bioihbjkbjnl/mcl2 huggingface dataset:
Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children
Condition: Dental Plaque; Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional

Summary: 
      Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk
      children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans
      in the plaque of high caries-risk children.
    


Intervention name(s): Novamin containing toothpaste; Fluoride containing toothpaste
Intervention type(s): Other; Other
Intervention description(s): children's teeth will be brushed using Novamin containing toothpaste.; children's teeth will be brushed using Fluoride containing toothpaste.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
An Open Label Phase I/II Study of the Safety and Dopamine Transporter Binding Properties of C-11 Altropane in Normal Human Subjects and in Subjects With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate the Binding Potential in subjects with
      ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be
      used to differentiate adults with ADHD from healthy control subjects.
    

Detailed description: 
      This protocol seeks to replicate and extend our investigation of DAT binding in adults with
      ADHD with specific aims:

        1. To examine dopamine transporter (DAT) receptor binding potential in adults with ADHD,
           using PET scanning with 11C altropane as the ligand. We hypothesize that compared to
           adults without ADHD, adults with ADHD will have greater DAT binding that will not be
           accounted by psychiatric comorbidity or age.

        2. To examine the relationship of DAT binding to clinical features of ADHD. We hypothesize
           that DAT binding will be positively correlated with a) severity of ADHD symptoms and b)
           neuropsychological and interpersonal dysfunction.

        3. To examine the relationship between DAT binding and genetic risk factors. We hypothesize
           that DAT binding will be specifically associated with homozygosity of the DAT (480) gene
           in adults with ADHD and not with other ADHD-associated genetic markers (e.g., DRD4-7,
           D2, DBH).
    

Intervention name(s): PET imaging using C-11 altropane as the ligand.
Intervention type(s): Radiation
Intervention description(s): A one-injection protocol will be used for the study. C-11 Altropane will be injected manually as an intravenous bolus.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        200 un-medicated subjects with ADHD and 100 subjects without ADHD will be recruited
        sequentially. No individual will be excluded based on gender, race, or ethnicity.
      
Biospecimen description: 
      A sample of blood (2 tablespoons) will be drawn from all subjects.
Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?
Condition: Hereditary Haemochromatosis
MeSH terms: Hemochromatosis; Iron Overload; Hemosiderosis
Study type: Interventional

Summary: 
      Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten
      life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to
      maintain normal iron levels. It is unclear, however, whether treatment is necessary when
      individuals have moderate elevation of iron in the body. This research project will study the
      effects of treatment in this group by assessing a number of scans, questionnaires and blood
      tests in treated and untreated individuals.
    

Detailed description: 
      There is mounting evidence that treatment of moderate iron overload in HFE related hereditary
      haemochromatosis (HH) is not necessary. This project aims to undertake a randomised
      patient-blinded trial of erythrocytapheresis compared to sham erythrocytapheresis (using
      plasmapheresis) in individuals who have serum ferritin (SF) above the upper limit of the
      normal range but < 1000ug/L (defined here as moderate iron overload) due to HFE mutations and
      to compare the prevalence of symptoms and objective markers of disease in the two treatment
      arms.
    

Intervention name(s): Erythrocytapheresis; Plasmapheresis
Intervention type(s): Procedure; Procedure
Intervention description(s): To achieve a blinded randomised trial, apheresis treatment will be used. Those in arm 1 will have erythrocytapheresis reducing iron levels and those in arm 2 will have plasmapheresis and their iron levels will not be reduced.
An apheresis machine will be used to remove red blood cells only from the erythrocytapheresis group. Subjects will have third weekly treatments until SF levels are reduced to ~100 ug/L in accordance with current guidelines.; An apheresis machine will be used to remove blood plasma only from the plasmapheresis group. Those in arm 2 will have the approximate number of episodes of apheresis that would be required to reduce their SF to normal had they been randomised to the true treatment arm. Those in the sham arm will be offered to have venesection at their choice of venue or to have their SF normalised by erythrocytapheresis after the initial blinded part of the study. This will be done because it will not be known for some time if there is benefit from normalisation of SF and therefore leaving people with elevated SF that may be harmful.
Other intervention name(s): red blood cell removal, red blood cell apheresis; plasma removal, sham erythrocytapheresis
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hereditary haemochromatosis; Moderate iron overload; Serum ferritin; Treatment
Synthetic Mesh Materials In Sling Surgery
Condition: Incontinence
Study type: Interventional

Summary: 
      The purpose of this study is to determine the clinical results contributions to surgical
      success,and complications of mixed type of mesh materials as well as prolen mesh materials in
      sling surgery in a 3 year follow-up the first time in literature.
    

Detailed description: 
      Broad based double forced sling operations were performed in 144 patients by using 3
      different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in
      whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom
      Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light
      mesh® (Johnson&Johnson,USA) was used. The data of the patients and the success of the
      operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire
      analysis.

      Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications
      incidence and higher success rates than the other synthetic slings in 3-year follow-up.
    

Intervention name(s): Synthetic sling surgery
Intervention type(s): Procedure
Intervention description(s): An incision of inverted A shape was inflicted on the anterior vaginal wall(AVW)of the vagina.The upper part of A shaped incision was formed into an island belonging to the vaginal wall.This patch was 3×4cm in most of the patients.Proximal AVWwas dissected as a flap.Synthetics mesh materials were first sutured onto the upper part of the A on the vaginal island with absorbable vicrly sutures.Then,with 2polypropilen sutures,these meshes were fixed on both the right and left sides of this island in a helical manner to form a suspension and using curved Kishner needles,the prolene sutures were transferred to suprapubic area.These sutures were ligated on the rectus fascia in a crosswise manner.The mobile lower wing was advanced onto the island and was sutured onto the vaginal skin with intermittent sutures using 3-0 monocryl sutures.After cystoscopy,the prolene sutures were ligated crosswise in the suprapubic region.Special attention was paid notto create much tension on the mesh material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sling surgery; synthetic meshes; ultrapromesh®; mix mesh; incontinence; The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.
A Randomized Trial of Vitamin D to Reduce Respiratory Infection
Condition: Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      The goal of this study is to assess the effectiveness of vitamin D in reducing
      laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract
      infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha
      Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly
      vitamin D supplements or placebo. Participants who develop acute respiratory infection over a
      12-month period, will be tested for influenza, the co-primary outcome, and other respiratory
      viruses, the other co-primary outcome, by RT-PCR.
    


Intervention name(s): vitamin D supplements; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will receive 7mls of D-drops (14,000U/week of vitamin D); 7mls of placebo drops per week for 8 months.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: human influenza children
Safety Study of AMI MultiStem® to Treat Heart Attacks
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if escalating doses of AMI MultiStem® delivered by
      catheter can safely be given to patients that have had a recent heart attack treated with
      stent implantation.
    

Detailed description: 
      The mortality rates associated with acute myocardial infarction (AMI) have significantly
      decreased over the past 2 decades. Beginning first with thrombolytic therapy for AMI, and
      more recently with growing acceptance and availability of primary percutaneous coronary
      intervention (PCI) for ST-elevation AMI, the mortality rates of this devastating ischemic
      event have decreased from almost 15% in clinical trials in the late 1980's to <5% in recent
      primary percutaneous coronary intervention trials. Though AMI-related mortality has been
      reduced, AMI survival is often accompanied by significant loss of function that may lead to
      subsequent treatments, congestive heart failure (CHF) and reduction in quality of life. A
      cell therapy that could reduce the damage associated with AMI and positively affect heart
      function would provide substantial benefits to the AMI patient.
    

Intervention name(s): AMI MultiStem®
Intervention type(s): Biological
Intervention description(s): AMI MultiStem® administered via catheter into peri-vascular space of the target vessel, 2-5 days post PCI. There will be 3 dose escalation cohorts, 6 patients per cohort.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myocardial Infarction, Heart Attack
the Effectiveness of Different Risk Scales In Predicting VTE in Respiratory Inpatients
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk
      assessment model and the VTE risk assessment in medical patients mentioned in the 2018
      edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary
      thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis
      for clinical VTE assessment and treatment.
    

Detailed description: 
      A case-control study was used to collect patients who developed VTE during hospitalization in
      the Department of Respiratory Medicine at Peking University Third Hospital Hospital from
      January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE
      matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as
      the control group. The general status of the patients was also assessed using the Padua risk
      model, the Caprini risk model, and the VTE risk assessment scale for medical patients
      mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention
      of pulmonary thromboembolism, and the relevant items involved in the assessment form were
      obtained by reviewing the cases.
    

Intervention name(s): risk evolution scale
Intervention type(s): Other
Intervention description(s): Padua score、Caprini score、Prime score
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2015 to December 2020, inpatients in respiratory department, Third Hospital of
        Peking University
      
Keywords: VTE
Effect of Carriere® Motion™ Appliance on Airway Dimensions
Condition: Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions; Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements
Study type: Interventional

Summary: 
      Objectives: to evaluate the effect of treatment with Carriere® Motion™ Appliance on
      pharyngeal airway, skeletal and dental dimensions using lateral cephalometric radiographs and
      to compare these changes with a control group.

      Materials and Methods: a prospective controlled clinical study on 17 patients treated at King
      Abdulaziz university dental hospital, Jeddah, Saudi Arabia with a mean age of 15.25 ± 2.49
      years with class II molar relationship (treatment group). They were treated with Carriere®
      Motion™ Appliance and initial and post treatment lateral cephalograms were taken to assess
      the effect of the appliance on the pharyngeal airway dimensions, skeletal and dental
      measurements. A matched sample of 18 untreated patients (with a mean age of 14.44 ± 2.25
      years) acted as a control group. Independent sample T-test and paired T-tests were conducted.
      The significance level was set at P< 0.05.

      Results: when the cephalometric changes associated with the treatment by Carriere® Motion™
      Appliance were compared to the changes in the untreated control group, no significant
      differences were found between the groups in regard to the pharyngeal airway and the skeletal
      dimensions. The only significant difference between the two groups was in the proclination
      and the protrusion of the lower incisors. The treatment group showed significantly increased
      lower incisors proclination and protrusion (L1 to mand plane°= 3.38±2.6, L1-Apo= 0.99±1.45)
      compared to the control group (L1 to mand plane°=0.49±2.81, L1-Apo=0.39±1.86) (P<0.05).

      Conclusion: treatment with Carriere® Motion™ Appliance does not have a significant effect on
      pharyngeal airway and skeletal dimensions. However, it significantly increases the lower
      incisors proclination and protrusion.
    


Intervention name(s): Carriere® Motion™ Appliance
Intervention type(s): Device
Intervention description(s): class II malocclusion corrector
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Expanded Safety Study of Dapivirine Gel 4789 in Africa
Condition: HIV Infections; Acquired Immunodeficiency Syndrome; Healthy
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use
      by healthy women in South Africa.
    

Detailed description: 
      To reduce the influence of adherence as a factor in the interpretation of efficacy results,
      IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal
      microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method
      as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and
      compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a
      matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of
      Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the
      feasibility of utilizing the DMA method for a large-scale phase III efficacy study.
    

Intervention name(s): dapivirine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): dosage form: vaginal gel
dosage: 1.25mg dapivirine/day
frequency: once daily
duration: 6 weeks; dosage form: vaginal gel
frequency: once daily
duration: 6 weeks
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Infections; Acquired Immunodeficiency Syndrome; Healthy; HIV seronegativity
Low Flow Anesthesia Without Initial High Flow Phase
Condition: Low Flow Anesthesia; Volatile Anesthetic Consumption
Study type: Interventional

Summary: 
      The aim of the study is to compare the effectiveness of conventional low flow anesthesia
      (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas
      flow rate (1L/min).
    


Intervention name(s): Conventional Low flow Anesthesia; Low Flow Anesthesia with fixed fresh gas flow rate
Intervention type(s): Procedure; Procedure
Intervention description(s): During the initial wash-in period 4 L/min Fresh gas flow will be used.; Fresh gas flow rate will be 1 L/min throughout the procedure.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects
Condition: Locally Advanced or Metastatic NSCLC
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single
      oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese
      subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate
      the safety of ASK120067 tablets administered orally in fast and fed.
    


Intervention name(s): ASK120067; ASK120067 in fed condition
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Take ASK120067 tablets orally in first day at 160 mg in fast condition.; Take ASK120067 tablets orally in first day at 160 mg in fed condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Chromium With Letrozole Versus Letrozole Only in Induction of Ovulation in Patients With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Combined letrozole with chromium versus letrozole only in induction of ovulation in
      polycystic ovary syndrome
    

Detailed description: 
      Randomized controlled trial
    

Intervention name(s): Letrozole with chromium
Intervention type(s): Drug
Intervention description(s): Letrozole versus letrozole with chromium
Intervention MeSH terms: Chromium; Letrozole
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Female patients aged from 18 to 35 years
Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple ascending
      oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and
      to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple
      oral administrations.
    


Intervention name(s): GLPG0492; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics
Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics
      (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate
      whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to
      alcohol cues in terms of urge to drink during the cue reactivity session and results in lower
      quantity of alcohol consumed during an alcohol self-administration session.
    


Intervention name(s): GET 73; inactive ingredients capsule
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg tid on 3 days cycle; 3 capsules tid on 3 days cycle
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol dependence; cue reactivity; alcohol self administration