bioihbjkbjnl/mcl2 huggingface dataset:
Ischemic Compression on Post-needling Soreness
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Myofascial trigger points (MTrPs) are identified through physical examination as
      hypersensitive spots within taut bands of skeletal muscle, painful on compression, triggering
      characteristic referred pain and generating motor dysfunction as well as autonomic phenomena.
      Different dry needling procedures have been described in the treatment of MTrPs. Needling
      therapies which consist in partially inserting and withdrawing the needle from the trigger
      point site in order to elicit local twitch responses are associated with higher effectiveness
      in releasing MTrPs. Deep dry needling has obtained a grade A recommendation compared to sham,
      for immediate reduction of pain in patients with upper-quadrant myofascial pain syndrome.
      Nevertheless, trigger point dry needling are frequently associated to a post-needling
      soreness. The application of ischemic compression (IC) after trigger point injection in the
      upper trapezius muscle has shown higher reduction of pain and disability in myofascial pain
      patients, compared with trigger point injection alone. To the authors' knowledge, no previous
      studies have evaluated the effectiveness of IC or any manual therapy methods for the
      treatment of post-needling soreness. The aims of this study were: (a) to evaluate the
      effectiveness of IC on reducing post-needling soreness after dry needling of one latent MTrP
      in the upper trapezius muscle, and (b) to investigate the effect dry needling combined with
      IC, compared to dry needling alone and dry needling combined with placebo IC will have on
      cervical range of motion (c) to determine whether psychological factors are predictive of
      postneedling pain and (d) to analyze if the relationships between psychological variables and
      postneedling pain varied as a function of postneedling soreness treatment
    


Intervention name(s): Ischemic compression. Dry Needling
Intervention type(s): Procedure
Intervention description(s): Ischemic compression was carried out after dry needling. Dry needling was performed with a solid filament needle. Subjects were asked to lie in a prone position. The MTrP was held firmly in a pincer grasp. Before inserting the needle, the patient was advised about the possible sharp pain and muscle twitching. The needle was inserted perpendicular to the skin. Then, the muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needles from the MTrP until two local twitch responses were elicited from the muscle. On removal of the needle, the area was compressed firmly with a cotton bud for two minutes. Immediately after the needling, subjects were randomly assigned to one of three groups (IC, sham and control).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic compression; Myofascial trigger points; Post-needling soreness
A New Measure of Egg Consumption and the Effect of Social Marketing Eggs
Condition: Nutritional Stunting
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be
      receive social marketing campaign to raise awareness about the benefits of eggs while the
      other 4 will not receive social marketing campaign. Children will provide a urine sample for
      analysis of metabolites to correlate with egg consumption.
    


Intervention name(s): Social Marketing Campaign
Intervention type(s): Other
Intervention description(s): aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Bingo Drug-eluting Balloon in Bifurcation
Condition: Bifurcation Lesions; Drug Eluting Balloon
Study type: Interventional

Summary: 
      The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon
      in the treatment of patients with bifurcation lesions of coronary artery.
    


Intervention name(s): Drug-eluting balloon; Uncoated ballloon
Intervention type(s): Device; Device
Intervention description(s): Treat the side branch of bifurcation lesion with drug-eluting balloon; Treat the side branch of bifurcation lesion with uncoated balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bifurcation Lesions; drug eluting balloon; paclitaxel; drug coated balloon
Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the
      Co-administration of CKD-501, D744, and D150 for Healthy Subjects in Fed State
    


Intervention name(s): CKD-383; CKD-501, D744, D150
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on
      carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine
      anti-rheumatic treatment.
    

Detailed description: 
      -  Controlled, randomized trial

        -  RA patients under routine anti-rheumatic care were randomized to receive the treatment
           with or without 400 mg puerarin injection

        -  Assessments were made at entry, 12 and 24 weeks

        -  The overall sample size was assessed before the enrollment

        -  Randomization was performed using concealed random allocation method

        -  The collected data was processed and assessed by two reviewers

        -  All the measurement and analysis procedures concerning CIMT were performed by a single
           ultra sonographer and a single reader, who were blinded to patient profiles and group
           assignment

        -  The reproducibility of the ultrasonographic method was test before the trial
    

Intervention name(s): Puerarin injection 400 mg; Control
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.Furthermore, patients were administrated with 400 mg intravenously infused puerarin injection once a day.Each treatment course lasted for 2 weeks followed by a regular time interval of 15 days.; Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis
Other intervention name(s): Puerarin injection 400 mg + routine anti-rheumatic drugs; Routine anti-rheumatic drugs
Intervention MeSH terms: Antirheumatic Agents; Puerarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: puerarin; rheumatoid arthritis; atherosclerosis; carotid intima-media thickness
A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      The primary objective of this study was to assess the dose-response relationship of SAR425899
      versus placebo in terms of glycemic control as measured by the change in glycosylated
      hemoglobin (HbA1c).

      Secondary Objectives:

        -  To assess the effect of SAR425899 on body weight.

        -  To assess the safety and immunogenicity profile of SAR425899, including assessment of
           the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.

        -  To assess the proportion of participants achieving predefined HbA1c targets of <7% and
           <6.5% as well as the proportion of participants achieving >=5% and >=10% body weight
           loss.

        -  To assess the effect of once daily dosing of SAR425899 on additional parameters of
           glycemic control and lipid metabolism.

        -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic
           (PD) biomarkers.

        -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual
           and inter-occasion variability in PK parameters using a population PK approach.
    

Detailed description: 
      The total study duration will be approximately 30 weeks, consisting of 3 weeks screening
      period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.
    

Intervention name(s): SAR425899; Placebo; Liraglutide; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Self-administered by SC injection using a solution for injection in cartridge.; Self-administered by SC injection using a solution for injection in cartridge.; Self-administered by SC injection using a pre-filled pen.; Orally administered at a stable dose , >=1500 mg daily stable dose or maximal tolerated dose.
Other intervention name(s): Victoza
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Development of Novel Designed Force Plate for Measuring the Balance Ability for the Elders
Condition: Healthy
Study type: Interventional

Summary: 
      To develop a force plate with a proper computing algorithm that can be used in the average
      household as well as within community care centers. An affordable price range will also be
      necessary.
    

Detailed description: 
      Many studies using force plates to examine the elders' balance ability for fall prevention.
      However, few studies compare the reliability differences among age in postural sway
      measurements even though many studies find significantly greater postural sway in the elder
      population than compared to the younger cohort. Investigation of this age difference is
      important for choosing variables to represent their postural sway improvement in order to
      determine the intervention outcome.
    

Intervention name(s): Closed eyes double-leg stance
Intervention type(s): Other
Intervention description(s): Closed eyes double-leg stance: Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Force plate, Balance ability
Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to
      reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to
      cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient
      fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid
      accumulation. However, the guideline for perioperative fluid management has not been yet
      established. The investigators hypothesized that intraoperative fluid management according to
      SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those
      by CVP(Central Venous Pressure). Therefore, the study is trying to determine if
      intraoperative fluid administration based on SVV could reduce metabolic acidosis when
      compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9%
      normal saline as main fluid regimen.
    


Intervention name(s): SVV; CVP
Intervention type(s): Drug; Drug
Intervention description(s): During the surgery, patients in group S receive additional fluids (400 ml of normal saline or 200 ml of colloid) when SVV is less than 13.; Patients in group C receive additional fluids (400 ml of normal saline or 200 ml of colloid) when CVP is less 8 during the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Condition: Basilar Migraine
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to assess the effectiveness and safety of topiramate in the
      prevention of basilar and hemiplegic migraine in children and adolescents.
    

Detailed description: 
      The objective of this study is to assess the efficacy and safety of topiramate in the
      prophylaxis of basilar migraine and hemiplegic migraine in children and adolescents, by
      comparing two doses, 25 and 100 mg/day.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Basilar/Hemiplegic Migraine; Prophylaxis
Comparison of Infusion Methods for Hysteroscopic Procedures
Condition: Complication of Surgical Procedure
Study type: Interventional

Summary: 
      This study is to perform a randomized controlled trial of comparing the manual syringe
      infusion method with the conventional pump infusion method to clarify if the manual syringe
      infusion method really needs less amount of distension medium.
    

Detailed description: 
      Hysteroscopy is frequently used for diagnosing abnormal uterine bleeding, endometrial polyp
      or submucous myoma. However, hysteroscopic procedure can cause morbidity and even mortality
      related to infusion distension medium. We had used a manual syringe infusion method to infuse
      fluid for distending the uterine cavity in our institute without significant morbidity, and
      it seems that this method need less amount of distension medium, and possible result in less
      possibility of hyponatremia. Therefore, the aim of this study is to perform a randomized
      controlled trial of comparing the manual syringe infusion method with the conventional
      infusion pump method to clarify if the manual syringe infusion method really needs less
      amount of distension medium during hysteroscopy.
    

Intervention name(s): Manual syringe infusion method; Pump infusion method
Intervention type(s): Procedure; Procedure
Intervention description(s): Infuse the distension medium of hysteroscopy by manual syringe infusion method; Infuse the distension medium of hysteroscopy by pump infusion method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: hysteroscopy, water intoxication, hyponatremia
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Condition: Physical Activity
Study type: Interventional
Phase: Phase 2

Summary: 
      Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse
      type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment,
      such as metformin. Recent data (animal and human) suggest that metformin may attenuate the
      favorable benefits of exercise training. In light of the physiological mechanism of
      Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that
      rather than inhibit, it will augment the favorable adaptations to exercise training.
    

Detailed description: 
      This is a randomized, placebo-controlled, double blind, repeated measures study. 30 sedentary
      adults will be recruited for participation and randomly assigned to one of two 12-week
      treatments: 1) supervised endurance exercise training 4 days per week plus daily oral
      administration of Dapagliflozin; 2) supervised endurance exercise training 4 days per week
      plus daily oral administration of placebo. Prior to and following completion of the treatment
      the following dependent variables will be quantified: a) maximal aerobic capacity; b)
      substrate utilization during standardized low-moderate intensity exercise; c) skeletal muscle
      aerobic enzyme activity; d) body composition; and, e) oral glucose tolerance, fasting glucose
      and insulin resistance.

      The dose of Dapagliflozin will begin as 5 mg/day for the first 14-days. In the absence of
      complications, side effects, or unfavorable reactions, the dose will then increase to 10
      mg/day for the remainder of the study.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.; Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
Other intervention name(s): Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Treatment Interruption of Natalizumab
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, rater blinded trial in patients who interrupt treatment with
      natalizumab with or without being treated with other immunomodulatory drugs, or continue
      treatment with natalizumab.

      The main purpose of this study is to find out the following, when participants stop taking
      natalizumab for 24 weeks:

        -  when MS symptoms return, and

        -  if other drugs for MS may help control MS symptoms during the natalizumab-interruption
           period.

      This study will also explore how quickly the effects of natalizumab return after resuming
      natalizumab dosing.
    


Intervention name(s): natalizumab; interferon beta 1-a; methylprednisolone; IV placebo; glatiramer acetate
Intervention type(s): Drug; Drug; Drug; Other; Drug
Intervention description(s): 300 mg intravenous every 4 weeks; 30 ug intramuscular once per week; 1000 mg intravenous every 4 weeks; placebo intravenous every 4 weeks; 20 mg subcutaneous once daily
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Methylprednisolone; Glatiramer Acetate; Natalizumab; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the safety, tolerability and antiviral
      activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB)
      adults on oral antiviral (OAV) agents.
    


Intervention name(s): Selgantolimod; Placebo; Hepatitis B virus (HBV) OAV Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet(s) administered orally once weekly; Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly; Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Other intervention name(s): GS-9688
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/ Phase 2, 12-week, multi-center, randomized, double-blind, cross-over,
      placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo
      in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe
      migraine headaches (2-8 per month).

      This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.
    

Detailed description: 
      Achelios is developing ELS-M11 for topical application for the acute treatment of migraine
      events in patients with a history of migraine with or without aura.

      To be eligible for the study, patients must have a one-year documented history of migraine
      headache (as defined by the International Headache Society IHS), with or without aura, with
      2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening
      visit.

      The total duration of the study is the completion of five migraine headaches per subject over
      a maximum 12 week period followed by a 3-14 day Follow-Up Period.
    

Intervention name(s): ELS-M11; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One dose of 5% ELS-M11 over 3 bilateral applications.; One dose of matching placebo over 3 bilateral applications.
Other intervention name(s): Topofen (ketoprofen) Gel 5%
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine headache; Photophobia; Phonophobia; Aura; Topical treatment
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
Condition: Gastric Ulcer
MeSH terms: Stomach Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics
      of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual
      Tablets in Healthy Adult Volunteers
    


Intervention name(s): BRI-1501; Lafutidine; Irsogladine maleate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Irsogladine; Lafutidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment