bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Telerehabilitation on Handwriting Performance in Children With ADHD: RCT
Condition: Handwriting; Telerehabilitation; Fine Motor Skills
Study type: Interventional

Summary: 
      This is a randomized controlled study examining the effect of telerehabilitation on fine
      motor performance and handwriting difficulties experienced by children with attention deficit
      hyperactivity disorder.
    

Detailed description: 
      It is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and
      hyperactivity disorder and their families will participate voluntarily. An informed consent
      form, BOT-2 and Minnesota Handwriting Test will be sent to volunteer participants via e-mail.
      An evaluation session on Zoom application will be held for each participant with the
      participation of the occupational therapist, child and family. After the evaluation, the
      participants will be randomized and allocated to study and control groups.

      Fine motor skills training will be given to the study group 3 sessions a week. The training
      will be given on the Zoom application and the duration is 8 weeks. At the end of 8 weeks, the
      evaluation will be done again with BOT-2 and Minnesota Handwriting Test.

      The control group will be evaluated with BOT-2 and Minnesota Handwriting Test for the second
      time after waiting 8 weeks and will receive fine motor skills training.

      The first and last data in the study group will be analyzed with the Wilcoxon Paired
      Test.Study and control group data will be compared by Mann-Whitney U or Independent T Test.
    

Intervention name(s): Fine Motor Skills Training
Intervention type(s): Other
Intervention description(s): Fine Motor Skills Training The sessions will be held by considering the fine motor skills training and the criteria of fidelity of the fine motor interventions suggested by Pfeiffer et al. Each goal was enriched with activities and games that improve fine motor skills and handwriting performance.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomly divided into two groups. The same intervention will be applied to the second group after the first group has received intervention for 8 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Handwriting; Occupational Therapy; Telerehabilitation
FEC With G-CSF Support Followed by Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in BC
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered
      every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil,
      Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of
      G-CSF.

      To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the
      axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due
      to toxicity of the regimen.
    

Detailed description: 
      Estrogen receptor negative breast cancer may be defined as distinct biologic subtype disease,
      more aggressive with a typical molecular portrait. [30] This subtype seems to have a poor
      prognosis and poor treatment options because these patients are not candidate to hormonal
      therapy. Novel treatment strategies focusing upon this subtype are necessary in the future.
      [31] There are reports of clinical benefit in estrogen receptor negative patients treated
      with dose-dense chemotherapy (see background CALGB 9741 and MIG-1 study). In the CALGB 9741
      study, patients randomized to receive dose-dense regimens experienced severe toxicities
      during paclitaxel treatment leading to dose reduction in 7% and 5%respectively.

      Ixabepilone has shown consistent activity and an acceptable safety profile in patients with
      all stages breast cancer. This phase II study evaluate the feasibility of dose-dense
      Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and
      Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as
      neo-adjuvant treatment for ER-negative breast cancer patients.
    

Intervention name(s): Ixabepilone
Intervention type(s): Drug
Intervention description(s): Ixabepilone is administered as 3-hour intravenous infusion (iv) at the dose of 40 mg/mq, every 14 days for 4 cycles (with G-CSF support), sequentially to Fluorouracil 600 mg/mq as intravenous (iv) infusion, Epirubicin 90 mg/mq as intravenous (iv) bolus and Cyclophosphamide 600 mg/mq as intravenous (iv) infusion every 14 days for 4 cycles (with G-CSF support)
Other intervention name(s): Ixempra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer
Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Dose Study of GBR 900 in Healthy Volunteers.
    

Detailed description: 
      This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to
      look at safety, how well the study drug is tolerated, how much of the study drug gets into
      the blood stream, and how long it takes the body to get rid of it when given to humans.
      Information about any side effects that may occur will also be collected. Each participant
      will remain in the study for approximately 3.5 months. This study is for research purposes
      only and is not intended to treat any medical condition.
    

Intervention name(s): GBR 900; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative
Condition: Carcinoma; Sarcoma; Myeloma; Lymphoma; Melanoma
MeSH terms: Melanoma; Sarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first time that a new experimental drug called [18F]-SKI-249380 is being
      used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that
      will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its
      injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find
      tumors in patients.

      This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is
      given to people in tiny amounts by an injection into a vein in their arm, and to see where
      [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study
      doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380
      are better for finding tumors compared to the standard types of scans that doctors use.
    


Intervention name(s): [18F]-SKI-249380; PET/CT scan; Blood draws
Intervention type(s): Radiation; Procedure; Other
Intervention description(s): PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. This includes an initial 30-minute PET scanning period, performed. At each subsequent time-point, a 30 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A 30-45 minute scanning time-period is typical for clinical PET studies. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point.; Blood will be drawn at the multiple time points for pharmacokinetic & metabolite analyses of 18F-SKI-249380. We anticipate these time points to be approximately 1, 5, 15, 30, and 90 minutes and 3 hours (optional), post-injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: [18F]-SKI-249380; PET Imaging; CT Imaging; 12-182
Pharmacokinetics of Two Formulations of Entecavir
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 4

Summary: 
      A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test
      Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent
      Dose of a Reference Drug Product (Baraclude 0.5mg Tablets) in Healthy
    


Intervention name(s): Entigin Film Coated Tablet 0.5mg; (Baraclude 0.5mg Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
Condition: Smell Loss
MeSH terms: Anosmia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a growing step of phase I study published on March 2021. The study was
      implicated on Minia university on small scale of patient (20) to investigate the impact of
      insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19
      infections. this record will modify the first formulation by addition certain concentration
      of steroid.
    


Intervention name(s): Prednisolone
Intervention type(s): Drug
Intervention description(s): intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this research study is to test the safety, tolerability, and the effect of
      vibration (delivered by an experimental device called PDVibe2) on freezing of gait (FOG) in
      persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC
      (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait
      and balance in persons with PD while wearing the device.
    

Detailed description: 
      Enrolled patients with Parkinson's disease, Hoehn and Yahr Stage 2, will be randomized to
      receive either vibration or no vibration and then will be crossed over to receive the
      opposite intervention. The study will consist of two treatment periods of two days followed
      by a washout period of 2 weeks. Each treatment period will consist of four treatments within
      2 days, no more than 2 sessions in one day.

      Patients will participate in an additional day for screening and another for follow-up (6
      days total). All visits will occur at the Virginia Commonwealth University Parkinson's
      Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief
      period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and
      study staff will measure the number of "freezes" before, during and after therapy.
      Participants will be asked to provide feedback on the device, the therapy session, and how
      they are feeling.
    

Intervention name(s): PDVibe2
Intervention type(s): Device
Intervention description(s): The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. PDVibe2 delivers vibration when activated by an easy to access switch on the device or by remote. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band.
Other intervention name(s): VibeForward
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gait; Balance
Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the present study was to evaluate the effects of subgingival delivery of boric
      acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.
    

Detailed description: 
      Background: The purpose of this double-masked, randomized, controlled clinical trial was to
      evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and
      root planing (SRP) on clinical and radiographic parameters and compare this method with SRP
      plus placebo gel alone in with chronic periodontitis (CP) patients.

      Methods: Thirty nine systemically healthy patients with CP are included in this study. They
      were divided into two groups: 1) SRP + 0.75% Boric acid gel (BA group); 2) SRP + Placebo gel
      (Placebo group). At baseline, 3 month, and 6 months after treatment, clinical measurements,
      including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD),
      clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD),
      percentage change in radiographic defect depth reduction (DDR%) were assessed.
    

Intervention name(s): SRP plus boric acid gel; SRP plus placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): SRP followed by 0.75% boric acid placement into intrabony defect; SRP followed by placebo gel placement into intrabony defect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Health Effects of Increasing Muscle Activation While Sitting in Office Workers
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases
      and the risk factors associated with cardiometabolic diseases. However, no study to date has
      examined if a chronic intervention that breaks up prolonged sitting in a real-world
      environment results in a reduction in the metabolic risk factors associated with
      cardiometabolic diseases. Thus, the objective of this study is to examine the potential
      health benefits of breaking up sitting bouts throughout the workday using a small cycling
      device (DeskCycle) in office workers involved with jobs that require prolonged bouts of
      sitting. The investigators hypothesize that breaking up sitting will be associated with
      improvements in cardiometabolic disease risk factors. More specifically, the investigators
      hypothesize that breaking up sitting will decrease blood glucose during an oral glucose
      tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure,
      decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol,
      and triglycerides.
    


Intervention name(s): DeskCycle
Intervention type(s): Device
Intervention description(s): A small cycling ergometer that can fit under a desk at the workplace.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Blood Glucose; Physical Fitness; Body Composition; Lipids
Smartphone Utilization for Glucose Monitoring and Antenatal Reporting
Condition: Gestational Diabetes; Pregestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      This project will utilize MHealth technology to address the barriers providers and obstetric
      patients experience when reporting blood glucose results. Half of the participants will
      record their blood glucose values with the assistance of a smartphone device, the other half
      will continue in the traditional care method of the clinic.
    

Detailed description: 
      This will be a prospective single center randomized trial piloting the use of mHealth
      applications in an obstetric population with diabetes. Participants will be enrolled in the
      study after the diagnosis of diabetes is made in pregnancy for those with gestational
      diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of
      prenatal care. Participants will be randomized to traditional care or mHealth intervention.
      Outcomes will include completeness and accuracy of the participant glucose log, unscheduled
      health care access episodes in the pregnancy, patient satisfaction, percentage of glucose
      values at goal and percent change in Hemoglobin A1C.
    

Intervention name(s): Completion of Glucose logs
Intervention type(s): Behavioral
Intervention description(s): Glucose logs will be assessed by provider for completeness and accuracy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers
Condition: Diet, Healthy; Antioxidative Stress
Study type: Interventional

Summary: 
      In the present study, the authors aimed to investigate the effects of hardaliye (grape juice)
      consumption on oxidative stress parameters, lipid profile and blood pressure in young
      football players.
    


Intervention name(s): Grape juice; Placebo drink
Intervention type(s): Other; Other
Intervention description(s): Hardaliye (grape juice) is a fermented, traditional non-alcoholic beverage made from fresh grapes. It is mainly produced by the fermentation of grapes, sour cherry leaves and mustard seeds. Hardaliye was purchased from traditional producers in Turkey. Hardaliye Group consumed 250 ml/day of hardaliye (grape juice) for 28 days.; Placebo drink has carbohydrate, energy and sensory properties similar to hardaliye. Placebo Group consumed 250 ml/day of placebo drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Smile-Kids: Study on Complementary Feeding Transition
Condition: Infant; Health Promotion; Nursery; Educators
Study type: Interventional

Summary: 
      The importance of families in the development of infants is well documented. Previous studies
      found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez,
      Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014). More,
      there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle,
      & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug, 2007).
      Therefore, there is a need to lock overweight and obesity in early childhood in order to
      contribute to health gains during the entire life cycle. The main purpose of this research is
      to evaluate the impact of an intervention program based on parenting skills and feeding
      practices, on infant's growth, development and adherence to new foods in early infancy

      Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized
      trial and were randomly allocated to intervention and control group. Infant outcomes were
      performed at baseline and post-intervention and included anthropometry, dietary assessment
      and temperament. In addition maternal and family outcomes such as anxiety, dietary intake
      were also assessed at both times.

      An intervention program was developed and Implemented according to two terms: educators'
      training with the researchers and the intervention with parents and infants developed by
      trained educators. The training program was developed between December 2013 and February
      2014, according to the topics of healthy eating and nutrition and development of the infant.
      The control group received the standard care.

      It is expected that this intervention program is able to promote healthy feeding practices to
      parents and nursery teachers. The results will be disseminated to the stakeholders and
      policymakers that work closely to the topic of this study. This will include papers'
      publication, participation in national and international meetings, contributing to the
      advance of research in this health area.
    


Intervention name(s): Intervention taught by trained educators
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Calamansi on Blood Glucose
Condition: Blood Glucose Response
Study type: Interventional

Summary: 
      It is important to bring the blood glucose levels of those with type 2 diabetes mellitus
      (T2DM) back to normal levels as this can stop the condition from worsening and prevent other
      conditions that are related to T2DM from developing. One way to maintain healthy blood
      glucose level is the use of the glycaemic index (GI), which ranks food according to how the
      body responds to its carbohydrate content. Low GI foods corresponds to low increase in blood
      glucose levels. Calamansi is a citrus that is believed not to induce an increase in blood
      glucose levels. Since beverages from calamansi are available and diabetes is a health concern
      in the community, it is important to investigate the effect of consuming this drink. Finger
      prick blood were tested in order to obtain the blood glucose levels for calculating the GI
      for the calamansi drink.
    


Intervention name(s): Calamansi; Glucose
Intervention type(s): Other; Other
Intervention description(s): 250 ml of a commercially sourced calamansi drink; 75 g of glucose dissolved in 250 ml of drinking water
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: calamansi; glycaemic index; post-prandial blood glucose