bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
Condition: Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox
      Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical
      considerations.
    

Detailed description: 
      This will be a multi-center, randomized, double-blind, comparator-controlled study. The study
      will take place in the EU, US and Canada.

      To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP
      treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with
      Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and
      subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing
      commercially available product (Botox Cosmetic).

      Two hundred subjects will be enrolled, which should allow for a precise estimate of response
      rate and for post-hoc sensitivity analyses.

      The duration of study participation for each subject will be up to 18 weeks, to include
      screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment
      (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox
      Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200
      subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and
      subjects will be blinded to treatment. Investigators and subjects will evaluate the severity
      of glabellar lines independently.
    

Intervention name(s): Botulinum toxin A "BoNT/A-DP"; Botulinum toxin A "Botox Cosmetics"
Intervention type(s): Biological; Biological
Intervention description(s): To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.; To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. The benefit of participation in this study is the expected reduction in the severity of glabellar frown lines. All subjects will benefit from free medical screenings and follow up.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Direct Use of Non-centrifuged Autologous Fat Graft
Condition: Wound Healing Delayed
Study type: Observational

Summary: 
      There are a limited number of reports related to the direct use of non-centrifuged adipose
      tissue graft in the literature. This preliminary study aims to present our experience on the
      efficacy of autologous fat graft use without centrifuging in the treatment of lower extremity
      wounds.
    

Detailed description: 
      16 wounds treated with non-centrifuged autologous fat grafts were included in the study. The
      data were retrospectively analyzed. VAC (vacuum-assisted therapy) or silver-impregnated
      dressing was used to achieve a healthy wound bed before fat grafting. Autologous fat grafts
      were harvested from abdominal or gluteal regions of the patients and injected into the wound
      bed and wound environment. Clinical observation and photograph records were used to follow
      the wounds.
    

Intervention name(s): non-centrifuge fat graft application to the wounds
Intervention type(s): Procedure
Intervention description(s): Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        16 lower extremity wounds were included in the study between January 2016-October 2019
        years. All patients were treated by two surgeons in the same clinic. The wounds were those
        that continued for at least three months of high to moderate exudate and required open
        management of the secondary intervention. The etiologies of the wounds were diabetic,
        venous or traumatic ulcers.
      
Keywords: diabetic food; lower extremity; fat graft; nonentrifuged
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma
Condition: Gastroenterology
MeSH terms: Adenoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp
      Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the
      other half will receive a placebo.
    

Detailed description: 
      There is no internationally recognized standard treatment for the prevention of recurrence of
      colorectal adenomatous polyps.

      Based on TCM,previous studies have found that Shenbai Granules can significantly reduce the
      recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation
      of tumor cells and promote apoptosis of tumor cells.
    

Intervention name(s): Shenbai Granules
Intervention type(s): Drug
Intervention description(s): In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: colorectal adenomatous polyp patients after colonoscopy under colonoscopy
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: colorectal adenoma; Clinical curative effect; Complementary and alternative medicine
Replication of the LEADER Diabetes Trial in Healthcare Claims
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Liraglutide; DPP-4 inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide dispensing claim is used as the exposure group; DPP-4 inhibitor dispensing claim is used as the reference group
Intervention MeSH terms: Liraglutide; Dipeptidyl-Peptidase IV Inhibitors
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, cohort study design comparing
        liraglutide to the DPP4 inhibitor (DPP4i) antidiabetic class as a proxy for placebo. Both
        2nd generation sulfonylureas (SUs) and DPP4is are not known to have an impact on the
        outcome of interest. The comparison against DPP4i is the primary comparison. Initiators of
        2nd generation SUs are used as a secondary comparator group. The patients will be required
        to have continuous enrollment during the baseline period of 180 days before initiation of
        liraglutide or a comparator drug (cohort entry date). Follow-up for the outcome (3P-MACE),
        begins the day after drug initiation. As in the trial, patients are allowed to take other
        antidiabetic medications during the study.
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical research study is to assess the effect of Famotidine given twice
      daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
    


Intervention name(s): Atazanavir/Ritonavir; Atazanavir/Ritonavir + Famotidine; Atazanavir/Ritonavir + Famotidine; Atazanavir/Ritonavir; Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine; Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.; Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.; Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.; Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.; Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.; Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.
Other intervention name(s): Reyataz; Reyataz; Reyataz; Reyataz; Reyataz; Reyataz
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Famotidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
IVES for Treatment of UUI and OAB
Condition: Urinary Bladder, Overactive; Urinary Incontinence, Urge
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The pilot study is intended to show the efficacy of intravesical electrical stimulation in
      treating overactive bladder with or without frequency and/or urgency urinary incontinence.
    

Detailed description: 
      The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is
      indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of
      overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or
      cannot tolerate other conservative treatments. EMED is interested in conducting a prospective
      randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain
      sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT,
      a pilot study will be initially conducted.

      The pilot study is intended to show the efficacy of IVES in treating overactive bladder with
      or without frequency and/or urgency urinary incontinence with safety profile of IVES being no
      worse than with standard urological catheters.

      A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient
      global impression of improvement will be established. Secondary endpoints will include PCI
      for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.

      Follow up at end of therapy and 3 months from the first therapy session will be conducted.
      6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES
      therapy if it is found to be effective at 3 months after the first treatment
    

Intervention name(s): EMED detruset(TM) intravesical electrical stimulation
Intervention type(s): Device
Intervention description(s): There will be a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a "maximal" level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons
Condition: AIDS
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine whether administration of the GSK Biologicals HIV vaccine
      732462 can lead to a reduction in viral load, and impact on the course of human
      immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet
      started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the
      initiation of treatment.
    


Intervention name(s): GSK Biologicals HIV Vaccine 732462; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 2 or 3 doses according to protocol schedule; 1 or 3 doses according to protocol schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus (HIV)-1; safety; vaccine; immunogenicity; reactogenicity; HIV infection
Surveillance Study of Bacterial Contamination of the Parent's Cell Phone in the NICU
Condition: Bacterial Contamination Rate of the Cell Phones
Study type: Observational

Summary: 
      The purpose of this study is to determine the contamination rate of the parents cell phone in
      a newborn intensive care setting and identify the types of bacteria contaminating the cell
      phone as well as evaluating the effectiveness of an antimicrobial gel in reducing the
      transmission of bacteria from the cell phone to the parents hands.
    

Detailed description: 
      J Perinatol. 2013 Dec;33(12):960-3. doi: 10.1038/jp.2013.108. Epub 2013 Sep 5.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parent's that have a cell phone when visiting their child in the NICU.
      
Keywords: bacterial contamination
Wear Experience With Daily Contact Lenses Over a Long Day
Condition: Contact Lens
Study type: Interventional

Summary: 
      This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16
      hours of lens wear.
    


Intervention name(s): Precision1® Daily Disposable Contact Lens
Intervention type(s): Device
Intervention description(s): Soft, spherical contact lens used to correct distance vision.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Daily Disposable Contact Lens; Spherical Contact Lens; Soft Contact Lens
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate how ensovibep is distributed throughout the body, the viral
      clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease
    


Intervention name(s): ensovibep
Intervention type(s): Drug
Intervention description(s): The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion.
Other intervention name(s): MP0420
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Corona; DARPin
Plaque Inhibitory Effect of Neutral Electrolysed Water in the Form of a Mouthwash in a 4-day Non-brushing Model
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Electrolysed water (EOW) is produced by the electrolysis of sodium chloride in an aqueous
      solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the
      cathode. EOW is known to have antimicrobial effects against various microorganisms, including
      viruses, bacteria, spores and fungi. Its antimicrobial activity is generally attributed to
      its hypochloric acid content - a product of chlorine gas dissolved in water. Due to its
      biocompatibility, known uses of EOW include ocular disinfection, nasal irrigation and chronic
      cutaneous wound care. In the dental setting, it may be used as a mouthwash, disinfectant,
      irrigant, mouthwash or dental gel.

      The aim of this study is to investigate the effect of a mouthwash containing neutral
      electrolyzed water on plaque accumulation (evaluated using a disclosing agent and an
      intraoral scanner), gingival inflammation, MMP-8 activity and the oral microbiome. In this
      double-blind, cross-over, 4-day experimental gingivitis model, each subject will participate
      in all three arms of the study. Each arm will last 4 days, during which the subjects will be
      asked to refrain from toothbrushing and the use of interdental cleaning devices. Instead,
      they will be instructed to rinse their oral cavities twice daily with either EOW, placebo or
      a positive control (chlorhexidine), according to a randomisation chart (each subject will
      receive a different mouthwash type in every arm of the study). The outcomes will be assessed
      at baseline and after 4 days. A washout period of at least 7 days will be implemented between
      each study arm.
    


Intervention name(s): Neutral electrolyzed water; Placebo; Chlorhexidine digluconate
Intervention type(s): Other; Drug; Drug
Intervention description(s): Use of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.; Use of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.; Use of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Dietary Nitrate Supplementation on Linear Running Sprint Performance, Agility and Vertical Jump Performance in a Rested and Fatigued State
Condition: Exercise Performance
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Dietary nitrate (NO3-) supplementation has been shown to improve skeletal muscle
      contractility and fatigue resistance, particularly in fast-twitch (type II) muscle fibers.
      Furthermore, NO3- supplementation has been shown to speed reaction time. Taken together,
      these findings suggest that NO3- ingestion may be ergogenic during all-out sprint running and
      reactive agility tasks. Moreover, increasing muscle force production at high contraction
      speeds would be expected to translate into improved muscle power and, subsequently, improved
      performance in very explosive forms of exercise, such as vertical jumping. Therefore, the
      purpose of this investigation is to assess the effect of short term (5 days) NO3-
      supplementation on linear running sprint performance, reactive agility and vertical jump
      performance in a rested and fatigued state.
    


Intervention name(s): Beetroot; Placebo beverage
Intervention type(s): Other; Other
Intervention description(s): Containing 385 mg nitrate; <0.1 mmol nitrate in sucrose solution with beet coloring
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy of Skeletal Anchorage (MINISCREW)
Condition: Tooth Extraction Status Nos
Study type: Interventional

Summary: 
      The main objective of the investigators' study is to assess the efficacy of a course of
      treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental
      anchorage (reference) during dentofacial orthopedic treatment.
    

Detailed description: 
      Multicenter prospective study on patients aged between 12 and 50 years, requiring orthodontic
      treatment with premolar extractions and closure of the extraction spaces by distalization of
      the 6 anterior teeth. In the experimental group (50 patients) distalization will be performed
      using skeletal anchorage (MINISCREW). In the control group (50 patients), distalization will
      be by dental anchorage.

      The main evaluation criterion will be extraction space closure after 8 months of treatment.
      Angle class I cuspid and the parallelism of the dental axes will also be taken into account.
      Evaluations will be made by very precise radiological analysis using 3D CT-scan. Examinations
      will be done before and after closure of the extraction sites and will assess treatment
      efficacy using skeletal anchorage versus dental anchorage. Patients will also be requested to
      complete a satisfaction questionnaire. The study will comprise an inclusion appointment
      during which patient consent will be obtained and a regular monthly appointment during the 8
      months of active treatment and space closure.
    

Intervention name(s): Skeletal anchorage (MINISCREW); dental anchorage
Intervention type(s): Device; Device
Intervention description(s): Skeletal anchorage; dental anchorage (reference)
Other intervention name(s): Skeletal anchorage; dental anchorage (reference)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MINISCREW; space extraction closure; anchorage; Orthodontic Treatment; Extraction of 2 Maxillary Premolar; closing of extraction space; patient aged from 12 to 50 years old