bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression
Condition: Bipolar Disorder; Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown
      efficacy in bipolar depressive episodes in retrospective studies. However, there has been no
      prospective study about the monotherapy of olanzapine. The investigators conducted a
      randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for
      treatment of the depressed phase of bipolar disorder.
    

Detailed description: 
      The study was designed as a double-blind randomized controlled trial, with research assessors
      and patients intended to be blind to the intervention status. The staff members performing
      the assessment were not involved in implementing any aspect of the intervention.68 patients
      were randomized to assigned 6 weeks by olanzapine or placebo. Medications were provided in
      double-blind fashion. The assessments include Montgomery-Asberg Depression Rating Scale,
      Young Mania Rating Scale, clinical Global Impressions-Severity of Illness scale, Clinical
      Global Impressions-Improvement scale, response and remission rates, and Treatment Emergent
      Symptom Scale.
    

Intervention name(s): olanzapine; Starch
Intervention type(s): Drug; Drug
Intervention description(s): Tablet The initial dose of olanzapine was 5mg daily and raised to 10 mg/day. After week 1, flexible dosing was allowed based on symptom response, up to 20 mg daily, as tolerated.
daily 6 weeks
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Olanzapine; Monotherapy; bipolar Ⅰ depression
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults
Condition: Colon Cancer; Colorectal Carcinoma; Colon Cleansing
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate
      Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that
      requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540
      patients will be randomised with the aim of achieving a minimum of 245 patients in each of
      the 2 groups.
    


Intervention name(s): NER1006; Trisulfate solution
Intervention type(s): Drug; Drug
Intervention description(s): The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.; The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Effects of Synbiotics on FC and Other Contributing Factors
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a
      16-week randomised, double-blind, placebo-controlled study conducted to assess the
      improvement in functional constipation among the respective individuals by using synbiotic
      supplement. Throughout the intervention, it was reported that significant improvements for
      defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation
      Symptoms (PAC-SYM) scores were reported within synbiotic group (p < 0.001). However, no
      significant different was reported when compared both groups as placebo group was found to
      have significant within-group difference too. Placebo effect was suspected in this study.
    

Detailed description: 
      Digestive system disease is the top ten principal causes of morbidity and mortality among
      Malaysians whereby functional constipation (FC) is the commonest functional gastrointestinal
      disorders (FGIDs) reported. Although numerous treatments are available, but over-the-counter
      drugs which have low product safety and possible toxicity were always given as the treatment
      option. Synbiotic have been well-studied to improve digestive health includes constipation.
      Thus, the objectives of this study were to determine the prevalence of FC and to evaluate the
      effects of synbiotic supplement on improving FC symptoms and contributing factors among
      constipated individuals in Serdang, Selangor. This study comprised of two parts which were
      screening and intervention part. The prevalence of functional constipation was relatively
      high in the study community. Synbiotic supplement was effective in the improvement of
      functional constipation symptoms, quality of life, and psychological factors. However, the
      positive improvement in placebo group indicated the existence of placebo effects which led to
      the improvement in quality of life and changes in psychological factors. Therefore, the
      current findings are useful information for future intervention in improving functional
      constipation symptoms.
    

Intervention name(s): Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01, Bifidobacterium lactis BB12, and inulin oligofructose; Non-active ingredients - Maltodextrins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prevalence; functional constipation; Rome III criteria; Bristol Stool Form Scale; defecation frequency; PAC-SYM; PAC-QOL; randomised controlled trial (RCT); synbiotic
A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy (assessed by clinical evaluation of
      eczema/atopic lesion severity [atopic dermatitis severity index {ADSI} scoring] and perceived
      benefits in itch [visual analog score {VAS} scoring]) and tolerability (assessed by clinical
      grading) of an investigational spot treatment Gel Cream when used on a target site of
      participants with mild to moderate atopic dermatitis.
    


Intervention name(s): Gel Cream
Intervention type(s): Other
Intervention description(s): Gel Cream
Other intervention name(s): Participants will apply gel cream on facial skin and target lesions for up to 14 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itching; Pruritus; Dryness; Excoriation; Xerosis; Eczema; Atopic Dermatitis
Effects on Metabolism and Cognitive Functions of a Commonly Used Commercial Food Supplement
Condition: Postprandial Blood Glucose Regulation
Study type: Interventional

Summary: 
      This project evaluate effects of a commonly used food supplement on glucose metabolism and
      cognitive function.
    

Detailed description: 
      The test product has previously been suggested to elicit beneficial effects on glucose
      metabolism and cognitive performance. The purpose with this study is to evaluate metabolic
      effects and effects on mood variables of the test product provided at breakfast. Test
      variables are determined at fating and postprandial a standardised breakfast. The results are
      compared with effects after a placebo product.
    

Intervention name(s): Panax ginseng; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Pananx ginseng is provided prior to a standardised breakfast, effects on test variables are determined at fasting and repeatedly postprandially the breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
Condition: Cardiovascular Disease; Hypercholesterolemia
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia
      and heart disease, however the mechanisms by which oats or oat fractions exert this effect is
      not totally clear. Furthermore, several large epidemiological studies and a number of recent
      meta-analyses of nutritional interventions have reported a positive association between
      increased whole grain intake and reduced risk of developing a range of chronic diseases.
      Recognising the important role of the gut microbiota in metabolism and metabolic disease
      risk, we examined the impact of whole grain oats on the human gut microbiota and
      cardio-metabolic risk factors.

      The main aims of this human study is to determine the effectiveness of a low GI whole grain
      oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially
      modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and
      inflammation markers in an at risk of cardio-metabolic disease population
    


Intervention name(s): wholegrain cereals oats (WGO); Non wholegrain cereals
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period; Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Prolonged Military Exercises With High Load Carriage, on Neuromuscular Fatigue and Physiological/Biomechanical Responses
Condition: Healthy
Study type: Observational

Summary: 
      Land military missions generally combine prolonged walking/moderate-pace-running and other
      physical actions such as creeping, jumping, shooting,… which are associated with the direct
      carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. For
      an infantry section, "typical" intervention phases last about 20-24 h and combine variable
      intensity grades. Consequently, military mission characteristics are an interesting
      investigation field of human fatigue. Previous studies have investigated human neuromuscular
      alterations after prolonged "normal" locomotion exercises [Millet et al., 2004, 2009], thus
      the aim of this study is to characterize the neuromuscular determinants of fatigue induced by
      a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed
      with high load carriage. Additionally, the consequences of fatigue on physiological and
      biomechanical parameters of locomotion will be investigated.
    


Intervention name(s): military equipment
Intervention type(s): Other
Intervention description(s): Military exercise of 24 hours
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        military retreated from national army
      
Biospecimen description: 
      Lactatemia, based on subject's arterialized capillary blood samples analysis.
    
Keywords: military exercises; neuromuscular fatigue; physiological responses; biomechanical responses; simulated military effort; high load carriage; Healthy voluntary
A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary:

      - To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to
      colonoscopy.

      Secondary:

        -  To assess the safety of Moviprep® versus Colopeg®.

        -  To assess acceptability of Moviprep® versus Colopeg®.
    

Detailed description: 
      Primary efficacy analysis will be performed on the ITT population. Secondary efficacy
      analysis will be performed on both ITT and PP sets. Results will be summarised by treatment
      and age (overall, 18-35, 36-49, 50-74 and 75-85 years old) and provided in individual data
      listings.

      Safety analysis will be performed on the safety set (ITT population). Safety data of all
      patients exposed will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and
      75-85 years old).

      Acceptability analysis will be performed on the ITT population. Acceptability data of all
      patients will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85
      years old).
    

Intervention name(s): MOVIPREP; COLOPEG
Intervention type(s): Drug; Drug
Intervention description(s): 2L Drug; 4L Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Proteomics and Orthodontic Root Resorption
Condition: Root Resorption; Orthodontic Appliance Complication; Orthodontic Pathological Resorption of External Root; Gingival Diseases; Tooth Plaque; Tooth Diseases
MeSH terms: Tooth Diseases; Root Resorption; Gingival Diseases; Tooth Resorption
Study type: Interventional

Summary: 
      The majority of previous studies for early detection of Orthodontically Induced Inflammatory
      Root Resorption (OIIRR) were conducted to assess individual biomarkers which are
      representative of single biological pathway. To our Knowledge, no studies have been employed
      Gingival crevicular fluid (GCF) proteomic analysis to identify potential biomarkers for
      OIIRR. Therefore; the aim of this study is to use the advantage of testing a package of
      biomarkers via doing proteomic analysis of GCF which could help in making a more precise
      personalize diagnosis and treatments, thereby providing orthodontists additional information
      that cannot be deduced from clinical parameters.
    

Detailed description: 
      Orthodontic patients with age range (18-years) indicated for bilateral maxillary first
      premolars extraction as part of their orthodontic treatment using specific fixed orthodontic
      appliance design with moderate anchorage were recruited for this study. Both of these
      premolars were allocated randomly to a heavy ( 225g) and light (25g) force in a split mouth
      design with a 1:1 allocation ratio. (GCF) was collected from the gingival sulcus of these
      teeth before extraction at six time intervals which are baseline, 1 hour, 1 day, 1 week , 2
      weeks, 3 weeks and 4 weeks. Plaque and Gingival Indices were recorded for those patients at
      each timeline. Premolars will be extracted after 4weeks to be examined by stereomicroscopy
      for surface area evaluation of root resorption. Proteomic analysis will be carried out on the
      GCF sample. The proteomic analysis of the collected GCF will be obtained by using
      matrix-assisted laser desorption ionization/ time-of-flight mass spectrometry (MALDI-TOF/MS).
      MS spectra will be used to search human protein sequence data bases for protein
      identification and the development of "Protein Print" specific for these biological
      conditions.
    

Intervention name(s): Heavy Force (225g); Light Force (25g)
Intervention type(s): Procedure; Procedure
Intervention description(s): Orthodontic Force; Orthodontic Force
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adult orthodontic patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Proteomic; Orthodontic Root Resorption; Gingival Crevicular Fluid
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare repeated intermittent IV dosing of diclofenac in patients with
      moderate to severe post-surgical pain from abdominal or pelvic surgery.
    

Detailed description: 
      The primary objective is to evaluate the efficacy and safety of two dosage levels of
      parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac
      tromethamine.
    

Intervention name(s): Intravenous Diclofenac (DIC075V); Intravenous Ketorolac; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels; Intravenous Ketorolac; placebo
Intervention MeSH terms: Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair
Condition: Hypertrichosis
MeSH terms: Hypertrichosis
Study type: Interventional

Summary: 
      The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety
      and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body
      hair.

      Subjects will have IPL treatment on one forearm area. Another area will serve as the
      un-treated control area. Subjects will be followed at 12-weeks post-final treatment.
    


Intervention name(s): Prowave LX IPL
Intervention type(s): Device
Other intervention name(s): Prowave; Prowave LX; Cutera Prowave LX; Intense Pulsed Light; IPL; Flashlamp Infared device; Hair removal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intense pulsed light; IPL; healthy volunteer; light-based hair removal; hair removal; epilation; laser hair removal; permanent hair reduction
A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential of tazarotene foam to cause sensitization during a 48
      hour challenge following 21 days of exposure on the skin of healthy volunteers.
    

Detailed description: 
      This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to
      evaluate the potential of tazarotene foam 0.1% to induce contact sensitization following
      repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately
      240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.

      All subjects will be exposed to patches containing tazarotene foam and vehicle foam.
      Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch
      sites will be visually assessed and scored according to the corresponding grading scales.

      The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 3
      week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest and
      1 week Repeat Challenge.
    

Intervention name(s): Tazarotene Foam; Vehicle Foam
Intervention type(s): Drug; Drug
Intervention description(s): Patches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours.
There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge).
These patches will then be evaluated at 24, 48, and 72 hours.
There may be a second rest period and a second 48-hour patch application and evaluation, if required.; Patches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours.
There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge).
These patches will then be evaluated at 24, 48, and 72 hours.
There may be a second rest period and a second 48-hour patch application and evaluation, if required.
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteer Subjects
T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)
Condition: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease; Coronary Artery Stenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Atherosclerosis; Coronary Stenosis
Study type: Interventional

Summary: 
      The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques
      in patients with bifurcation lesions in the CTO segment.
    


Intervention name(s): T-provisional stenting; Mini-crush stenting; CTO coronary angioplasty
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Standard endovascular T-provisional stenting technique; Standard endovascular Mini-crush stenting technique; A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary stenosis; Drug-eluting stent; Coronary angioplasty with stenting; Ischemic Heart Disease; Chronic total occlusion; Bifurcational lesion; Bifurcational stenting