bioihbjkbjnl/mcl2 huggingface dataset:
Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)
Condition: Blood Pressure; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study aims to assess the performances of optical blood pressure monitoring device,
      Aktiia.product in the context of cardiac rehabilitation program.
    


Intervention name(s): Aktiia.product
Intervention type(s): Device
Intervention description(s): The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to investigate mechanisms which cause acute asthma exacerbations
      by examining blood and airway secretions during an acute onset (sputum or tracheal
      aspirates). This pilot study is intended to uncover new mechanisms of asthma exacerbation and
      to generate hypotheses for future study. By collaborating with Genentech, we (scientists at
      UCSF) plan to incorporate the latest scientific findings into our work to discover and
      develop new treatments for asthma.
    

Detailed description: 
      Asthma is a common airway disease with persistent unmet needs in terms of treatment. Although
      many asthmatics enjoy good control of their disease by using regularly scheduled
      corticosteroid treatment, a significant minority do not achieve optimal control with steroids
      and suffer asthma exacerbations which can be severe and even fatal. Asthma pathophysiology is
      complex and involves multiple cell types and multiple signaling mechanisms. One approach to
      this complexity has been to study responses of isolated airway cells to experimental
      conditions which model asthmatic inflammation; another has been genetic manipulations of
      candidate mediators of asthma in inbred mice. These studies have yielded important insights
      about possible mechanisms of asthma in humans, but the relevance of these mechanisms to human
      disease has not always been proven, and it is possible that unsuspected mechanisms have not
      yet been revealed by these approaches.

      In the current study, we propose to collect samples of airway secretions and blood from
      asthmatic subjects when their asthma is uncontrolled and they are being treated in the
      hospital or emergency room. Our goal will be to identify abnormal gene expression profiles
      and protein concentration abnormalities in these biological fluids. We will then study them
      again 6-10 weeks later when their asthma is controlled. This study design will allow us to
      compare airway and blood biomarkers of asthma exacerbation during acute asthma and recovery.
      "
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with acute asthma who seek treatment in the Emergency Department or who require
        admission to the hospital for their asthma
      
Biospecimen description: 
      whole blood, DNA, RNA, sputum, nasopharyngeal swab
    
Keywords: Acute Asthma
Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This is prospective randomized open single center clinical study to compare effect of
      sirolimus vs mycophenolate tacrolimus based protocol on pancreas and kidney graft survival in
      simultaneous pancreas and kidney recipients.
    

Detailed description: 
      MTOR (mammalian target of rapamycin) inhibitors represent group of immunosuppressive drugs
      with mechanism of T-cell blockade complementary to calcineurin inhibitors. The investigators
      presume that combination of sirolimus with tacrolimus will result in better survival of
      pancreatic and kidney grafts in simultaneous pancreas and kidney transplantations.

      The study is proposed as a single-center extension of EUROSPK 002 trial originally started in
      2004 by the EUROSPK Study Group. Recruitment of recipients started in 2004 with approval of
      EUROSPK 002. The patient recruitment has continued in a single center (Institute for Clinical
      and Experimental Medicine in Prague, Czech Republic) using the same inclusion and exclusion
      criteria. The recipients of primary kidney and pancreas transplantation have been randomized
      into 2 arms.

        -  In the intervention arm sirolimus is added to protocol at a dose of 5 mg immediately
           before transplantation, the dose is adjusted to maintained trough sirolimus trough
           levels between 5-10ng/ml.

        -  In the control arm mycophenolate mofetil was added to tacrolimus. Starting with 1g
           before transplantation, the dose has been increased to 1g bid afterwards.

      Induction protocol at day 0. consists of ATG (antithymocyte globulin)induction 8mg/kg ,
      Tacrolimus 0.05mg/kg, Methylprednisolone 125mg. Dosing of tacrolimus has been adjusted to
      maintain trough levels between 5-10ng/ml. ATG was administered at 3mg/kg on days 1.-3.
      Steroids have been gradually tapered from a dose of 20 mg prednison orally and withdrawn by
      6w after transplantation.
    

Intervention name(s): Sirolimus Oral Product; Mycophenolate Mofetil
Intervention type(s): Drug; Drug
Intervention description(s): Oral form of sirolimus, daily dosing to achieve target trough levels between 5-10ng/ml since 1.day of transplantation; Mycophenolate Mofetil dosing 1g before transplantation and 1g bid afterwards
Other intervention name(s): Rapamune; CellCept
Intervention MeSH terms: Mycophenolic Acid; Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adipose Derived Stem Cells in Facial Fat Grafting
Condition: Facial Atrophy
MeSH terms: Atrophy; Facies
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase two, randomized, double-blind study is designed to demonstrate the enhanced
      efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF
      enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted
      region over the course of one year.
    

Detailed description: 
      Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large
      therapeutic potential for many rare and common diseases that impacts millions of patients
      worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to
      extract with minimally invasive procedures such as elective liposuction in large quantities
      and therefore may be a cost effective source for cellular therapies in a wide range of
      medical specialties.

      The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a
      result of the aging process as well as some pathological diseases. It can be corrected via
      autologous fat transfer but usually the majority of the grafted cells will die after 6-12
      months. Several publications demonstrate that the addition of SVF cells to the graft may
      enhance the graft survival.

      This double blind, randomized study aims to demonstrated the efficacy of Antria Cell
      Preparation Process in autologous facial fat grafting.
    

Intervention name(s): Stromal Vasular Fraction; Biopsy
Intervention type(s): Biological; Procedure
Intervention description(s): The stromal vascular fraction obtained from adipose tissue will be added to the graft; A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months
Other intervention name(s): Stromal Vascular Fraction; Adiployx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Facial Atrophy; Autologous; Adult; Adipose Derived Stem Cells; Stromal Vascular Fraction; Collagenase
A Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate Inhalation Powder Administered by Novel Dry Powder Inhaler (NDPI)
Condition: Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram
      (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI
      containing FF formulated with lactose. In addition, the aim of this study is to determine the
      absolute bioavailability of the FF single strip product using the high strength product
      administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV)
      FF.

      This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult
      subjects. During each period, subjects will receive FF in the morning and serial
      pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days
      for the IV treatment) and safety assessments will be performed. Each period will be separated
      by a washout period of at least 7 days and a follow-up telephone call will occur 7 -14 days
      after the last dose of study drug. The total duration of the study will be approximately
      13-14 weeks for each subject.
    


Intervention name(s): FF, 50 mcg; FF, 100 mcg; FF, 200 mcg; FF, 250 mcg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Novel dry powder inhaler; Novel dry powder inhaler; Novel dry powder inhaler; Intravenous
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability; Fluticasone Furoate; pharmacokinetics; dose proportionality
Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help
      elucidate reasons for variable treatment response and identify novel treatment targets.
      Exposure-based therapies have been associated with decreased amygdala and increased cingulate
      cortex response during emotional processing. The current study examined whether cognitive
      therapy for PTSD in women reduces activation in insula and amygdala and enhances activation
      in prefrontal regions during emotional anticipation and pre-treatment prefrontal activation
      predicts treatment response.
    


Intervention name(s): Cognitive Trauma Therapy for Battered Women (CTT-BW)
Intervention type(s): Behavioral
Intervention description(s): 10 individual sessions of this form of cognitive therapy, with a trained therapist.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: PTSD; domestic violence; intimate partner violence; functional MRI; neuroimaging
Treatment of Androgenetic Alopecia in Males and Females
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy
      system configured in a novel product called the TopHat 655 system, for promoting hair growth
      in males and females diagnosed with androgenetic alopecia of the head.
    


Intervention name(s): TopHat 655 rejuvenation system; Laser and/or Light Hair Rejuvenation System
Intervention type(s): Device; Device
Intervention description(s): TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period; A red incandescent light source replaces all lasers and light emitting diodes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Human Pulpal Response After Pulp Capping With Four Different Agents
Condition: Dental Pulp Exposure
MeSH terms: Dental Pulp Exposure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Application of four different pulp capping methods on human sound premolars after intentional
      exposure of the buccal pulp horn through a class one occlusal cavity.
    

Detailed description: 
      The purpose of this clinical trial is to compare the effect of different direct pulp capping
      methods on human pulpal response in the terms of inflammation & dentinal bridge formation.
      Methods: Eight patients providing 32 sound first premolars are selected. As recommended by
      ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of
      eight specimens each will be defined according to the pulp capping method. Group A, will
      receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide
      Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after
      its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group
      D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the
      terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness
      and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to
      none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true
      tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.
    

Intervention name(s): Pro Root MTA; Pro Root MTA- single visit; MultiCal; Dycal
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): application of MTA in second group and 24 hour interval before restoration; application of MTA in third group and 15 minute interval before restoration; application of Multical in forth group as a pulp dressing agent; application of Dycal in first group as a pulp dressing agent
Other intervention name(s): Mineral Trioxide Aggregate; Mineral Trioxide Aggregate; Hard set calcium hydroxide paste; chemical set calcium hydroxide
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: direct pulp capping; MTA; Single visit pulp cap; Multical
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
Condition: Adherence, Medication; Risk Behavior; Pre-Exposure Prophylaxis; HIV Prevention
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers are working with a technology company, AiCure, to develop a smartphone app,
      DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is
      time to take their medication, and uses motion-sensing technology to visually and
      automatically confirm the pill was swallowed. The goal of this study is to understand
      people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for
      the prevention of HIV.
    

Detailed description: 
      In the DOT Diary research project, the AiCure aDOT smartphone app has been adapted for use in
      monitoring and supporting HIV pre-exposure prophylaxis (PrEP) use among young men who have
      sex with men (YMSM). The aDOT app uses automated directly observed therapy (DOT) that use the
      smartphone camera and artificial intelligence software to confirm that the right person is
      taking the right medication at the right time. A sexual diary has been integrated into the
      aDOT app to assist YMSM in understanding whether they are receiving protection from PrEP for
      individual sexual episodes, and when it is particularly important to take PrEP (e.g. after a
      sexual episode).

      In the next stage of app development, the researchers are conducting this study to identify
      areas of the app that require refinement to maximize the acceptability and ease of use of the
      DOT adherence monitoring app. The researchers will assess overall acceptability and ease of
      use of the integrated DOT Diary (D2) app over an 8 week period.The goal of this pilot study
      will be to refine and optimize the app for further testing in a larger and longer pilot study
      among YMSM at risk for HIV acquisition. The researchers will conduct this pilot protocol
      among YMSM in Atlanta and San Francisco Bay Area, two metropolitan regions heavily impacted
      by HIV, yet differing in sociodemographics, as well as in the availability and uptake of HIV
      prevention services, including PrEP. These diverse research locations will allow collection
      of data to inform app development among a broad group of YMSM.
    

Intervention name(s): Emtricitabine / Tenofovir Disoproxil Oral Tablet; DOT Diary mobile app
Intervention type(s): Drug; Other
Intervention description(s): Open label daily emtricitabine/tenofovir disoproxil oral tablet; DOT Diary mobile application for tracking medication adherence and sexual activities.
Other intervention name(s): Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adherence; PrEP; HIV Prevention; Truvada; HIV Risk Reduction; Mobile App
Analysis of Bacterial Microbiome of Endodontically Infected Primary and Permanent Teeth
Condition: Endodontic Disease; Endodontic Inflammation
MeSH terms: Dental Pulp Diseases; Pulpitis; Inflammation
Study type: Interventional

Summary: 
      Recognition of community profiles in endodontic infections may allow a better understanding
      of the pathogenesis of the disease and the establishment of more effective treatment
      protocols.

      Therefore, the aim of the present study was to investigate bacterial diversity in
      endodontically infected primary and permanent teeth using 16S rRNA gene sequencing and QIIME
      2TM (Quantitative Insights Into Microbial Ecology 2) bioinformatics pipeline
    

Detailed description: 
      Endodontic infections are defined as an infection of the pulp and periapical tissues. This
      infection is caused by microorganisms that invade the pulp via dental caries or dental
      trauma. In these mixed population infections, anaerobic bacteria have been reported to be
      conspicuously dominant and the number of microorganisms per canal may vary. Traditionally,
      the endodontic microbiome has been identified by culture-based (phenotype-based) techniques.
      Inability to cultivate approximately 40-55% of bacteria in the endodontic microbiome, bias or
      inexperience of researchers may limit the results of cultural research. Microbiome-based new
      generation sequencing (NGS), which was initially used in ecological studies, has been widely
      used in recent years to identify bacterial diversity using the 16S ribosomal RNA (rRNA) gene
      in endodontic infections microbiome, bias or inexperience of researchers may limit the
      results of cultural research. There are few studies investigating the endodontic microbiome
      in primary teeth. However, to the best of our knowledge, to date, there is no metagenomic
      study that investigates the endodontic microbiome of the primary and permanent teeth. It is a
      still question of whether there is a difference in the endodontic microbiomes during the
      mixed dentition period when both dentition types can be seen.
    

Intervention name(s): sampling
Intervention type(s): Diagnostic Test
Intervention description(s): sampling from endodontically infected primary and permanent teeth by using paper point method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Endodontic disease; Microbiome; Permanent teeth; Primary teeth
AM-111 in the Treatment of Acute Inner Ear Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to test the effectiveness and safety of the study drug,
      AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the
      cause is unknown.
    

Detailed description: 
      This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of
      intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden
      sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the
      JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a
      c-Jun N-terminal kinase (JNK) ligand.
    

Intervention name(s): Placebo; AM-111 0.4 mg/ml; AM-111 0.8 mg/ml
Intervention type(s): Other; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deafness; Hearing Loss, Sensorineural; Ear Diseases; Hearing Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Signs and Symptoms; Hearing and Speech impairment; Hearing Loss, Unilateral