bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Condition: Chronic Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of IONIS-AGT-LRX weekly subcutaneous (SC)
      injection on plasma angiotensinogen (AGT) concentration from Baseline to Study Day 85 (Week
      13) and to evaluate the effect of IONIS-AGT-LRx weekly SC injection on plasma AGT
      concentration and N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) levels at
      each scheduled visit in chronic heart failure participants with reduced ejection fraction
      (HFrEF).
    

Detailed description: 
      This study will be a Phase 2, double-blind, randomized, placebo-controlled study in up to 72
      participants. Participants will be randomized in a 2:1 ratio to either IONIS-AGT-LRX or
      matching placebo and receive a once-weekly SC treatment. The length of participation in the
      study will be approximately 35 weeks, which includes an up to 10-week screening period, a
      12-week treatment period, and a 13-week post-treatment period.
    

Intervention name(s): IONIS-AGT-LRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses of IONIS-AGT-LRx will be administered by SC injection.; IONIS-AGT-LRx-matching placebo will be administered by SC injection.
Other intervention name(s): ISIS 757456
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart Failure; AGT; NT-proBNP
Video-based Family Therapy for Peripartum Depression in Home Visited Mothers
Condition: Peripartum Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This pilot study will explore the feasibility and acceptability of implementing a
      family-based treatment, using HIPAA-compliant video-based communication technology, for
      adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the
      context of home visiting.
    

Detailed description: 
      The purpose of the pilot study is to partner with two Federal Maternal, Infant and Early
      Childhood Home Visiting (HV) Program sites to implement a family-based treatment for
      depression, using HIPAA-compliant video-based communication technology, in adolescent mothers
      (pregnant and post-delivery). This implementation-effectiveness hybrid trial includes
      depressed adolescent mothers and their adult family members.

      It has three aims:

        1. Explore the feasibility of integrating the treatment model into two Federal HV Program
           sites in New Hampshire.

        2. Test the acceptability of the treatment model among depressed adolescent mothers and
           their families.

        3. Explore preliminary impacts of the treatment on maternal depressive symptoms and
           parenting attitudes, family emotion regulation, and family functioning at two months
           post-intervention.
    

Intervention name(s): family therapy
Intervention type(s): Behavioral
Intervention description(s): The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Observational

Summary: 
      The purpose of this study is to identify risk factors associated with indwelling urinary
      catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The
      study will also include a very extensive literature search in an attempt to create a national
      standard or guideline.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. Patients who acquired a CA-UTI while hospitalized in the PICU between 2004-2007.

          2. Patients who had an indwelling urinary catheter while hospitalized in the PICU between
             2004-2007 but did not acquire a CA-UTI.

          3. Nurses currently employed in the PICU at Children's Mercy Hospital.

          4. All Patient's who acquired a CA-UTI during 2009
      
Keywords: indwelling urinary catheters; urinary tract infections; foley-catheter related infections; hospital acquired CA-UTI
Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga
      (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after
      ingestion of a high-carbohydrate control meal.
    

Detailed description: 
      Although we have generated a good quantity of animal and human data on the salacinol extract,
      we have not explored the effect of the salacinol extract on postprandial glycemia or
      insulinemia in patients with type 2 diabetes.

      We planned to study 66 patients with diabetes in this multicenter, randomized, double-blind,
      three-treatment, crossover study. While in a fasted state, subjects were to consume one of
      the following three meals: a standard liquid meal containing 110 g carbohydrate, 18 g
      protein, 12 g fat, and 620 kilocalories (Control); Control plus 240 mg Salacia oblonga
      extract; and Control plus 480 mg Salacia oblonga extract. Postprandial serum glucose and
      serum insulin samples were to be analyzed for 180 min.
    

Intervention name(s): nutritional herbal extract from Salacia oblonga
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in
      adult subjects who have no evidence of previous exposure to the Leishmania parasite.
    

Detailed description: 
      Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis,
      a more serious and possibly fatal form of Leishmania disease. All available medical therapies
      require weeks of treatment and cause significant toxicity.

      It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune
      responses. These findings argue that a vaccine that generates a T helper 1 response against
      the parasite will prevent the infection and disease. This is a phase 2, randomized, double
      blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in
      Montenegro skin test (MST)-negative healthy adults of an investigational vaccine being
      developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as
      Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein
      (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). In addition, the safety and
      immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg)
      given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study
      subject three times at 4 week intervals.
    

Intervention name(s): Leish-111f + MPL-SE vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Leishmaniasis; Subunit Vaccine; Prevention; T cell
A Feasibility Study of a Health Coaching Programme for Middle-aged Adults With Cardiometabolic Risk
Condition: Cardiometabolic Disease; Health Coaching; Middle-aged Adults; Primary Prevention
Study type: Interventional

Summary: 
      Cardiometabolic disease has been an increasing trend globally and remains the major cause of
      morbidity and mortality. Health coaching, a process of goal-oriented and client-centered
      partnership that is health-focus and through client enlightenment and empowerment, are
      generally effective for chronic disease management and prevention of complication. However,
      there is inconclusive result on the effects of health coaching in the primary prevention of
      cardiometabolic diseases. Therefore, this study aimed to assess the feasibility and
      acceptability of a theory-guided health coaching programme for middle-aged adults with
      cardiometabolic risk.
    

Detailed description: 
      A single group pretest-posttest feasibility study was conducted. The health coaching
      programme included four monthly health coaching sessions for three months. Feasibility of the
      study was measured by eligibility rate, enrollment rate, adherence rate, and attrition rate.
      Intervention acceptability was measured by satisfactory survey after completion of health
      coaching intervention. Feasibility of outcome measures was measured by the completion of
      outcome measures assessment at baseline and 6 months after enrollment.
    

Intervention name(s): Health coaching
Intervention type(s): Behavioral
Intervention description(s): The health coaching programme includes four monthly health coaching sessions for three months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiometabolic disease; feasibility study; health coaching; middle-aged adults; primary prevention
A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR)
Condition: Rhinitis, Allergic, Perennial and Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block
      crossover study to evaluate the effect of single and repeat doses of levocabastine, FF,
      placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study
      duration for each individual participating in the study will be a maximum of up to 20 weeks
      (including the screening and follow-up). This will be a three period study and subjects will
      be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days
      between two treatment periods. The rational for this study is to demonstrate proof of concept
      with the FDC of FF and levocabastine compared with each of the components administered alone.
    


Intervention name(s): FF/levocabastine; FF; levocabastine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): FF/levocabastine (25mcg/50 mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.; FF (25mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.; levocabastine (50mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.; Placebo will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
Intervention MeSH terms: Levocabastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: levocabastine fixed dose combination, Rhinitis, Allergic, Perennial and Seasonal, Allergic Rhinitis, fluticasone furoate
The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease
Condition: Chronic Pelvic Pain
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Pelvic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial attempts to evaluate the efficacy and safety of Jincaopian Tablets in the
      treatment of subjects with chronic pelvic pain after pelvic inflammatory disease.
    

Detailed description: 
      Chronic pelvic pain is the major sequela of pelvic inflammatory disease and it's a common,
      burdensome, and costly condition that disproportionately affects women. This multicenter,
      randomized, double-blind, dose-parallel, placebo-controlled phase II clinical trial is
      designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of
      subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 180
      subjects were enrolled and randomized to either "high-dose Jincaopian Tablets" group,
      "low-dose Jincaopian Tablets " group, or the "placebo" group in a 1:1:1 ratio. The treatment
      period is 12 weeks and the follow-up period is 4 weeks. The outcome measures of chronic
      pelvic pain relief in this trial are pain visual analog scale (VAS), modified McCormick scale
      and SF-12 Score.
    

Intervention name(s): Jincaopian Tablets high dose; Jincaopian Tablets low dose; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Jincaopian Tablets 0.2g tid p.o.; Jincaopian Tablets 0.1g tid p.o.; Placebo tid p.o.
Other intervention name(s): ZY5301; ZY5301
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to provide high quality evidence from a double-blinded, randomized controlled
      trial on the efficacy of perioperative pregabalin in reducing morphine requirements,
      improving pain scores and reducing chronic neuropathic pain when compared with placebo for
      primary total knee arthroplasty. It hence aims to improve on choice of analgesia adjuncts for
      total knee arthroplasty.
    

Detailed description: 
      Aims:

      Whether pregabalin given preoperatively and for one week postoperatively in addition to
      patient-controlled analgesia (PCA) morphine is effective in reducing morphine requirements,
      improving pain scores and reducing chronic neuropathic pain when compared with placebo for
      primary total knee arthroplasty.

      Methodology:

      A single-centre double-blind randomized controlled trial in patients undergoing primary total
      knee arthroplasty. All subjects receive PCA morphine, paracetamol 1g every six hours,
      etoricoxib 120mg once daily postoperatively. Subjects receive either pregabalin 75mg po
      preoperatively followed by 75mg OM and 25mg ON for two days postoperatively or matching
      placebo. The primary outcome is cumulative morphine consumption at 72 hr following surgery.
      Secondary outcome measures included pain scores, knee range of motion and patient
      satisfaction.
    

Intervention name(s): pregabalin; Placebo; Etoricoxib; paracetamol; Morphine; Ropivacaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.; Placebo capsule containing lactose and MCC (no active ingredients).; Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore; Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia; patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3.
Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany; Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden
Other intervention name(s): Lyrica (Pfizer Pte Ltd, Singapore); Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.; 'Arcoxia'; acetaminophen; 'Naropin'
Intervention MeSH terms: Acetaminophen; Etoricoxib; Pregabalin; Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Smart Walk 50+: Feasibility of a Smartphone-delivered Physical Activity Program for African American Women 50 Years and Older
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to establish the acceptability and feasibility of a culturally
      relevant, theory-based smartphone-delivered physical activity intervention among African
      American women aged 50-65 years.
    

Detailed description: 
      This study will establish the acceptability and feasibility of a culturally relevant,
      theory-based smartphone-delivered physical activity intervention among African American women
      aged 50-65 years. To accomplish this, we will deliver our previously developed Smart Walk
      physical activity intervention, originally developed for African American women aged 24-50
      years old, to 20 sedentary and obese African American women aged 50 to 65. We will collect
      data on the acceptability and feasibility of the intervention, as well as areas of
      intervention refinement to enhance the social, cultural, and behavioral relevance of the
      intervention for women in this age group.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Smartphone-delivered physical activity intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise; African American women; mHealth; eHealth; smartphone
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Condition: Eyelash Hypotrichosis
MeSH terms: Hypotrichosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or
      0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the
      upper eyelid margins in increasing eyelash prominence
    


Intervention name(s): bimatoprost ophthalmic solution 0.005%; bimatoprost ophthalmic solution 0.015%; bimatoprost ophthalmic solution 0.03%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin); One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin); One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Other intervention name(s): LATISSE®
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study on the Effect of a XOS95 on the Human Gut Microbiome
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to assess the efficacy of a novel prebiotic, XOS95, at
      two different dosages, in comparison to a placebo by assessing shifts in microbial
      populations after 8 weeks of supplementation, assessed as changes in abundance of microbial
      populations.
    


Intervention name(s): Xylooligosaccacharide; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): XOS95 powder; Maltodextrin powder
Other intervention name(s): XOS95
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, 3-arm, parallel, dose ranging study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Potential Effects of Intermittent Fasting to Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The survey is designed to investigate whether 8 weeks of discrete two-day intermittent
      fasting per week will impact gut microbiota and cardiovascular risks of metabolic syndrome
      subjects.
    

Detailed description: 
      Intermittent fasting was demonstrated to optimize energy metabolism and promote health.
      However, the benefits of intermittent fasting to gut microbiota are remain unclear. Further
      evidence is needed in understanding the effects of intermittent fasting to gut microbiota and
      cardiovascular risks in subjects with metabolic syndrome
    

Intervention name(s): Intermittent fasting
Intervention type(s): Behavioral
Intervention description(s): The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of AQX-1125 in IC/BPS
Condition: Interstitial Cystitis; Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of 6 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo on average daily pain in subjects
      with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using
      a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary
    


Intervention name(s): AQX-1125; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Synthetic SHIP1 activator; Double blind placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interstitial cystitis; Bladder pain syndrome; IC/BPS; AQX-1125; SHIP1