bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique
Condition: Cholecystectomy
Study type: Interventional

Summary: 
      Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as
      a fundus first dissection.

      Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way
      of dissection has to be established. Patients are at 4 hospitals randomised to the different
      techniques and the different methods of dissection.
    

Detailed description: 
      Patients at the participating hospitals are randomized to:

        1. dissection starting at the triangle of Calots with electrocautery.

        2. dissection by fundus first technique with electrocautery.

        3. dissection by fundus first technique with ultrasonic dissection.
    

Intervention name(s): Laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Randomized to three arm.
Other intervention name(s): Randomised study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholecystectomy
Reproducibility of Child-Turcotte-Pugh (CTP) Rating and NRL972 Pharmacokinetics in Patients With Cirrhosis
Condition: Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open, randomized study in patients with different severity stages of hepatic
      cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater
      reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32
      to 40 pairs of raters. The raters will perform the required assessments in the capacity of
      sub-investigators of the phase I (co-ordinating) unit.

      Up to 240 patients with clinically established hepatic cirrhosis without confounding
      end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of
      eligibility, Visit 1 will take place to determine the investigational parameters (NRL972
      pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At
      approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational
      parameters will again be assessed.
    


Intervention name(s): NRL972
Intervention type(s): Drug
Intervention description(s): 2 mg NRL972 in 5 mL solution for injection administered as a 15-second intravenous injection on each of four occasions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies
Condition: Gingival Recession; Gingival Recession, Generalized
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of two different treatment agents used in
      conjunction with subepithelial connective graft technique on root coverage outcomes in
      multiple recession defects. Half of patients will receive root treatment with antimicrobial
      photodynamic therapy and the other half will receive photobiomodulation therapy by laser on
      surgery site.
    

Detailed description: 
      Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction
      of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial
      resistance. Also, it has properties of root demineralization and exposure of collagen fibers.
      These properties may enhance root coverage in procedures of subepithelial connective graft.
      Laser photobiomodulation has the potential to increase healing and repair, this can generate
      gains in the root coverage and dental hypersensitivity.
    

Intervention name(s): Control; antimicrobial photodynamic therapy; Photobiomodulation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.; In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml); After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.
Other intervention name(s): Scaling and root planing only; Low level laser therapy
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness and Economic Evaluation of Glass Ionomer Material Using as Dental Sealant
Condition: Glass Ionomer Cement; Cost-effectiveness; Pit and Fissure Caries (Disorder)
Study type: Interventional
Phase: Phase 4

Summary: 
      Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high
      occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure
      caries in this tooth is therefore of great importance for the preservation of a healthy
      dentition in one's life long time.

      It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly
      effective method to prevent pit and fissure caries. It has also been shown that the
      performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,
      classification type 2 GIC material) using finger press method used in the atraumatic
      restoration method is as significant as that of using the traditional resin sealant material
      and technique.

      The purpose of this study is to evaluate the long-term cost-effectiveness performance of the
      two sealing materials in the prevention of pits and fissures caries in young permanent molars
      of schoolchildren in a dental public health program to be held in primary schools. The
      findings will provide valuable information for decision making on the election of proper
      material and method for use in dental public program, especially for child population in the
      rural or social-economically deprived areas.
    

Detailed description: 
      Primary school children will be recruited and cluster randomized into three groups. Baseline
      dental check-up will be conducted to all the recruited children and dental status will be
      recorded. Placement of resin sealant or sealant using the glass ionomer material to the
      eligible permanent first molars or providing of oral health education will be interventions
      to the three groups respecively according to the group allocation. All the interventions will
      be provided only once in this study, and the children will be followed for at least 24 months
      at an six month interval to motor the dental caries of the included permanent first molars.
      Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated
      and reported.
    

Intervention name(s): resin sealant; ART sealant
Intervention type(s): Drug; Drug
Intervention description(s): Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.; Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix" glass ionomer cement once.
Other intervention name(s): SDI conseal f; GIC sealant; 3M ESPE KetacTM Molar Easymix" glass ionomer cement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the use of repetitive transcranial magnetic
      stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational
      procedure, where a device called a "stimulator" provides electricity to a device that creates
      a magnetic field. This device is placed against the scalp in the front of the head so that
      the magnetic field is focused on an area of the brain that is thought to be involved in
      craving for cigarettes. rTMS is an investigational procedure so therefore being tested in
      research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes
      in magnetic fields during rTMS administration change electrical currents which may affect
      brain activity and function.
    

Detailed description: 
      The goal of this study is to evaluate the effects of rTMS on cue-induced craving in dependent
      smokers. We hypothesize that low frequency rTMS over the SFG will block cue-induced craving.
      In order to test this hypothesis, subjects will undergo three conditions:

        1. active condition: low frequency rTMS was administered over the superior frontal gyrus
           (SFG) during the presentation of smoking and control cues

        2. location control condition: low frequency rTMS was administered over motor cortex (MC)
           during the presentation of smoking and control cues

        3. frequency control condition: high frequency rTMS was administered over the SFG during
           the presentation of smoking and control cues
    

Intervention name(s): Active rTMS Condition; rTMS Location Control Condition; rTMS Frequency Control Condition
Intervention type(s): Device; Device; Device
Intervention description(s): Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.; Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues.; High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Cigarette Smoker; Cigarette Dependence; To block cue-elicited craving in dependent cigarette smokers
In Vivo Sun Protection Factor Determination
Condition: Skin Care
Study type: Interventional

Summary: 
      The study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo on
      the back of human participants, according to the International Standard Sun Protection Test
      method by using a sun simulator.
    


Intervention name(s): Negative Control; Positive Control; Test Product A; Test Product B; Test Product C; Test Product D; Test Product E; Test Product F; Test Product G; Test Product H
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Untreated area; High SPF Standard P3/SPF 15; Yosemite Falls (Forte Day SPF upgrade) Variant A; Yosemite Falls (Forte Day SPF upgrade) Variant B; Yosemite Falls (Forte Day SPF upgrade) Variant C; Yosemite Falls (Forte Day SPF upgrade) Variant D; Yosemite Falls (Forte Day SPF upgrade) Variant E; Yosemite Falls (Forte Day SPF upgrade) Variant F; Yosemite Falls (Forte Day SPF upgrade) Variant G; Yosemite Falls (Forte Day SPF upgrade) Variant H
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
Condition: Spina Bifida
MeSH terms: Spinal Dysraphism
Study type: Interventional

Summary: 
      In this research the effects of progressive resistance exercise training on endurance and
      functional mobility in children with spina bifida are assessed.
    


Intervention name(s): Conventional treatment; Progressive resistance exercise
Intervention type(s): Other; Other
Intervention description(s): Conventional protocol that involves simple active and passive range of motion exercises of lower limb with positioning for assistive devices was provided; The protocol that was applied on the members of (experimental group) are progressive resistance exercises. These passive resistance exercises included Flexion, Extension, Abduction, Adduction of hip; Flexion, Extension of knee; with minimum time in start and minimum quantity of loads, with Thera bands and sandbags,.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: resistance exercise; endurance; functional mobility
Bioavailability and Effectiveness of Transdermally Administered Morphine
Condition: Cancer; Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients will participate in two arms of the trial, one in which morphine will be
      administered transdermally, and, after a 3 day wash out period, one in which morphine will be
      administered subcutaneously.
    

Detailed description: 
      Patients will participate in two arms of the trial, one in which morphine will be
      administered transdermally, and, after a 3 day wash out period, one in which morphine will be
      administered subcutaneously. Blood draws will be done after both dosing methods in order to
      compare blood levels of morphine by the different routes.
    

Intervention name(s): morphine
Intervention type(s): Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transdermal morphine; cancer; pain; bioavailability; pharmacokinetics; cancer related pain; stable baseline pain; currently taking opioids
Combination Osteogenic Therapy in Established Osteoporosis
Condition: Osteoporosis, Post-Menopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR)
      therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of
      the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e.,
      decreased bone formation and no further increase in bone density) that is observed within
      18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can
      occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an
      increase in bone density which is maintained after treatment is discontinued.
    

Detailed description: 
      This is a 3-yr, single center, open label, active controlled, randomized study of
      approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. Patients
      will be assigned to 1 of 3 groups: 1) PTH 1-34; 2) Fluoride; 3) PTH and fluoride. The
      treatment period is 3 years with 3-month cycles of therapy. PTH will be administered
      subcutaneously by injection 600 units daily for 28 days the first month of each 3-month
      cycle. Fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg
      fluoride/day), during the last 2 months of each cycle. Calcium will be provided 800mg/day
      during month 1 and 1500-2000mg for months 2 and 3 of each cycle.
    

Intervention name(s): PTH 1-34; MFPSR-fluoride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluorides
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoporosis
Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Observational

Summary: 
      Schistosomiasis is increasingly encountered among travellers returning from the tropics and
      is known for its focal endemicity, associated with the presence of the snail intermediate
      host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic
      due to the low intensity of infection, many infections likely go undiagnosed and will develop
      into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with
      praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of
      schistosomiasis relies on egg detection, which has a poor sensitivity in low burden
      infections, or serology, which is inadequate to monitor cure. The department of parasitology
      of the Leiden University Medical Center has developed a novel diagnostic test based on the
      up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test
      can be performed on serum and urine to detect low intensity schistosomiasis infections and
      confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA
      in travellers with high-risk water contact.
    


Intervention name(s): Urine CAA detection
Intervention type(s): Other
Intervention description(s): In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Travellers with reported high-risk water contact <12 weeks before inclusion.
      
Biospecimen description: 
      serum, urine and faeces
    
Keywords: circulating anodic antigen
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER)
      in participants with schizophrenia (psychiatric disorder with symptoms of emotional
      instability, detachment from reality, often with delusions and hallucinations, and withdrawal
      into the self).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-centric
      (conducted in more than one center), prospective (study following participants forward in
      time), single arm, and non-comparative study of paliperidone Extended Release(ER) in
      participants with schizophrenia. The total study duration will be approximately of 104 weeks
      per participant. The study consists of following parts: Screening (that is, 14 days before
      study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12
      weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance
      treatment which will be followed by additional Extension phase 2 and long-term maintenance
      treatment. Efficacy of the participants will primarily be evaluated by Clinical Global
      Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): Paliperidone
Intervention type(s): Drug
Intervention description(s): Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Other intervention name(s): R076477; Invega extended-Release (ER) tablet
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone; R076477; Schizophrenia
Effect of Gingest on Symptoms of Dyspepsia
Condition: Dyspepsia; Epigastric Fullness; Bloating; Epigastric Pain
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      This is a randomised, double-blind, placebo controlled study on the effect of Gingest (ginger
      root extract) on symptoms of dyspepsia in 150 participants with mild to moderate dyspepsia.
    

Detailed description: 
      Functional dyspepsia (FD) is a chronic disorder of sensation and movement (peristalsis) in
      the upper digestive tract. A diagnosis of functional dyspepsia is determined when there is no
      evidence of structural disease and there have been at least three months of one or more of
      the following (with onset at least six months earlier). Ginger (Zingiber officinale) is
      traditionally used to treat a number of medical conditions, including those affecting the
      digestive tract, such as dyspepsia, flatulence, nausea and abdominal pain. Recent human
      clinical studies have found beneficial effects of ginger extract in patients with dyspepsia
      and gastric emptying in healthy populations.

      The aim of the present study is therefore to investigate if two different doses of Gingest
      (100mg and 200 mg) reduces intensity of functional dyspepsia (based on a symptom severity
      questionnaire) compared to placebo (maltodextrin) in 150 subjects with mild to moderate
      dyspepsia (as determined through the Leeds Dyspepsia Questionnaire).
    

Intervention name(s): Gingest powdered extract obtained from Ginger rhizomes; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Description: Powdered extract obtained from Ginger rhizomes. Botanical name: Zingiber officinale Roscoe Plant part used: Dried rhyzome Extraction solvent: CO2 Extract Ratio 45-60 / 1 100mg of extract are equivalent to an average of 4400 mg of dry ginger rhizomes
Composition: Natural extract, Calcium Hydroxide, Polysorbate 80, De-oiled soya lecithin, Calcium silicate; 200 mg/d maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, 4-week parallel intervention in subjects with mild to moderate Dyspepsia (as defined by the Leeds Dyspepsia Questionnaire) in 3-treatment arms: 1.) 100 mg/d Gingest; 2.) 200 mg/d Gingest; 3.) Placebo (maltodextrin)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomized, double-blind, placebo-controlled study. The study will use a
      three-period, six-sequence, complete-block, cross-over study design to characterize two doses
      of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to
      an allergen. Each of the three periods will be 14 days, followed by a washout period before
      the next period.
    


Intervention name(s): TD-8236; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.; The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TD-8236; Asthma; Proof of concept