bioihbjkbjnl/mcl2 huggingface dataset:
Clarithromycin as Adjuvant to Periodontal Debridement
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional

Summary: 
      To assess the periodontal clinical response and the possible adverse effects of the
      clarithromycin combined to periodontal mechanical therapy in the treatment of patients with
      generalized aggressive periodontitis.
    

Detailed description: 
      To assess the periodontal clinical response and the possible adverse effects of the
      clarithromycin combined to periodontal mechanical therapy in the treatment of patients with
      generalized aggressive periodontitis.Forty patients were select and randomly assigned into
      two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth
      ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3
      days; group placebo with 20 subjects that received FMUD associated with placebo. Probing
      depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were
      evaluated at baseline, 3 and 6 months post- operatively.
    

Intervention name(s): Clarithromycin; Placebo; One-stage full-mouth ultrasonic debridement (FMUD)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Use of 500mg of Clarithromycin twice a day for 3 days; Use of placebo tablets twice a day for 3 days.; One session of Periodontal debridement using ultrasonic device.
Other intervention name(s): macrolide
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: clarithromycin; periodontal debridement; aggressive periodontitis
Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder
Condition: Auditory Neuropathy
MeSH terms: Hearing Loss, Central
Study type: Interventional

Summary: 
      This study aimed to assess the clinical evaluations and potential underlying pathologies in
      patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual
      results in audiological tests. The research involved the retrospective analysis of
      audiological tests of 11 patients conducted by expert audiologists at Istanbul Medipol Mega
      Hospital between 2010 and 2020. These patients displayed abnormalities in their Auditory
      Brainstem Response (ABR) tests. The study sought to investigate patients with ANSD who
      presented atypical audiological findings, shedding light on the associated clinical aspects
      and potential causes of such anomalies.
    


Intervention name(s): Hearing Thresholds Assessments
Intervention type(s): Diagnostic Test
Intervention description(s): Auditory Neuropathy Spectrum Disorder (ANSD) is a type of hearing disorder that affects the transmission of sound signals from the inner ear to the brain. In individuals with ANSD, the outer hair cells in the cochlea, which are responsible for amplifying sound, typically function properly. However, there is a disruption in the transmission of auditory information from the cochlea to the auditory nerve and then to the brain. It is characterized by a mismatch between the results of objective hearing tests, such as Auditory Brainstem Response (ABR), and subjective hearing experiences. In ABR tests, the responses of the auditory nerve to sounds may be abnormal, while the individual perceives their hearing to be better than suggested by the test results. In this study we showed ANSD patients with abnormal ABR results by using ABR, Otoacoustic Emissions, Tympanometry and behavioral test batteries.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Randomized Double-Blind Controlled Clinical Trial
Condition: Chronic Wounds; Acute Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The study is a randomized double-blind controlled clinical trial designed to compare the
      ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic
      wounds.
    

Detailed description: 
      The study is a randomized double-blind controlled clinical trial designed to compare the
      ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic
      wounds. Using the generally accepted surrogate endpoint of surface area reduction at 4 weeks,
      the study will also compare the healing of subjects utilizing NaOCl vs. NSS.

      After consenting, the ulcers of eligible subjects are measured, photographed and undergo the
      MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms:
      target ulcer cleansed with NaOCl or NSS. After cleansing the wound a second MiX is performed.
      The subject is given a four-week supply of either NaOCl or NSS.
    

Intervention name(s): AnaSept®; NSS
Intervention type(s): Device; Other
Intervention description(s): AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline. It has a broad-spectrum of antimicrobial action inhibiting the growth of Staphlyococcus aureus, Psuedomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Clostridium difficile, including antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enterococcus faecalis (VRE), Carbapenem Resistant E.coli (CRE) and Acinetobacter baumannii, that are commonly found in wound bed as well as fungi such as Candida albicans and Aspergillus niger. However, NaOCL is non-toxic to mammalian cells.; NSS
Other intervention name(s): ANTISEPTIC
Intervention MeSH terms: Anti-Infective Agents, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
Condition: Acute Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
Study type: Interventional

Summary: 
      The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to
      Jan 2018 at Institute of Liver & Biliary Sciences, New Delhi. Study group will comprise of
      patients with acute liver failure (ALF) who have no option for liver transplant (due to any
      reason) or have contraindications for liver transplant or have no prospective living donor
      and will be assessed for enrollment in the trial.
    


Intervention name(s): Plasma Exchange; Management of cerebral edema/intracranial hypertension:; Transfer to Intensive Care Unit; Prophylactic Antibiotics; Intubation of trachea; Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure; Volume Replacement; Pressor Support; N-acetyl-L-cysteine; Correction of metabolic parameters; Correction of nutrition
Intervention type(s): Biological; Other; Other; Drug; Other; Other; Other; Other; Drug; Other; Dietary Supplement
Intervention MeSH terms: Anti-Bacterial Agents; Acetylcysteine; Mannitol; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier
      Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.
    

Detailed description: 
      The study was designed as a randomized, single blind, sham controlled, pilot efficacy study
      of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were
      enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure,
      subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for
      an additional 8-12 weeks.

      Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in
      diabetic medications, and meal tolerance tests. Safety was monitored through the collection
      of clinical labs, physical assessments, endoscopy and adverse events.
    

Intervention name(s): EndoBarrier Gastrointestinal Liner; Sham: endoscopy and standard of care
Intervention type(s): Device; Other
Intervention description(s): The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.; Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
Other intervention name(s): GI Sleeve; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design :

        -  A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,
           crossover study

      Primary Objective:

        -  To assess the bioequivalence of combination oral formulation of amlodipine/losartan
           versus two co-administered products containing amlodipine and losartan
    

Detailed description: 
      Secondary Objective:

        -  To evaluate the safety and tolerability of these formulations.
    

Intervention name(s): Amlodipine plus Losartan; Amlodipine, Losartan
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipine/Losartan low dose; Amlodipine, Losartan
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Amlodipine, Losartan
Histology of Functional Density in Premenopausal Breast
Condition: Dense Breasts; Breast Cancer
Study type: Observational

Summary: 
      The investigators hypothesize that knowledge of the functional behavior of areas of
      mammographic density will enable more specific identification of dense tissue at-risk for
      breast cancer, ultimately providing predictive information on an individual's risk of
      developing breast cancer.
    

Detailed description: 
      The specific aims are:

        -  In women with increased mammographic density (MD), determine the histological
           characteristics of functionally dense tissue compared to that of non-functionally dense
           tissue via core-needle biopsy of the breast.

        -  In women with increased mammographic density (MD), determine the correlations between
           the total percent area of functional density (FD) on MBI, percent density of MD on
           mammogram, and histological characteristics of dense tissue
    

Intervention name(s): breast biopsy
Intervention type(s): Procedure
Intervention description(s): ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with mammographically dense breasts who demonstrate either photopenic or marked
        background parenchymal uptake on MBI
      
Biospecimen description: 
      core biopsy samples from mammographically dense breast tissue
A Study to Evaluate Effects of CC-99677 on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of CC-99677 coadministration on the
      pharmacokinetics (PK) of an oral contraceptive (OC).
    


Intervention name(s): Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent); CC-99677
Intervention type(s): Drug; Drug
Intervention description(s): Daily; Daily
Intervention MeSH terms: Moxifloxacin; Contraceptive Agents; Norgestimate, ethinyl estradiol drug combination; Contraceptives, Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Female Volunteers; CC-99677; Contraceptive
Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To compare the effectiveness of aerobic training and resistance training and combined
      training on heart failure patients.
    


Intervention name(s): Aerobic exercises; Resistance exercises; Combined training
Intervention type(s): Other; Other; Other
Intervention description(s): For Week 1 and 2 : Treadmill 3-5days/weeks
Intensity:
50-70 vo2 peak Or HRR 60-80% Duration of 10-20 minutes For Week 3 and 4; Cycle ergometer 3-5days/weeks
Intensity:
50-70 vo2 peak Or HRR 60-80% Duration of 30-40 minutes; For Week 1 and 2; 2 x 10 rep (unilateral leg press) 4x 12 reps (Bilateral leg press
1 x 8 rep ( unilateral arm curls For Week 3 and 4; 1 x 10 reps Shoulder press
1 x15 rep Bilateral knee extension
1 x 10 reps Bilateral arm curls; For Week 1 and 2; Aerobic exercise on Treadmill along with dumbbell to perform upper limb exercises (biceps curls, side curls extensions, upright row, back fly) and used Thera band to perform lower limb exercises for 10-20 minutes For Week 3 and 4; Aerobic exercise on Treadmill along with dumbbell and Thera band to perform upper limb and lower limb exercises for 30-40 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Aerobic Exercises; Resistance Training; Combined Training
Evaluation of an Entrepreneurship Program for American-Indian Youth
Condition: Depressive Symptoms; Substance Use
MeSH terms: Substance-Related Disorders; Depression
Study type: Interventional

Summary: 
      This study will use a randomized controlled design to evaluate whether a youth
      entrepreneurship/life-skills intervention for reservation-based American Indian adolescents
      (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes
      from baseline for up to 3 years follow-up as compared to a recreational sports league control
      condition.
    

Detailed description: 
      Intervention activities will be held over a 3 night/4 day residential camp and 6 weekend
      workshops during the academic year. The control condition will consist of a recreational
      sports league held on 3 Saturdays, also during the academic year.
    

Intervention name(s): Arrowhead Business Group Curriculum; Recreational League Control Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Arrowhead Business Group (ABG) is a culturally tailored entrepreneurship/life-skills intervention, which features instruction from American Indian paraprofessionals in an effort to decrease drug use, depressive symptoms, hopelessness and other high-risk behaviors among youth while improving their school performance and college/career aspirations.; The control condition will consist of a recreational sports league that will be led by local American Indian study staff who are experienced with Johns Hopkins camps and community-based Apache sports programs. Activities will be conducted on 3 Saturdays during the academic year to mixed gender groups of approximately 50 participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: American Indian; Adolescents; Entrepreneurship; Paraprofessional; Life skills
Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome
Condition: Climacteric Syndrome; Menopause
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart
      B by women with a typical (without complications) form of climacteric syndrome, with mild to
      moderate symptoms.
    

Detailed description: 
      1. To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B (vs
           placebo) by women with a typical (without complications) form of climacteric syndrome,
           with mild to moderate vegetative symptoms during perimenopause and menopause in regards
           to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions;

        2. To evaluate safety of combined use of dietary supplements Amberen and Smart B (vs
           placebo) by women with a typical (without complications) form of climacteric syndrome,
           with mild to moderate vegetative symptoms during perimenopause and menopause, lasting no
           less than 1 year in regards to vasomotor, endocrine-metabolic, and neuro-psychological
           dysfunctions;

        3. To develop recommendations for combined use of dietary supplements Amberen and Smart B
           for women with a typical (without complications) form of climacteric syndrome, with mild
           to moderate vegetative symptoms during perimenopause and menopause (menopausal for at
           least 1 year).
    

Intervention name(s): Amberen; Smart B; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.; Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.; Placebo capsules are identical to Amberen and Smart B capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Succinate; B complex vitamins; menopause
Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg
      BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules
    


Intervention name(s): BIBB 515 BS; Standard breakfast (40 g fat)
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      A prospective, double-blind, randomized, sham-controlled, multicentre investigation.
    

Detailed description: 
      The study period will begin with a four week run-in period, during which there is no
      investigational treatment. The purpose of the run-in period will be observation for baseline
      comparison.

      The run-in period will be, followed by a 12 week randomized period when the subjects will be
      randomized (1:1) to either active treatment or sham (inactive) treatment.

      The randomized period will be followed by a 24 week open label period, where the subjects in
      the sham treatment group will switch in treatment assignment and receive a gammaCore®-R and
      the gammaCore®-R will continue to receive an active treatment.
    

Intervention name(s): gammaCore®-R; gammaCore®-R Sham
Intervention type(s): Device; Device
Intervention description(s): Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).; Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction
Condition: Abdominal Fat
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical performance of the Ultrashape system
      with VelaShape II device for reduction of the waist.
    

Detailed description: 
      UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound
      for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing
      focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral
      nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by
      ultrasound-induced mechanical effects during a very short exposure time.

      VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape
      combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies
      with mechanical manipulation.
    

Intervention name(s): Ultrashape; Velashape II
Intervention type(s): Device; Device
Intervention description(s): All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.; All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.
Other intervention name(s): Vela, Velashape
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Syneron; Velashape; ELOS; Ultrashape