bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate Dental Plaque
Condition: Gingival Diseases
MeSH terms: Dental Plaque; Gingival Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3
      week brushing regiment.
    


Intervention name(s): Triclosan/Fluoride; Fluoride/triclosan
Intervention type(s): Drug; Drug
Intervention description(s): Brush twice daily for 3 weeks; Brush daily for 3 weeks
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
Condition: Influenza; Orthomyxoviridae Infections
MeSH terms: Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support
      the immunogenicity data from previous clinical studies.

      Objectives:

        -  To describe the immune response 21 days after each vaccination.

        -  To describe the safety profiles following each vaccination.
    


Intervention name(s): A/H5N1 inactivated, split-virion influenza virus
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; A/H5N1 strain; Orthomyxoviridae Infections; Influenza Pandemics
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate
      vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity
      of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an
      adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will
      be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1.
      Blood samples will be collected at intervals to examine systemic vaccine antigen-specific
      immune responses.
    


Intervention name(s): Shigella vaccine
Intervention type(s): Biological
Intervention description(s): Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: S.dysenteriae; Healthy volunteers; Conjugate vaccine; Safety; Immunogenicity; Dose scaling
Whole Body Vibration In Vestibular Rehabilitation
Condition: Vestibular Disease
MeSH terms: Vestibular Diseases
Study type: Interventional

Summary: 
      The aim of this study was to compare the efficacy of home based vestibular rehabilitation
      program, posturographic biofeedback training and whole body vibration therapy on balance,
      fall risk, functional mobility, vertigo symptom severity and functions in patients with
      unilateral vestibular weakness.
    

Detailed description: 
      A total of 90 patients who were diagnosed as unilateral vestibular weakness were included in
      this prospective randomized controlled study. They were randomized into three groups each
      consisting of 30 patients. Home based vestibular rehabilitation program was given to all
      groups. Fall risk yielded by posturography, Berg balance scale, Timed Up-and-Go test, vertigo
      visual analogue scale and Dizziness Handicap Inventory were used for comparison.
    

Intervention name(s): Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Posturography, Whole body vibration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vestibular rehabilitation; Vestibular weakness; Whole Body Vibration; Biofeedback; Posturography
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized phase II trial to compare two different hormone therapy regimens in preventing
      endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer.
      Hormone therapy may prevent the development of endometrial cancer in women with a genetic
      risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy
      regimen is more effective in preventing endometrial cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. The primary objective is to evaluate the effect of progesterone therapy versus combination
      estrogen and progesterone therapy on potential surrogate endpoint biomarkers (SEBs) relevant
      to endometrial carcinogenesis.

      II. To evaluate changes in histology and ultrasound appearance of the endometrium in women
      with HNPCC after 3 months of progesterone therapy versus combination estrogen and
      progesterone therapy compared with baseline.

      III. To establish a point estimate of the baseline frequency of endometrial abnormalities
      looking at histological and molecular markers in a cohort of females carrying an HNPCC gene
      mutation.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      All patients undergo a baseline transvaginal ultrasound and endometrial biopsy.

      Arm I: Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90
      days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial
      biopsy.

      Arm II: Patients receive oral contraceptive pills (OCP) comprising ethinyl estradiol and
      norgestrel once daily on days 1-21. Treatment repeats every 28 days for 3-4 courses (3-4
      packs of OCP) in the absence of unacceptable toxicity. Approximately 1 week after starting
      the fourth pack of OCP, patients undergo a repeat transvaginal ultrasound and endometrial
      biopsy.

      Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in
      continued endometrial screening.
    

Intervention name(s): medroxyprogesterone; ethinyl estradiol; norgestrel; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Given intramuscularly; Given orally; Given orally; Correlative studies
Other intervention name(s): Depo-Provera; medroxyprogesterone acetate; MPA; Provera; Provera Dosepak; Diogyn E; EE; Estinyl; Ethinoral; Eticylol; Microlut; NORGES; Ovrette; Wy-3707
Intervention MeSH terms: Medroxyprogesterone Acetate; Ethinyl Estradiol; Medroxyprogesterone; Norgestrel; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tailored H. Pylori Eradication Based on Clarithromycin Resistance
Condition: Helicobacter Pylori Infection; Antibiotic Resistant Strain
Study type: Observational

Summary: 
      The investigators investigated the point mutations in the 23S rRNA genes of patients infected
      with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on
      the identified clinically significant point mutations.
    

Detailed description: 
      Sequencing-based detection of point mutations identified four mutations that were considered
      clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were
      considered clinically insignificant.

      Participants who did not have point mutations related to clarithromycin resistance and/or had
      clinically insignificant point mutations were treated with PAC (proton pump inhibitor,
      amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point
      mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7
      days. H. pylori eradication rates were compared between the two groups.
    

Intervention name(s): proton pump inhibitor, amoxicillin, clarithromycin; proton pump inhibitor, amoxicillin, metronidazole
Intervention type(s): Drug; Drug
Intervention description(s): non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin; clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Proton Pump Inhibitors
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Helicobacter-pylori positive patients with gastritis, ulcer, adenoma
The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design
Condition: Class II Div 1 Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      23 female participants with class II div I will have extraction of bilateral first bicuspids
      10 weeks after bond- up appointment. The extracted teeth will be preserved in special
      containers for subsequent microscopic analysis. Four months later, upon space closure phase,
      the patient will have a piezocision surgery on one side randomly chosen. Virtual models will
      be generated once before the surgery and monthly after for four and a half months. The models
      will be scanned by CADCAM and later tooth movement will be analyzed in regards to the rugae
      area.
    


Intervention name(s): Piezocision Surgery
Intervention type(s): Procedure
Intervention description(s): After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design will be a split-mouth where the participants should need extraction based treatment in collateral sides of the upper arch with one of the sides serving as the treatment while the other will be the control. Then they will be grouped based on their facial type.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Canine retraction; Space closure; Rate of tooth movement; Facial divergence; Piezocision
Treatment of Androgenetic 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 efficacy of the HairMax LaserComb 2009 7 Beam
      model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment
      is applied as directed.
    

Detailed description: 
      This is randomized, double-blind, control device clinical study across 2 sites, evaluating
      changes in terminal hair-count in the evaluation zone having evidence of androgenetic
      alopecia (miniaturized hair).

      The trial will involve 45 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 nonconcurring days a week as directed per device for 26
      weeks treatment duration.

      Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).

      Safety analysis will be assessed based on the reports of adverse events during study.
    

Intervention name(s): HairMax LaserComb 2009, 7 Beam; HairMax LaserComb
Intervention type(s): Device; Device
Intervention description(s): Device application 3 times week (non-consecutive days), for 26 weeks; Device application 3 times week (non-consecutive days), for 26 weeks
Other intervention name(s): HairMax LaserComb; Control device
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
Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based
      Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA
      adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile
      of the vaccine composition in healthy adult volunteers under the accelerated regimen. The
      secondary objective is to achieve higher seroconversion of the vaccine under accelerated
      regimen at Day 7.
    

Detailed description: 
      A multi-center, open labelled, randomized study in healthy naïve adult subjects. Subjects
      were randomly assigned to groups A (60) and B (60). Group A as a control arm of the study,
      had received a commercially available rabies vaccine, RABIPUR®. Group B had received doses of
      the investigational PIKA rabies vaccine in an accelerated regimen.

      Group A followed the vaccine regimen of (1-1-1-1),one injection on days 0, 3, 7 and 14 was
      administered respectively. Group B received the accelerated regimen (2-2-1), two injections
      on both days 0 and 3 were administered in different arms; and only one injection was
      administered on day 7.

      Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and 1.0 ml of RABIPUR®
      for Group A after reconstitution. The route of administration is intramuscular injection,
      given in the deltoid region of the arm.
    

Intervention name(s): RABIPUR®; PIKA rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Biological rabies vaccine; Biological rabies vaccine
Other intervention name(s): PIKA rabies vaccine with PIKA adjuvant
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with schizophrenia are much more likely to be engaged in smoking and other addictive
      behaviors, possibly related to biochemical abnormalities in the reward center of the brain.
      The primary purpose of the present study is to investigate whether switching patients with
      schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of
      action, will have an impact on smoking behavior.
    

Detailed description: 
      This is an 8 week open label trial being conducted in stable adult outpatients with
      schizophrenia who are smokers. The primary intervention is a switch in the subject's
      antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures
      include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and
      saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum
      glucose and lipids, rating of symptom severity using the PANSS, and both ratings and
      instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to
      obtain the needed 15 completers at the week 8 endpoint.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Smoking; Metabolic; Health; Glucose; Lipids
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
Condition: Islet Transplantation
Study type: Observational

Summary: 
      Islet transplantation for type 1 diabetes results are still improving, and actually
      Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of
      c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological
      interventions to inject islets, an immunosuppressive regimen is needed, which can be
      deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet
      transplantation on stabilization or prevention of macro and micro vascular complications of
      diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or
      improvement of microvascular complications when compared to pre-transplant data.

      The aim of this study is to compare the evolution of diabetes complications, especially
      nephrologic, 10 years after islet transplantation and to compare it to patients with a
      brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.

      This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine
      clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of
      type 1 diabetes) before islet transplantation and 10 years after the transplantation or after
      the first evaluation in patients who finally did not underwent islet transplantation for
      various non nephrologic reasons
    


Intervention name(s): islet transplanted; non islet transplanted
Intervention type(s): Other; Other
Intervention description(s): islet transplantation; no islet transplantation (for a non nephrologic reason)
Other intervention name(s): Islet transplantation; no islet transplantation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering of type 1 diabetes since at least 10 years
      
Biospecimen description: 
      serum and DNA
Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group,
      efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with
      Type 2 Diabetes Mellitus with insufficient glycaemic control
    


Intervention name(s): Empagliflozin; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): For blinding purposes
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics
      of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable
      to exon 51 skipping.
    

Detailed description: 
      Safety, including adverse event monitoring and routine laboratory assessments, will be
      followed on an ongoing basis for all patients.

      Clinical efficacy, including functional tests and MRI, will be assessed at regularly
      scheduled study visits. Patients will undergo one baseline and one follow-up muscle biopsy.

      Population and serial PK will be collected.
    

Intervention name(s): eteplirsen
Intervention type(s): Drug
Intervention description(s): Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks.
Other intervention name(s): AVI-4658; EXONDYS 51®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DMD; Duchenne muscular dystrophy; eteplirsen; Dystrophin; exon 51
Cue-based Tactile Stimulation and Infant Stress Reactivity
Condition: Premature; Infant, Light-for-dates
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The present study is an examination of cue-directed tactile stimulation (CTDS), administered
      by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system
      functioning, maternal parenting cognitions, and parenting competence.
    

Detailed description: 
      The overarching aim of this study is to assess the effects of a program of mother-delivered,
      cue-based infant massage on stress reactivity in the mother-infant dyad, and on other
      measures of mother-infant functioning. The study has several interrelated objectives:

        1. To evaluate the short-term effects of infant massage intervention on infant and maternal
           stress reactivity from assays of maternal and infant salivary cortisol, and cortisol
           levels in mothers' breast milk.

        2. To examine the impact of mother-delivered infant massage on the development of infant
           resistance to infectious pathogens and antibody-based protective immunity in response to
           routine scheduled vaccinations, and to examine if the degree of immunity is mediated by
           infant stress reactivity.

        3. To examine the impact of mother-delivered infant massage, and of changes in stress
           reactivity in response to massage, on infant physiological functioning (vagal tone,
           heart rate variability), infant physical development (weight, height, and head
           circumference), mothers' perception of infant temperament and infant state regulation,
           parenting self-efficacy, symptoms of depression and anxiety, and mother-infant
           interaction.

        4. To examine associations between cortisol levels in mothers' saliva, mothers' breast
           milk, and infants' saliva. Establishing such linkages would support recent animal data
           suggesting that infant glucocorticoid levels can be affected by glucocorticoid levels
           transferred to the infant in mother's milk.

        5. To examine whether a single nucleotide polymorphism (SNP) in three candidate genes (Mu
           opioid receptor, brain-derived neurotropic factor, and vasopressin V1b receptor), each
           associated with hypothalamic-pituitary-adrenal axis (HPA) functioning, moderates the
           effects of infant massage on stress-related outcomes.
    

Intervention name(s): Cue directed tactile stimulation
Intervention type(s): Behavioral
Intervention description(s): Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
Other intervention name(s): Massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prematurity; massage; stress; parenting; infancy; sleep; intervention