bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The present study is a double-blinded randomized clinical trial with a duration of 28 days.
    

Detailed description: 
      The present study is a double-blinded randomized clinical trial with a duration of 28 days.

      80 orally and systemically healthy participant will be allocated in the test (probiotic) and
      the control (placebo) group at baseline.

      The intervention is oral hygiene discontinuation, which will be applied at baseline and
      continue through day 14, followed by 14 days with regular oral care.

      Clinical measurements and sampling will be performed at baseline, day 14 and day 28

      Primary endpoint: Changes in microbial composition.

      Secondary endpoints: Changes in clinical and immunological parameters
    

Intervention name(s): Oral hygiene discontinuation
Intervention type(s): Behavioral
Intervention description(s): Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded randomized clinical trial with a test and placebo group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
Condition: Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional

Summary: 
      Study population: Patients admitted or seen in OPD (Out Patient Department), Department of
      Hepatology.

      Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017
      Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA
      (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).

      Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).

      Group C -Placebo group

      Monitoring and assessment- :- The following tests will be done in these patients:-

        1. Complete clinical examination.

        2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels

        3. BUN (Blood Urea Nitrogen)

        4. Serum free fatty acid levels

        5. Lipid profile.

        6. Arterial ammonia

        7. Arterial lactate

        8. Blood sugar and serum insulin levels
    


Intervention name(s): ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml); ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml); No Lipid Emulsion/Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute
TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of different doses of
      TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of
      high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein
      cholesterol (LDL-C), alone and in combination with statin therapy.

      The secondary objectives of this study are to determine the safety and tolerability of
      TA-8995 in patients with mild dyslipidaemia.
    


Intervention name(s): TA-8995; Atorvastatin; Rosuvastatin; TA-8995 0mg (placebo); Placebo Statin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Stability of Implants With Two Different Surface Treatments
Condition: Dental Implant Failed; Pre-osseointegration Failure of Dental Implant
Study type: Interventional

Summary: 
      The aim of this study is to compare the stability of dental implant surface treated by
      sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces
      dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks
      after installation. The evaluation will be made by analyzing the resonance frequency
      (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show
      increased secondary stability prior to the implants treated by acid etching.
    

Detailed description: 
      The selected patients will be randomly divided into two groups by computer-generated list.
      The control group will receive implant surface treated by acid etching and test group receive
      implants with hydrophilic surface (Test). Both the test and the control group will undergo
      the same pre-surgical, surgical and post-surgical protocols.

      The evaluation of the implant will be done by the analysis of resonant frequency wich will be
      performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden)
      immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th,
      8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on
      these dates will be measured on a scale from 0 to 100. The smartpeg be used with special
      developed Healing without the use of pillars or intermediaries.
    

Intervention name(s): Implant surgery
Intervention type(s): Procedure
Intervention description(s): Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)
Other intervention name(s): Neodent Neoporos (SLA surface); Neodent Acqua (Modified SLA surface)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: dental implant; Surface energy; Hydrophilicity; Contact angle; Titanium implant roughness; Surface conditioning
Physical Therapy in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      It is a randomized clinical trial comparing surgical and conservative (physical therapy)
      treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to
      determine the efficacy of physical therapy versus endoscopic surgery in pain and disability
      in women with carpal tunnel syndrome at medium and long-term follow-up periods. We
      hypothesized that proper physical therapy approach can be equally effective than surgical
      intervention for improving pain and function in patients with carpal tunnel syndrome.
    

Detailed description: 
      Scientific evidence for the management of CTS has exhibited conflicting results. The Cochrane
      review concluded that surgical treatment relieves symptoms significantly better than
      splinting but further research is needed. A systematic review focused on physical therapy for
      the management of CTS included 6 studies and found weak to strong effect of neural gliding
      exercises. Recent studies have revealed complex nociceptive mechanisms involved in CTS which
      should be carefully considered during the management of these patients. Proper physical
      therapy interventions can modulate nociceptive processes found in CTS. We will perform a
      randomized clinical trial nested within a prospective cohort as our study design to determine
      if proper physical therapy approach targeted to modulate sensitization processes is equally
      effective than surgical intervention for improving pain and function in patients with carpal
      tunnel syndrome.
    

Intervention name(s): Conservative group; Surgical group
Intervention type(s): Other; Procedure
Intervention description(s): The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.; The surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal tunnel; Physical therapy; Surgery; Efficacy
The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The investigator would like to investigate the impact of theta-burst stimulation over
      posterior superior temporal sulcus in children and adolescents with autism spectrum disorder
    


Intervention name(s): intermittent theta burst stimulation
Intervention type(s): Device
Intervention description(s): stimulatory protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Measuring Quality of Decisions About Treatment of Menopausal Symptoms
Condition: Menopause
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is to examine the impact of a patient
      decision aid on the quality of decisions about managing symptoms of menopause. In particular,
      we will examine whether the decision aid increases knowledge about menopause/managing
      menopause symptoms and concordance between goals and treatment choices.
    


Intervention name(s): DVD & Booklet called: Managing Menopause
Intervention type(s): Behavioral
Intervention description(s): DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms
Other intervention name(s): Decision aids; Shared decision making programs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Menopause; Decision making; Decision aids; Decision quality instrument
A Post Marking Study to Evaluate the Safety of FluMist in Children
Condition: Healthy
Study type: Observational

Summary: 
      To assess the safety of FluMist vaccination
    

Detailed description: 
      -  To assess the safety of FluMist vaccination Rates of medically attended events in
           FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria,
           asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related
           to wild-type influenza, will be compared to rates in multiple non-randomized control
           groups.

        -  To assess the safety of annual FluMist re-vaccination [Rates of MAEs in the subset of
           children who receive FluMist in ≥2 consecutive years will be compared to rates in
           first-time vaccinees during the same season.]

        -  To assess the safety of FluMist vaccination in children previously vaccinated with
           trivalent inactivated influenza vaccine (TIV) [Rates of MAEs in the subset of children
           who received one or more prior TIV vaccinations will be compared to rates in children
           who did not receive prior TIV.]
    

Intervention name(s): FLuMist; TIV (Injection); Unvaccinated Control
Intervention type(s): Biological; Biological; Other
Intervention description(s): One or two vaccinations with FluMist depending on prior vaccination status.; One or two injections of TIV depending on previous status.; no vaccine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The populations to be assessed are FluMist recipients, TIV recipient controls, and
        unvaccinated controls.

        Members of the Kaiser Permanente Health Care Plan may be included in this study as part of
        routine care at their participating health centers within the Kaiser Permanente health
        maintenance organization (HMO) of Northern California.
Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER)
Condition: Violence; Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      This study is designed to address both alcohol misuse and violence among adolescents ages
      14-18 seeking care in an urban emergency department (ED). The study is a randomized
      controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing
      and Skills Training intervention, delivered either by a computer or by a counselor, and an
      informational handout control condition.
    

Detailed description: 
      This study will screen ~3000 adolescents in the ED (ages 14-18) over 30 months. Eligible
      adolescents will be asked to participate in the longitudinal study, stratified by age and
      gender and randomized to conditions (n=225/group): Computer Prevention Program, Counselor
      Prevention Program, or an informational handout control condition. Primary outcomes will be
      evaluated at 3, 6 and 12-months and include alcohol use/misuse, violent behaviors, illicit
      drug use, unintentional injury, delinquency, and weapon carriage. The proposed study
      integrates brief intervention strategies for alcohol misuse and violent behaviors using
      state-of-the-art technology to tailor the interventions to the specific risk factors of the
      adolescent. Tailored computerized programs use available technology to replace the need for
      clinical staff in the ED setting, where there is limited staff time to effect behavior
      change. This project will provide the critical first step toward the implementation of an
      integrated prevention program addressing overlapping risk factors that has the potential to
      be delivered to the millions of adolescents visiting urban Emergency Departments each year.
    

Intervention name(s): Adapted Motivational Interviewing & Skills Training
Intervention type(s): Behavioral
Intervention description(s): Single session, 45 minute brief intervention during Emergency Department Visit
Other intervention name(s): 1: Therapist delivered brief intervention; 2: Computer delivered brief intervention; 3: Control condition
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Alcohol; Violence; Alcohol consumption; Alcohol, drinking
Savella in Treatment for Provoked Vestibulodynia
Condition: Vestibulodynia; Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in
      women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to
      fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The
      investigators will also determine whether associated symptoms in PVD, including psychological
      distress, impairment of sexual function, physical function, and quality of life, are
      correlated with a reduction in vulvar pain.
    

Detailed description: 
      This is an 18-week, open-label, flexible-dose "proof of concept" trial where women with a
      diagnosis of vestibulodynia will be evaluated at baseline for eligibility. Eligible patients
      will be openly treated with 200 mg/d milnacipran (or the maximum tolerated dose) for a total
      of 12 weeks. The study design involves 4 phases: screening and washout, baseline assessment,
      dose escalation, and stable-dose phase (Figure 1). After completing a 2-week washout of
      prohibited medications, patients will enter a 2-week baseline period, where they will be
      trained in the use of daily diaries and the tampon test, and baseline safety and efficacy
      data will be recorded. Patients who continue to meet the eligibility criteria at the end of
      the baseline period will begin a 6-week period of dose escalation. All patients will be
      scheduled to receive a total of 12 weeks of stable dose treatment after the 6-week
      dose-escalation period for a total of 18 weeks of drug exposure.
    

Intervention name(s): Milnacipran
Intervention type(s): Drug
Intervention description(s): 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: provoked vestibulodynia; vulvodynia; PVD
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the
      current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I
      study now a multi-center phase II-trial was conducted.
    


Intervention name(s): Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian neoplasms; paclitaxel, carboplatin; clinical trials, phase II; first-line chemotherapy; weekly therapy schedule
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY
      vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at
      approximately 24 months after the last meningococcal vaccination in the parent study
      V102_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at
      similar age at enrolment.
    

Detailed description: 
      Naive subjects will be randomized 1:1 to receive MenABCWY or rMenB+OMV at Day 1. No
      randomization to treatment arm for follow-on subjects is required as vaccine groups remain
      the same as in the parent study V102_15 (NCT02212457).

      Response to a booster dose of MenABCWY vaccine will also be assessed in follow-on subjects
      who received 2 or 3 doses of MenABCWY (at 0.2-, 0,.6- or 0,.2,.6-month schedules) in the
      parent study, and will be compared with responses to a single dose of MenABCWY in naive
      subjects (subjects who are meningococcal vaccine-naive and of similar age to subjects
      enrolled from the parent study).

      Response to a booster dose of GSK Meningococcal B Recombinant vaccine (rMenB+OMV) will be
      assessed in subjects who received 2 doses of rMenB+OMV (at 0, 2-month schedule) in the parent
      study, and will be compared with responses to a single dose of rMenB+OMV in naive subjects.
    

Intervention name(s): Meningococcal ABCWY Vaccine; Meningococcal B Recombinant vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY_ 0_2 Group, ABCWY_ 0_2_6 Group and ABCWY_ 0_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.; Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B_0_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.
Other intervention name(s): MenABCWY; rMenB+OMV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal disease; meningitis; booster; antibody persistence
Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser
Condition: Acne; Acne Scars
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using
      lower energy settings in order to make the treatments less painful
    

Detailed description: 
      Numerous light based therapies are currently being used for the treatment of acne.
      Non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and
      improving acne scars. Specifically, the 1450 nm laser has been shown to be quite effective.
      However, it is associated with considerable pain at higher fluences despite topical
      anesthetics, especially when treating inflammatory acne. The goal of this study was to
      determine the possibility of using low fluence settings to treat moderate to severe acne at a
      more tolerable pain level without compromising treatment effectiveness.
    

Intervention name(s): 1450nm diode laser
Intervention type(s): Device
Observational model: Defined Population
Time perspective: Prospective
Keywords: diode; laser; acne; acne scar
Effect of Preoperative Oral Carbohydrates on Quality of Recovery
Condition: Evidence of Cholecystectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative
      carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery
      (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been
      widely investigated and have been shown to be associated with improved postoperative
      outcomes, some individual constituents of these protocols, including preoperative
      carbohydrate treatment, have not been subject to such robust analysis.To assess the effects
      of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on
      postoperative recovery and insulin resistance in adult patients undergoing elective surgery.
    

Detailed description: 
      Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before
      anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate
      per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50
      kcal.
    

Intervention name(s): Allocated to Carbohydrated group; Allocated to Placebo group; Allocated to MN NPO group,
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.; Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.; Patients received NPO from MN.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care