bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Deficiency and Asthma Exacerbation
Condition: Asthma; Vitamin D Deficiency; Disease Exacerbation
MeSH terms: Asthma; Vitamin D Deficiency; Disease Progression
Study type: Interventional

Summary: 
      The study aim is in two phases. First phase: to evaluate the influence of vitamin D
      deficiency on asthma severity, degree of airway obstruction and frequency of asthma
      exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH
      vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease
      exacerbations.
    

Detailed description: 
      The first phase of the study consisted of a cross-sectional examination of a cohort of 119
      asthmatic patients, who had at least one year regular follow-up in our respiratory clinic,
      and were not receiving any vitamin D supplementation.

      In the second phase patients with vitamin D deficiency (25-OH D values below 20 ng/ml), were
      recruited in a one year longitudinal study, during which they received vitamin D
      supplementation. The study started and ended in late autumn-winter season when, at our
      latitude, sun exposure is lowest. Symptoms, spirometry and number of exacerbations were
      recorded during both study phases.
    

Intervention name(s): oral cholecalciferol
Intervention type(s): Drug
Intervention description(s): Inhaled corticosteroids and long-acting beta-agonists, salbutamol
Other intervention name(s): intramuscular cholecalciferol
Intervention MeSH terms: Cholecalciferol; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; vitamin D; exacerbations; airway obstruction
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Condition: Schizophrenia; Schizo-affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be a 6-month, open-label, multiple center study in approximately 50 stable
      subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety,
      tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation
      of two or three, 300 mg Risperidone Implants.
    

Detailed description: 
      The study will be a 6-month, open-label, study in approximately 50 stable subjects diagnosed
      with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and
      pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three,
      300 mg Risperidone Implants.

      Subjects who are diagnosed with schizophrenia or schizoaffective disorder according to DSM-V
      and are stable on a daily 4 mg oral dose of Risperidone for at least 8 weeks will be
      recruited into the study.

      Subjects stable on a 4 mg oral dose of Risperidone will be implanted with two or three, 300
      mg, Risperidone Implants. All implants will be placed in the inner aspect of the upper arm.
      Plasma concentrations of Risperidone and the active moiety will be measured prior to
      placement of the Risperidone Implants, throughout the implantation period, and after
      re-converting to oral Risperidone following the removal of the Risperidone Implants.
    

Intervention name(s): Risperidone Implant
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion
Condition: Intrauterine Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of
      myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as
      symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual
      abortion, which seriously affect the patients quality of life.

      Preventing IUA has been tried using different methods such as barrier or stent in order to
      separate the opposing endometrium during the tissue healing processes. Although some
      successes have been reported there are still some challenges need to be dealt with.

      One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a
      natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound
      repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA
      in clinical studies.

      A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with
      proprietary technologies. This product is a highly viscoelastic crosslinked gel that
      overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation
      in vivo. For this product, the results of animal experiments and various safety features have
      been designed and tested conforming to the national regulations and standards. In order to
      launch this product to the market, this prospective, randomized and controlled clinical trial
      is designed and will be performed to verify its safety/efficacy.
    


Intervention name(s): Crosslinked hyaluronic acid gel; Foleys balloon catheter
Intervention type(s): Device; Device
Intervention description(s): After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.; After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.
Other intervention name(s): MateRegen Gel IU.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intrauterine adhesion; crosslinked hyaluronan gel; hysteroscopy; clinical trial
Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to demonstrate that the combination therapy of aspirin and
      clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with
      respect to its effectiveness in inhibiting platelet aggregation, if it is given for four
      weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting
      stent before > 12 months and had remained in a stable condition with a single antiplatelet
      agent, aspirin.
    


Intervention name(s): Clopidogrel; aspirin 100mg
Intervention type(s): Drug; Drug
Other intervention name(s): Pidogul®; Plavix®
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of a LRC™ (L. Reuteri NCIMB 30242) Capsule on Managing Cholesterol in Adults
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242),
      taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on
      serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic
      adults after 9 weeks of product consumption.
    


Intervention name(s): LRC™ capsule; Placebo capsule
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Twice per day (BID), 9 weeks; Twice per day (BID), 9 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Antiretroviral Therapy on Cardiac Biomarkers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      Cardiovascular risk appears to be linked to some degree with inflammation. HIV medications
      have been linked with cardiovascular risk. In this study we will be measuring levels of
      chemicals in the body associated with inflammation before and after starting HIV medications
      in patients with HIV. We hope to understand what happens to these chemicals once a patient
      with HIV is started on these medications to understand their role in cardiovascular risk.
    

Detailed description: 
      With the advent of antiretroviral therapy, death due to opportunistic diseases have seen a
      major decline among patients with HIV. However, several antiretroviral medications, in
      particular protease inhibitors (PI), have been associated with increased cardiovascular risk
      in large cohort studies. The role of inflammation in cardiovascular risk is currently being
      elucidated. High sensitivity C-reactive protein (hsCRP) has been identified as a strong
      independent predictor of cardiovascular disease among healthy individuals in several large
      cohort studies. Other inflammatory biomarkers such as serum amyloid A (SAA) and interleukin-6
      (IL-6) have also been correlated with cardiovascular risk. Among patients with HIV, studies
      have revealed inappropriate immune activation with increased pro-inflammatory cytokines such
      as IL-6, IL-10, interferon-γ (IFN- γ), and tumor necrosis factor-α (TNF-α). The effects of
      this immune dysregulation and the impact of antiretroviral therapy on the cytokines and
      biomarkers associated with cardiovascular risk remain to be delineated.

      Objective: Our aims are to characterize the levels of inflammatory biomarkers at the time of
      antiretroviral initiation, to define the time period over which the biomarkers change and
      stabilize, and to determine if the type of antiretroviral drug class used has an impact on
      the rate of alteration of these biomarkers. Given the disparate cardiovascular risk between
      women and men of similar age groups, we will study the additional impact of gender on these
      biomarkers. We will also explore whether there is a correlation between change of CD4
      T-lymphocyte counts and the response of the biomarkers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a
        tertiary care hospital
      
Keywords: Cardiovascular risk; Inflammatory biomarkers; Human immunodeficiency virus
Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics
Condition: Type1diabetes; Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Investigators aim to further the understanding of environmental factors that underlie the
      progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal
      microbiota composition and function, has been hypothesized to increase the risk of developing
      T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits,
      such as broad consumption of the highly processed Western Diet, or by widespread use of
      antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous
      innate inflammation known to exist within families affected by T1D and if probiotic
      supplementation may beneficially modulate this inflammatory state.

      Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood
      samples will be analyzed before and after the six week course of probiotics.
    


Intervention name(s): VSL#3
Intervention type(s): Dietary Supplement
Intervention description(s): VSL#3 is a commercially available probiotic supplement manufactured and distributed by Alfasigma USA, Inc of Covington, Louisiana, USA. As with other probiotics, VSL#3 is considered a supplement and is not FDA-approved or regulated. VSL#3 contains eight probiotic strains: bifidobacteria (B. longum, B. infantis, and B. breve), lactobacilli (L. acidophilus, L. casei, L. bulgaricus, and L. plantarum) and Strepococcus thermophiles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Siblings
Home or Away From Home - Descriptive Interviews (Aim 2)
Condition: Pediatric Acute Myeloid Leukemia
Study type: Observational

Summary: 
      The primary objectives of this study are to identify what outcomes related to the management
      of neutropenia are most important to children with AML and their caregivers. Patients who
      have completed treatment for AML and their caregivers will be interviewed in order to better
      understand the impact of neutropenia management on children with AML and their families. The
      primary outcome of these interviews is to identify patient-centered outcomes related to
      neutropenia management to include in a subsequent comparative-effectiveness analysis.
      Investigators will use these data to develop a structured survey for administration to
      prospectively identified patients in subsequent studies.
    

Detailed description: 
      Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens
      that result in periods of profound neutropenia leaving patients susceptible to severe
      infectious complications. There are little clinical data to inform whether management of
      neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting.
      Further, no studies have been conducted that assess the impact of neutropenia management
      strategy on the quality of life of pediatric patients with AML. Given that infectious
      complications are the leading cause of treatment related mortality among AML patients, it is
      important to identify the neutropenia management strategy that will lead to the best
      clinician- and patient- identified outcomes in order to improve the care of these patients.

      This is a qualitative interview study where interviews of patients and/or caregivers will be
      performed. Participants will be patients less than 19 years of age at diagnosis (and their
      caregivers) receiving or having received chemotherapy for AML from eleven participating
      pediatric hospitals across the United States. Participants (children and caregivers) will be
      interviewed in an effort to develop a survey that captures patient- and caregiver- identified
      outcomes related to neutropenia management.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will consist of patients who are less than 19 years of age at the time of
        diagnosis (and their caregivers) receiving or having received chemotherapy for AML.
      
Keywords: Pediatric; Cancer; AML; Qualitative Interview
Virtual Health Focused Acceptance-Based Program for Parents and Youth
Condition: Pediatric Obesity; Executive Function
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy
      lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to
      (1) Transition a previously developed acceptance-based behavioral treatment to web-based
      platform, utilizing qualitative and quantitative program evaluation data from past
      participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the
      adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment
      (self-guided treatment + brief coaching) is similar to the traditional treatment
      (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary
      outcomes utilizing a non-randomized sequential arm design.
    

Detailed description: 
      Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle
      program including education on health and wellness topics such as food groups, physical
      activity and stress management. Special skill builders for managing the thoughts, feelings
      and emotions associated with changing health behaviors will also be included. Pairs will have
      biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and
      problem solve. Optional group sessions will be offered for peer support. In order to assess
      progress, pairs will also complete assessment visits before and after the program. These
      visits include one virtual assessment via Zoom and one in-person assessment at the University
      of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures
      such has height, weight, blood pressure and a finger prick.
    

Intervention name(s): Web Based Treatment
Intervention type(s): Behavioral
Intervention description(s): The literature regarding the efficacy of web-based platforms for behavioral weight management interventions in pediatric populations continues to grow. Considering the continued increase in technology and internet use among youth, web-based interventions have the potential to serve as a more cost-effective and personalized approach to pediatric behavioral weight management. Extant research supports this consideration. More research that compares web-based vs. traditional delivery of acceptance-based pediatric behavioral weight management interventions is necessary to understand the utility of this platform as well as which aspects are most effective.
Other intervention name(s): Acceptance-Based Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Obesity; Executive Function; Behavioral Intervention; Acceptance Based
Lifestyle Modifications and the Progression of Chronic Kidney Disease
Condition: Patients With Stage 2-4 Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Aerobic training has been shown to favorably alter several of the known risk factors for
      coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It
      seems logical that if these risk factors were aggressively controlled in patients with
      chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise
      training) to support the pharmacologic interventions that are necessary for the control of
      the disease, then the rate of progression of the disease may be altered. However, to date,
      there is no clear research evidence to support this hypothesis. Therefore the aims of the
      proposed study are:

        1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and
           regular, long-term aerobic exercise training) will favorably alter the natural
           progression of CKD in a sample of patients compared to a control group who will receive
           the current standard care.

        2. To explore possible mechanisms that could contribute to the observed changes.
    


Intervention name(s): Exercise training; Diet modification
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects exercise trained for 48 weeks with personal trainers at a college wellness center; Exercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CKD
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Condition: HIV Positive Youth That Are Newly Engaged in Care
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The proposed study is a two-group randomized repeated measures design that will examine the
      efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting
      Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU
      sites across the United States. Youth will be randomized into one of two study arms; Project
      ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison
      condition. Both arms consist of two individual sessions followed by six group sessions and a
      final individual session which is expected to take approximately nine weeks after which youth
      will have four follow-up visits at the following time points:

        -  post intervention (immediately after the last session);

        -  3 months post the last session;

        -  6 months post the last session; and

        -  12 months post the last session. The trial will be repeated in up to three waves.
    


Intervention name(s): Project ACCEPT; HEALTH
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention, Project ACCEPT, combines weekly individual and group sessions that address a range of issues that impact engagement in care for youth living with HIV, including stigma, disclosure, health relationships, substance use, and future life plans.; The comparison condition, HEALTH, matches Project ACCEPT in number of sessions and duration. The weekly sessions will cover information on alcohol, drugs, HIV and other sexually transmitted diseases (STDs) to meet the ethical responsibility to provide risk reduction information to youth assigned.
Other intervention name(s): Adolescents Coping, Connecting, Empowering and Protecting Together
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
Condition: Stroke, Acute; Infarction, Middle Cerebral Artery
MeSH terms: Stroke; Ischemic Stroke; Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to determine the safety and tolerability of an autologous CD34+
      subset bone marrow stem cell infusion into the middle cerebral artery in patients who have
      suffered acute total or partial anterior circulation syndrome (TACS/PACS).
    

Detailed description: 
      The proposed trial will involve the recruitment of a total of 10 patients.

      The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem
      cells will then be isolated and harvested during a process of immuno-selection in accordance
      with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly
      infused into the area of the stroke intra-arterially using the middle cerebral artery.

      Initially, the investigator will monitor each patient for a period of 6 months post-stem cell
      infusion. Thereafter, they will revert to their previous treatment regime in the clinic.

      Assessment of adverse events will be by physical examination and measurement of laboratory
      parameters. Assessment of efficacy will be by physical examination and the measurement of
      laboratory, CT and MRI parameters.
    

Intervention name(s): Infusion of autologous CD34+ stem cells into middle cerebral artery
Intervention type(s): Biological
Intervention description(s): intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Stroke; Middle Cerebral Artery