bioihbjkbjnl/mcl2 huggingface dataset:
Combined Suprascapular and Axillary Nerve Blocks for Arthroscopic Shoulder Surgery
Condition: Arthroscopic Shoulder Surgery; Suprascapular Nerve Block; Axillary Nerve Block
Study type: Interventional

Summary: 
      Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve
      block adding to general anesthesia might improve the quality of postoperative analgesia. The
      aim of the study is to compare the subacromial local anesthetic infiltration and the
      suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption,
      postoperative analgesia and analgesic consumption.
    

Detailed description: 
      After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective
      arthroscopic shoulder surgery will be included in this study. Patient will be divided to two
      groups by using computer -generated list for randomization. In group A, the surgeon will
      apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In
      Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250%
      bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction
      of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization
      general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and
      rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O
      mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be
      recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative
      analgesic consumption (Tramadol, patient controlled analgesia), complications will be
      recorded.
    

Intervention name(s): Suprascapular nerve- axillary nerve block combination; Subacromial infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia; In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement
Condition: Edentulous; Alveolar Process, Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Evaluation the amount of bone height gained when using titanium mesh in closing the lateral
      window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained
      when using of the titanium mesh to close the lateral window of the maxillary sinus as a new
      option for tenting compared to collagen membrane.
    

Detailed description: 
      this study is aimed to review the bone height, quality and closure of lateral osteotomy used
      for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.
    

Intervention name(s): titanium mesh; collagen membrane
Intervention type(s): Procedure; Procedure
Intervention description(s): closing the lateral window for maxillary sinus floor elevation with titanium mesh; closing the lateral window for maxillary sinus floor elevaion with collagen membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)
Condition: Diabetic Polyneuropathy
MeSH terms: Diabetic Neuropathies; Polyneuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the trial is to determine the optimal dose of orally (tablet)
      administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP). It
      is expected that at least one of the three dosages to be tested (600, 1200, or 1800 mg
      tablets) of orally administered thioctic acid improves the symptoms of dPNP as compared to
      placebo.

      Secondary objectives are evaluations of other variables pertinent to dPNP, safety, and
      tolerability.
    

Detailed description: 
      Following a screening visit, patients will receive placebo oral for 7 days. Eligible patients
      with chronic symptoms will then randomly be assigned to one of 4 treatment groups and treated
      with trial medication for 5 weeks.
    

Intervention name(s): Thioctic Acid
Intervention type(s): Drug
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the mass balance and metabolic distribution of
      C14-labeled HKI-272 in healthy male subjects.
    


Intervention name(s): neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272, Single-dose capsule and solution
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy subjects
Gestational Diabetes in Central Asia: Prevalence and Management
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Evaluate prevalence and management of gestational diabetes in Tajikistan in two different
      settings (one rural and one urban).
    


Intervention name(s): Observation
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women in rural setting; pregnant women in urban setting;
Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in
      healthy adult subjects.
    


Intervention name(s): Period 1: AT-527 550 mg; Period 2: carbamazepine; Period 3: AT-527 550 mg + carbamazepine; Period 3: AT-527 1100 mg + carbamazepine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1; Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25; AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26; AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Other intervention name(s): AT-527 is also known as RO7496998; AT-527 is also known as RO7496998; AT-527 is also known as RO7496998
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion
Condition: Vitamin D Deficiency; Recurrent Spontaneous Abortion
MeSH terms: Abortion, Spontaneous; Vitamin D Deficiency; Recurrence
Study type: Observational

Summary: 
      The observational study is to compare vitamin D deficiency and related indicators among
      different spontaneous abortions in describe female reproductive health.The main question aim
      to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin
      D.

      Participants, who visit the RSA specialty clinic, will provide medical history information,
      regularly exam based on the condition, following up on pregnancy status.Participants will be
      asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect
      after treatment.
    

Detailed description: 
      Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes
      tested voluntarily, plasma VD content and the level of anticardiolipin antibody.
    

Intervention name(s): Binom Vitamin D drops
Intervention type(s): Dietary Supplement
Intervention description(s): Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added
Intervention MeSH terms: Vitamin D
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women of childbearing age visited the RSA specialty clinic of Hangzhou First People's
        Hospital from January 2021 to June 2023, conducting a prospective clinical study.
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and
      tolerability in pediatric participants with moderately to severely active UC or CD.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
      treat pediatric participants who have moderately to severely active UC or CD. This study will
      look at the PK, efficacy, immunogenicity, safety, and tolerability in participants who take
      vedolizumab.

      The study will enroll approximately 80 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two dose regimens (high or low) per weight
      group >=30 kg and 10 kg to <30 kg in ratio 1:1-which will remain undisclosed to the
      participant and study doctor during the study (unless there is an urgent medical need):

        -  Vedolizumab high dose group - Vedolizumab 300 mg or 200 mg

        -  Vedolizumab low dose group - Vedolizumab 150 mg or 100 mg

      All participants will be administered vedolizumab via IV infusion. Participants assigned to
      the low dose group who do not achieve clinical response (based on pediatric UC/CDAI) at Week
      14 will receive the high dose (that is, 300 mg for participants >=30 kg baseline weight and
      200 mg for participants 10 kg to <30 kg baseline weight) of vedolizumab IV at Week 14.
      Participants assigned to the high dose group who had not achieved clinical response continued
      on the same blinded high dose at Week 14.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is up to 36 weeks. After completing the Week 22 Visit procedures, eligible participants
      may enter a blinded extension study. Participants will make multiple visits to the clinic,
      and those who do not enter extension study will have a final visit 18 weeks after last dose
      of study drug for a follow-up assessment. Participants who do not enter the extension study
      will also participate in a long-term safety follow-up, by telephone, 6 months after the last
      dose of study drug.
    

Intervention name(s): Vedolizumab
Intervention type(s): Drug
Intervention description(s): Vedolizumab IV infusion.
Other intervention name(s): MLN0002; ENTYVIO; KYNTELES
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Drug therapy
Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an intervention designed to help men share
      decisions about prostate cancer screening with their physician results in better decision
      making, more shared decisions, and changes in intended and actual screening rates.
    

Detailed description: 
      Background: Professional societies recommend shared decision making for prostate cancer
      screening, however, most effort has been directed at informed rather than shared decision
      making. In this study, we plan to test the effects of a shared decision making intervention
      on key components of shared decision making. We secondarily plan to test its effects on the
      presence of a shared decision, men's intention to be screened, and actual screening rates.

      Methods: We plan to conduct two separate randomized controlled trials of shared decision
      making interventions, one in which the intervention focuses on prostate cancer screening only
      and one in which the intervention focuses on prostate cancer screening in the context of
      other men's health issues. Each trial will use the same attention control and identical
      implementation and measurement strategies to allow combination of data if no differences
      exist in the effect of the interventions. Trials will include a convenience sample of men
      with no prior history of prostate cancer who present to their primary care physician for
      routine care. Men will be randomly assigned to a shared decision making intervention
      (including a video and coaching session for patients and an education session for providers)
      or a control group, in which men will receive a video on highway safety. Data on key
      components of shared decision making and intent for screening will be measured at baseline,
      after the intervention, and after men's visit with their provider. Additionally, medical
      charts will be reviewed 9 months later to assess for actual screening.
    

Intervention name(s): You Decide; Reducing Your Risks in the Crash
Intervention type(s): Other; Other
Intervention description(s): For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician
For Physicians: a one-time educational session on prostate cancer and the value of shared decision making; Publicly available video on highway safety and reducing individual risks in a crash
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prostate cancer screening; shared decision making; prostate-specific antigen; decision making; physician-patient relations
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Condition: Infections, Meningococcal; Meningococcal Vaccines
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority
      of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one
      month after vaccination, from the first 75% enrolled subjects per country independent of the
      treatment group.
    

Intervention name(s): Nimenrix; Mencevax
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, intramuscular injection; Single dose, subcutaneous injection
Other intervention name(s): Meningococcal vaccine GSK134612
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; meningococcal vaccine; immunogenicity
Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
Condition: Periodontal Bone Loss; Chronic Periodontitis
MeSH terms: Alveolar Bone Loss; Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study aimed to evaluate the effects of enamel matrix derivatives either alone or
      combined with autogenous bone graft applied to intrabony defects in chronic periodontitis
      patients on clinical/radiographic parameters and gingival crevicular fluid transforming
      growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test
      whether the use of autogenous bone graft and enamel matrix derivative combination in the
      treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical
      parameters in comparison to the use of open flap debridement alone.
    

Detailed description: 
      The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either
      alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic
      periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid
      (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement
      (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG
      (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters
      including plaque index, gingival index, bleeding on probing, probing depth, relative
      attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony
      defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was
      evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.
    

Intervention name(s): Open Flap Debridement; EmdogainⓇ(Enamel Matrix Derivative); EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
Intervention type(s): Procedure; Biological; Biological
Intervention description(s): Open Flap Debridement (Control Group); Open Flap Debridement+Enamel Matrix Derivative; Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autogenous bone graft; Chronic periodontitis; Enamel matrix derivatives; Gingival crevicular fluid; Periodontal flap surgery
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the
      treatment of mild headaches in people who have migraines.
    

Detailed description: 
      This multi-center, adaptively randomized, double-blind, placebo-controlled trial will
      evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide
      (CO2) in the treatment of mild headaches. An estimated 250 patients who meet the eligibility
      criteria will be enrolled into this study at approximately 15 sites to ensure that about 220
      patients are randomized and complete the study.
    

Intervention name(s): Nasal CO2; Inactive Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache; Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nasal CO2; Phase II; Adaptive; Randomized; Double-Blind; Placebo-Controlled; Multiple-Dose; Multi-center; Safety; Efficacy; Mild Headache; Migraineur
Effects of Thoracic Mobilization on Shoulder Range of Motion
Condition: Shoulder Range of Motion in Healthy Individuals
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of thoracic spine joint manipulation
      versus a sham intervention on active and passive shoulder flexion (elevation), external
      rotation, and internal rotation range of motion.
    

Detailed description: 
      Many individuals who have a primary complaint of shoulder pain often demonstrate deficits in
      glenohumeral and scapulothoracic mobility. Typically individuals will have limitations in
      shoulder range of motion, specifically, flexion (elevation) as well as external and internal
      rotation. Although the glenohumeral joint is the primary joint for shoulder motion adjacent
      joints such as the sternoclavicular, acromioclavicular, scapulothoracic, and thoracic spine
      also contribute to maximal shoulder motion. Limited shoulder motion may be a result of joint
      hypomobility, muscle inhibition, or pain. Typically interventions such as stretching and
      joint mobilization/manipulation are directed at the glenohumeral joint to improve shoulder
      motion, but little is known about interventions targeting adjacent sites which may also
      improve shoulder range of motion. This study will evaluate the effect of thoracic spine joint
      manipulation on active and passive shoulder range of motion.
    

Intervention name(s): Thoracic Mobilization; Sham
Intervention type(s): Other; Other
Intervention description(s): The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.; The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.
Other intervention name(s): manipulation; Grade V joint mobilization; small amplitude, quick thrust mobilization/manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Thoracic; Manipulation; Manual Therapy; Mobilization; Shoulder; Range of Motion
Effects of Red Wine on Cardiovascular Risk Factors in Humans
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink
      1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes
      in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body
      composition.
    


Intervention name(s): red wine
Intervention type(s): Dietary Supplement
Intervention description(s): intake of red wine on a daily basis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science