bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Pyridostigmine in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Heart failure, a common heart disease affecting nearly 6 million Americans, is associated
      with high rates of hospitalization and death. Abnormalities in the autonomic nervous system
      are thought to play an important role in the progression of heart failure. This proposal aims
      to determine whether novel application of pyridostigmine, a drug currently approved by the
      FDA only for the treatment of neuromuscular disease, can improve autonomic nervous system
      function in heart failure patients.
    

Detailed description: 
      Autonomic dysregulation of the cardiovascular system, characterized by heightened sympathetic
      activity and withdrawal of parasympathetic activity promotes progression of heart failure.
      Pharmacological blockade of sympathetic overactivity is associated with reduced mortality
      risk, but there are few data on pharmacologic augmentation of parasympathetic withdrawal.
      Acetylcholinesterase inhibitors augment parasympathetic neurotransmission by blocking the
      enzymatic breakdown of acetylcholine at cholinergic receptor sites. Pyridostigmine is a
      short-acting, reversible acetylcholinesterase inhibitor approved by the FDA for the treatment
      of myasthenia gravis. Investigators propose a Phase II prospective randomized, double-blind
      trial to compare 12 weeks of treatment with ascending doses of pyridostigmine (15, 30, and 60
      mg every 8 hours) vs. matching placebo in 60 patients with symptomatic chronic heart failure
      associated with left ventricular systolic dysfunction.
    

Intervention name(s): Pyridostigmine Bromide
Intervention type(s): Drug
Intervention description(s): 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue.
Other intervention name(s): Mestinon
Intervention MeSH terms: Bromides; Pyridostigmine Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; autonomic function; sympathovagal balance; cholinesterase inhibitors; pharmacology
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
Condition: Restless Legs Syndrome; Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with
      extended release ropinirole over 12 weeks
    


Intervention name(s): ropinirole Extended Release (XR)
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Restless Legs Syndrome
An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives: The objective of this study will be to determine the safety, tolerability, drug
      blood levels, and efficacy of each of three doses of NS 2330 (Tesofensine) given once daily
      compared with placebo in patients with mild to moderate Dementia of the Alzheimer's Type.
    


Intervention name(s): NS 2330 (Tesofensine)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to compare the skin irritation potential of two marketed gels for acne treatment,
      each applied to half of the face of healthy volunteers.
    

Detailed description: 
      At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all
      subjects will be applying two products on their faces, each on half face. The side of face
      receiving each product is randomly assigned. One group will use tretinoin facial gel on the
      left side and adapalene facial gel on the right side of the face daily for two consecutive
      weeks after washing with study-supplied facial wash. The other group will use the same
      products, but on opposite sides of the face for two consecutive weeks after washing with the
      same study-supplied facial wash.

      Subjects will return to the study center every weekday morning for evaluation and for the
      morning application of both study products. Study personnel will monitor application on the
      weekdays. There will be a daily clinical evaluation of skin irritation by a blinded
      dermatologist and by subjects. At baseline and at the end of each week subjects will be
      photographed and have chromometer readings.
    

Intervention name(s): Adapalene Gel; Tretinoin Gel
Intervention type(s): Drug; Drug
Intervention description(s): adapalene gel 0.3% topically applied daily in a split-face model for two weeks; Tretinoin 0.1% topically applied daily in a split face model for two weeks
Other intervention name(s): Differin Gel .3%; Retin-A MICRO Gel
Intervention MeSH terms: Adapalene; Tretinoin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: acne; irritation; objective sensory methods
Cyanotic Heart Disease and Thrombosis
Condition: Thrombosis
MeSH terms: Heart Diseases; Thrombosis
Study type: Interventional

Summary: 
      The purpose of the study is to examine previously examined patients with cyanotic congenital
      heart disease to assess how many of the patients have obtained additional blood clots since
      they were examined 8 years ago.
    

Detailed description: 
      Patients with cyanotic congenital heart disease have reduced oxygen content in their blood
      due to abnormal connection between the heart's right and left sides. The reduced oxygenation
      of the blood affects several organs of the body and a common complications to the disease is
      blood clots. Despite the patients are young and do not have typical risk factors, previous
      studies have shown, that they have a very high prevalence of thrombosis in the lungs and
      brain.

      The reason for the increased prevalence of blood clots is not known. A previous study
      investigated the prevalence of blood clots systematically in patients with cyanotic
      congenital heart disease and found that approximately 30-40% of the patients had had a clot
      in the lung or brain. Thus, the study could not predict, when the patient had had a
      thrombotic event, and most of the patients did not previously had imaging performed.
      Therefore the aim of this study is to re-examine previously examined cyanotic patients
      regardless of previous medical history, to assess how many of the patients have obtained
      additional blood clots since they were examined 8 years ago.
    

Intervention name(s): Cerebral MRI and V/Q SPECT/CT
Intervention type(s): Radiation
Intervention description(s): Cerebral MRI and V/Q SPECT/CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cyanotic congenital heart disease; pulmonary thrombosis; cerebral thrombosis
Pharmacologic Treatment of PTSD in Sexually Abused Children
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused
      Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic
      Stress Disorder (PTSD).
    

Detailed description: 
      Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors
      (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are
      the only medication class with demonstrated efficacy in treating all three PTSD symptom
      clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact
      of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in
      several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and
      adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other
      medications. This study will evaluate whether adding the SSRI sertraline provides additional
      benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If
      adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are
      included, it may also be possible to evaluate whether any benefit of adding sertraline is
      restricted to those children with comorbid disorders.
    

Intervention name(s): Trauma-Focused Cognitive Behavioral Therapy; Sertraline Pill; Placebo Oral Tablet
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent; 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT; 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Depression; Anxiety
Contraceptive Effectiveness of Sino-implant (II) in China
Condition: Contraception
Study type: Observational

Summary: 
      A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the
      3rd and 4th years of use in Chinese women
    

Detailed description: 
      A Study to Evaluate the Contraceptive Effectiveness during the Third, Fourth and Fifth Year
      of Sino-implant (II)Use and the Pharmacokinetics (PK) over Five Years of use in Chinese Women

      Population: A total of 590 Chinese Sino-Implant (II) users between 20and 44 years of age
      enrolled in one of four prospective cohorts:

      Cohort 1: n=20 women with insertion dates 3-5months prior to enrollment and followed for 2-6
      months Cohort 2:n=20 women with insertion dates 9-11 months prior to enrollment and followed
      for 2-6 months Cohort 3: n=250 women with insertion dates 21-24 months prior to enrollment
      and followed through month 36 Cohort 4:n=300 women with insertion dates 33-36 months prior to
      enrollment and followed through month 6

      Study Duration: 33 total months in the field: 3 months of participant recruitment(all
      cohorts); up to 27 months of pregnancy monitoring and PK blood sampling in Cohort 4 (up to 15
      months in Cohort 3 and 6 months in Cohort 1 and Cohort 2);and 3 months of close-out
      activities.

      For secondary PK outcomes, blood samples will be taken 2 to 6 months apart from each woman in
      Cohort 1 and Cohort 2; at enrollment, month 30 and month 36 from the first 20 consenting
      women in Cohort 3; and at enrollment and months 42, 48, 54, and 60 from the first 30
      consenting women in Cohort 4.

      Primary Objective: To evaluate the contraceptive effectiveness of Sino-implant (II) during
      the third and fourth years of use

      Secondary Objectives:

        1. To evaluate the contraceptive effectiveness of Sino-implant (II) during the fifth year
           of use.

        2. To characterize the total and free levonorgestrel (LNG) plasma concentration-time
           profiles over five years following Sino-implant (II) insertion

        3. To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile
           and its relationship to total LNG levels over five years following Sino-implant (II)
           insertion
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Population: Women who have received contraceptive implants from the Tongxiang, An
        Yang, Lingbao, and Lushi Family Planning Service Stations.
Measures of Obesity and Co-Morbid Conditions in Maori
Condition: Body Composition
Study type: Observational

Summary: 
      It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori
      to define overweight and obesity. However, no one has assessed the prevalence of co-morbid
      conditions associated with BMI. It is well known that Maori are at greater risk of diabetes
      and cardiovascular disease compared to non-Maori and a delay in the identification of those
      who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures
      of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched
      non-Maori population.
    

Detailed description: 
      This is a body composition analysis study of people self-identifying Maori and non-Maori
      participants from both Dunedin and Invercargill. The study consists of a clinical visit for
      anthropometry and oral glucose tolerance test (OGTT), followed by a single Dexa Scan visit.
      Participants meeting all the inclusion criteria were invited to participate in the study.

      Outcome will be determined by examining Dexa Scan data and surrogate clinical endpoints. The
      clinical endpoints include: anthropometric measurements, Dexa analysis, bioelectric
      impedance, and BP measurements, and the biochemical measures of: lipid profile, fasting
      insulin and glucose, liver functions and uric acid levels.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Maori; Body Composition; DEXA; Cardiovascular disease; Diabetes
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
Condition: Allergic Rhinitis; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal
      treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic
      rhinoconjunctivitis during the following birch pollen season
    


Intervention name(s): placebo; AllerT low dose; AllerT full dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SC injections of placebo on days 1, 7, 14, 28 and 56; SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56; SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
Other intervention name(s): AllerT 25-50 micrograms; AllerT 50-100 micrograms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; birch pollen; immunotherapy
Rewarding Healthy Behaviors in Pregnancy and Postpartum
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      This is a single-arm pilot clinical trial with two primary research goals:

        1. To test the efficacy of a software's ability to profile eligible individuals who decline
           participation in a clinical trial ("non-consenters") so that research staff may improve
           recruitment strategies for subsequent waves of potential participants.

        2. To test the feasibility of using the software's contingency management program in a
           population of pregnant persons in their third trimester of pregnancy.
    

Detailed description: 
      The first aim of the study is to test the feasibility of using a software program to
      incentivize pregnant patients to adhere to their prescribed prenatal appointments, postnatal
      appointment, and healthy behaviors. Participants will receive daily text messages that
      encourage engagement with health behaviors, and then participants earn points when they
      attend their scheduled appointments, bring in prescribed monitoring logs, and take their
      medications as prescribed.

      A related aim of the study is to examine the effectiveness of the software system in
      providing support to researchers in implementing targeted participant recruitment in a manner
      that is labor-efficient and sustainable. The study will determine the efficacy of the
      software for (1) using psycho-demographic data to achieve more representative enrollment
      vis-à-vis target populations and (2) iteratively tailoring outreach materials and
      communication techniques based on actionable insights about those who participate and those
      who decline to participate.
    

Intervention name(s): Aqueduct Contingency Management Platform
Intervention type(s): Behavioral
Intervention description(s): All individuals who consent to participate will engage with the Aqueduct contingency management system. Once participants are enrolled, they accumulate points in Aqueduct for each prenatal/postpartum appointment they attend. They also earn points for attending pregnancy and birth related classes, monitoring their health (e.g., blood sugar, blood pressure), and taking prescribed medications. Participants then redeem their points for money on a Visa gift card.
Enrolled participants also receive daily text messages that contain motivational and mini-educational content regarding pregnancy from trusted sources such as the American College of Obstetricians and Gynecologists, Evidence Based Birth, and Postpartum Support International. These texts serve as reminders to participants to remain engaged in their pregnancy care.
Intervention model: Single Group Assignment
Intervention model description: All participants will receive daily text messages and incentives for medical adherence. Recruitment will occur on a rolling basis, with participants completing the protocol in multiple waves.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Postpartum; Adherence; Prenatal
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 2)
Condition: SARS-CoV-2
Study type: Interventional

Summary: 
      Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody
      titer level and T cell response level (spot formation cell counting).

      Provide a reference for determining the appropriate oral regimen. Provide necessary
      parameters for estimating the sample size of confirmatory clinical trial.
    

Detailed description: 
      In selected communities or assigned clinical trial institutions, participants who intend to
      complete the third dose of SARS-CoV-2 vaccination will be invited in this study. Informed
      consent form will give to potential participants with well explained of trial contents during
      baseline. Participants who gave their signed informed consent form will be blocked randomized
      in a 1:1:1:1 ratio to intervention group A, intervention group B, intervention group C, or
      placebo group D.
    

Intervention name(s): 1 week placebo(Week 1); 1 week of probiotics(Week 1); 1 week placebo(Week 2); 1 week of probiotics(Week 2); 1 week placebo(Week 3); 1 week of probiotics(Week 3)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 week of consecutively consuming oral placebo (1 time/day); 1 week of consecutively consuming oral probiotics (1 time/day); 1 week of consecutively consuming oral placebo (1 time/day); 1 week of consecutively consuming oral probiotics (1 time/day); 1 week of consecutively consuming oral placebo (1 time/day); 1 week of consecutively consuming oral probiotics (1 time/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Probiotic; lactobacillus plantarum
AXIOS CHINA (E7148)
Condition: Pancreatic Pseudocyst and Walled-off Necrosis
MeSH terms: Pancreatic Pseudocyst; Necrosis
Study type: Interventional

Summary: 
      To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced
      Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off
      necrosis in Chinese population, to support the regulatory approval by CFDA
    


Intervention name(s): HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Intervention type(s): Device
Intervention description(s): The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment