bioihbjkbjnl/mcl2 huggingface dataset:
Smart Capsule for Automatic Adherence Monitoring
Condition: Medication Adherence
Study type: Interventional

Summary: 
      In pharmacotherapy trials in drug-dependent populations, medication compliance is a
      significant issue, as rates tend to be low and adherence to medication may predict improved
      outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).
      However, methods commonly used to determine compliance may result in inaccurate measurement
      of adherence. It is therefore essential to develop measurement systems that not only
      accurately and objectively measure compliance, but can also have the potential to increase
      compliance in difficult to treat disorders such as addiction. In this study, we propose to
      assess the acceptability, tolerability, and efficacy of the ID-Cap System, a novel compliance
      measurement device, in a healthy population.
    

Detailed description: 
      The primary objective of the clinical trial is to evaluate the acceptability, tolerability,
      and efficacy of the ID-Cap System in a healthy population.

      Participation in the study takes 10 visits over a period of approximately five weeks. The
      first visit is a screening visit to determine if participants are eligible to participate.
      After inclusion into the study, participants will be randomized into one of three groups.
      Participants randomized to Group 1 will have compliance measured by patient reports, pill
      count, and riboflavin measurement. Participants randomized to Group 2 will have compliance
      measured by patient reports, pill count, riboflavin measurement, and data collected by the
      e-Tect reader. Participants randomized to Group 3 will also have compliance measured by
      patient reports, pill count, riboflavin measurement, and data collected by the ID-Cap reader.
      However, participants randomized to this group will also receive reminder calls and/or text
      messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the
      study team within one hour of the scheduled medication administration time.

      After the initial screening visit, participants will present to the clinic twice weekly to
      complete self-reports of compliance, provide urine samples for riboflavin assessment, and be
      assessed for adverse effects.

      They will also be asked to attend one follow-up visit to include abdominal x-ray in order to
      confirm passage of the capsules.
    

Intervention name(s): ID Capsule; Riboflavin; Prompts
Intervention type(s): Other; Dietary Supplement; Behavioral
Intervention description(s): Capsule containing ingestible sensor; 50mg; Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
Intervention MeSH terms: Riboflavin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Medication compliance; Technology; Drug study
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Condition: Autistic Disorder
MeSH terms: Autism Spectrum Disorder; Autistic Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to see whether or not Family Navigators, who 1 ) help families
      after their child is diagnosed with autism and help them get autism specific services for
      their child 2) help families identify barriers to obtaining these services and 3) help
      families problem solve to overcome these barrier, are helpful to parents of a child newly
      diagnosed with an Autism Spectrum Disorder.
    


Intervention name(s): Family Navigator
Intervention type(s): Other
Intervention description(s): Families in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will:
Help family identify key issues they need to address to get their child autism-specific services
Help family address barriers to obtaining these services and strategize approaches to overcome them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Family Navigator; Autistic Disorder; Early Intervention; Developmental Disabilities; Child Development Disorders
HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia
Condition: Hiv
Study type: Observational

Summary: 
      The population of inpatients is large in Zambia; however, because of poor linkages between
      hospitals and community HIV care, there are few data to analyze their engagement in HIV care
      before and after hospitalization. The goal of the study is to learn more about Zambian adults
      who are HIV-infected and get hospitalized. The purpose of this study is to gather formative,
      preliminary data, to be used in future grant applications to improve linkage and engagement
      in HIV care in Zambia.
    

Detailed description: 
      The main objective of this study is to generate preliminary data on the outcomes of Zambian
      HIV-infected individuals after discharge from University Teaching Hospital (UTH) Internal
      Medicine wards which can inform development of a linkage intervention. Our central hypothesis
      is that in Sub-Saharan African settings like Zambia hospitalizations among HIV-infected
      individuals are driven by suboptimal linkage and initiation of ART following HIV diagnosis.
      Specific Aims: (a) Characterize the distribution of hospitalized 300 HIV-infected adults
      across the HIV care continuum. (b) Identify structural, psychosocial, clinic, and medical
      factors that predict suboptimal linkage to care and ART initiation after 90 days of hospital
      discharge among HIV-infected Zambians.
    

Intervention name(s): Standard of care
Intervention type(s): Other
Intervention description(s): Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In part 1, people will be recruited in a random fashion from HIV-infected patients
        hospitalized at the University Teaching Hospital (UTH) as documented in their UTH medical
        file regardless of their HIV treatment status. The bed spaces in the wards will be
        enumerated and using a random number generator the team will select patients for screening
        for study inclusion.
      
Biospecimen description: 
      Blood will be drawn via phlebotomy for patients for whom CD4 and HIV viral load results are
      not available at baseline. For participants that have initiated ART treatment, we will
      collect a dried blood spot card using 5 drops of blood from finger prick to measure viral
      load 90 days after discharge.
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Condition: Precocious Puberty, Central
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 3

Summary: 
      This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension
      for treatment of children with Central Precocious Puberty.
    

Detailed description: 
      Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by
      binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease
      in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian
      steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the
      progression of puberty.
    

Intervention name(s): Leuprolide Acetate 45 mg
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Safety and Effectiveness of Breath-O Lenses
Condition: Myopia; Safety Issues
MeSH terms: Myopia
Study type: Interventional

Summary: 
      In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is
      intense interest currently in the potential role of peripheral defocus as a clinical
      treatment to slow myopia progression. One of the most successful treatments for myopia is
      orthokeratology. Currently, Breath-O correct lenses are new designed ready-made
      orthokeratology lenses. This study is to evaluate the safety of wearing this new
      orthokeratology lens and the effectiveness of clinical performance in young adult.
    

Detailed description: 
      Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong,
      approximately 80% of children are myopic by the end of childhood. Current treatment
      strategies to control (i.e. slow) myopia progression in children are primarily designed to
      harness the natural "emmetropization" process, in which visual feedback from retinal image
      clarity regulates the rate of eye growth. There is intense interest currently in the
      potential role of peripheral defocus as a clinical treatment to slow myopia progression, not
      least since this approach permits clear central vision. One of the most successful treatments
      for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable
      contact lens. The special design of this contact lens can reshape the corneal profile to
      minimize the central refractive error while producing beneficial peripheral defocus.
      Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which
      are made of new material with more elasticity as compared traditional lens material. This
      study is to evaluate the safety of wearing this new orthokeratology lens and the
      effectiveness of clinical performance in young adult.
    

Intervention name(s): Breath-O-Correct Lens
Intervention type(s): Other
Intervention description(s): Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia; Orthokeratology
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if Dapagliflozin in addition to insulin is effective
      and safe in treating patients with type 2 diabetes when compared to placebo (identical
      looking inactive treatment) in addition to insulin
    


Intervention name(s): Dapagliflozin; Dapagliflozin; Dapagliflozin; Placebo; Dapagliflozin; Dapagliflozin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I); Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I); Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I); Placebo; tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II); tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dapagliflozin; efficacy; safety; add on to insulin; Oral AntiDiabetic; Type 2 diabetes
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients
Condition: IBS - Irritable Bowel Syndrome; Diarrhea
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional

Summary: 
      The goal of this interventional clinical study is to study whether the consumption of
      QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 -
      175) will reduce the frequency of Diarrhea.

      140 eligible participants (70 males and 70 females) will be enrolled in two study sites and
      randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants
      will consume assigned products once a day after meals and record the critical data such as
      photo of feces. Three site visits will be arranged and all clinical data will be captured and
      recorded into CTMS (Clinical Trial Management System) for statistical analysis.

      Researchers will compare the two groups to validate if the daily consumption of QiMeiYan
      Probiotics will reduce the frequency of Diarrhea in the study population.
    


Intervention name(s): QiMeiYan Probiotics; Placebo product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume one sachet of the assigned product, once a day after meals.; consume one sachet of the assigned product, once a day after meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Probiotics; QiMeiYan
The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy
Condition: Pain and Anxiety of Children During Phlebotomy
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of diverting the children's attention to a
      different point during phlebotomy which is an invasive procedure with acute pain. This is a
      randomized controlled experimental study. The study was conducted with two groups: the
      intervention group (n=127) and the control group (n=129). The control group was applied to
      standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment
      that looks like a blood tube in front of them during the phlebotomy process to divert their
      attention from the phlebotomy process to the equipment.
    

Detailed description: 
      The equipment used for the intervention group was designed and developed by the researchers
      with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a
      blood tube with a fixed arm on the right and a moving arm on the left with a total height of
      80 cm. It has some answers to common questions of parents as well as the key concerns of the
      children " Will it hurt me?"
    

Intervention name(s): Equipment to divert the focus of children
Intervention type(s): Device
Intervention description(s): The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Glycemic Response in Persons With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized crossover design with nutrition supplement interventions.
    

Detailed description: 
      This will be a randomized crossover design with three oral nutrition supplement
      interventions. The subjects will be randomized to one of three interventions on three
      separate study days, one week apart.
    

Intervention name(s): Balanced Nutritional Drink; Diabetes Specific, Balanced Nutritional Drink (DMA); Diabetes Specific, Balanced Nutritional Drink DMB
Intervention type(s): Other; Other; Other
Intervention description(s): Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.; Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.; Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
Masking: Single (Participant)
Primary purpose: Supportive Care
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Condition: Pneumonia, Pneumocystis Carinii; HIV Infections
MeSH terms: Infections; Communicable Diseases; Pneumonia; HIV Infections; Acquired Immunodeficiency Syndrome; Pneumonia, Pneumocystis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and
      children; to study the pharmacokinetics of orally administered dapsone in HIV-infected
      infants and children.

      Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP )
      breakthrough in children receiving two different dose regimens of dapsone.

      Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected
      children considered to be at high risk. Approximately 15 percent of children are intolerant
      to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many
      children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second
      choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been
      established.
    

Detailed description: 
      Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected
      children considered to be at high risk. Approximately 15 percent of children are intolerant
      to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many
      children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second
      choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been
      established.

      Ninety-six HIV-infected infants and children who are intolerant to trimethoprim /
      sulfamethoxazole ( TMP / SMX ) are randomized to receive oral dapsone in a lower dose once
      daily or at a higher dose once weekly. Treatment continues until the last patient enrolled
      has received at least 3 months of therapy. Blood samples are drawn between weeks 4 and 8, at
      weeks 12 and 24, and every 3 months thereafter during dapsone administration.
    

Intervention name(s): Dapsone
Intervention type(s): Drug
Intervention MeSH terms: Dapsone
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Pneumonia, Pneumocystis carinii; Dapsone; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Drug Administration Schedule
Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C
Condition: Hepatitis C, Chronic; Hepatitis C Virus Infection, Response to Therapy of
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional

Summary: 
      This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an
      investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin
      for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most
      prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred
      and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with
      sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The
      treatment course lasted 12 successive weeks and thereafter all the study participants entered
      into a 12-week treatment-free follow-up period.
    

Detailed description: 
      It is estimated that China has a population of over 10 million infected with HCV and also a
      highly variable HCV genotype geographic distribution. Genotype 2 HCV is reported to be the
      second most common type (~25%) in Chinese population and associated with a high risk of acute
      liver disease exacerbation and other extrahepatic diseases. Sofosbuvir is a pan-genotypic HCV
      ribonucleic acid (RNA) polymerase inhibitor directing at HCV RNA replication. Genotype 2
      chronic hepatitis C has a high treatment response to the combined regimen of peginterferon
      and weight-adjusted ribavirin. The all-oral combination regimen of sofosbuvir and ribavirin
      is expected to completely suppress genotype 2 HCV replication in subjects chronically
      infected with HCV and achieve a sustained virologic response, namely, HCV not detected or
      below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment.
    

Intervention name(s): Sofosbuvir; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Generic sofosbuvir tablet 400 mg; Ribavirin was provided in 100-mg tablets.
Other intervention name(s): SOF; RBV
Intervention MeSH terms: Ribavirin; Sofosbuvir
Intervention model: Single Group Assignment
Intervention model description: Open label, single arm, historical control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus; Sofosbuvir; RNA polymerase inhibitor; Ribavirin; Genotype 2; Sustained virologic response; Confirmatory study
Effect of Fiber Supplementation in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition
      Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay
      glucose absorption and reduce postprandial glycemic excursion. They also appear to have a
      beneficial effect on cholesterol levels. It has been shown, in few short term adult studies,
      that high fiber foods reduce postprandial blood glucose levels. The American Diabetes
      Association feels that there is little evidence confirming the positive effect of high fiber
      foods on blood glucose control. It is not clear whether a high fiber diet can improve
      glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that
      children with type 1 diabetes will benefit from having added fibers in their diet. The
      investigators plan to study blood glucose values using a continuous blood glucose monitor
      before and after dietary fibers are introduced. This will help us determine whether a diet
      rich in fiber should be recommended in all children with type 1 diabetes mellitus
    


Intervention name(s): soluble fiber in the form of benefiber
Intervention type(s): Dietary Supplement
Intervention description(s): Benefiber, sugar free in an amount to total 20gms/1000kcal/day of fiber
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment