bioihbjkbjnl/mcl2 huggingface dataset:
Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground
Condition: Balance
Study type: Interventional

Summary: 
      This study developed a controlled soil reaction force platform that provided controlled
      mechanical stimuli to quantify the distribution of the center of mass as a function of the
      angular variation of the ankle in the elderly in the upright position.
    

Detailed description: 
      Usually the balance evaluation the center of mass displacement for the analysis of postural
      control is assessed by means of force platforms. However, most of these devices are
      stationary, that is the patient is the dynamic element which can generate an evaluation with
      high subjectivity index. Therefore, this study aimed at developed a reaction force to the
      ground platform which provides mechanical stimuli controlled to quantify the distribution of
      the mass center as a function of the angular variation in the elderly ankle in the upright
      position. The construction of the prototype was divided into 3 steps, based on the
      two-dimensional movement of the ankle joint. In the 1st stage the construction of the
      mechanical assembly; in the 2nd stage development of the electronics; and 3rd stage the
      development of the supervisory system (control system). The force plataform was evaluated
      following the engineering functional tests such as: characterization and calibration of the
      sensors, the definition of the transfer function and accuracy of tests of angular movements
      (+ 10 ° and -10 ° to the movements of inversion and eversion, + 15 and -15º to the movements
      of dorsiflexion and plantar flexion). For the tests with volunteers were selected 30
      volunteers.
    

Intervention name(s): Force plate
Intervention type(s): Device
Intervention description(s): Device: force plate An equipment model with the approach of providing the evaluated person with the movement that is closest to the biomechanical and functional reality of the ankle and foot joint and which could equalize the possible changes of the center of mass would contribute to the clinical evaluation and would provide a more efficient therapeutic reasoning rehabilitation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Force plate; Center of mass
Exercise Time in Sedentary Middle-aged Female
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The exercise time is an important factor among the medical guides for weight loss; however,
      there is still little knowledge about exercise duration paths in middle-aged and older women.
      The present study aimed to determine the effects of the interval training on weight loss and
      lipid profile, and to compare its efficiency with the continuous training.
    

Detailed description: 
      Participants included sedentary women (age 45-75 years) with overweight or obesity (n= 115).
      They were randomly divided into two groups including continuous exercise, and interval
      exercise. The weight assessment parameters including change in weight and body composition,
      blood sample tests were performed pre- and three month post-intervention.
    

Intervention name(s): Exercise time
Intervention type(s): Other
Intervention description(s): Continuous training, Interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether adult DKA patients who present to the
      emergency department treated with early subcutaneous long acting insulin versus standard care
      receive a shorter total duration of intravenous (IV) insulin infusion.
    

Detailed description: 
      Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus
      standard care on time of insulin infusion in DKA patients and other secondary outcomes listed
      in this application.

      Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3
      units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin
      infusion. Besides timing of the glargine dose, no other changes in standard patient care will
      occur in those patients enrolled in this study, the same labs will be collected and the
      insulin infusion will be titrated using the same hospital protocol algorithm.

      Patients enrolled in the prospective arm will be compared with the retrospective control
      group, which received standard insulin therapy (subcutaneous insulin glargine administered at
      least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients
      in this group selected in reverse chronological order from our pre-specified date range of
      8/1/2014 to 7/31/2016.
    

Intervention name(s): Early administration of subcutaneous insulin glargine dose; IV insulin infusion; IV fluid repletion
Intervention type(s): Other; Other; Drug
Intervention description(s): DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.; All patients will receive the standard of care which is a protocol based continuous insulin infusion; 0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emergency department; Insulin; Adult
Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Observational

Summary: 
      Functional dyspepsia (FD) is a common functional gastrointestinal disease. Several
      patient-reported outcome questionnaires have been established to evaluate the severity of FD,
      including Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and
      Short-Form Nepean Dyspepsia Index (SF-NDI). Functional Dyspepsia Symptom Diary (FDSD) is a
      newly symptom-focused patients-reported outcome measure raised by the Patient-Reported
      Outcome Consortium's Functional Dyspepsia Working Group. The association of the novel FDSD
      and other scores-related to FD has not been fully investigated. Furthermore, the severity of
      FD is varied among different patients. It remains unclear how the moderate and severe FD can
      be defined by the FDSD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients 18-70 years old who met the Rome IV diagnostic criteria of FD with normal upper
        endoscopy and abdominal ultrasonography within one year were eligible for our study.
        Patients with local or systemic diseases which may cause dyspeptic symptoms were excluded.
        Patients who were pregnant or unable to give informed consent were also excluded.
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional

Summary: 
      Vaccines have been responsible for preventing millions of deaths and extending the average
      human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes
      and associated functions that bring about protective immunity.This study aims to define
      cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in
      healthy individuals. The investigators hypothesize that many genes associated with innate and
      adaptive immune functions are important for an effective HBV vaccine response.
    

Detailed description: 
      Vaccines have been responsible for preventing millions of deaths and extending the average
      human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes
      and associated functions that bring about protective immunity. Knowledge of those genes and
      cellular functions activated by effective vaccination can improve our understanding of how
      the immune system works and define the features necessary for a successful vaccine response.
      This study aims to define cellular functions important for the hepatitis B (HBV) vaccine
      immune response in healthy individuals. The investigators will identify those genes that are
      activated or suppressed in immune cells at various times after each dose of the HBV vaccine.
      The investigators will explore these vaccine-induced "gene signatures" to characterize the
      cellular functions associated with an effective immune response to HBV vaccination. The
      investigators hypothesize that many genes associated with innate and adaptive immune
      functions are important for an effective HBV vaccine response.
    

Intervention name(s): Hepatitis B Vaccine (Recombinant)
Intervention type(s): Biological
Intervention description(s): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Other intervention name(s): Recombivax HB - Merck & Co., Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatitis B vaccine
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Condition: Medium and Lower Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis:

      In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one
      and a half times higher in men than in women. The average age of diagnosis is 65. Unlike
      colon cancer, technical management remains challenging with unresolved operating
      difficulties. Morbidity of surgical procedures remains high with a very large number of
      preventive or curative stoma derivations.

      Reference in surgical treatment is total excision of the rectum and its mesentery, followed
      by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate
      of fistula that results is reported in the literature between 15 and 25%.

      An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on
      retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of
      fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and
      mortality are reduced, and patient's quality of life greatly improved. Direct costs
      (consumables intraoperative, hospitalization, stoma complications) and indirect
      (pocket-fitting stoma) are greatly reduced.

      This study is a multicentre, two arms, phase 2 clinical trial.
    


Intervention name(s): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA); Colo-anal anastomosis (CAA)
Intervention type(s): Procedure; Procedure
Intervention description(s): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.
After surgical resection, the colon is exteriorized through the anus and attached to the buttock.
By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation; After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.
In the absence of fistula, the patient will reoperation for stoma closure of its branch
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two multicenter parallel single-arm phase II trials.
One trial assessing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.
One trial assessing colo-anal anastomosis (CAA) in centers who routinely performing this intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal cancer; Coloanal anastomosis; Phase 2 clinical trial
Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      To assess the effect of water temperature and additives on pregnant women's taste and side
      effect during the oral glucose tolerance test (OGTT) evaluation.
    


Intervention name(s): oral glucose tolerance test using water at room temperature; oral glucose tolerance test using hot water; oral glucose tolerance test using cold water; oral glucose tolerance test using hot water with tea bag; oral glucose tolerance test using room temperature water with tea bag; oral glucose tolerance test using cold water with tea bag; Oral glucose tolerance test using bubble water at room temperature; Oral glucose tolerance test using bubble water
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The use of water at room temperature to solve the 75g glucose.; The use of hot water to solve the 75g glucose.; The use of cold water to solve the 75g glucose.; The use of hot water with tea bag to solve the 75g glucose.; The use of room temperature water with tea bag to solve the 75g glucose.; The use of cold water with tea bag to solve the 75g glucose.; The use of bubble water at room temperature to solve the 75g glucose.; The use of cold bubble water to solve the 75g glucose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory
      and other mental functions (referred to as cognitive functions). The seizures, and other
      examples of overactive electrical activity in the brain that is not noticeable, contribute to
      the loss of cognitive function. Studies in animal models of AD suggest that a drug that
      prevents seizures called levetiracetam may reduce neuronal over-excitation and improve
      cognition. Based on this evidence, the investigators propose to determine if levetiracetam
      can be used to treat patients with AD. The investigators developed novel instruments for this
      population that will also be used in future large-scale clinical trials.

      The current study will last for 12 weeks and will involve people with AD. Participants will
      be initially examined with an overnight brain wave study to assess for silent epileptic
      (seizure-like) activity. Presence of epileptic activity on the screening exam is not required
      to enter the trial. Participants will then be assigned to groups in a randomized manner. One
      group will receive levetiracetam for 4 weeks, then no drug for 4 weeks, and then placebo for
      4 weeks. For another group, the order of treatments will be reversed. The cognitive abilities
      of participants will be retested every 4 weeks and compared to those at the beginning. The
      cognitive tests include a virtual-reality navigation test of memory and computerized tests of
      mental flexibility and problem solving. The participants will be monitored with a
      magnetoencephalogram (MEG) with simultaneous EEG (M/EEG) at each visit. M/EEG is a highly
      effective non-invasive method for identifying brain regions of epileptic activity. The
      investigators will need to recruit 36 randomized participants to test the study hypotheses.
      This study will take place at the University of California, San Francisco (UCSF) and the
      University of Minnesota.
    

Detailed description: 
      For a more detailed explanation of the study and what our results were, please read our
      publication at https://jamanetwork.com/journals/jamaneurology/fullarticle/2784539
    

Intervention name(s): levetiracetam
Intervention type(s): Drug
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease; AD; Early-onset AD; EOAD; Early-onset Alzheimer's; Early-onset Alzheimer's disease
Brief Mood Enhancement Intervention
Condition: Stress, Psychological; Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological; Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of the current study is to test the efficacy of two brief, behavioral
      interventions intended to improve burnout among doctoral-level graduate students (n = 102).
      Specifically, individuals will be randomly assigned to one of three intervention conditions:
      1) Reward: a brief intervention to help participants increase engagement in healthy and
      rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants
      identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control
      condition that involves monitoring only. Multilevel modeling will be used to assess changes
      in burnout, mood, and stress, following the interventions, controlling for participants'
      individual baseline levels of these variables.
    


Intervention name(s): Reward; Approach
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are rewarding and pleasurable and to integrate these activities into their schedule.; Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are challenging, but important to their long-term goals and values, and to integrate these activities into their schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: graduate student; burnout; stress; mood
Targeted Ballet Class for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to investigate the effect of the targeted ballet dance on participants with
      cerebral palsy
    

Detailed description: 
      Cerebral palsy (CP) is the most common motor disorder in childhood, with a prevalence of 3.1
      to 3.6 cases per 1000 living births in the United States. The motor signs of CP include
      abnormal muscle tone and motor control, preventing individuals with CP from participating in
      normal daily activity. The most common type of CP is spastic CP, in which spasticity is
      present and range of motion in the joints is reduced. Physical therapy is one fundamental
      method of rehabilitation that attempts to recover motor function via exercises, while the
      effects of physical therapy are still elusive due to the lack of comprehensive evidence. This
      study uses a targeted ballet class to promote balance, increased range of motion, and reduced
      spasticity. The combination of qualitative clinical measures and quantitative assessment
      spasticity aims to demonstrate the benefits brought by the dance class.
    

Intervention name(s): Targeted ballet dance
Intervention type(s): Behavioral
Intervention description(s): The one-hour ballet dance class will be provided twice per week for six weeks. The syllabi are adapted from the Joffrey Ballet Academy and Royal Academy of Dancing that are targeting grades primary to level 1 and typically developing kids at the age of 6 to 10 years old. PI will be the class instructor, and the class structure will follow the guidelines in 'Dance program for physical rehabilitation and participation in children with cerebral palsy' by Lopez-Ortiz et al.
Intervention model: Single Group Assignment
Intervention model description: Children and adults with cerebral palsy
Masking: None (Open Label)
Primary purpose: Treatment
Study of GMI-1070 for the Treatment of Sickle Cell Pain Crisis
Condition: Sickle Cell Disease; Vaso-occlusive Crisis; Pain Crisis
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      GMI-1070 is a new drug that may reduce the stickiness of cells in the blood. The purpose of
      this study is to evaluate whether GMI-1070 can reduce the time it takes for pain to go away
      in patients with vaso-occlusive crisis (also known as a sickle cell pain crisis). The study
      will also collect information on the safety of GMI-1070, how much of the drug is in the blood
      and urine, and if there are any other effects when used in patients who are in the hospital
      for a sickle cell pain crisis.
    

Detailed description: 
      Patients being admitted to the hospital for pain crisis may be eligible for this study. In
      addition, patients should be 12-60 years old and have sickle cell types SS or
      S-beta-thalassemia. People who take part in the study will be evaluated and then randomly
      assigned to receive either GMI-1070 or a placebo by IV, in addition to all other usual
      treatments for their pain crisis.

      During the hospital stay for pain crisis, GMI-1070 or placebo will be given twice a day, and
      patients will be asked about their pain severity (pain score) at the beginning of the study
      and every few hours during their hospital stay. Their general health, vital signs, lab tests,
      and pain medications will also be checked on a regular basis through the hospital stay. When
      a patient is feeling well enough to go home, the study drug (GMI-1070 or placebo) will be
      stopped, and the patient may go home. Participants will be asked to come back to clinic for a
      check-up a few days after leaving the hospital, and one month after leaving the hospital.
    

Intervention name(s): GMI-1070; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous GMI-1070 given twice a day during hospital stay for sickle cell pain crisis; Intravenous Placebo given twice a day during hospital stay for sickle cell pain crisis
Other intervention name(s): saline placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sickle Cell Disease