bioihbjkbjnl/mcl2 huggingface dataset:
Mirror Box Imaging Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of mirror box therapy on upper
      extremity, motor recovery and motor functioning in patients that have suffered a stroke.
    

Detailed description: 
      Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors,
      with 30%-60% of patients being unable to fully recover functional use of their upper limbs.
      As recovery may be due to insufficient or inadequate therapeutic interventions, the progress
      and evaluation of upper limb treatment is currently being investigated.

      Mirror Box therapy is a task orientated, non-invasive, economic and patient directed therapy
      for hemiparetic upper limb post stroke patients. The study is intended to evaluate cerebral
      reorganization by using mirror therapy. Movements of the stronger limb trick the brain into
      thinking that the weaker arm is moving and to stimulate the respective brain areas.

      Patients are enrolled into two groups using standard upper limb rehabilitation for three
      weeks followed by standard rehabilitation plus Mirror Box for another three weeks (Group 1).
      Group 2 will receive the same therapy in inverted order.

      Patients will receive clinical and functional assessment at baseline, three weeks and six
      weeks including brain MRI using functional resting state MRI.

      The primary outcome is functional connectivity (correlation coefficient) at baseline and
      after treatment. Secondary endpoints include motor and functional recovery using outcome
      measures like Fugl Meyer assessment, Action Research Arm Test, grip and pincer strength.
      Further secondary endpoints are increase in sensorimotor cortex activation across the period
      of therapy and cortical reorganization.
    

Intervention name(s): Mirror Box therapy
Intervention type(s): Other
Intervention description(s): In mirror box therapy the patient uses the reflection of their good arm to trick to brain into thinking that the effected arm is working.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed
      nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed
      prostate cancer, using a fixed dose escalation schema every 21 days.
    

Detailed description: 
      Human aspartyl-asparaginyl-β-hydroxylase (HAAH), also known as aspartate-β-hydroxylase, is an
      ~86 kDa type 2 transmembrane protein that belongs to the α-ketoglutarate-dependent
      dioxygenase family. It is a highly conserved enzyme, which catalyzes the hydroxylation of
      aspartyl and asparaginyl residues in epidermal growth factor-like domains of proteins
      including Notch and homologs. HAAH was initially identified in a novel screen to identify
      cell surface proteins up-regulated in liver cancer. It has subsequently been detected in a
      diverse array of solid and blood cancers, including: liver, bile duct, brain, breast, colon,
      prostate, ovary, pancreas, and lung cancers as well as leukemia. HAAH is not found in
      significant quantities in normal tissue or in proliferative disorders.

      The investigators have designed a bacteriophage lambda system to display HAAH peptides fused
      at the C terminus of the head protein gpD of phage lambda. The phage carry 200-300 copies of
      the gpD protein on their head and thus display many copies of an approximately 25 kDa
      molecular weight fragment of HAAH on their surface. The drug substance is one of these HAAH
      bacteriophage lambda constructs: HAAH-1λ (PAN-301-1).

      This study evaluates the safety and immunogenicity of the PAN-301-1 vaccine in patients with
      biochemically-relapsed prostate cancer.
    

Intervention name(s): PAN-301-1
Intervention type(s): Biological
Other intervention name(s): SNS-301
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis
Condition: Pain; Inflammation
MeSH terms: Osteoarthritis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effects of tart cherry juice to reduce pain and
      inflammation among individuals with arthritis.
    

Detailed description: 
      Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and
      a study among healthy, non-exercising individuals demonstrated that cherry consumption
      decreased serum inflammatory biomarkers after 14 days. Osteoarthritis (OA) is a common
      syndrome affecting 65 million Americans characterized by pain, inflammation, and disability.
      Such natural anti-inflammatory effects of cherry consumption may be beneficial for the
      management and treatment of osteoarthritis and inflammatory diseases. The purpose of this
      randomized, double-blind, placebo controlled study is to examine individuals with
      inflammatory OA and assess the analgesic and anti-inflammatory effects of tart cherry juice
      as compared to a placebo drink among twenty 30-70 y/o OA subjects.
    

Intervention name(s): tart cultivar Montmorency cherry juice
Intervention type(s): Dietary Supplement
Intervention description(s): 21 ounces of experimental or placebo juice, consumed daily for 21 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; inflammation; osteoarthritis
Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma
Condition: Liposarcoma of Soft Tissue; Surgical Procedure, Unspecified
MeSH terms: Liposarcoma; Recurrence
Study type: Observational

Summary: 
      Soft tissue sarcomas are rare malignant tumors. Liposarcoma constitute the most frequent
      histological subtype of retroperitoneal sarcoma. The prognosis of soft tissue sarcomas depend
      on clinical and histologic characteristics. Objective: Evaluate variables that may be related
      to overall survival and local recurrence free survival in patients with retroperitoneal
      liposarcoma. Methods: retrospective analysis of medical records of 60 patients attended from
      1997 to 2017, who underwent surgical resection of retroperitoneal liposarcoma.
    


Intervention name(s): Retroperitoneal Liposarcoma resection
Intervention type(s): Procedure
Intervention description(s): Retroperitoneal Liposarcoma resection
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients attended at the University of São Paulo Medical School Hospital (HC-FMUSP) and
        the Cancer Institute of the State of São Paulo (ICESP) from 1997 to 2017, who underwent
        surgical resection of the primary tumor at these institutions, as well as those referred
        after resection at other services.
      
Keywords: retroperitoneal liposarcoma; overall survival; local recurrence free survival
Exercise and Ectopic Fat Deposition
Condition: Overweight
MeSH terms: Cardiac Complexes, Premature; Overweight
Study type: Interventional

Summary: 
      Excess ectopic fat deposition is associated with development of cardiovascular and metabolic
      diseases. This study investigates how lifestyle interventions can have an effect on different
      sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the
      clinical and economic value of exercise to supplement a hypocaloric diet is investigated.

      Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women
      during consultations. Also, recruitment posters will be used in the University Hospital of
      Antwerp and the University of Antwerp. Potential participants meeting all a priori set
      inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric
      diet group (usual care) or a group of hypocaloric diet combined with physical fitness
      training. Both groups will undergo an intake procedure in which personal goals are set and
      barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by
      imaging techniques after three and six months of intervention. Based on the known
      relationship between ectopic fat and cardiovascular outcomes, the short term study results
      will then be extrapolated to an estimation of the reduction of cardiovascular events.

      The following clinical outcomes will be presented: change in ectopic fat in the abdomen
      (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids),
      heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The
      impact of supervised exercise in addition to diet will be expressed in projected healthcare
      costs and quality adjusted life years.
    

Detailed description: 
      protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87)
    

Intervention name(s): lifestyle intervention (diet OR diet+exercise)
Intervention type(s): Behavioral
Intervention description(s): diet or diet+fitness training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: overweight; ectopic fat; exercise; diet
Almonds and Health Effects on Metabolism, Vascular Function and Cognition
Condition: PreDiabetes; Impaired Glucose Tolerance; Impaired Fasting Glucose; Overweight and Obesity
MeSH terms: Overweight; Glucose Intolerance
Study type: Interventional

Summary: 
      The primary objective of the proposed study is to examine and understand the impact of
      long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose
      tolerance and/or impaired fasting glucose.
    

Detailed description: 
      Objectives:

      Secondary objectives are to investigate if improved chronic glucose metabolism in subjects
      with impaired glucose tolerance and/or impaired fasting glucose after long-term almond
      consumption translates into improved peripheral and brain vascular function, and enhanced
      cognitive performance. In addition, the investigators will address to what extent improved
      chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired
      fasting glucose after long-term almond consumption can be explained by (combined) effects of
      lowered hepatic lipid accumulation and inflammation, skeletal muscle characteristics,
      visceral and subcutaneous fat accumulation, pancreatic function or fecal microbiota
      composition.

      Study design:

      The proposed study will be a 12 months randomised, controlled trial with a cross-over design.
      Two experimental periods of five months will be separated by a two months washout period.

      Study population:

      Forty-three impaired glucose tolerant and/or impaired fasting glucose subjects, with
      overweight and mild obesity (BMI 25-35 kg/m2), aged 40-70 years.

      Intervention:

      During the intervention period of 5 months, subjects will receive daily 50 gr almonds, but
      not in the 2 months washout and 5 months control periods.
    

Intervention name(s): Almonds
Intervention type(s): Dietary Supplement
Intervention description(s): During the intervention period of 5 months, subjects will receive daily 50 gr almonds. Subjects are free to consume the almonds during the day whenever they want to, i.e. there will not be guidelines when to consume the almonds.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week
      dispensing study. Subjects will wear both Test and Control lenses in each eye in a random
      order for 1-week each as a daily disposable modality with a wash-out period of 1 week between
      the wearing periods.
    


Intervention name(s): 1-DAY ACUVUE® MOIST; 1-DAY ACUVUE® MOIST
Intervention type(s): Device; Device
Intervention description(s): etafilcon A contact lenses made with a new manufacturing technology; etafilcon A contact lenses made with the current manufacturing technology
Other intervention name(s): Test; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if multiple doses of vancomycin over the course of
      3 months will perturb the intestinal flora (microbiome) and result in reduced serum
      concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the
      study will permit investigators to assess the variability of serum uremic retention solute
      concentrations with and without antibiotic over a three-month period.
    


Intervention name(s): Vancomycin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral vancomycin 250mg capsules; Placebo Pills distributed by Research Pharmacy labeled "placebo."
Other intervention name(s): vancomycin hydrochloride capsules
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized double-blinded placebo-controlled crossover study
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
Condition: Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      Ketone ester supplementation has become increasingly popular as an athletic supplement.
      However, the metabolic effects of these supplements on exercise performance are
      controversial. One potential reason for lack of an ergogenic benefit could be the effects of
      ketone bodies on other bodily systems, such as the sympathetic nervous system. During
      exercise and stress the body increases the activity of the sympathetic nervous system. This
      causes blood vessels to constrict (get smaller) and can increase blood pressure. Studies have
      shown that ketone bodies can suppress the sympathetic nervous system in mice. Additionally,
      ketone ester supplementation can reduce blood pressure in healthy adults. In humans, direct
      measures of sympathetic activity are usually made from sympathetic outflow to muscle, also
      called muscle sympathetic nerve activity (MSNA). Using a ketone ester supplement, the
      investigators plan to measure blood pressure and sympathetic outflow to muscle at rest and
      during handgrip exercise and a mathematical task stress test to investigate the effect of
      ketones on neuro-cardiovascular stress responses.
    


Intervention name(s): D-beta-hydroxybutyrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.; Isocaloric flavored water with medium-chain triglyceride oil.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
ConsCIOUS2 Study of the Isolated Forearm Technique Commands
Condition: Anesthesia Awareness
MeSH terms: Intraoperative Awareness
Study type: Interventional

Summary: 
      ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test
      (IFT) responder while under anesthetic.
    

Detailed description: 
      500 participants between the ages of 18-40 who will be undergoing surgery requiring general
      anesthetic will be recruited for this study. This study will use the Isolated Forearm Test
      (IFT) to identify patients at risk of anesthesia awareness. In the IFT, induction of
      anesthesia is followed by inflation of a cuff on the dominant arm before neuromuscular
      blockade (paralysis) is induced. The cuff prevents paralysis of the hand allowing the patient
      to communicate to an observer through predefined hand movements, typically following a
      command like: "Mrs. Jones, if you can hear me, squeeze my hand". Participants will thus be
      asked to follow a series of commands intraoperatively to assess awareness.

      Routinely recorded clinical data will be collected to frame the observations about IFT
      responsiveness, and non-invasive EEG data will also be collected to provide information about
      the "brain state" of the patients. Patient reported confusion and objectively measured
      confusion using the Nurse Based Delirium Screening Tool (NuDesc) will be collected post
      operatively. Finally, participants will be contacted 24 hours and 7 days following their
      operation to complete an anesthesia satisfaction questionnaire.
    

Intervention name(s): IFT Testing1; IFT Testing 2; IFT Testing 3; IFT Testing 4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Command List A; Command List B; Command List C; Command List D
Other intervention name(s): Command List A; Command List B; Command List C; Command List D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Consciousness; Electroencephalography; Anesthesia
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label prospective non-comparative ascending dose randomized cohort study of single and
      multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
    

Detailed description: 
      Open-label prospective non-comparativerandomized cohort study of safety, tolerability,
      pharmacokinetics and the effect of food of PBTZ169 in adult healthy volunteers after single
      and multiple oral administration. Study was conducted in one study center in the Russian
      Federation. The study included two stages:

      Stage 1 - single or double oral administration with dose escalation (fasted/after meal) in 5
      cohorts 10 healthy volunteers each plus 5 back-up volunteers;

      Stage 2 - multiple oral administration once a day after meal for 14 days in 1 cohort of 10
      healthy volunteers.
    

Intervention name(s): PBTZ169 640 mg OD; PBTZ169 640 mg BiD; PBTZ169 960 mg SD; PBTZ169 1280 mg SD; PBTZ169 1280 mg MD
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Two administrations once a day with a wash-out period: food effect; Twice a day fasted; 1 day of administration; Once a day fasted; Once a day fasted; Once a day after meal, 14 doses
Other intervention name(s): Macozinone (PBTZ169); Macozinone (PBTZ169); Macozinone (PBTZ169); Macozinone (PBTZ169); Macozinone (PBTZ169)
Intervention MeSH terms: Macozinone
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PBTZ169; Macozinone; Antimycobacterial; Tuberculosis; Drug Resistant Tubercolosis; MDR-TB; XDR-TB
Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The IMASH trial is a simple, randomized, double-blinded, placebo-controlled, multi-center
      trial to answer the question: "Does intravenous magnesium sulfate improve clinical outcome
      after aneurysmal subarachnoid hemorrhage?"
    

Detailed description: 
      Vasospasm worsen outcome in patients with aneurysmal subarachnoid hemorrhage (ASAH).

      Magnesium is known to dilate cerebral arteries and to block N-methyl-D-aspartate receptors in
      the injured neurons.

      Intravenous magnesium may prevent vasospasm after subarachnoid hemorrhage and may protect
      neurons against damage during established vasospasm.

      The IMASH trial is a randomized, placebo-controlled, double-blinded, multi-center trial to
      evaluate the effect that intravenous magnesium sulfate infusion on the clinical outcome of
      patients with aneurysmal subarachnoid haemorrhage.

      Methods:

      After obtaining randomisation code:

        -  Start MgSO4 20 mmol over 30 minutes, followed by infusion of 80 mmol/day or equivalent
           volume of saline within 48 h after onset of symptom,

        -  Study drug to be infused for 14 days from the day of hemorrhage (regarded as day 0).

        -  Measure plasma magnesium concentration daily and perform transcranial Doppler to monitor
           blood flow velocities of both middle cerebral arteries and extracranial segment of the
           internal carotid arteries.

        -  Plasma magnesium concentration in the IV MgSO4 group should be raised to 2.0-2.5 mmol/L
           or twice the serum baseline level. Patients that are randomized to saline infusion will
           only have their magnesium levels normalized if there is a clinical indication to do so.

      Outcome assessment Primary outcome: Extended Glasgow Outcome Scale at six months Secondary
      outcome: Incidence of clinical vasospasm, Barthel Index; modified Rankin score, modified
      National Institute of Health Stroke Score, MCA velocities, other major complications

      Study duration:

      6 years with a refined sample size of 340 after analysis of pilot study data; with planned
      interim analysis.
    

Intervention name(s): Intravenous magnesium sulfate infusion
Intervention type(s): Drug
Intervention description(s): 80mg per day
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: subarachnoid hemorrhage; magnesium sulfate