ghrelin, total peptide YY [PYY], total and active glucagon-like
           peptide -1 [GLP-1], glucagon and total gastric inhibitory polypeptide-1 [GIP]), body
           weight, FGF21, biomarkers of lipid metabolism and HbA1c.
    

Detailed description: 
      The total study duration is approximately 10-15 weeks.
    

Intervention name(s): SAR425899; placebo; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress
      Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine
      (TCM) diagnostic patterns.
    

Detailed description: 
      This study will evaluate: 1) the TCM diagnostic differentiation patterns of people who have
      PTSD as defined by the Diagnostic and Statistical Manual, 4th edition; 2) if an acupuncture
      treatment approach is acceptable to people with PTSD; and 3) if an acupuncture treatment
      approach is associated with a reduction in PTSD symptoms that is comparable to that of
      standard treatments. Because symptoms of depression, insomnia, and pain are often associated
      with PTSD, we will also evaluate the potential benefit of an acupuncture approach to
      depression, insomnia, and pain symptoms in people with PTSD.

      Patients in this study will be randomized to one of three groups. Group A will receive
      acupuncture therapy. Group B will receive standard Cognitive Behavior Therapy. Group C is a
      control group and will receive no treatment. Patients in Groups A and B will undergo a total
      of 24 hours of therapy over the 3 month study course. All patients will have five
      nontherapeutic study visits; these visits will address diagnosis and assessment. Study visits
      will include assessments of PTSD symptoms, sleep symptoms, and level of impairment.
    

Intervention name(s): Acupuncture; Cognitive Behavioral Therapy
Intervention type(s): Procedure; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Acupuncture; Medicine, Chinese Traditional
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and blood levels of
      AZD5847 after daily oral dosing for 14 days.
    


Intervention name(s): AZD5847; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, 15 days; oral suspension, 15 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety
The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction
Condition: Lower Esophageal Sphincter
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction
      with respect to the barrierpressure in the esophagogastric junction.

      The secondary aim was to investigate whether the effect of cricoid pressure influences the
      barrierpressure.
    

Detailed description: 
      During anesthesia induction and tracheal intubation one major concern is to avoid passive
      regurgitation of gastric content and aspiration.

      The lower esophageal sphincter is a muscle located at the distal end of the esophagus. It
      plays an important role in creating a barrier between the stomach and the esophagus. The term
      "barrierpressure" is defined as the pressure difference between the lower esophageal
      sphincter pressure and the pressure in the stomach (intragastric pressure).

      There are studies showing that opioids given iv/im, in the vein or in the muscle, may
      decrease the pressure in the lower esophageal sphincter and hereby increase the risk of
      aspiration.

      Nevertheless,other studies shows that opioids are still frequently given to patients during
      anesthesia induction. This is done in order to prevent the cardiovascular response to (the
      painful) intubation which can often be seen as an equally high risk for the patient as the
      risk of aspiration.

      In light of the above description, the investigators are planning a study in volunteers with
      the primary aim of investigating the effects of an opioid (alfentanil) on the pressures in
      the lower esophageal sphincter.

      Another safety measure taken during anesthesia induction is the so called "cricoid pressure".
      This is based on the theory that passive regurgitation of gastric content may be prevented by
      occluding the esophagus by pressing on the cricoid cartilage. However, there are studies
      indicating that the application of cricoid pressure also may decrease the tonus of the lower
      esophageal sphincter.

      The secondary aim of the study is to investigate the effect of cricoid pressure application
      on the pressure in the lower esophageal sphincter.

      Measurements are being done using high-resolution solid-state manometry.
    

Intervention name(s): alfentanil; saline
Intervention type(s): Drug; Drug
Intervention description(s): 20 mikrogr/kg; The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.
Other intervention name(s): alfentanil = rapifen
Intervention MeSH terms: Alfentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lower Esophageal Sphincter; Barrier pressure
A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
Condition: Glomerulonephritis; IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA; Glomerulonephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy
      have been proved,and the efficacy of probucol in combination with valsartan is to be proved
      in patients with IgA nephropathy.

      This is a prospective randomized controlled, double blinded pilot study to identify the
      efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The
      renal function deterioration will be the primary outcome studied. The expected study duration
      will be 36 months.
    


Intervention name(s): Valsartan; Probucol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Valsartan (80-160mg/day); Probucol (750mg/day); Placebo
Intervention MeSH terms: Valsartan; Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IgA nephropathy; probucol; valsartan; treatment; antioxidant; IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious
      among the elderly. A Vaccine given as a nasal spray may improve compliance and local
      immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and
      together they enhance the local immune response in mice when given as nasal spray.This study
      aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to
      the commercial muscular vaccine.
    


Intervention name(s): Vaccination
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Intranasal vaccination, Influenza
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat in Adult Patients With Mild Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium
      compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be
      delivered via Respimat inhaler and will be examined on top of maintenance inhaled
      corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be
      assessed by measuring the effects on lung functions, effects on lung exacerbations, effects
      on asthma control and numbers of adverse events.
    


Intervention name(s): placebo; tiotropium 2.5 mcg; tiotropium 5 mcg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler; To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler; To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Oral Ivermectin for Chikungunya Viral Infection
Condition: Clinical Syndrome
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Chikungunya viral infection (CVI) is a mosquito-borne infection, caused by chikungunya virus
      (CHIKV), an alphavirus, belonging to the family Togaviridae. This infection causes febrile
      illness associated with high fever, rash, acute deliberating and persistent arthralgia. There
      is no licensed vaccine or specific treatment for this infection. Ivermectin (IVM),
      commonly-used antiparasitic, has been demonstrated to inhibit replication of CHIKV.
    


Intervention name(s): Ivermectin
Intervention type(s): Drug
Intervention description(s): 3-day 1 daily dose of 400 μg/kg oral ivermectin
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
Condition: Periorbital Edema
Study type: Interventional

Summary: 
      1. To establish clinical efficacy, safety and patient satisfaction of reducing lower eyelid
           convexities or "bags" and/or malar crescents (festoons) with catheter-based injectable
           RF (InMode AccuTite) and variable depth Fractional RF Microneedle skin rejuvenation
           (InMode Morpheus8).

        2. To determine the relative effectiveness of dual-modality treatment (AccuTite + Morphues8
           initial treatment followed by two consecutive Morpheus8 treatments 1 month apart) versus
           single modality treatment (AccuTite only)
    

Detailed description: 
      This prospective study is intended to evaluate the efficacy of radio frequency energy in
      reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with RFAL
      (InMode AccuTite) and variable depth Fractional RF resurfacing skin rejuvenation (InMode
      Morpheus8).

        1. 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the
           two study sites)

        2. 15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly
           Morpheus8 treatments (7-8 patients per arm at each of the two study sites) Treatment
           areas include: periorbital zones with Morpheus8/Lower Eyelid with Accutite
    

Intervention name(s): AccuTite; AccuTite + Morpheus 8
Intervention type(s): Device; Device
Intervention description(s): Subjects will undergo treatment with AccuTite; Subjects will undergo treatment with AccuTite and Morpheus 8
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the
      treatment of manic episodes of bipolar disorder.
    


Intervention name(s): Licarbazepine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bipolar disorder; manic episode; treatment; licarbazepine