bioihbjkbjnl/mcl2 huggingface dataset:
Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to
      sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is
      known to reduce post-meal glucose excursions but it is unknown whether lowering the
      carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout
      the day. The aim of this study is to examine, under free living conditions and using typical
      dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal
      glycemia when compared to consuming a low-fat breakfast (per the current diabetes
      guidelines).
    


Intervention name(s): Low Carbohydrate Breakfast; Guidelines Breakfast
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.; A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.
Other intervention name(s): Low-fat Breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world,
      represents an important public health challenge. It is also a major cause of chronic
      morbidity, mortality and disability throughout the world, leading to a heavy social and
      economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently,
      pulmonary rehabilitation is recognized as a core component of the management of individuals
      with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea,
      increase exercise capacity, and improve quality of life.

      Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of
      the best available means of improving muscle function in COPD.The most commonly form is cycle
      training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an
      additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient
      with COPD.

      There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle
      training and cycle training. This study will evaluate the effects of combined inspiratory
      muscle training and cycle training in patients with COPD.
    

Detailed description: 
      The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants
      in the proposed study will be randomly programmed into one of three intervention groups:

        1. Cycle training program alone (performing on calibrated stationary cycle ergometer).

        2. Combined cycle training and inspiratory muscle training(performing on calibrated
           stationary cycle ergometer and threshold loading device).

        3. Neither cycle training nor inspiratory muscle training.
    

Intervention name(s): Control group; calibrated cycle ergometer; calibrated cycle ergometer and threshold loading device
Intervention type(s): Device; Device; Device
Intervention description(s): Neither cycle training nor inspiratory muscle training.; The most common device to proform cycle training is calibrated cycle ergometer.; Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary rehabilitation; inspiratory muscle training; exercise training
Pre-Visit Prioritization for Complex Patients With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient
      and provider priorities during primary care visits represents a barrier to effective primary
      care. The investigators propose to design, implement, and evaluate in a randomized clinical
      trial a web-based tool linked to the electronic health record (EHR) that will enable complex
      patients to easily define care priorities for their upcoming visit.
    

Detailed description: 
      Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and
      complicated medical regimens. For these patients, diabetes management decisions and treatment
      goals must be addressed within the larger context of other competing health concerns. In
      parallel, clinical advances have led to a substantial increase in the number of tasks that
      primary care providers must perform during each visit. These twin trends present a formidable
      challenge to effective diabetes primary care. We hypothesize that among complex patients not
      meeting diabetes management goals, a web-based health IT tool to help patients explicitly
      prioritize all health issues (both related and unrelated to diabetes) and then submit these
      priorities directly into the electronic health record (EHR) for a scheduled visit with their
      primary care provider will result in more effective diabetes management over time. To test
      this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial
      a web-based tool linked to the EHR that will enable complex patients to easily define care
      priorities for their upcoming visit.
    

Intervention name(s): Pre-Visit Tool; Usual Care Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive a secure electronic message from their primary providers asking them to prepare for their visit by reviewing important areas of care and identifying their top priorities for discussion at a scheduled visit; Patients continue to receive usual care from their primary care provider
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Electronic Medical Records; Primary Health Care; Diabetes Mellitus, Type 2
Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma
Condition: Hepatectomy; Hepatecellular Carcinoma; Cirrhosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Selection criteria for safe hepatectomy for HCC are not well established. The aim of this
      study was the validation of the selection criteria for safe hepatectomy for hepatocellular
      carcinoma.
    

Detailed description: 
      All consecutive patients submitted to hepatectomy for HCC based on the same preoperative
      selection criteria from our prospectively-maintained liver unit database. Such criteria
      included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of
      ascites, the presence of esophageal varices, and the rate of residual liver volume.
    

Intervention name(s): Hepatectomy
Intervention type(s): Procedure
Other intervention name(s): Liver surgery; Liver resection; Hepatic resection
Intervention MeSH terms: Liver Extracts
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012
        were reviewed.
Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab
      (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function
      in patients with COPD
    


Intervention name(s): Canakinumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.; Matching placebo to ACZ885 administered via intravenous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluation of Postural Control in Children With Idiopathic Toe Walking
Condition: Idiopathic Toe Walking; Gait Disorders in Children; Postural Control; Postural Stability; Balance
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to evaluate postural control in children with idiopathic toe walking
      using computerized dynamic posturography (Biodex Balance System), which is reported to be a
      reliable and valid instrument for detecting changes in balance and postural control in the
      literature.
    

Detailed description: 
      Idiopathic toe walking (ITW) is a term used to describe the condition in which children walk
      with a toe-toe gait pattern in the absence of any known cause. When the literature is
      examined, it is reported that a possible neuromechanism of idiopathic toe walking is related
      to postural disorder and a deterioration of sensory information coming from the
      proprioceptive, vestibular, visual and / or tactile systems. The most important function of
      the posture is to maintain the balance during the initiation and continuation of the
      movement. Postural control regulates maintaining the balance and keeping the center of
      gravity within the body's stability limits. It includes resistance to gravity forces and
      mechanical support during movement. Postural control is an integral part of achieving
      targeted action. Although there are few studies showing the possible relationship, no studies
      have been found to evaluate postural control by computerized posturography in these children.
      In this study, we aimed to evaluate postural control in children with idiopathic toe walking
      using computerized dynamic posturography (Biodex Balance System).
    

Intervention name(s): Biodex Balance System; Balance Error Scoring System (BESS)
Intervention type(s): Other; Other
Intervention description(s): For the computerized evaluation of postural control, Biodex Balance System will be used.; For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 children with idiopathic toe walking aged 6-15 years followed by Bezmialem Vakıf
        University Department of Orthopedics and Traumatology.

        16 healthy volunteers aged 6-15 years will be included in the control group.
Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers
Condition: Severe Acute Respiratory Syndrome
MeSH terms: Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the
      safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and
      immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute
      respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to
      determine an Alferon LDO dose level that increases or upregulates genes known to be mediators
      of interferon response. Secondary endpoints include the development of SARS symptomatology,
      rate of hospitalization, and mortality rate. In the event that no subjects with recent
      exposure to a person with SARS or possible SARS are available, this study will be conducted
      with 10 normal volunteers.
    

Detailed description: 
      This study will be an open-label, randomized, outpatient study in subjects potentially
      infected with the SARS-CoV (SARS-associated coronavirus) or normal volunteers using two dose
      levels of LDO interferon.

      Subjects will be randomized to receive Alferon® LDO (natural interferon alfa-n3) in a buffer
      solution once each day for 10 consecutive days at doses equal to 650 IU or 1300 IU/day.

      Pretherapy baseline evaluations will be performed prior to randomization.

      Subjects will be randomly assigned to each dose level, and both dosage levels will be started
      concurrently. Drug will be dispensed for a ten day treatment period, during which time any
      clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for
      microarray analysis evaluations will be made twice during baseline and 12-14 hours following
      doses 1, 5, and 10 on study days 2, 6, and 11, respectively.

      The conduct of this study will comply with International Conference on Harmonisation - Good
      Clinical Practice (ICH - GCP) and the 1996 or later version of the Declaration of Helsinki.
    

Intervention name(s): Alferon LDO
Intervention type(s): Drug
Intervention MeSH terms: Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS; Alferon LDO; Low Dose Oral Interferon ALFA-n3; Human Leukocyte Derived; Exposure to SARS; Possible SARS
Peer Intervention for Social Skills (Brain Injury)
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      To investigate the effectiveness of a peer-led group intervention compared to a staff-led
      activity group to improve social communication skills for people with severe acquired brain
      injury (ABI).
    

Detailed description: 
      An earlier pilot study tested the feasibility of the approach and the sensitivity of existing
      outcome measures to changes in group social interaction (NCT02211339). Following amendments
      to the pilot study protocol, twelve new participants with severe ABI were recruited from a
      residential post-acute rehabilitation centre. An experimental parallel group design was used
      to compare a peer-led group intervention to a staff-led social activity group. Participants
      were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual
      care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was trained
      separately to facilitate interaction the peer-led group. The training took place in 16
      individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after
      intervention and at maintenance (4 weeks) using measures meeting reliability, validity and
      responsiveness criteria tested in the pilot study.
    

Intervention name(s): Peer facilitator training; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Peer facilitation of a project-based activity without staff present; Staff-led social activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An experimental parallel group design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Transcutaneous Levator Recession for Non-thyroid Lid Retraction
Condition: Eye Diseases
MeSH terms: Eye Diseases
Study type: Interventional

Summary: 
      This work aims to describe and assess the efficacy of transcutaneous levator palpebrea
      superioris muscle recession as a surgical procedure for treatment of upper lid retraction of
      various causes other than thyroid eye disease
    


Intervention name(s): Transcutaneous levator recession
Intervention type(s): Procedure
Intervention description(s): recession of the upper and lower eyelid retractors can improve the upper eyelid contour if the patient has lateral flare (common in TED). The choice of procedure depends on severity of lid retraction and associated features like proptosis, status of extraocular muscles, and corneal condition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy
Condition: Inflammatory Bowel Disease; Endoscopy; Sedation
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Sedation for endoscopy is a service more than a necessity. Therefore it should be patient
      driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic
      control. Therefore, satisfaction with the procedure experience is paramount for patients with
      IBD. Investigators wish to study the feasibility and the effect on patient experience of two
      drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a
      combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with
      propofol has a better procedure experience, that a well performed sedation equals a better
      experience and that NAPS is as feasible as fentanyl with midazolam sedation.
    


Intervention name(s): Propofol; Midazolam; Fentanyl
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Midazolam "Hameln" ATC-code: N05CD08; Fentanyl "Hameln" ATC-code: N01AH01
Intervention MeSH terms: Midazolam; Fentanyl; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammatory Bowel disease; IBD; Sedation; NAPS; Propofol; Midazolam; Satisfaction; Feasibility
Dacron vs Dardik for Fem-Pop Bypass
Condition: Intermittent Claudication; Arterial Occlusive Diseases; Atheroslerosis
MeSH terms: Intermittent Claudication; Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human
      umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.
    


Intervention name(s): heparin-bonded and collagen coated polyster; Human umbilical vein femoro-popliteal bypass
Intervention type(s): Device; Device
Intervention description(s): femoro-popliteal bypass
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults
Condition: Respiratory Syncytial Viruses
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300
      eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into
      multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will
      be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions
      of subjects in various strata will not be pre-specified and the goal will be to achieve an
      approximately equal distribution of subjects with these characteristics across the treatment
      groups. Serology measures consistent with the study outcomes will be reported.
    


Intervention name(s): RSV F Vaccine with Aluminum Phosphate Adjuvant; RSV F Vaccine; Matrix-M1 Adjuvant; Phosphate Buffer
Intervention type(s): Biological; Biological; Biological; Other
Intervention MeSH terms: Aluminum phosphate; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RSV
Development of Serologic Assays for Human Herpes Virus-8
Condition: Kaposi Sarcoma; HIV Infection
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Observational

Summary: 
      Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively
      detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We
      would like to apply this technique to develop an assay for detecting antibodies to HHV-8
      (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially
      plan to examine samples from patients with Kaposi's sarcoma, since all those patients are
      almost certainly infected with HHV-8. We are thus using samples from patients with previously
      diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository
      operated by SAIC Frederick or in Rockville, MD.
    

Detailed description: 
      Our colleagues have developed a technique for rapidly and quantitatively detecting antibody
      responses in sera to a variety of antigens using recombinant proteins. We would like to apply
      this technique to develop an assay for detecting antibodies to HHV- 8 (KSHV, the etiologic
      agent of Kaposi s sarcoma, an AIDS-defining condition). In addition we would like to
      potentially measure antibody responses to HIV, other infectious agents, and human antigens,
      to see if antibodies (or high antibody titers) to these antigens are associated with Kaposi s
      sarcoma or HIV infection. We initially plan to examine samples from patients with Kaposi s
      sarcoma, since all those patients are almost certainly infected with HHV-8. We would
      subsequently plan to examine samples from HIV positive and HIV negative patients without
      known Kaposi s sarcoma. We are thus requesting permission to use samples from patients with
      and without previously diagnosed Kaposi's Sarcoma. In addition to antibody testing, we would
      also like to examine these samples for evidence of infection with other infectious agents,
      such as newly identified or unknown viruses, using techniques such as PCR or deep

      sequencing.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Stored samples from individuals who had previously participated in studies conducted by the
        NIAID CCMD HIV/AIDS program
      
Keywords: Antibody; Kaposi's Sarcoma; HIV; Kaposi Sarcoma
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective was to investigate whether multiple-dose administration of
      eslicarbazepine acetate affects the pharmacokinetics of metformin.
    


Intervention name(s): Metformin; Eslicarbazepine acetate
Intervention type(s): Drug; Drug
Intervention description(s): 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days
Other intervention name(s): Glucophage; Zebinix
Intervention MeSH terms: Metformin; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eslicarbazepine acetate; zebinix; metformin