bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This was a pilot study to assess the feasibility and acceptability of training Community
      Health Agents in Motivational Interviewing in real-life primary care centers.
    

Detailed description: 
      Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and
      middle-income countries such as Brazil. Scalable primary care-based interventions are needed
      to improve self-management and clinical outcomes of adults with diabetes. This pilot study
      examines the feasibility, acceptability, and outcomes of training community health agents
      (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled
      diabetes in a primary care center in São Paulo, Brazil.

      Nineteen salaried CHAs participated in 32 hours of training in MI and behavioral action
      planning. With support from booster training sessions, they used these skills in their
      regular monthly home visits over a 6 month period with 57 diabetes patients with baseline
      HbA1cs > 7.0%. The primary outcome was patients' reports of the quality of diabetes care as
      measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC)
      scale. Secondary outcomes included changes in patients' reported diabetes self-management
      behaviors and in A1c, blood pressure, cholesterol and triglycerides. CHAs' fidelity to and
      experiences with the intervention were also assessed.
    

Intervention name(s): Pilot Study
Intervention type(s): Behavioral
Intervention description(s): Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
WREX Outcome Study
Condition: Muscular Dystrophy; Arthrogryposis; Spinal Muscular Atrophy
MeSH terms: Muscular Dystrophies; Arthrogryposis; Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Observational

Summary: 
      This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for
      children who are using the WREX, or have used it in the past. The survey consists of a set of
      questions a) performed online and b) performed over the phone.
    

Detailed description: 
      The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular
      conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for
      Children alone has provided a WREX for about 80 children in the last 3 years. This is being
      done through the orthopedic and muscle clinics in the hospital. We would like to perform a
      retrospective study to see how well the children are doing with the WREX. We propose getting
      this feedback through a survey administered to families using the WREX. The survey will be
      performed in two parts. 1) A phone survey will use the Canadian Occupational Performance
      Measure (COPM). 2) an online survey with additional questions. The parents are asked to
      submit answers on behalf of the children if they are unable to.
    

Intervention name(s): WREX orthosis
Intervention type(s): Device
Intervention description(s): Upper extremity exoskleton used to assist movement
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        People with Neuromuscular disease who use the Wilmington Robotic Exoskleton
MR Fingerprinting: A Novel Sequence Applied to Neuroimaging
Condition: Disease;Neurological
MeSH terms: Nervous System Diseases
Study type: Interventional

Summary: 
      Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over
      the past 30 years because it is non-invasive, requires no ionizing radiation, and provides
      exquisite images of soft tissues and anatomic structures with many tissue/disease specific
      contrasts. While MRI has served the community well for many years, it is increasingly clear
      that it also has significant limitations.

      One of the principle limitations is the lack of quantitative information for tissue/structure
      characterization. The current paradigm of MRI is to use a set of scanner settings to generate
      an image "weighted" by a specific MR contrast mechanism (physical parameter), where it is
      hoped that variations in the parameter will be accentuated. However, without quantitative
      knowledge of the parameters, the final image contrast may depend on many factors, which
      complicates image interpretation and diagnostic performance. Quantitative measurement can
      provide a great deal of information about tissue properties and pathological conditions,
      since these parameters ultimately determine the contrast that is observed in conventional
      images.
    

Detailed description: 
      The purpose of this study is to evaluate novel quantitative MRI techniques in clinical
      studies to determine whether they can provide better, faster and more useful information for
      clinical diagnosis. Quantitative MRI has been a continuous interest in the MRI community, but
      extremely challenging due to long acquisition times and sensitivity to motion. Recently, the
      investigators have introduced a novel MRI data acquisition approach, namely MR Fingerprinting
      (MRF), for simultaneous measurement of several important parameters in a single MRI scan.

      In this study, the investigators propose to apply MR Fingerprinting at UNC and evaluate its
      performance for different neurological diseases. The investigators hypothesize that the
      quantitative MR imaging technique will lead to improved tissue characterization and
      diagnosis.
    

Intervention name(s): MR Fingerprinting
Intervention type(s): Device
Intervention description(s): The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Condition: Acupuncture; Homelessness; Pain; Veterans
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture
      (BFA) on homeless and at risk for homelessness veterans with chronic pain for 12 weeks.
    

Detailed description: 
      Methodology: This is a mixed methods prospective design study. A total of 35 subjects will be
      recruited for this study. The primary study outcome variables are: pain level- pre and post
      treatment, stress, mood and usual activity levels, sleep patterns and behavioral factors such
      as ; anxiety, depression, suicidal ideation, substance use and housing stability.

      4. Findings: Pending

      5. Clinical Relationships: This study is conducted to demonstrate whether or not BFA
      treatment will decrease pain and improve quality of life for homeless and at risk for
      homelessness veterans.

      6. Impact/Significance: Pending
    

Intervention name(s): Battlefield Acupuncture
Intervention type(s): Other
Intervention description(s): Battlefield Acupuncture
Intervention model: Single Group Assignment
Intervention model description: Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
Masking: None (Open Label)
Primary purpose: Treatment
Bovine Milk Oligosaccharide Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to elucidate tolerability and effectiveness in consumption of
      the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO)
      to enrich intestinal microflora toward beneficial populations.
    

Detailed description: 
      This is a single-blind crossover study designed to determine if BMO at two different doses
      selectively enrich beneficial bacteria in the human gut and will be tolerated in healthy
      participants compared with a placebo control supplement. Each participant will consume two
      sachets of supplement for eleven days, separated by a two-week washout before starting the
      second and third arms. To determine the effect of dose, the placebo-control supplement will
      be administered in the first arm, followed by the low and high dose. Participants will
      collect stool and first morning urine and study personnel collected blood from each
      participant at baseline (day 0) and at the end (Day 11) of each study arm for all three arms.
    

Intervention name(s): Bovine Milk Oligosaccharide; Placebo Glucose Polymer
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The BMO powder will be isolated from whey streams by Hilmar Ingredients (Hilmar, California 95324). Hilmar Ingredients employs the same membrane filtration, and centrifugation processes used to purify whey protein in their commercial practice to extract and purify BMO from whey permeate. Furthermore, the same sterilization processes used on the equipment to purify whey products will be used to purify BMO. This method uses a novel high-throughput food-grade isolation protocol that leads to purification of specific BMOs with bifidogenic activity as prebiotic oligosaccharides that mimic the activities observed for Human Milk Oligosaccharides (HMO). This strategy of developing methods for their large scale fractionation allows us to obtain a final product that mimics the naturally beneficial oligosaccharides present in human milk.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The standard treatment for decompensated cirrhosis is liver transplantation, however, it has
      several limitations. Recent animal studies suggest that bone marrow stem cell transplantation
      can lead to regression of liver fibrosis. The investigators have already completed the phase
      1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with
      cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results
      (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find
      efficacy of this new treatment strategy in the setting of a multicenter, randomized
      placebo-controlled trial in 50 patients with decompensated cirrhosis.
    

Detailed description: 
      The standard treatment for decompensated cirrhosis is liver transplantation, however, it has
      several limitations, including small donor pool, long waiting list, and several
      complications. Recent animal studies suggest that bone marrow stem cell transplantation can
      lead to regression of liver fibrosis. The investigators have already completed the phase 1
      study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with
      cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results
      (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find
      efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo
      controlled trial. After assignment of the written informed consent, thirty six patients with
      decompensated cirrhosis will be enrolled, and will be randomized by block randomization into
      treatment or placebo arm. All the enrolled patients will be in the waiting list of liver
      transplantation. In the treatment arm bone marrow of the patients will be aspirated, and
      autologous bone marrow mesenchymal stem cells will be cultured, and then will be infused
      through a peripheral vein. Also, the corresponding placebo will be infused for the placebo
      group. The patients will be followed up for 1 year after performing the procedure.
    

Intervention name(s): Autologous mesenchymal stem cell transplantation
Intervention type(s): Procedure
Intervention description(s): Arm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cirrhosis; Bone marrow; Mesenchymal stem cell; MELD score; Quality of life
Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors
Condition: Brain and Central Nervous System Tumors; Chemotherapeutic Agent Toxicity; Infertility
MeSH terms: Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Infertility
Study type: Observational

Summary: 
      RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors
      may help doctors learn about the long-term effects of treatment and plan the best treatment.

      PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in
      patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess if temozolomide induces any changes in standard semen or sperm analysis
           parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile
           count, motility, presence of round cells, agglutination, and morphology) in patients
           with newly diagnosed, recurrent, or progressive primary malignant brain tumors.

      OUTLINE: This is a pilot study.

      During treatment with temozolomide, patients undergo semen or sperm sample collection at
      baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume,
      viscosity, pH, forward progression, total count, total motile count, motility, presence of
      round cells, agglutination, and morphology.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients recieving temozolimide for malignant brain tumor
      
Keywords: infertility; chemotherapeutic agent toxicity; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult giant cell glioblastoma; adult gliosarcoma; adult pilocytic astrocytoma; adult brain stem glioma; adult central nervous system germ cell tumor; adult choroid plexus tumor; adult craniopharyngioma; adult ependymoblastoma; adult medulloblastoma; adult supratentorial primitive neuroectodermal tumor (PNET); adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic meningioma; meningeal melanocytoma; adult meningeal hemangiopericytoma; adult papillary meningioma; adult grade I meningioma; adult grade II meningioma; adult grade III meningioma; adult anaplastic oligodendroglioma; adult oligodendroglioma; adult pineoblastoma; adult pineocytoma; adult mixed glioma; recurrent adult brain tumor; adult subependymal giant cell astrocytoma
Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      This project aims to investigate how dysfunctional learning and habitization are affected by
      acute alcohol exposure, and whether individual differences in such alcohol effects can
      predict later development of Alcohol Use Disorders (AUDs). Eighty 18-year-old healthy male
      subjects are tested on two days in a within-subjects design with blinded administration of
      alcohol vs. placebo and different behavioral and learning tasks. The investigators
      investigate how alcohol influences the performance during these tasks, whether alcohol
      effects differ between high- and low-risk subjects, and whether task performance under
      alcohol predicts future AUDs.
    

Detailed description: 
      This project is part of a large multi-center study in Dresden and Berlin on Learning and
      Alcohol Dependence (LeAD). Project 4 aims to investigate how dysfunctional learning and
      habitization are affected by acute alcohol exposure, and whether individual differences in
      such alcohol effects can predict later development of AUDs. The project investigates eighty
      18-year-old healthy male subjects, a subsample of LeAD project 1 that were already tested in
      Dresden using fMRI(Clinical Trials.govID: NCT01744834). Participants are tested on two days
      in a within-subjects design with blinded administration of alcohol or placebo. On 2 days
      participants are performing three behavioral and learning tasks measuring: 1. conditioning of
      money vs. drink stimuli 2. habitization vs. instrumental learning and 3. approach and
      avoidance behavior towards money and drink stimuli. The investigators investigate how alcohol
      influences the performance during these tasks, whether alcohol effects differ between high-
      and low-risk subjects, and whether task performance under alcohol predicts future AUDs.
      Participants will be followed up after three years. The project investigates whether single
      doses of alcohol affect the conditioning of monetary reward or alcoholic stimuli, impair
      instrumental learning, and enhance stimulus-response associations. The investigators want to
      test whether individual performance parameters are related to other risk factors for AUDs,
      e.g. family history of alcoholism or impulsivity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        random sampling of representative sample of 18 year old men in the area of Dresden
      
Keywords: CAIS Computer Assisted Infusion System; real life drinking behavior; family history of alcoholism; conditioning; instrumental learning; habitization
Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic
      options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as
      compared with 50 mg/day topiramate.
    

Detailed description: 
      Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic
      options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as
      compared with 50 mg/day topiramate.

      We conducted a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Patients
      with CM were randomized (1:1) to flunarizine and topiramate treatment groups.

      This study consisted of two periods: a prospective baseline screening period lasting up to 2
      weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks
      0-8, T1-T4).

      The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance
      period (T2-T4). During the titration period, subjects were given 25 mg/day topiramate or 5
      mg/day flunarizine once daily in the first week, followed by 50 mg/day topiramate or 10
      mg/day flunarizine in divided doses (twice daily) in the second week. When subjects could not
      tolerate this target dose, the initial dose was continued through T4.

      Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were
      collected and directed to the outcome evaluators, who were blinded to the patients'
      treatment.

      The primary outcomes assessed were the reductions in the total numbers of headache days and
      migraine days after 8 weeks of treatment (weeks 7 to 8 vs. weeks -2 to 0). Secondary outcomes
      were reductions in the numbers of days of acute abortive medication intake and acute abortive
      medication tablets taken, and the 50% responder rate.
    

Intervention name(s): Flunarizine; Topiramate
Intervention type(s): Drug; Drug
Intervention description(s): as in "arm descriptions"; as in "arm descriptions"
Other intervention name(s): sibelium; topamax
Intervention MeSH terms: Topiramate; Flunarizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic migraine; prophylaxis; flunarizine; topiramate
A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of
      2 different dupilumab drug product in healthy volunteers. The duration per participant is up
      to 11 weeks.
    

Detailed description: 
      Duration per participant is up to 11 weeks.
    

Intervention name(s): Dupilumab (SAR231893); Dupilumab (SAR231893)
Intervention type(s): Drug; Drug
Intervention description(s): Injection solution, subcutaneous; Injection solution, subcutaneous.
Other intervention name(s): REGN668; REGN668
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Benefits of R Anastomotic Technique for Billroth-Ⅱ Reconstruction With Braun Anastomosis After Totally Laparoscopic Distal Gastrectomy
Condition: Time for R Anastomosis; Complication Related to Anastomosis
Study type: Observational [Patient Registry]

Summary: 
      This study proposes a novel, straightforward, and viable technique for performing posterior
      gastrojejunostomy anastomosis during totally laparoscopic Billroth-II reconstruction with
      Braun anastomosis (named R anastomosis). This study prospectively evaluated clinical and
      pathological data from patients who underwent totally laparoscopic distal gastrectomy with R
      anastomosis at Northern Jiangsu People's Hospital, China, in order to investigate the
      feasibility and functional outcomes of R anastomosis for B-II-B anastomosis.
    

Detailed description: 
      Paients were recruited who were confirmed to have malignant tumors in the gastric antrum or
      body through endoscopic and pathological examinations, and multi-slice spiral CT scans
      revealed no distant metastasis. All case underwent totally laparoscopic distal gastrectomy
      with R anastomosis. Prospectively examined the intraoperative data, including operation time,
      time for R anastomosis, blood loss; Postoperative data including pathological data, duration
      of gastric tube placement, time to initiate liquid diet, the length of hospital stay; other
      functional outcomes and short-term postoperative complication data, graded according to the
      Clavien-Dindo complication classification system
    

Intervention name(s): R anastomosis
Intervention type(s): Procedure
Intervention description(s): Modifying the surgical technique of totally laparoscopic Billroth-II reconstruction with Braun anastomosis and to name it as the R anastomosis.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All cases were confirmed to have malignant tumors in the gastric antrum or body through
        endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no
        distant metastasis.