bioihbjkbjnl/mcl2 huggingface dataset:
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Condition: HIV; Pre-exposure Prophylaxis
Study type: Interventional

Summary: 
      This study aims to use a mini-application on the popular Chinese social media mobile
      platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who
      have sex with men (MSM). UNC investigators will work in close partnership with a
      well-established HIV special hospital and the local MSM community to understand key barriers
      to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM
      in Guangzhou, China.
    

Detailed description: 
      This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting
      HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM
      community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention
      strategy against HIV infection, which has been proved save and effective.

      Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a
      brief survey to collect demographic data. The interview topics include PrEP-related
      perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will
      inform refining the mini-app before the start of Part 2.

      In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be
      conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related
      perceptions and actual PrEP uptake, compared to a control group of standard of care.

      Participants in Part 2 will be followed up for 12 weeks (8 week intervention and
      after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the
      intervention arm and the control arm will receive two rounds of in-depth interviews,
      separately at the 4th and 8th week, to share their experience of using the app and changed
      perceptions and/or behaviors related to PrEP.
    

Intervention name(s): Phone application
Intervention type(s): Behavioral
Intervention description(s): The mini-app (used in Part 2) has four main functions:
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
an asynchronous message function that allows users to chat with a study staff (C.Li); and
a user profile page where users can manage all HIV test orders.
Other intervention name(s): mini-app
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Mixed methods study, including a 2-arm randomized controlled trial.
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV; PrEP
Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, single-dose, period-balanced, three-period crossover study
      conducted in healthy subjects designed to evaluate whether the absorption of the FDC
      formulation is affected by the ingestion of a high fat meal or is altered when taken in a
      fasted state.
    


Intervention name(s): COREG CR and lisinopril (FDC)
Intervention type(s): Drug
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COREG CR,; lisinopril,; hypertension,; dose proportionality,; fixed dose combination (FDC)
The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Approximately 5-10% of people with asthma do not respond to to standard therapy and are
      referred to as having difficult asthma. Evidence shows that this poor response is not always
      related to asthma severity and non-adherence to treatment is recognized as a common
      underlying problem, in 35% of these patients. Recognising non-adherence in the clinic is
      problematic as there is no straightforward objective test to identify it.

      Previous studies have demonstrated up-regulation of FKBP51 gene expression following
      treatment with steroids, making it a potential biomarker of steroid exposure. It is therefore
      also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The
      investigators plan to assess the feasibility of distinguishing non-adherent subjects who are
      by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene
      expression in sputum and throat swabs.

      To do this the investigators will obtain throat swab and sputum samples from healthy
      volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if
      FKBP51 gene expression is comparable in each group.

      The investigators will then compare the FKBP51 gene expression response to directly observed
      inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will
      identify if the response in gene expression distinguishes steroid exposed (adherent) from
      steroid naïve (non-adherent) patients.

      Identifying non-adherence will benefit patients by enabling appropriate tailored management
      for non-adherence to enhance treatment effectiveness. It will also identify patients with
      therapy resistant asthma who have an unmet need and may benefit from expensive novel
      therapies such as Omalizumab.
    


Intervention name(s): inhaled steroid
Intervention type(s): Drug
Intervention description(s): inhaled budesonide for 7 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: To identify changes in FKBP51 expression with inhaled steroid treatment in asthma
Single Low-dose Primaquine Efficacy and Safety.
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The World Health Organization has recommended addition of a 0.25 mg/kg
      single-dose primaquine (PQ) to standard artemisinin-based combination therapy (ACT) for
      elimination of malaria in low transmission-settings and for containment in areas threatened
      by artemisinin resistance. However, PQ metabolism is dependent on a highly polymorphic
      cytochrome P450 (CYP) 2D6 isoenzyme which probably compromises the drugs' safety and
      efficacy, particularly in individuals with reduced isoenzyme activity. This trial therefore,
      aims to assess the safety and efficacy of 0.25 mg/kg single-dose PQ when added to standard
      artemether-lumefantrine regimen for clearance and sterilization of Plasmodium falciparum
      gametocytes in patients with CYP450 2D6 reduced/null activity as compared to those with
      normal/increased enzyme activity.

      Methods: On hundred and fifty-five children aged between 1 and 10 years and with
      uncomplicated P. falciparum malaria will be enrolled, treated with standard
      artemether-lumefantrine regimen plus a 0.25 mg/kg single-dose of PQ and then followed up on
      days 0, 1, 2, 3, 7, 14, 21 and 28 for clinical and laboratory assessment. Primaquine will be
      administered together with the first dose of artemether-lumefantrine. Safety assessment will
      be performed using the Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT).
      Gametocytes will be detected and quantified by microscopy and Pfs25 mRNA quantitative nucleic
      acid sequence based amplification (QT-NASBA) on days 0 and 7. For a subset of 100
      participants, post-treatment infectiousness will be assessed by mosquito feeding assays on
      day 7. The CYP2D6 status will be determined using a polymerase chain reaction (PCR) followed
      by a restriction fragment length polymorphism (RFLP). The primary outcome will be the safety
      of single low-dose primaquine in patients with CYP2D6 reduced/null compared to those with
      normal/increased activity.

      Expected outcomes: The findings will provide the much-needed information on the safety and
      efficacy of single low-dose primaquine for clearance and sterilization of P. falciparum
      gametocytes in individuals with reduced/null compared to those with normal/increased CYP450
      2D6 isoenzyme activity prior to the implementation of the treatment policy particularly in
      Africa.
    


Intervention name(s): Primaquine
Intervention type(s): Drug
Intervention description(s): All patients will be administered with a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen, and then followed-up for 28 days for clinical and laboratory assessment to assess safety and efficacy.
Intervention MeSH terms: Primaquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Conventional Collagen Crosslinking in Young Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive
      steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual
      acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young
      patients.

      The investigators intend to evaluate the effectiveness of conventional collagen cross linking
      in young patients diagnosed with keratoconus.
    

Detailed description: 
      Keratoconus is progressive ectatic corneal disorder characterised by progressive corneal
      thinning, steep corneal curvatures and usually associated with high irregular myopic
      astigmatism.

      The major problems concerning keratoconus in young patients are;

        1. Rapid rates of progression in young keratoconic corneas as compared to adults.

        2. Poor biomechanical properties of young corneas.

        3. Poor quality of vision, which predisposes to a very poor quality of life.

        4. High rates of complications and failure post keratoplasty in young patients.

      The investigators intend to evaluate the effectiveness of conventional collagen crosslinking
      in young patients with keratoconus with regards to keratometric indices and visual acuity.
    

Intervention name(s): Conventional CXL
Intervention type(s): Radiation
Intervention description(s): Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin (<0.1%) to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/cm2 with riboflavin and distilled water alternated every 2 minutes was used for the procedure..
Other intervention name(s): Conventional collagen cross linking, C3R, Dresden protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: paediatric, keratoconus, collagen cross linking
Examining Two Print-based Exercise Interventions for Women
Condition: Physical Activity Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      Print-based interventions, specifically interventions that are theoretically-based have been
      shown to be effective for individuals. These types of interventions are of particular
      importance for those individuals who, due to transportation, work, family, social, or
      financial demands have difficulty participating in face-to-face programs. Therefore, we
      decided to test 2 such print based programs for women.
    

Detailed description: 
      We conducted a randomized controlled trial in which participants were randomly assigned to
      one of three groups: (1) Choose to Move (CTM), a gender-targeted intervention (2) Jumpstart,
      a motivationally-tailored print-based intervention, or (3) Wellness contact control group.
      Objective and self-report measures of physical activity and psychosocial mediators of change
      were assessed at 3 months to evaluate the efficacy of the programs and maintenance of these
      programs will be conducted by examining a 9 month follow-up phase. This design allows a
      direct comparison between two print-based physical activity self-help programs. The use of
      non face-to-face interventions is critical to reach the large numbers of women in United
      States who are not physically active. Tailored print materials (i.e., Jumpstart) will enable
      participants to have information that is matched to their level of motivation, and thus might
      be expected to be more efficacious than a standard self-help intervention.
    

Intervention name(s): 2 print based physical activity interventions
Intervention type(s): Behavioral
Intervention description(s): physical activity promotion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; physical activity; women; community
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Condition: Hypercholesterolemia; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C
      levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
    


Intervention name(s): Atorvastatin injection
Intervention type(s): Drug
Intervention description(s): statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand
Condition: Adhesion of Flexor Tendon of Hand
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to dissolve flexor tendon adhesions associated with failed
      tendon repair surgery.
    

Detailed description: 
      In an open label study, collagenase injection therapy was investigated in 3 subjects for it's
      ability to lyse flexor tendon adhesions in zone II of the hand.

      Results indicate that two of three subjects had improved range of finger motion at the PIP
      and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to
      correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies
      remain to be done.
    

Intervention name(s): Collagenase; Collagenase injection
Intervention type(s): Drug; Drug
Intervention description(s): Collagenase injection into adhesion restricting tendon gliding; injection of collagenase into adhesion restricting tendon gliding
Other intervention name(s): Collagenase Clostridium Histolyticum; Collagenase Clostridium Histolyticum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Flexor Tendon Adhesions; Zone II of the Hand
Chinese Version of Fibromyalgia Criteria and Severity Scales Study
Condition: Chinese Version; Fibromyalgia; Diagnosis; Fibromyalgia Impact Questionnaire
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational [Patient Registry]

Summary: 
      Up to now, there is no Chinese version of fibromyalgia diagnosis criteria and severity
      assessment scales. The aim of this study is to translate, adapt, and validate the Chinese
      version of the 2011 modification of the 2010 ACR preliminary criteria for the diagnosis of
      fibromyalgia (2011ModCr) and 2016 ACR revisions to the 2010/2011 fibromyalgia diagnostic
      criteria, as well as the Fibromyalgia Impact Questionnaire (FIQ-C).
    

Detailed description: 
      Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome that causes substantial
      physical and psychological impairments. The provisional criteria of the ACR 2010 and the 2011
      self-report modification for survey and clinical research are widely used for fibromyalgia
      diagnosis. However, there is no Chinese version of fibromyalgia diagnosis criteria and
      severity assessment scales until now. The aim of this study is to investigate the reliability
      and the validity of the Chinese version of the 2011ModCr and 2016 ACR revisions to the
      2011ModCr, as well as its quantification scale, the Chinese version of Fibromyalgia Impact
      Questionnaire (FIQ-C) and Revised FIQ (FIQR-C). In this study, we'll divide patients with
      chronic pain without psychiatric disorders other than depression into two groups according to
      the 1990 ACR diagnostic criteria for fibromyalgia, a fibromyalgia group and a
      non-fibromyalgia group. Patients in both groups will be assessed using the 2011ModCr and 2016
      ACR revisions to the 2011ModCr. Furthermore, those in the fibromyalgia group will also
      complete FIQ-C, FIQR-C and several other validated questionnaires including the Medical
      Outcome Survey Short Form-36 (SF-36), the Beck Depression Inventory (BDI), ect.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The fibromyalgia patients who meet the ACR 1990 criteria for diagnosis without psychiatric
        disorders other than depression will be recruited. During the study period, other patients
        with diseases associated with chronic pain, such as rheumatoid arthritis (RA),
        osteoarthritis (OA), and gout, who have not been diagnosed previously with fibromyalgia
        will be recruited as control patients. An experienced rheumatologist familiar with
        fibromyalgia assessed these patients.
Oral Progesterone for Prevention of Preterm Birth
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate whether daily oral micronized progesterone is effective in preventing recurrent
      spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal
      serum progesterone levels.
    

Detailed description: 
      To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is
      effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized
      progesterone use increases maternal serum progesterone levels.
    

Intervention name(s): oral micronized progesterone; Identical Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks; Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
Other intervention name(s): Prometrium(TM); Placebo
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preterm birth, prevention, progesterone, oral
Lypo-hypertrofia Characterization in Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly
      influence blood sugar control in patients with diabetes mellitus on insulin therapy. In
      response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on
      injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no
      imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue.
      Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy is
      characterized and defined by clinical tapping or by ultrasound with multi frequency linear
      probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those areas
      so defined. Patients are reevaluated 3 and 12 months later
    

Detailed description: 
      An observational study has been carried out, checked with parallel arms in which type 1
      diabetes patients are recruited with clinical evidence of lypo-hypertrophy in insulin
      injected areas. Patients attend to the Diabetes Unit of Niguarda Ca' Granda Hospital. Obese
      patients with a thickening fat subcutaneous tissue that could have interfered with the
      interpreting and analyzing of the data are left out of this first study. In the control group
      the investigators manage to define the lypo-hypertrophic area by tapping and body inspection.
      In the study group the investigators can define and mark out the area/areas with
      lipo-hypertrophy by ultrasound scan test. All the tested patients both the control group and
      the study group, are discouraged from use insulin in areas where lypo-hypertrophy is present.
      Patients are reassessed after 3 months with a clinical assessment of glucose control by
      HbA1c. After 12 months subcutaneous tissue scan is repeated in 10 patients within the
      experimental group and a new assessment of HbA1c is performed. Ultrasound assessment. The
      scan used is Esaote My Lab70 linear probe multi-frequency [6-18 Mhz)
    

Intervention name(s): Ultrasound; Tapping and body inspection to define the area of insulin injection
Intervention type(s): Other; Other
Intervention description(s): Ultrasound measurements; Obese patients with a thickening fat subcutaneous tissue that could have interfered with the interpreting and analyzing of the data are left out of this first study. In the control group we manage to define the lypo-hypertrophic area by tapping and body inspection
Intervention MeSH terms: Insulin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetes patients with visible lypo-hypertrphy that attend consecutively in our
        outpatient clinic
      
Keywords: Ultrasound; Lypo-hypertrophy