bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major
      depressive disorder (depression) who have responded inadequately to another antidepressant
      drug during the current episode. This trial will assess the effects of GLYX-13 on depression
      when added to another antidepressant drug that the patient is already taking.
    

Detailed description: 
      To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for
      the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week
      randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal
      period).
    

Intervention name(s): GLYX-13 5 mg/kg; GLYX-13 10 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous administration of 5 mg/kg into arm.; Intravenous administration of 10 mg/kg into arm.; Intravenous administration of normal saline into arm.
Other intervention name(s): GLYX-13 IV Dose; GLYX-13 IV Dose; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; MDD; GLYX-13; HDRS-17; HAMD-17
Preoperative Carbohydrate Loading in Elective Surgery
Condition: Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      Postoperative infectious morbidity remain the most frequent, threatening and costly event
      after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent
      such complications and given the preliminary data on the positive effect of carbohydrate load
      on glucose metabolism it might also be valuable in improving outcome. If this treatment will
      be proved effective on relevant outcome measure such as rate of infections, it might be used
      routinely and extensively because preoperative carbohydrates administration is cheap, simple
      and applicable by everyone in any surgical ward.

      The aim of the trial is to evaluate if the normalization of blood glucose by means of
      preoperative oral administration of maltodextrine, in patients candidate to elective major
      surgery, may be effective in improve surgical morbidity.
    


Intervention name(s): PREOP; water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL; The control group will receive plain water with the same volume and timing of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: carbohydrate; glucose metabolism; surgery, outcome; major elective surgery; urology; hyperglicemia
Integrative Therapy in Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The main aim of this project consists in the investigation of the interaction of behavior
      therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized,
      prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A
      total of 371 patients has been randomly assigned immediately after detoxification to one of
      three different outpatient treat-ment conditions.
    

Detailed description: 
      The objective of this multi-center study is to optimize the long-term treatment of patients
      with alcohol dependence. This investigation should contribute to the issue of effective
      relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy +
      Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate.
      Follow-up examinations carried out 3 and 6 months after the end of treatment.
    

Intervention name(s): Acamprosate; Integrative behavior therapy; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Acamprosate; Integrative behavior therapy; Placebo
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism; abstinence enhancement; psychotherapy; cognitive behavior therapy vs. supportive counseling; Acamprosate vs. Placebo; multi-center study
A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers
Condition: Safety and PK in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of
      MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics.
      Subjects are dosed for 14 days.
    


Intervention name(s): MS-553; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug; Matching placebo to MS-553
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Pericapsular Nerve Group Block and Quadratus Lumborum Block
Condition: Total Hip Surgery; Pericapsular Nerve; Quadratus Lumborum
Study type: Interventional

Summary: 
      Adequate pain management following total hip arthroplasty (THA) is a key component for
      patient satisfaction and early ambulation. However, due to the complexity of the innervation
      of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains
      unclear. A femoral nerve block is commonly performed and well established but is associated
      with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced
      as an effective choice which targets the articular branches of the hip. The quadratus
      lumborum block (QLB) is a relatively new regional block that has been reported to provide
      effective analgesia for THA.

      The main objective of this study is to compare the effectiveness of the ultrasound-guided
      PENG block technique compared to QLB block in terms of efficacy of pain control and the
      safety profile after total hip arthroplasty under spinal anesthesia.
    

Detailed description: 
      The patients will be randomly classified into two equal groups (40 patients each). Group
      allocation will be done by computer generated random numbers and closed opaque sealed
      envelopes. The study will be designed to be double blind as all patients and outcomes
      assessor will be blinded to group assignment.

      Patients will be randomized to one of three equal groups:

      Group I (n= 40 patients): Patients in this group will receive an ipsilateral single shot of
      QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

      Group II(n= 40 patients): patients in this group will receive an ipsilateral single-shot of
      PENG block (25 ml of plain bupivacaine 0.25%) and LFCN block (5 ml of plain bupivacaine
      0.25%) after surgery using ultrasonographic guidance.
    

Intervention name(s): PENG/LFCN and QL Blocks
Intervention type(s): Drug
Intervention description(s): Bupivacaine 0.25% injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Hip Surgery; PENG block; QLB
Efficacy and Safety of Extract of Gelidium Elegans
Condition: Obesity
Study type: Interventional

Summary: 
      Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in
      vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing
      body fat. In a preliminary study of obese adults aged 20 years or older, the extracts of
      Gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase
      lean body mass. Based on these results, we tried to confirm the effect of body weight and
      body fat reduction of Gelidium elegans extract in overweight and obese people.
    


Intervention name(s): Exract of Gelidium elegans; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Exract of Gelidium elegans will be given to the test group.; Placebo supplement will be given to the test group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Plaque, Atherosclerotic
Study type: Interventional

Summary: 
      This study aims to explore whether the increased supply of dietary plant sterols and plant
      stanols have any influence on serum levels of phytosterols and on consistency of carotid
      atheromatous plaques.
    

Detailed description: 
      This is a double-blind randomized study. The study population will consist of 30 consecutive
      patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic
      stenosis. The patients will be randomized into two groups consuming either plant sterol
      (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum
      lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation
      and one month after the operation. The carotid arteries will be examined for their
      composition of sterols.

      This study gives new information concerning the relationship between dietary consumption of
      plant sterols and stanols and the sterol composition of the carotid plaques.
    

Intervention name(s): Plant Stanol; Plant Sterol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Plant stanols in margarines daily 2 grams; Plant sterols in margarines daily 2 grams
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cholesterol; Plant sterols; Atherosclerotic carotid plaques
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct
      size and improves regional wall motion
    

Detailed description: 
      The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI)
      are limited by reperfusion injury. In animal models, nicorandil, a hybrid of an ATP-sensitive
      K+ (KATP) channel opener and nitrates, reduces infarct size, so the Japan-Working groups of
      acute myocardial Infarction for the reduction of Necrotic Damage by a K-ATP channel opener
      (J-WIND-KATP) designed a prospective, randomized, multicenter study to evaluate whether
      nicorandil reduces myocardial infarct size and improves regional wall motion when used as an
      adjunctive therapy for AMI.

      Twenty-six hospitals in Japan are participating in the J-WIND-KATP study. Patients with AMI
      who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or
      placebo. The primary end-points are (1) estimated infarct size and (2) left ventricular
      function. Single nucleotide polymorphisms (SNPs) that may be associated with the function of
      KATP-channel and the susceptibility of AMI to the drug will be examined. Furthermore, a data
      mining method will be used to design the optimal combined therapy for post-myocardial
      infarction (MI) patients.

      It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as
      an adjunct to PCI for AMI and that the SNPs information that will open the field of
      tailor-made therapy. The optimal therapeutic drug combination will also be determined for
      post-MI patients.
    

Intervention name(s): nicorandil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): (0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion; Control
Intervention MeSH terms: Nicorandil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Data mining; Nicorandil; Randomized clinical trial; SNPs
Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform
Condition: Mobile Applications; Cell Phone Use; Mental Health Issue; Acceptability of Health Care; Feasibility
Study type: Interventional

Summary: 
      The primary objective of this project is to test the acceptability and feasibility of a
      mobile application to facilitate mental health symptom monitoring and follow-up among
      Veterans. During the course of the study, the research application will be installed on
      participants' mobile phone. The application on the participants' phone will be recording data
      about their behavior. Participants will also be asked to complete bi-weekly surveys via the
      app.
    


Intervention name(s): Cogito Companion
Intervention type(s): Behavioral
Intervention description(s): During the course of the study, the research application (Cogito Companion) will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      As current study is conducted to provide additional information regarding safety and efficacy
      Bydureon, exenatide once weekly for injectable suspension, in the Korean population open
      label, non-comparative, multi-centre design is used.
    


Intervention name(s): Bydureon
Intervention type(s): Biological
Intervention description(s): exenatide once weekly
Other intervention name(s): exenatide
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide
DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
Condition: Coronary Stenosis
MeSH terms: Coronary Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      A prospective, Multi-center, Randomized Study designed to evaluate the acute lumen gain and
      device procedural success of the DK ScoreTM Scoring balloon versus NSE Scoring Balloon for
      patients with coronary arteries stenosis.
    

Detailed description: 
      This is a prospective, multi-center, randomized controlled, open-label, noninferior study to
      evaluate Acute Lumen Gain after dilatation. A total of 200 patients will be enrolled from 4
      sites in China. All patients enrolled will be randomly assigned to the test group (DK ScoreTM
      group, n=100) and the control group (NSE group, n=100) with randomized allocation ratio of
      1:1. Patients in the test group and the control group will be treated with DK ScoreTM Scoring
      balloon catheters or NSE Coronary Dilatation Catheter. A 30-day after procedure follow-up
      will be conducted for all 200 patients.
    

Intervention name(s): DK ScoreTM Coronary Scoring Balloon; Non-Slip Element Coronary Dilatation Catheter
Intervention type(s): Device; Device
Intervention description(s): After pre-dilation balloon is used (if any), DK Score is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.; After pre-dilation balloon is used (if any), NSE is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.
Other intervention name(s): DK Score; NSE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Scoring balloon; DK Score; NSE
Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor
      targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination
      with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple
      myeloma.
    


Intervention name(s): Ciforadenant; daratumumab
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg orally twice daily for 28-day cycles; 16 mg/kg administered intravenously as follows based on 28-day cycles:
Cycles 1 - 2: Days 1, 8, 15, and 22
Cycles 3 - 6: Days 1 and 15
Cycles 7 - 24: Day 1
Other intervention name(s): CPI-444
Intervention MeSH terms: Daratumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains
      unanswered.
    

Detailed description: 
      A 14-day hybrid therapy invented by our study group appears very promising in H. pylori
      eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol
      and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that
      the eradication rate of reverse hybrid therapy was higher than that of standard triple
      therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than
      concomitant therapy remains unanswered.
    

Intervention name(s): (dexlan+amox+clar+metr)+(dexlan+amox); dexlan+clarith+amox+metro
Intervention type(s): Drug; Drug
Intervention description(s): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily; dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
Other intervention name(s): dexlansoprazole MR 60 mg; amoxicillin 1 g; clarithromycin 500 mg; metronidazole 250 mg; dexlansoprazole MR 60 mg; clarithromycin 500 mg; amoxicillin 1 g; metronidazole 250 mg
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication rate
Treatment of Androgenic Alopecia in Males
Condition: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks
      compared to baseline measurements.
    

Detailed description: 
      This is randomized, double-blind, control device clinical study across 3 sites, evaluating
      changes in terminal hair-count in the evaluation zone having evidence of androgenetic
      alopecia (miniaturized hair).

      The trial will involve approximately 75 male subjects who have been diagnosed with
      androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types
      I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the
      last 12 months.

      Subjects will use the device on three non-consecutive days a week as directed per device for
      26 weeks treatment duration.

      Safety analysis will be assessed based on the reports of adverse events during study.
    

Intervention name(s): HairMax LaserComb; Control device
Intervention type(s): Device; Device
Intervention description(s): Device application 3 times week (non-consecutive days), for 26 weeks; Device is used 3 times a week on non-consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness
Rosuvastatin and Renal Endothelial Function
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The endothelium plays an important role in the regulation of vascular tone and regulation of
      blood flow. Nitric oxide (NO) is the most important known endothelium-derived vasodilating
      factor. Prospective studies have shown that hypercholesterolemia impairs endothelial function
      in different vascular beds. Lowering total cholesterol and particularly LDL-cholesterol with
      statins leads to an improvement in endothelium-dependent vasodilation in the forearm
      vasculature. There is strong evidence to suggest that the benefit is not merely related to
      the decrease in cholesterol-levels. A recent study in the forearm vasculature demonstrated
      that short-term lipid-lowering therapy improves endothelial function and NO availability
      already after 3 days of lipid lowering therapy. Whether endothelial function in the renal
      vasculature of hypercholesterolemic patients is similarly influenced has not yet been
      addressed adequately. In the present study we investigate whether lipid lowering therapy with
      rosuvastatin alters renal endothelial function, as assessed by systemic infusion of the NO
      synthase inhibitor L-NMMA, after 3 and 42 days of therapy.
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: endothelium, NO, renal, statins