bioihbjkbjnl/mcl2 huggingface dataset:
The Dual-task Training Under Different Priority Instructions on Gait Speed in Community-dwelling Older Adults
Condition: Gait; Postural Balance
Study type: Interventional

Summary: 
      This study analyzed the effect of different modalities of dual-task training in the
      improvement of gait biomechanics, postural balance, falls episodes, executive functioning,
      and quality of life in community-dwelling older adults. Half of the participants have
      undertaken a dual-task protocol training with progression from variable-priority to
      fixed-priority instructions, while the other half have undertaken a dual-task protocol
      training under variable-priority instructions.
    

Detailed description: 
      Although dual-task training for improving postural balance is an emerging interest area, the
      effects of dual tasks and dual-task training on static and dynamic postural stability remain
      unclear. Even though variable (alternating) instructional priority dual-task training has
      been shown higher effect than fixed (concurrent) priority dual-task training approach to
      improving the balance impairments, we must consider in everyday pragmatic situations, motor,
      and cognitive tasks are often demanded simultaneously and this requires an individual's
      attention toward an external source of attention while performing a primary task. Then, our
      rationale for this study is older adults who underwent a training protocol composed of a dual
      task with variable and fixed instructional priority will achieve better improvements
      regarding the studied variables in comparison to the group who will be submitted a protocol
      composed only by dual-task with variable priority training. Therefore, this protocol for a
      six-month, double-blind, randomized controlled trial with six-month follow-up post-training
      analyzed whether examine whether a dual-task protocol training with progression from variable
      priority to fixed priority instructions is effective in improvement of gait biomechanics,
      postural balance, falls episodes, executive functioning and quality of life in
      community-dwelling older adults.
    

Intervention name(s): Dual task with variable- and fixed-priority instructions; Dual-task with variable-priority instructions
Intervention type(s): Other; Other
Intervention description(s): The participants were asked to perform dual-task activities focused, interchangeable or simultaneously, on balance (motor tasks) and on cognitive tasks performance, according to the instructional priority established by the physical therapist.; The participants were asked to spend half the session focused on balance (motor tasks) and half the session focused on cognitive tasks performance, according to the instructional priority established by the physical therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Epigenetic Reprogramming in Relapse/Refractory AML
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study using decitabine and vorinostat before and during chemotherapy with
      fludarabine, cytarabine and G-CSF (FLAG).
    

Detailed description: 
      Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of
      demethylating agents and HDAC inhibitors in combination have been previously shown to have
      synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in
      human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal
      cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the
      leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This
      study will ask the question as to whether or not the combination of decitabine and vorinostat
      followed by chemotherapy is feasible and whether it can positively impact outcome in patients
      with relapsed or refractory acute myelogenous leukemia.
    

Intervention name(s): Decitabine; Vorinostat; Filgrastim (G-CSF); Fludarabine; Cytarabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose Level #0: 5 mg/m2 Dose Level #1: 7.5 mg/m2 Dose Level #2: 10 mg/m2 Dose Level #3: 15 mg/m2 Dose Level #4: 20 mg/m2 given IV over __ hour on days 1 through 5; Age <18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.; Given on days 5 until evidence of ANC recovery (>500/µL)5µg/kg/dose IV or SQ (starting at hour 0); 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF); 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
Other intervention name(s): Dacogen; Zolinza, SAHA, suberoylanilide acid; G-CSF, neupogen; Fludara; Cytosine arabinoside, Ara-C, Cytosar
Intervention MeSH terms: Cytarabine; Fludarabine; Decitabine; Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapse; Myelogenous; Leukemia; Refractory; Acute; Pediatric
MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage; Basal Ganglia Hemorrhage
MeSH terms: Cerebral Hemorrhage; Intracranial Hemorrhages; Basal Ganglia Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The primary objective of this trial is to provide preliminary safety data of minimally
      invasive endoscopic surgery using the Axonpen™ system for spontaneous intracerebral
      hemorrhage (ICH). The effectiveness of the Axonpen™ system in early hematoma removal and the
      surgical impact on subject's functional recovery will also be evaluated.

      The Axonpen™ system, consisting of a neuroendoscope (Axonpen) and a monitor (Axonmonitor), is
      cleared by FDA and indicated for the illumination and visualization of intracranial tissue
      and fluids and the controlled aspiration of tissue and/or fluid during surgery of the
      ventricular system or cerebrum.
    

Detailed description: 
      In the present trial, the FDA-cleared Axonpen™ system was applied on the ICH surgery. The
      Axonpen™ System is a neuroendoscope combined with the functions of hematoma aspiration and
      irrigation, aiming to minimize surgical brain injury, optimize surgical procedure, and be
      available for early hematoma evacuation.

      The technique of minimally invasive endoscopic neurosurgery for ICH is still considered in
      development; however, a retrospective study [Kuo et al.] has shown that early and complete
      evacuation of ICH may lead to improved outcomes in selected patients, where the neurosurgeons
      utilized combination of the existing instruments, such as a rod-lens endoscope with
      irrigation system and a suction coagulator, to enable visualization, aspiration, and
      irrigation of the hematoma to be worked simultaneously. The technology employed and the
      results revealed in the previous study provide a proof of concept for the Axonpen™ system,
      and also imply that the current device could be safe and effective in the management of ICH.
    

Intervention name(s): Axonpen system
Intervention type(s): Device
Intervention description(s): The Axonpen™ system, containing the Axonpen and the Axonmonitor, has been cleared for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum.
The Axonpen is a neuroendoscope integrated with suction (sourced from hospital vacuum) and irrigation (sourced from third-party saline infusion bag) functions. The Axonmonitor is used for view and storage of the endoscopic image. The Axonpen™ system is intended to optimize the procedure of minimally invasive neurosurgery for early ICH evacuation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage; ICH; Stroke; Endoscopic Hematoma Evacuation; Minimally Invasive Surgery; Endoscopic Neurosurgery
A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter-
      and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as
      Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to
      healthy subjects Receiving a low-fat Meal.
    


Intervention name(s): Avatrombopag maleate 40 mg
Intervention type(s): Drug
Intervention description(s): Avatrombopag maleate 40 mg (2 x 20 mg tablets- all doses are expressed as avatrombopag, the amount of free base) given with 240 mL water in three single oral doses, one during each of three treatment periods. Participants randomized to one of three treatment sequences:
Fed, Fed, Fasted; or
Fed, Fasted, Fed; or
Fasted, Fed, Fed
During the Fasted period, participants must have fasted for at least a 10-hour overnight fast and to refrain from eating for 4 hours.
During the Fed period, participants were allowed approximately 30 minutes to eat a low-fat breakfast and required to take the drug within 15 minutes of completion of breakfast.
Randomization Phase consists of three single-dose treatment periods:
Treatment Period 1 and 2 separated by a 7-day washout interval. Treatment Period 2 and 3 separated by a 28-day washout interval. Treatment period 3 and the Follow-up/ Termination Visit will be separated by a 30-day (+1 day) washout interval.
Other intervention name(s): E5501
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)
Condition: Infertility; Subfertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To assess the impact of the female genital microbiome on ART outcome.
    

Detailed description: 
      The main objective of this study is to learn more about which microbial spectra are
      negatively or positively impacting IVF pregnancy outcome. This information is needed before
      proceeding to the next step in which an adaptation of the microbiome can be attempted to
      improve IVF outcome. The study is expected to shed light over the possible influence of the
      microbiome on causes for subfertility, endometrial receptivity and obstetrical complications.
      A diagnostic link may be found with entities that are often unexplained today, e.g.
      (recurrent) miscarriage and repeated implantation failure.
    

Intervention name(s): 3 Sampling points
Intervention type(s): Other
Intervention description(s): When entering the in-vitro fertilization/intracytoplasmatic sperm injection 4 samples will be harvested: a rectal swab, a cervical swab, a vaginal swab and an intra-uterine sample using an empty embryo catheter. After the ovarian stimulation treatment, the same patients will be sampled two more times: once at the moment of oocyte retrieval (rectal, cervical, vaginal and intra-uterine samples) and again just before the embryo transfer (at this stage, the embryo culture medium will be harvested, as well as an intra-uterine sample using the tip of an empty embryo inner catheter before the embryo transfer and a rectal sample)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing in-vitro fertilization
      
Biospecimen description: 
      Microbiome analysis using 16S ribosomal RNA sequencing
    
Keywords: Assisted reproductive technologies; Microbiome
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A
      inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This
      rationale is based on several findings from previous work: 1) cigarette smoke contains
      constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2)
      that severity of depression symptoms after smoking abstinence is correlated with the level of
      MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was
      found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women
      show a greater association between smoking and depression than men and women smokers in our
      previous trials report smoking to alleviate symptoms of depression to a greater extent than
      men.
    


Intervention name(s): Nicotine Patch; Moclobemide
Intervention type(s): Drug; Drug
Intervention description(s): Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks); Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
Other intervention name(s): Nicoderm; reversible MAO-A inhibitor
Intervention MeSH terms: Moclobemide; Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nicotine addiction; Smoking Cessation; Quit Smoking; moclobemide; Nicotine Patch
EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus
Condition: Diabetes Mellitus Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)
      supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum
      levels of some indicators of vascular inflammation, and the gene expression of PON2 in the
      peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.
    

Detailed description: 
      The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)
      supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and
      several indicators of vascular inflammation and the gene expression of PON2 in the peripheral
      blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this
      randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women
      aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes
      Association. After signing informed consent, all individuals complete a general information
      form. a 24-hour food recall for 3 days will be taken from the participants at the beginning
      and the end of the study,. Selected samples are randomly classified into 2 blocks of groups
      receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The
      supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also
      receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and
      size). Patients are recommended to sustain their diets and medication dose (s) during the
      study and also advised to maintain a constant level of physical activity. Blood samples will
      be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters,
      target gene expression and physical activity before and after the trial will be measured.
    

Intervention name(s): EPA Supplement; EPA Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.; EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.
Other intervention name(s): Eicosapentaenoic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: EPA; Paraoxonase 1; Paraoxonase 2; Type 2 diabetes
AURAIA Study : Impact Evaluation at 3 Months Follow-up of a Brief Motivational Intervention in Reducing Alcohol Consumption Among Adolescents Aged 16-24 in Pontchaillou Hospital Emergency Department in Rennes, France
Condition: Alcohol Abuse, Episodic Drinking Behavior
MeSH terms: Emergencies; Alcoholism; Alcohol Drinking; Drinking Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a Brief Motivational
      Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful
      drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested
      positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.

      Patients receive either an information leaflet or an information leaflet plus a referral to a
      psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face
      interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are
      also invited to attend the BMI session. If necessary, patients can be referred to relevant
      care and treatment services for alcohol misuse.

      In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are
      allocated to the treatment group and 140 to the control group. Randomisation is stratified
      according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used
      for randomisation.

      Alcohol consumption is measured by self-report at 3 months. The principal criteria used to
      assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks
      in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking
      and driving, sexual intercourse without protection will also be assessed. It is the first
      clinical trial in France comparing these two interventions among young patients in ED with
      this design.
    

Detailed description: 
      Eligible patients are recruited by ED physicians. Staff in ED involved in the study is
      provided with a teaching session on the importance of alcohol misuse and inclusion
      procedures. Prior to enrolment, a written informed consent is requested from every patient.
      For patients under 18, a consent form is also requested from parent(s) or the legal tutor.
    

Intervention name(s): Brief Motivational Intervention (BMI); Simple written advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive an information leaflet plus a referral to a psychologiste. BMI is provided by the psychologist. BMI consists in a first face-to-face interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are also invited to attend the BMI session.; Patients receive an information leaflet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: alcohol; hazardous or harmful drinking; emergency department (ED)
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on
      alternate dosing schedules will enhance the immune response to the vaccine in a low-resource,
      high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose
      vaccine schedule at a slightly older age and giving an additional dose of the vaccine.
    


Intervention name(s): Human Rotavirus Vaccine
Intervention type(s): Biological
Intervention description(s): Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age, 10 & 14 weeks of age, or 6, 10, & 14 weeks of age, depending on study arm assignment.
Other intervention name(s): Rotarix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Condition: Acellular Pertussis; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b; Tetanus; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this booster study is to evaluate, in subjects primed in the primary study
      106786, the persistence, at the time of the booster vaccination, of antibodies elicited by
      the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will
      also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This
      protocol posting deals with the objectives and outcome measures of the booster phase. The
      objectives and outcomes measures of the primary phase are presented in a separate protocol
      posting (NCT = 00376779).
    

Detailed description: 
      This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
    

Intervention name(s): Infanrix Hexa
Intervention type(s): Biological
Intervention description(s): Vaccine administered as a booster dose at 16-20 months of age
Other intervention name(s): GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hexavalent vaccine; Booster