bioihbjkbjnl/mcl2 huggingface dataset:
A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania
Condition: HIV; Health Behavior
Study type: Interventional

Summary: 
      HIV antiretroviral therapy (ART) has the potential to dramatically decrease HIV transmission
      worldwide. In Tanzania, HIV prevalence is ~5%, with 1.6 million people living with HIV/AIDS;
      it is the leading cause of hospitalization and death among Tanzanian adults. However, less
      than 50% of HIV-infected Tanzanian adults know their status.Successful implementation of
      community-based services requires an understanding of the social and cultural context that
      influence community engagement with HIV services. Specifically, many HIV endemic regions are
      also medically pluralistic communities, where multiple explanatory frameworks for health and
      disease co-exist. In these areas, HIV testing and ART clinical care do not occur in
      isolation; traditional healers are commonly utilized instead of or concurrently with
      biomedical services. Therefore, the success of decentralized, community-based HIV services
      must be founded upon a thorough understanding of medical pluralism, and engagement with
      traditional healers as stakeholders in community health.

      This study will investigate the feasibility of involving traditional healers in HIV testing,
      and pilot an intervention to expand HIV testing within communities that use traditional
      medicine in Mwanza, Tanzania.
    

Detailed description: 
      This study has two specific aims.

      Specific Aim 1:

      Tailor a point of care HIV testing intervention for delivery in northwestern Tanzania, using
      data from 1) qualitative interviews and 2) community engagement strategies. Interviews with
      traditional healers, traditional and biomedical clients, and HIV clinic staff will illustrate
      local variables impacting HIV testing engagement. A community advisory board with stakeholder
      members will guide program implementation, tailoring protocols to maximize uptake.

      Specific Aim 2:

      Conduct a cluster-randomized pilot of the HIV testing intervention. This pilot will offer HIV
      testing at five traditional healer practice sites, compared with a control group of five
      healers providing education on community HIV resources..
    

Intervention name(s): Point-of-care HIV testing; HIV testing education
Intervention type(s): Diagnostic Test; Behavioral
Intervention description(s): Participants will undergo an HIV 1/2 antibody point of care test (Oraquick) and receive pre- and post-test counselling.Participants with positive tests will be referred to the HIV clinic for Western Blot confirmation, and linkage to care.; Participants will be provided with education on community based HIV resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multi-center study designed to extend the evaluation of the safety,
      tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.
    

Detailed description: 
      Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and patients with
      ALS who were actively receiving RTPB
      [(6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydro-chloride monohydrate]
      under Research IND #60,948 were eligible to participate in this study.

      Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg
      total daily dose) for up to 180 weeks.
    

Intervention name(s): KNS-760704
Intervention type(s): Drug
Intervention description(s): 150 mg Q12H KNS-760704 given orally (300 mg total daily dose)
Other intervention name(s): dexpramipexole
Intervention MeSH terms: Pramipexole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig; Lou Gehrig's; Lou Gehrig's disease; Motor Neuron Disease; Nervous System Diseases; KNS-760704; RTPB
Study on OsseoSpeed™ TX Short Implants in a Chinese Population
Condition: Partially Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm
      implants in a Chinese population by evaluation of marginal bone level alteration, implant
      stability and implant survival in the posterior mandible and maxilla up to 3 years after
      loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the
      posterior region is safe and predictable.
    


Intervention name(s): OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Pharmacokinetic Study of a Prolonged-release Formulation of St. John's Wort Extract Ze 117
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A pilot phase I, randomised, open mono-center, two parallel group clinical trial
      investigating the pharmacokinetics of a prolonged-release formulation in comparison to an
      immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers
      under fasting condition.
    


Intervention name(s): St. John's wort prolonged-release tablet 500 mg; St. John's wort film coated tablets 250 mg
Intervention type(s): Drug; Drug
Other intervention name(s): Prolonged-release formulation; Immediate-release formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
Condition: Corneal Staining
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the association of inflammatory mediators found
      in the tear film during the development and following the induction of contact lens
      solution-induced corneal staining.
    


Intervention name(s): Opti-Free RepleniSH; ReNu MultiPlus; Balafilcon A; Unisol 4
Intervention type(s): Device; Device; Device; Other
Intervention description(s): Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.; Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.; Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.; Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Other intervention name(s): Renu; PureVision
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Contact lenses; Contact lens solution; Corneal staining
Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this research is to study the effects of a novel artificial intelligence (AI)
      tool for automatic facial expression recognition that runs on Google Glass through an Android
      app to deliver social emotion cues to children with autism during social interactions. This
      novel device will use a camera, microphone, head motion tracker to analyze the behavior of
      the subject during interactions with other people. The system is designed to give
      participants non-interruptive social cues in real-time and will record social responses that
      can later be used to help aid behavioral therapy. It is hypothesized that the system's
      ability to provide continuous behavioral therapy during social interactions will enable
      faster gains in social skills.
    


Intervention name(s): Autism Glass
Intervention type(s): Device
Intervention description(s): The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mobile health, autism, ASD, mobile therapy, digital, wearable computing, technology
Evaluation of Integrated Optimization Schemes for Female Stress Incontinence
Condition: Stress Urinary Incontinence in Women
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added
      sham EA for SUI in women.
    

Detailed description: 
      We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group
      clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs
      sham EA added to PFMT for women with SUI.

      The participated women with SUI will be recruited from four participating hospitals or
      through community clinics by advertising. Participated hospitals include: Yueyang Hospital of
      Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of
      Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese
      Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese
      Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing
      University of Chinese Medicine (Nanjing, China).

      Patients will be screened for eligibility. Chief complaint, medical history, and general
      characteristics (such as age, race, education level, body mass index, manner of child
      delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in
      participating in the study will sign an informed consent form and then make another
      appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h
      pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
      score, the weekly mean number of urine pads used). Participants will then be assigned
      randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group
      or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to
      32. The participant-reported severity of UI and subjective self-evaluation of therapeutic
      effects will be recorded. Written informed consent will be obtained from all participants
      before they are included in the study. All clinical investigations will be conducted
      according to the principles of the Declaration of Helsinki.
    

Intervention name(s): Electroacupuncture group; Sham electroacupuncture group; Pelvic floor muscle training
Intervention type(s): Device; Device; Behavioral
Other intervention name(s): SDA-V electroacupuncture apparatus(Huatuo,made in China); Sham SDZ-V electroacupuncture apparatus(Huatuo,China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress Urinary Incontinence; Acupuncture
Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      TME (Total mesorectum excision) is the golden standard of radical resection for mid-low
      rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle
      will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic
      nerve preservation) surgery played a role in decreasing incidence of urinary and sexual
      function disorder. However, 32%-44% patients still suffered from urinary and sexual function
      disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).

      In the early stage of work, the investigators performed preservation of Denovilliers' fascia
      in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal
      cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME
      significantly decreased incidence of urinary and sexual function disorder. In order to
      further confirm the early work, the investigators design a multicenter randomized controlled
      clinical trial to compare differences in urinary and sexual function protection and long-term
      outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.
    


Intervention name(s): Preservation of Denonvilliers Fascia during L-PANP surgery
Intervention type(s): Procedure
Intervention description(s): In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The epidemic nature of type 2 diabetes mellitus, along with the downsides of current
      treatments, has raised the need for therapeutic alternatives. The aim of this study is to
      evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral
      electrical stimulation (PES) as an alternative treatment for diabetes.
    


Intervention name(s): Stimulator
Intervention type(s): Device
Other intervention name(s): BEAC Biomedical Intellistim BE-28TC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does LMA Instead of ET Tube Affect Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction?
Condition: Strabismus
MeSH terms: Strabismus; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      The effect of airway management on vomiting after strabismus surgery is unknown. The purpose
      of this study is to find out whether the use of different airway devices, such as LMA, which
      is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube
      placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six
      children between the ages of 2 and 12 years are expected to take part in this study.
    

Detailed description: 
      The child will be checked by the study doctor to determine if he/she qualifies to be part of
      the study. The study doctor may not want the child to take part in this study if he/she is
      currently in another research study; or if the child has been in any other research study
      within the last 30 days, or if the child is extremely obese, or has reflux or another GI
      problem.

      If the child qualifies for the study, he/she will receive routine general anesthesia. For
      airway management, the child will have either a LMA or ET tube. The child has an equal chance
      of receiving either one of these airways devices, much like the coin flip.

      After surgery, the child will be transferred to the recovery room (PACU). If the child vomits
      in PACU, he/she will receive rescue medication, which can be repeated if the need arises.

      A research coordinator will call the parents the following day to find out whether the child
      vomited after leaving the hospital, in the car or at home, for any complications and
      receiving any medications.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Two hundred six children between the ages of 1 and 12 years are expected to take part in
        this study.
      
Keywords: Strabismus; LMA; ET Tube; POV
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever
Condition: Neutropenic Fever
MeSH terms: Febrile Neutropenia; Fever
Study type: Observational

Summary: 
      The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established
      biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1
      in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP)
      were also measured. We planned to investigate and explore the role of sTREM-1 in early
      diagnosis of infection in patients with neutropenic fever.
    

Detailed description: 
      Patients with hematological malignancies developed neutropenia after chemotherapy. We checked
      the serum level of sTREM-1 in patients with neutropenic fever. Those patients were classified
      to 2 groups: documented infection or low likelihood of infection. Their sTREM-1 level was
      measured and was compared with other biomarker such as CRP and procalcitonin. The value of
      sTREM-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hematological malignancy developing neutropenic fever after chemotherapy
      
Biospecimen description: 
      whole blood
Effect of Cardiac Preconditioning Upon the Inotrope Score
Condition: Open Heart Surgery; Preconditioning
Study type: Interventional

Summary: 
      preconditioning of no debate has a valuable effect upon myocardial protection .
      pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative
      inotropic support
    

Detailed description: 
      Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart
      from subsequent ischemia. PC stimulus may be ( ischemic ;pharmacologic or Physical)
      Pharmacological pc may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids
      etc ) Ischemic pc includes local ;remote and the idea is temporary interruption of blood
      supply to the organ so that liberation of protective mediators occurs The liberated mediators
      have favorable effects not only upon the myocardium But ;it extend to protect other organs
      against inflammatory activation ;ischemia reperfusion injury Inotropic score IS is already an
      evident predictor of postoperative cardiac mobidity and mortality
    

Intervention name(s): ischemic preconditioning
Intervention type(s): Procedure
Intervention description(s): ) ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease
Condition: Overactive Bladder in Parkinson's Disease
MeSH terms: Parkinson Disease; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing
      symptoms of overactive bladder in Parkinson's disease (PD) patients.
    


Intervention name(s): solifenacin succinate (VESIcare); placebo
Intervention type(s): Drug; Drug
Intervention description(s): up to 10mg every day orally; placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overactive bladder; Urinary incontinence; Urinary frequency; Parkinson's disease
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Condition: Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding
MeSH terms: Bone Diseases; Uterine Hemorrhage; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators are doing this study to look at how different doses of the Depot
      medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens.
      The investigators hope that what the investigators learn from this study will be used to
      develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
    

Detailed description: 
      Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When
      receiving the birth control shot some girls gain a lot of weight while others do not. Some
      girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and
      thickness of the bones.

      In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm.
      The 150mg dose is approved for use in this age group by the Food and Drug Administration
      (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the
      FDA only when given under the skin therefore it is considered experimental. The 75mg dose is
      also considered experimental as this dose is not FDA approved regardless of how it is given.
    

Intervention name(s): Depot medroxyprogesterone acetate (DMPA)
Intervention type(s): Drug
Intervention description(s): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other intervention name(s): Generic Depo Provera manufactured by Greenstone, LLC
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Birth Control; Contraceptive Methods; Female Contraception; Weight Gain; Bone Density