bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study the effect of intraoperative magnesium on
      remifentanil-induced postoperative hyperalgesia after thyroidectomy
    


Intervention name(s): remifentanil, MgSO4
Intervention type(s): Drug
Intervention description(s): Patients undergoing thyroidectomy will be randomly assigned to one of three groups. Remifentanil will be infused intraoperatively at 0.05 ㎍/㎏/min (group Ⅰ) or 0.2 ㎍/㎏/min (group Ⅱ & Ⅲ). Patients in group Ⅲ will be received 30 ㎎/㎏ MgSO4 at the induction of general anesthesia followed by a maintenance infusion of 10 ㎎/㎏/hr intraoperatively until skin closure.
Intervention MeSH terms: Remifentanil
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Remifentanil induced postoperative hyperalgesia
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart
      and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or
      infusion set occlusion.

      Main Secondary objectives:

      To compare insulin glulisine, insulin aspart and insulin lispro on:

        -  Unexplained hyperglycemia

        -  Infusion set occlusion

        -  Hypoglycemic episodes,7-point blood glucose profiles

        -  Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis

        -  Time to change the infusion set

        -  HbA1c (Glycosylated hemoglobin)

        -  Overall safety: incidence of adverse events
    

Detailed description: 
      The maximal duration of the study participation for patients was 41 weeks and one day, split
      in:

        -  a 2-week screening period,

        -  a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative
           regimen, including a dose adjustment period of 1 week at the beginning of each period
           (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2:
           insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro,
           then insulin glulisine, then insulin aspart)

        -  and a follow-up period of 24 hours.
    

Intervention name(s): Insulin glulisine; Insulin lispro; Insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump; 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump; 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels
Condition: Asymptomatic Subjects With Atopy and Elevated Serum IgE
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE
      in asymptomatic subjects with atopy.
    


Intervention name(s): PG102, a water soluble extract from Actinidia arguta; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks; placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: atopy, IgE
Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions
Condition: Gynecologic Disease
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Surgery remains the backbone of modern management of benign gynecologic conditions. Some
      common surgical procedures include hysterectomy for uterine leiomyoma or adenomyosis,
      adnexectomy for ovarian and tubal pathology, and other conservative surgeries. These
      procedures can be accomplished by different surgical approaches comprising abdominal,
      vaginal, and laparoscopic routes. Although the use of vaginal and laparoscopic approach has
      increased in recent years, the open abdominal route is still the most commonly employed
      approach. This is especially the case in developing countries where resources to support the
      more expensive approach such as laparoscopy are quite limited. However, the procedure can be
      associated with significant morbidity. Delayed functional recovery influenced by pain and
      immobilization are important contributing factors for increased morbidity. Elastic abdominal
      binder, a wide elastic belt that is wore around the patient's abdomen to support surgical
      incision after surgery, has been employed by clinicians for pain relief, wound complications
      prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder
      use in this patient population have not been properly examined.

      The aim of this study is to examine the effect of postoperative elastic abdominal binder use
      on recovery by comparing pain scores and mobility function (through the 6-minute walk test
      [6MWT]) in postoperative gynecologic patients who use versus do not use the elastic abdominal
      binder to support incisional site.
    


Intervention name(s): Elastic abdominal binder
Intervention type(s): Device
Intervention description(s): Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients
Condition: Patients, Resistant Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study was to determine whether LHW090 displays the clinical safety
      and efficacy profile to support further development in patients with resistant hypertension.
    


Intervention name(s): LHW090; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule - oral dose; Capsule - oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: resistant hypertension
Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The investigators determined the effectiveness of a group intervention for the treatment of
      shoulder pathologies.
    

Detailed description: 
      The investigators performed a two-armed prospective clinical trial study, analyzing a sample
      formed by 76 patients with shoulder pain. The patients were allocated to one group randomly
      (intervention or control group). The data was obtained in the San Juan de Alicante Hospital
      between November 2014 and July 2015.
    

Intervention name(s): Physiotherapy exercises guideline
Intervention type(s): Procedure
Intervention description(s): Exercises controlled by a physiotherapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women
Condition: Caesarian Section
Study type: Interventional

Summary: 
      The study aimed to compare successful spinal needle insertion between obese and non-obese
      pregnant women in crossed leg sitting position undergoing cesarean section
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the
      study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted,
      knees flexed medially, each feet soles were under their contralateral thighs. The back was
      flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow.
      Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it
      reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were
      the number of attempt for the successful spinal puncture, the number of spinal needle-bone
      contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package
      for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test,
      for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested
      by Kolmogorov-Smirnov test. Significant value is p<0.05.
    

Intervention name(s): Crossed leg sitting position
Intervention type(s): Procedure
Intervention description(s): Spinal anesthesia done in crossed leg sitting position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: spinal anesthesia; spinal-bone contact; caesarian section; crossed leg sitting position
The Effect of Protein Ingestion on the Recovery of Skeletal Muscle Function Following Eccentric Exercise.
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will assess the effect of the type and timing of protein ingestion 6 days
      prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of
      muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.
    


Intervention name(s): Post exercise protein-polyphenol supplement; Post exercise placebo supplement; Pre bed protein-polyphenol supplement; Pre bed placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.; Participants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.; Participants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.; Participants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Periostin and Non-Surgical Periodontal Treatment
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases; Chronic Periodontitis
Study type: Interventional

Summary: 
      A total of 90 subjects, 30 patients with chronic periodontitis, 30 with gingivitis and 30
      periodontally healthy subjects were included. Patients with periodontal disease received
      non-surgical periodontal treatment. Gingival crevicular fluid periostin levels were assessed
      at baseline, at the 6th week and the 3rd month after treatment.
    

Detailed description: 
      Periostin is commonly found in collagen-rich tissues, which is thought to affect the
      production of collagen fibers. Additionally, periostin is synthesized in tissues exposed to
      constant mechanical forces such as the periosteum, periodontal ligament, tendon, heart valve
      and skin. Periostin mediates inflammation and fibrosis during diseases of various organs,
      including the heart, lung, kidney, skin, liver, skeletal muscle and retina.

      This study evaluated periostin levels in gingival crevicular fluid from patients with chronic
      periodontitis, gingivitis and periodontally healthy as well as the effect of non-surgical
      periodontal treatment on gingival crevicular fluid periostin levels.
    

Intervention name(s): Non-Surgical Periodontal Treatment
Intervention type(s): Procedure
Intervention description(s): Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.
Other intervention name(s): Initial periodontal therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic periodontitis; Gingival crevicular fluid; Gingivitis; Non-surgical periodontal treatment; Periostin
A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain
Condition: Pain; Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in
      patients with pain associated with osteoarthritis of the knee.
    

Detailed description: 
      The study will be randomized, double blind, placebo and active control, a 3-way, 3-period
      crossover design, where each of the estimated 50 enrolled patients will receive alternately
      (i) NEO6860 (500 mg bid), (ii) placebo and (iii) Naproxen (500 mg bid). To ensure blinding,
      double dummy techniques will be used, so that at each period, patient will receive an oral
      liquid suspension (NEO6860 or its placebo) and one capsule (naproxen or its placebo).

      Following a screening period, a maximum of 28 days before dosing, subjects will be randomized
      to one of the scheduled sequences. At each dosing period, subjects will be requested to
      participate in 2 clinic visits:

        -  One residential visit, the morning of investigational product dosing. Subjects will stay
           in the Clinical Research Unit approximately 13 hours

        -  One end of period visit, 24 h after first dosing A total of 2 washout periods of 1 to 3
           weeks will separate the dosing periods. Once the 3 dosing periods will be completed, the
           subjects will come back to the clinic for a follow up visit (7 to 10 days post last
           dose).

      Note: for a subpopulation, at one site, an assessment of heat pain threshold and tolerance
      will be conducted requiring a residential period of approximately 24 hours.
    

Intervention name(s): NEO6860; NEO6860 placebo; Naproxen; Naproxen placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TRPV1 antagonist; Inactive substance; NSAID; inactive substance
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to
      support dose selection for Phase 3 development in Japanese adults with obesity disease.
    


Intervention name(s): LIK066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LIK066 will be supplied in different doses as tablets to be taken orally daily.; Placebo will be supplied as tablets to be taken daily orally.
Intervention MeSH terms: Licogliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity disease; Over weight; T2DM; interventional study; Weight loss
Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
Condition: Hyperthyroidism
MeSH terms: Hyperthyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall objective of the HEAT study is to determine the acute effect of propranolol on
      energy expenditure in patients suffering from hyperthyroidism and to evaluate the
      consequences of the change of hyper- to euthyroidism on metabolism during the course of
      treatment, especially with regard to the reaction to cold ambient temperatures.
    


Intervention name(s): Propranolol
Intervention type(s): Drug
Intervention description(s): Patients receive a single dose of 80 mg propranolol p.o.
Other intervention name(s): beta blockade
Intervention MeSH terms: Propranolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Brown adipose tissue (BAT); Hyperthyroidism
Intravascular Injection Rates During Lumbar Medial Branch Block
Condition: Intravascular Injection
Study type: Interventional

Summary: 
      The purpose of this study is to compare using Toughy needle has an advantage of reducing the
      incidence of vasucular puncture during lumbar medial branch block.
    

Detailed description: 
      In previous reports, the use of Toughy needle was thought to reduce the incidence of
      intravascular injection during lumbar transforaminal injection. Blunt needles with a pencil
      point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles,
      which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel
      during a procedure. Hence, the investigators postulated the incidence of intravenous uptake
      would be significantly lower using a Toughy needle than using a Quincke needle for lumbar
      medial branch block. To confirm the intravascular injection rates, the investigators used the
      real time fluoroscopy after injection of contrast medium.

      The goal of this study was to compare the incidence of intravascular injection rate betweeen
      Toughy and Quincke needles using real time fluoroscopy during lumbar medial branch block
    

Intervention name(s): medial branch block
Intervention type(s): Procedure
Intervention description(s): lumbar medial branch block
Other intervention name(s): lumbar medial branch block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intravascular injection
Auricular Acupuncture for Chronic Pain and Insomnia
Condition: Insomnia; Chronic Pain
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain
Study type: Interventional

Summary: 
      Background: In the U.S. approximately 1.6 million adults use complementary and alternative or
      integrative medicine therapy for pain and insomnia. However, very few studies have tested the
      use of auricular acupuncture (AA) using a standard protocol for participants with chronic
      pain and insomnia.

      Objective: To assess the feasibility and acceptability of AA and to evaluate the
      effectiveness of AA on pain severity score, pain interference score, and insomnia over an
      8-day study period.

      Subjects: 45 participants who met the eligibility criteria and signed the consent were
      randomized to either the AA group (AAG) or the usual care control group (CG) on day 4.

      Intervention: A standard AA protocol using penetrating semi-permanent acupuncture needles and
      in-place for up to four days.

      Main Outcome Measures: Brief Pain Inventory pain severity and interference scores for pain
      and Insomnia Severity Index (ISI) for insomnia.

      Results: The use of the standard AA protocol in the AAG led to significant within- and
      between-group reduction in pain severity and interference scores when compared to the CG.
      Both groups showed within-group decrease in ISI. However, the AAG showed significant
      between-group reduction in ISI severity and from moderate to sub-threshold insomnia.

      Conclusions: AA was found to show effectiveness in the treatment of chronic pain and
      insomnia. With a heightened focus on the opioid crisis in the U.S., this easy-to-administer
      protocol can be an option for treatment modality for military beneficiaries with chronic pain
      and insomnia.
    


Intervention name(s): Sterile acupuncture semi-permanent (ASP) gold needles
Intervention type(s): Device
Other intervention name(s): Sedatelac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: auricular acupuncture; battlefield acupuncture; insomnia; chronic pain; randomized
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the pharmacokinetics of Dimebon in subjects with severe renal
      impairment to subjects with normal renal function after oral administration of a single oral
      20-mg dose of Dimebon. This study is also to assess the safety and tolerability of a single
      oral 20-mg dose of Dimebon in subjects with severe renal impairment and subjects with normal
      renal function.
    


Intervention name(s): Dimebon; Dimebon
Intervention type(s): Drug; Drug
Intervention description(s): a single oral dose of 20 mg Dimebon; a single oral dose of 20 mg Dimebon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dimebon; renal impairment; pharmacokinetics