bioihbjkbjnl/mcl2 huggingface dataset:
Heart at Home- a Self-care Study
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      In the study benefits of using mobile phone assisted remote patient monitoring including
      self-measurements of blood pressure, heart rate and weight as well as monitoring of personal
      health status are investigated in the care of heart failure patients.
    


Intervention name(s): Telemonitoring assisted self-care
Intervention type(s): Device
Intervention description(s): Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: self-care, heart failure, telemonitoring, health care utilization
Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
Condition: Environmental Enteropathy
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the therapeutic effectiveness of micronutrients
      (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut
      absorptive and immunological function as measured by the dual sugar permeability test and
      additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental
      Enteropathy.
    


Intervention name(s): Fish oil and Micronutrient Supplementation; Micronutrient Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): 0.9 mL highly purified fish oil (200 mg docosahexaenoic acid, 300 mg eicosapentaenoic acid) to be given daily for 6 months
1 RDA of all known micronutrients needed for normal child growth in powder form to be given daily for 6 months; 1 RDA all known micronutrients needed for normal child growth to be given daily in powder form for 6 months 0.9 mL palm oil given daily for 6 months; 10 g sugar in granule form to be given daily for 6 months 0.9 mL palm oil to be given daily for 6 months
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
Condition: Deep Overbite
MeSH terms: Overbite
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used
      with resilient archwires during the leveling and alignment phase in intruding lower incisors.
    


Intervention name(s): Auxiliary cantilever intrusion arches on initial archwires; Routine leveling and alignment
Intervention type(s): Device; Device
Intervention description(s): Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment.; Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment.
Other intervention name(s): Relative Intrusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
Condition: Hemiparesis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of lateralization on the spatio-temporal
      characteristics of gait in individuals with hemiparesis.
    

Detailed description: 
      A total of 108 individuals within the age range of 20-65 and 36 of whom are right hemiparetic
      (Group1; 16F, 20M), 36 of whom are left hemiparetic (Group2; 16F, 20M) and 36 of whom are
      healthy (Group3; 19F, 17M) have been included in the study. BTS G-Walk Gait Analysis System
      has been used to assess the spatio-temporal gait characteristics.
    

Intervention name(s): assessment of gait parameters
Intervention type(s): Other
Intervention description(s): Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hemiparesis; Lateralization; Spatio-temporal analysis; Gait
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Condition: Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Relapsed Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the
      treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute
      lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is
      based on the induction of complete responses. Randomized trials demonstrating increased
      survival or other clinical benefit have not been conducted.

      The purpose of the phase 1 portion of this study was to determine if clofarabine added to a
      combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory
      acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the
      phase 2 portion of the study was to measure the effectiveness of the combination therapy in
      children with ALL.
    


Intervention name(s): clofarabine; Etoposide; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.; Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.; Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Other intervention name(s): Clolar; Evoltra; Eposin; Endoxan; Revimmune; Cytoxan
Intervention MeSH terms: Cyclophosphamide; Etoposide; Clofarabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clofarabine; acute leukemia; ALL; AML; clolar; CLO218
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether in patients with early type 2 diabetes, a
      short-term intensive metabolic intervention comprising iGlarLixi, metformin, and lifestyle
      approaches will be superior to standard diabetes therapy in achieving sustained diabetes
      remission.
    

Detailed description: 
      This is a multicentre, open-label, randomized controlled trial in 160 patients with
      recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week
      course of treatment with iGlarLixi, metformin and lifestyle therapy, and (b) standard
      diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all
      participants with HbA1C<7.3% at the 12 week visit, glucose-lowering medications will be
      discontinued and participants will be encouraged to continue with lifestyle modifications and
      regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience
      hyperglycemia relapse after stopping drugs will receive standard glycemic management as
      informed by the current Canadian Diabetes Association clinical practice guidelines.
    

Intervention name(s): iGlarLixi; Insulin Glargine; Metformin; Lifestyle therapy
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): Dose is titrated to achieve fasting normoglycemia; In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.; Dose is titrated to 2000 mg daily or maximal tolerated dose; Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Other intervention name(s): glargine insulin / lixisenatide; Lantus; diet and exercise
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; iGlarLixi; Metformin; Insulin; Diet; Exercise; Lifestyle
A Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in Patients With Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on
      blood glucose control in 24 patients with diabetes for 2 days.
    

Detailed description: 
      The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved
      by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the
      glucose concentration of the interstitial fluid every 10 seconds and then stores an average
      glucose value for each 5 minutes period, for a total of up to 288 measurements each day.
    

Intervention name(s): Commercially Available Wet Noodle; PPB-R-203-02 Noodle
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Commercially Available Wet Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of same macronutrient composition.; PPB-R-203-02 Noodle is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203-02 Noodle is resistant starch (RS). By definition, resistant starch (RS) is any starch that is not digested in the small intestine but passes to the large intestine (or the colon). Therefore, resistant starch can be regarded as a component of dietary fiber. PPB-R-203-02 Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Current recommendations today suggest that use of therapeutic lifestyle changes, such as
      supplementation with specific dietary components and moderate exercise, are appropriate
      interventions for individuals with borderline high blood pressure. Dietary intervention with
      natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular
      disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the
      cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical
      trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels
      Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing
      blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009).
      Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit
      of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic
      lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the
      effectiveness of FLC supplementation alone or in combination with moderate exercise merits
      investigation.
    


Intervention name(s): BeneFlax®; Walking training; Flexibility training; Placebo (Whey Protein); Dash Eating Plan
Intervention type(s): Dietary Supplement; Behavioral; Behavioral; Dietary Supplement; Behavioral
Intervention description(s): Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training; 30-60 minutes walking training, 5 days/week.; 5 days/week; e.g. stretching training at home; 0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training; Dietary Approaches to Stop Hypertension (DASH), a balanced eating plan - all participants in all treatment arms will be encouraged to adopt a DASH eating plan.
Other intervention name(s): Flaxseed lignan enriched complex
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: High normal blood pressure; Stage I
Do Prostheses of SphinkeeperTM Migrate After Operation?
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Observational

Summary: 
      32 patients who underwent sphinkeeper operation got enrolled in this study. The primary
      endoint is to explore the movement of the prostheses examined by manometry and ultrasound.
      The secondary endpoint is to find out about the functional outcome when migration of
      prostheses occurs and to examine differences in morphology of the sphincters after operation.
    

Detailed description: 
      The SphinkeeperTM is a new surgical procedure in order to treat refractory fecal
      incontinence, which includes up to ten self-expandable prostheses. These get implanted into
      the intersphincteric space and due to constriction of the anal canal and better
      contractibility continence should be improved. Because this is a new technique, there is only
      limited data about its clinical efficacy.

      In this study, patients, aged 18-90 years, who met the inclusion criteria and have received a
      SphinkeeperTM operation, were enrolled. Functional outcomes and quality of life got measured
      by standard questionnaires before surgery and 1, 2, 3 and 6 months after surgery.
      Furthermore, in routine check ups patients received endoanal anorectal manometry for pressure
      measurement and endoanal ultrasound to determine the position of the prostheses.
    

Intervention name(s): SphinkeeperTM
Intervention type(s): Procedure
Intervention description(s): The SphinkeeperTM includes up to 10 self-expandable prostheses, which get inserted into the intersphincteric place. They are made of inert Hyexpan (polyacrylonitrile)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Candidates for sphinkeeper operation due to fecal incontinence will be enrolled in this
        study.
Goal Setting and Lifestyle
Condition: Physical Activity; Diet
Study type: Interventional

Summary: 
      The primary aim of this feasibility study is to determine if a theory-based lifestyle
      intervention consisting of telephone counseling is associated with improvements in physical
      activity and dietary intake.
    

Detailed description: 
      Goal setting has become an integral part of physical activity and dietary interventions;
      however, few studies have examined the theoretical constructs that drive goal-setting theory.
      To address the limitations and gaps in the literature, we designed an 8-week health behavior
      intervention for a racially and ethnically diverse sample of older adults. The primary aim of
      this study was to determine whether older adults randomized to a goal-setting intervention
      for physical activity or fruit and vegetable (F&V) intake would make significant improvements
      in physical activity or F&V intake. The secondary aim of this study was to determine whether
      participating in goal-setting interventions was associated with changes in theoretical
      constructs related to goal-setting. We hypothesized that older adults assigned to the
      physical activity condition would significantly increase metabolic minutes (MET-minutes) of
      physical activity from baseline to follow-up and that participants assigned to the F&V intake
      condition would significantly increase mean servings of F&V. In addition, we hypothesized
      that mean scores of goal specificity, difficulty, effort, commitment, persistence, barrier
      self-efficacy, and task self-efficacy would significantly increase from baseline to follow-up
      for both groups.
    

Intervention name(s): Physical activity; Fruit and vegetable
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for physical activity.; Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for fruit and vegetable consumption.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Aging; physical activity; diet; goal setting
Aphasia Therapy: Factors of Efficacy
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has
      remained unclear, however, whether intensity of therapy or constraint is the relevant factor.
      This study will give an answer to this question to improve speech and language therapy.
    

Detailed description: 
      Although there is clear evidence that aphasia therapy is effective, questions remain as to
      the intensity of administered therapy, the preferred therapeutic approach and its initiation
      with regard to stroke onset. CIAT is a a high intense group therapy administered over 2
      weeks. Additionally, patients have to communicate solely in spoken words or sentences
      (constraint). This study compares CIAT with an approach of the same intensity without
      constraints and a less intense house-typical therapeutic approach.
    

Intervention name(s): Control group; CIAT-group; communication treatment group (CTG)
Intervention type(s): Other; Other; Other
Intervention description(s): This is the control group with 14 h treatment over 10 workdays.; Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.; Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: communication disorders; language and speech disorder rehabilitation; stroke
The Optimization of Bioavailability From Iron Supplements: Study 1
Condition: Iron Deficiency; Anemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem
      worldwide, especially in women of reproductive age and young children. Iron supplementation
      is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron
      bioavailability from different supplementation regimens and how to optimize bioavailability
      in a cost-effective and patient-friendly way. The present study will test whether the
      fractional and total iron absorption from iron supplements (60 mg) administered daily for 14
      days differs from that of iron supplements (60 mg) administered every second day for 28 days.
      The prevailing serum hepcidin concentration (SHep) is the major determinant of iron
      absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole
      supplementation period. We hypothesize that the fractional and total iron absorption from the
      daily administration of 60 mg is lower than that from the administration on every second day
      due to increased SHep levels when supplements are administered daily.

      The study will provide important insights about the optimization of iron bioavailability from
      different supplementation regimens including the performance of SHep, a key regulator of
      human iron metabolism.
    


Intervention name(s): Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days; Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Iron bio availability; Hepcidin; Iron absorption