bioihbjkbjnl/mcl2 huggingface dataset:
Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
Condition: Facial Rhytides; Crow's Feet Lines; Glabellar Lines; Nasolabial Fold
MeSH terms: Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to evaluate patient satisfaction, aesthetic and psychological impact of combined
      treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS
      XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).
    


Intervention name(s): onabotulinumtoxinA; bimatoprost ophthalmic solution 0.03%; JUVÉDERM® ULTRA XC; JUVÉDERM® ULTRA PLUS XC; JUVÉDERM® VOLUMA® XC
Intervention type(s): Biological; Drug; Device; Device; Device
Intervention description(s): onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.; bimatoprost ophthalmic solution 0.03% (LATISSE®) 1 drop applied to the upper eyelid at the base of eyelashes once daily in the evening for 17 weeks.; JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.; JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.; JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Other intervention name(s): botulinum toxin Type A; LATISSE®
Intervention MeSH terms: Bimatoprost; Ophthalmic Solutions; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Herbal Mouth Rinse for Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      This double blind, randomized, placebo controlled, parallel clinical trial involved seventy
      five patients, suffering with chronic periodontitis, which were randomly divided in three
      groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group
      (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while
      clinical parameters [plaque index (PI), gingival index (GI), sulcus bleeding index (SBI),
      probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), stain
      index (SI)] were evaluated at base line, 1 month, and 3 months. CFU was also evaluating at
      above said time periods.
    

Detailed description: 
      This double blind, randomized, placebo controlled, parallel clinical trial involved seventy
      five patients, suffering with chronic periodontitis, which were randomly divided in three
      groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group
      (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month.The
      primary outcome of this study was CAL, while PPD was the secondary outcome measure. A single
      clinician (AA) who was blinded to the groups assigned to the individuals, recorded all the
      parameters i.e. PI, GI, SBI, PPD, CAL, GR, SI at base line (prior to the treatment), 1 and 3
      months after therapy. PPD, CAL and GR were recorded at the six sites per tooth in every
      tooth, except third molar, with a manual UNC-15 periodontal probe (Hu-Friedy, Leinmen,
      Germany) to the nearest millimeter. For recording of parameters at different time periods
      patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the
      evaluation. Staining of the six maxillary anterior teeth was assessed using the Lobene index.
      CFUs of P. ginigvalis, T. forsythia, and T. denticola were evaluated at baseline , 1 months,
      3 months.
    

Intervention name(s): Placebo mouth rinse; Chlorhexidine mouth rinse; Test group
Intervention type(s): Other; Drug; Drug
Intervention description(s): Normal saline; Chlorhexidine gluconate; Chamomile mouth rinse
Other intervention name(s): NS; CHX; CMT
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of a Youth Mentoring Program
Condition: Self Concept
Study type: Interventional

Summary: 
      This study will be used to determine the effectiveness of GirlPOWER!, an innovative mentoring
      program for adolescent minority girls living in urban areas.
    

Detailed description: 
      The potential benefits of adolescent mentoring programs cannot be overemphasized. Mentoring
      may be especially beneficial to urban-living, minority adolescents who may lack role models.
      The Big Brothers Big Sisters (BBBS) organization administers a widely-praised and
      empirically-supported program that is committed to building successful mentoring
      relationships between adolescents and adults in their community. In collaboration with the
      BBBS affiliate agency in Chicago, the PI has developed an intervention called GirlPOWER!
      GirlPOWER! combines mentoring with self-esteem enhancement and health education and promotion
      strategies. This study will determine the effectiveness of the GirlPOWER! intervention and
      determine its feasibility in being applied to other populations.

      Participants will be randomly assigned to receive either the GirlPOWER! intervention or
      traditional mentoring through BBBS and followed for 1 year. Participants in the GirlPOWER!
      group and their mentors will engage in structured activities that focus on strengthening the
      mentoring relationship, promoting self-esteem, reducing levels of health-compromising
      behaviors such as substance use and violence, and increasing levels of health-enhancing
      behaviors. Traditional mentoring comprises less structured activities and typically includes
      general discussion of an adolescent's day-to-day life and any accomplishments and challenges
      he or she may have experienced. Participants will be assessed at study entry, 3 months
      following entry, and at the end of one year. Assessments will include surveys completed by
      youth as well as their parents, mentors, and teachers; academic data also will be obtained
      from school records.
    

Intervention name(s): GirlPOWER! mentoring program; Traditional mentoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): GirlPOWER! mentoring program includes monthly 3-hour workshops for youth and mentors combined with monthly supplemental activities to be completed independently by youth-mentor pairs.; Traditional mentoring includes a community-based mentoring program, in which the youth-mentor spends time together in activities of their choosing 2 to 4 times a month.
Other intervention name(s): Big Brothers Big Sisters Community-Based Mentoring Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mentors; Self-esteem; Adolescent; Mental health; Social support; Substance use; Violence; Exercise; Nutrition; Sexual behavior; Female
S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is studying blood samples from patients with metastatic prostate
      cancer previously treated with bicalutamide and goserelin.
    

Detailed description: 
      OBJECTIVES:

        -  To test the association between serum PSA response (< 4 ng/mL) at 7 months with
           inherited variability of germline single nucleotide polymorphisms, in a set of candidate
           genes, in patients with metastatic prostate cancer treated with combination induction
           androgen-deprivation therapy comprising bicalutamide and goserelin.

      OUTLINE: DNA extracted from whole blood or serum samples is analyzed for inherited
      variability of germline single nucleotide polymorphisms.
    

Intervention name(s): gene expression analysis; polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        S9346 patients
      
Keywords: recurrent prostate cancer; stage IV prostate cancer
Vitamin D Deficiency of Couples and Infertility
Condition: Vitamin D Deficiency; Infertility; Couples; In-vitro Fertilization
MeSH terms: Infertility; Vitamin D Deficiency
Study type: Observational

Summary: 
      Between March 2016 and March 2017, we performed a large retrospective, non-interventional,
      single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation
      in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and
      reproductive capacity .
    

Detailed description: 
      Before conducting ovarian stimulation, all couples must conduct preoperative routine
      examination such as routine blood test, blood group examination and infectious disease
      examination. We collected 2ml remaining blood from the examination by use of sodium heparin,
      which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry.

      All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and
      fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization
      rate was defined as the presence of two pronuclei (2PN) at the time of fertilization
      assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality
      embryos was defined as the percentage of top quality embryos among the total number of 2PN
      embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by
      number of cultured blastocysts.
    

Intervention name(s): vitamin D is below 20ng/ml
Intervention type(s): Diagnostic Test
Intervention MeSH terms: Vitamin D
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        non-interventional, single-center cohort study and measured 25(OH) D plasma levels prior to
        ovarian stimulation in couples who underwent IVF/ICSI.
Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg
      autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe
      dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
    

Detailed description: 
      A randomized, open-label, 3-treatment, 6-sequences, 3-period Williams Square crossover
      single-dose, relative bioavailability study in healthy adult participants. The study includes
      Screening period, a Treatment period and a Follow-up contact (SoA). At least twelve (12)
      participants will be enrolled. If the number of evaluable participants falls below 12,
      participants may be replaced.
    

Intervention name(s): NaxRedy ™; Naloxone Hydrochloride Injection, USP; Naloxone Hydrochloride Injection, USP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg (5 mg/0.5 mL) IM autoinjector injection into lateral thigh; 2 mg IM (2mg/2 mL) injection into gluteal muscle; 2 mg bolus IV (2mg/2 mL)
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Williams Square Study Design with 6 sequences
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: naloxone; autoinjector; intramuscular; high dose; 5 mg; healthy volunteers; safety; cross-over study; pharmacokinetics; 3 treatment arms
Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
Condition: Postoperative Pain; Regional Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Main purpose of this prospective single center randomized study is to compare the analgesic
      effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane
      (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local
      anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American
      society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic
      cholecystectomy will recruit to the study.
    


Intervention name(s): Unilateral ESP Block; Unilateral OSTAP Block; Injection of Local Anesthetic to Trocar Insertion; intravenous patient controlled analgesia
Intervention type(s): Procedure; Procedure; Procedure; Drug
Intervention description(s): USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture; USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture; Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.; All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Degarelix Neo-Adjuvant Radical Prostatectomy Trial
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on
      intratumoral levels of androgens.
    


Intervention name(s): Degarelix; Casodex; LHRH Agonist
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity
Condition: Metabolic Syndrome; Obesity
MeSH terms: Obesity; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to identify early cardiovascular disease risk factors in those
      with "normal-weight obesity" (i.e., normal body, but high body fat percentage) that better
      track with their long-term cardiovascular disease risk.
    


Intervention name(s): High-fat shake
Intervention type(s): Other
Intervention description(s): All participants will be given a high-fat test meal to examine their postprandial triglyceride response.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 study groups: control (normal body mass index, low body fat percentage), normal-weight obesity ((normal body mass index, high body fat percentage), and metabolic syndrome
Masking: None (Open Label)
Primary purpose: Screening
A Teleintervention in Developmental Coordination Disorder
Condition: Developmental Coordination Disorder
MeSH terms: Motor Skills Disorders
Study type: Interventional

Summary: 
      The principal study goals are to determine if a randomized control trial would be feasible,
      particularly with regards to i) recruitment and retention of parents of children having a
      diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the
      teleintervention. The study will also examine quantitatively and qualitatively families'
      acceptability of- and satisfaction with the teleintervention.
    

Detailed description: 
      Developmental coordination disorder (DCD) is a neurodevelopmental disorder characterised by
      difficulties in planning and execution of motor coordination activities like dressing, sports
      and writing. Increasing parents' capacity to manage their children's needs is part of the
      recommended DCD best practices, as soon as children are suspected to have DCD or early
      following diagnosis. Parents' capacity could be increased through simple, community-based
      interventions using a consultative approach. Using the Internet could be an interesting
      avenue to develop public community-based services and build parents' capacity to manage their
      child with DCD. The feasibility of recruiting and using the Internet to build parents'
      capacity is however unknown, since no such study have been conducted.

      This randomized feasibility trail will experiment a teleintervention, characterized by a
      virtual interaction between a health professional and a user by Internet, for children with
      DCD. The principal study goals are to determine if a randomized control trial would be
      feasible, particularly with regards to i) recruitment and retention of parents of children
      having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the
      teleintervention. The study will also examine quantitatively and qualitatively families'
      acceptability of- and satisfaction with the teleintervention. As part of the evaluation of
      acceptability, the impact of the teleintervention on parental competencies will be explored.
      At the end of the 3-months randomized feasibility trial, the influence of the number of
      participants on the utilization of the teleintervention will be explored by providing access
      to the teleintervention to all participants (control and intervention).
    

Intervention name(s): Teleintervention
Intervention type(s): Behavioral
Intervention description(s): Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to
      placebo in patients with mild to moderate insomnia.
    


Intervention name(s): Songha Night ®; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
YAZ, Oral Contraceptive Registration in China
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness in terms of prevention of
      pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
    


Intervention name(s): YAZ (SH T00186, BAY86-5300)
Intervention type(s): Drug
Intervention description(s): 20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraceptives,; Oral Hormonal;; Contraceptive Methods;; Female
Effect of Oseltamivir on Cognitive Function in Subjects With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study has been designed to determine if subjects treated with oseltamivir in addition to
      standard of care treatment for influenza demonstrate a greater improvement in attention /
      working memory / processing speed / mood as compared to subjects receiving standard of care
      alone. The cognitive tests employed are objective measures developed and administered online
      by HeadMinder Inc.
    

Detailed description: 
      Primary Objective:

      To determine if subjects treated with oseltamivir in addition to standard of care treatment
      for influenza demonstrate a greater improvement in attention as compared to subjects
      receiving standard of care alone.

      Secondary Objectives:

      To determine if subjects treated with oseltamivir in addition to standard of care treatment
      for influenza demonstrate a greater improvement in working memory and processing speed as
      compared to subjects receiving standard of care alone.

      Supportive Objectives:

        1. To determine if subjects treated with oseltamivir in addition to standard of care
           treatment for influenza demonstrate a greater improvement in self-rated alertness as
           compared to subjects receiving standard of care alone.

        2. To determine if subjects treated with oseltamivir in addition to standard of care
           treatment for influenza demonstrate a greater improvement in self-rated calmness and
           contentment as compared to subjects receiving standard of care alone.

        3. To determine if there is a correlation between the rate of improvement in symptom scores
           and the rate of change in attention and working memory.
    

Intervention name(s): Oseltamivir
Intervention type(s): Drug
Intervention description(s): Oseltamivir 75mg BID for 5 days
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Influenza; Cognition; Attention; Simple Reaction Time; Alertness; Calmness; Contentment; Mood