bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity
Condition: Obesity; Body Fat; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the study is to analyze the effects of Lipoic acid and/or EPA supplementation on
      weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters,
      metabolomic profile as well as on adipose tissue gene profile in healthy overweight/obese
      subjects following an energy-restricted diet.
    


Intervention name(s): Double blind dietary intervention with EPA and lipoic acid
Intervention type(s): Dietary Supplement
Intervention description(s): Placebo-controlled dietary intervention during 10 weeks. All groups will have a dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline, supplemented with eicosapentaenoic acid (EPA) and/or lipoic acid (LA).
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Calorie restriction; Eicosapentaenoic acid (EPA); Lipoic acid; Weight loss; Insulin sensitivity; Lipid metabolism; Adipokines; Inflammation; Oxidative stress; Adipose tissue gene profile; Metabolomic profile
Online Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients
Condition: Hemodialysis
Study type: Interventional

Summary: 
      this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high
      flux hemodialysis and low flux hemodialysis
    


Intervention name(s): online hemodiafiltration; high flux hemodialysis; low flux hemodialysis
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 20 patients on regular hemodialysis received online hemodiafiltration; 20 patients on regular hemodialysis received high flux hemodialysis; 20 patients on regular hemodialysis received low flux hemodialysis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb
      rehabilitation of post-stroke subjects with moderate and severe compromise.
    


Intervention name(s): Functional Electrical Stimulation (FES); Combination of Transcranial direct brain stimulation (tDCS) and FES
Intervention type(s): Device; Device
Intervention description(s): Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS); Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebrovascular Accident; Cerebrovascular Stroke; Cerebral Stroke
Inhaled Iloprost in Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to determine if inhaled iloprost given four times daily can
      improve symptoms and lung function in adults with mild asthma.
    

Detailed description: 
      Animal studies have suggested that prostacyclin may downregulate allergic inflammation, thus
      providing the scientific basis for trials of inhaled prostacyclin agonists such as iloprost
      for the treatment of asthma. This study will examine the tolerability of four times daily
      iloprost on asthma symptoms and pulmonary function over a two week treatment period.
    

Intervention name(s): Iloprost
Intervention type(s): Drug
Intervention description(s): Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days
Other intervention name(s): Ventavis
Intervention MeSH terms: Iloprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Asthma
Analgesia After Cesarean Section
Condition: Preeclampsia; Pregnancy
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia
      in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an
      effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of
      magnesium in parturients undergoing Cesarean section.
    


Intervention name(s): Magnesium Sulphate
Intervention type(s): Drug
Intervention description(s): Magnesium sulphate was infused for the management of preeclampsia at perioperative period.
Intervention MeSH terms: Magnesium Sulfate
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        medical record review
A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)
Condition: Human Immunodeficiency Virus; AIDS Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve
      participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity
      compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid
      (RNA) at 168 hours postdose.
    

Detailed description: 
      Up to five panels (Panels A-E) of 6 participants each will be enrolled in a sequential
      manner. In each panel, participants will receive a single dose of MK-8527 up to 50 mg.
      Historical data from previous single does studies will be used for placebo (control)
      comparisons.
    

Intervention name(s): MK-8527
Intervention type(s): Drug
Intervention description(s): Single oral capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia
Condition: Stroke; Aphasia
MeSH terms: Stroke; Aphasia; Aphasia, Broca
Study type: Interventional

Summary: 
      The aim of this study is to assess the safety and clinical efficacy of high or low-frequency
      repetitive transcranial magnetic stimulation based on brain activation with functional near
      infrared spectroscopy in poststroke nonfluent aphasia patients.
    

Detailed description: 
      In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies
      aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be
      achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory
      protocol to reduce activities in the contralesional area. However, most conventional rTMS
      studies employed an inhibitory low frequency protocol for the contralesional homologs of
      Broca's area.

      In the present pilot study, investigators will perform functional near-infrared spectroscopy
      (fNIRS) prior to rTMS treatment for selection of the most appropriate application of
      stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be
      determined by activation pattern from the fNIRS findings with language task in individual
      patients.
    

Intervention name(s): High frequency rTMS; Low frequency rTMS
Intervention type(s): Device; Device
Intervention description(s): Most activated area from fNIRS findings: Perileisional Broca's area, High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session; Most activated area from fNIRS findings: Contralesional homologs of Broca's area, Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
Condition: Tuberculosis (TB)
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals'
      candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
    


Intervention name(s): GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
Crestal vs Lateral Sinus Lift Augmentation
Condition: Edentulous Alveolar Ridge; Bone Atrophy, Alveolar
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The aim of this randomised controlled trial (RCT) of split-mouth design was to compare
      patient preference and effectiveness of two different techniques for lifting the maxillary
      sinus: the crestal approach versus the lateral window approach.
    

Detailed description: 
      Each patient having bilateral edentulism in posterior maxillae was randomised to receive one
      partial fixed prosthesis supported by one to three implants placed either with a crestal or
      with lateral window sinus lift procedure.

      Eligibility criteria for participants

      Only healed implant sites were considered (at least 3 months after tooth extraction). The
      vertical bone height at the implant sites to be included had to be between 2 to 6 mm and bone
      thickness at least 6 mm as measured on cone-bean computed tomography (CBCT) scans.

      Patients were not admitted in the study if any of the following exclusion criteria was
      present:

      general contraindications to implant surgery subjected to irradiation in the head and neck
      area immunosuppressed or immunocompromised treated or under treatment with intravenous
      amino-bisphosphonates poor oral hygiene and motivation untreated periodontal disease
      uncontrolled diabetes pregnant or lactating substance abusers psychiatric problems
      unrealistic expectations lack of opposite occluding dentition/prosthesis in the area intended
      for implant placement acute or chronic infection/inflammation in the area intended for sinus
      augmentation/implant placement referred only for implant placement who cannot be
      rehabilitated and followed at the treatment centre unable to attend a 5-year post-loading
      follow-up. Smokers were included and patients were categorised into three groups according to
      what declare: i) non-smokers; ìì) moderate smokers, if smoking up to 10 cigarettes/day; iii)
      heavy smokers if smoking more than 10 cigarettes/day.

      Patients were recruited and treated in one private practice in Tirana, Albania by two
      operators: Marco Tallarico who performed all surgical interventions and Erta Xhanari who
      performed all prosthetic and maintenance procedures.
    

Intervention name(s): Maxillary sinus augmentation
Intervention type(s): Procedure
Intervention description(s): Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.
Other intervention name(s): Sinus lift
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental implants; Maxillary sinus augmentation; Crestal approach
Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
Condition: Idiopathic Hypercalciuria; Hypokalemia Caused by Thiazide Diuretics
MeSH terms: Hypokalemia; Potassium Deficiency; Hypercalciuria
Study type: Interventional

Summary: 
      Kidney stone formation due to an excess of calcium in the urine is a common problem. It is
      treated with thiazide diuretics. These drugs often cause excessively low blood potassium
      levels that in turn require large doses of potassium supplements. These supplements are often
      large, unpleasant and easy to forget. We are trying the addition of spironolactone to these
      patients' medications to see if it allows them to take a lower dose of potassium.
    

Detailed description: 
      See rationale above

      Ten patients who have had multiple kidney stones primarily due to hypercalciuria and who are
      currently on stable dose of thiazide or thiazide plus amiloride will be enrolled in the
      study. In addition, pts have to require at least 60mEq of K supplementation a day or be on
      40mEq and be hypokalemic and unable to tolerate increased K supplements. We will then give
      them 50mg a day of spironolactone for four weeks. A complete 24-hour urine stone profile will
      be obtained before and after the drug is administered. After four weeks the patients' serum
      potassium will be rechecked, and their dose will be lowered according to a nomogram.

      Primary end point is the mean change in serum K before and after spironolactone. Secondary
      endpoints are the change in urine calcium on and off the drug and the mean reduction in K
      dose on the drug.
    

Intervention name(s): Spironolactone
Intervention type(s): Drug
Intervention MeSH terms: Spironolactone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nephrolithiasis; hypercalciuria; hypokalemia; thiazide diuretics
Peripheral Benzodiazepine Receptors (PBR28) Brain PET Imaging With Lipopolysaccharide Challenge for the Study of Microglia Function in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To examine the differences in the capacity to activate microglia in patients with Alzheimer's
      Disease (AD) compared to age-comparable cognitively normal subjects and younger healthy
      controls.
    

Detailed description: 
      The primary outcome is Microglia Activation Reserve Index (MARI) (calculated in the parietal
      region of interest (ROIs)) in AD patients compared to elderly controls. The researchers will
      recruit up to 20 participants. The investigators will use 7 AD and 7 comparably aged
      cognitively normal successfully scanned subjects to calculate the microglial activation
      reserve index. The expectations are significant differences between the two groups suggesting
      altered reactivity of the microglia in AD. The result would be an exciting one suggesting at
      least one mechanism by which some patients with significant amyloid load have progressive
      dementia while comparable others are either cognitively normal or have stable Mild Cognitive
      Impairment (MCI). It will also suggest avenues for intervention in amyloid positive MCIs to
      prevent progression to Alzheimer's dementia. The exploratory analysis will include:

        1. Effects of aging on MARI: The researchers will evaluate the effects of aging on MARI.
           Comparisons will be made for MARI between cognitively normal elderly and the 8 healthy
           individuals to whom the investigators applied this protocol in an earlier study. The
           reactivity of microglia is reported to change with age and so the investigators expect
           MARI to change in the cognitively normal elderly. However, the expectation is that the
           differences between the young and elderly cognitively normal subjects to be small
           relative to the comparison of AD and elderly normal controls.

        2. Effects of amyloid on MARI: The researchers will look at the relationship of regional
           and global amyloid load to MARI. The presence of a relationship suggests that one of the
           reasons for altered microglial reactivity might be interactions of microglia with
           pathologic amyloid.

        3. Effects of MARI on cognition: The researchers will explore whether MARI would correlate
           with the measure of disease stage, with higher MARIs associated with worse
           neuropsychological score and more severe disease. The researchers will look for
           correlations between MARI and the individual neuropsychological scores. This would
           determine if disease severity is correlated with microglial activation reserve.
    

Intervention name(s): LPS
Intervention type(s): Drug
Intervention description(s): LPS (0.4 ng/kg)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Varied Estrogen Doses on Endometrial Receptivity
Condition: Luteal Phase Defect
Study type: Observational

Summary: 
      This study will help determine the effect of varied estradiol levels on the uterine lining in
      healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.
    

Detailed description: 
      Volunteers who wish to participate in the study, will undergo a diagnostic and screening
      phase to determine their eligibility. Once eligibility is determined, participants will
      undergo three, separate "endometrial preparatory cycles". These cycles will consist of
      estrogen supplementation to mimic normal, above normal, and highly elevated estradiol levels.
      Once supplementation is complete uterine procedures will be done to hopefully determine the
      effects of the estrogen levels on the uterine lining. Subcutaneous leuprolide injections,
      intramuscular estrogen, and progesterone injections will be used to mimic the levels needed.
      Blood draws will monitor the needed estradiol and progesterone levels during the injection
      phase of the cycle. Once the injection phase is complete, transvaginal ultrasound, uterine
      aspiration, and endometrial biopsy will be done.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy human subjects
Effect of Physical Therapy on Breast Cancer Related Lymphedema
Condition: Lymphoedema; Breast Cancer
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      The objective of this study is to investigate if Complete Decongestive Therapy is equally
      effective whether it includes manual lymphatic drainage or not in the treatment of
      lymphoedema among patients with breast cancer.
    

Detailed description: 
      Physical therapy treatment of patients with lymphoedema includes treatment based on the
      principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components;
      skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of
      treatment of treatments is most effective, the scientific evidence is sparse. Studies have
      focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not
      consistent.

      A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with
      lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment
      groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive
      TherapyB (except manual lymphatic drainage
    

Intervention name(s): Physical TherapyA; Physical TherapyB
Intervention type(s): Procedure; Procedure
Intervention description(s): Group A:
Skin care
Manual lymphatic drainage
Bandaging using Coban™2Lite
Guidance on physical activity; Group B:
Skin care
Bandaging using Coban™2Lite
Guidance on physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
Condition: Secondarily Infected Traumatic Lesions (SITL); Impetigo
MeSH terms: Impetigo
Study type: Interventional
Phase: Phase 2

Summary: 
      A national, prospective single arm phase II study investigating the pharmacokinetics and
      safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with
      impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be
      enrolled.
    


Intervention name(s): 2% TD1414 Cream
Intervention type(s): Drug
Intervention description(s): Application 3 times daily for 7 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea
Condition: Vomiting Syndrome; Irritable Bowel Syndrome; Postural Orthostatic Tachycardia Syndrome; Abdominal Pain; Chronic Nausea
MeSH terms: Irritable Bowel Syndrome; Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome; Nausea; Vomiting; Abdominal Pain
Study type: Observational

Summary: 
      Retrospectively review the charts of all children who had heart rate variability, deep
      breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing,
      quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's
      Hospital of Wisconsin.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),
        Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain
        (FAP)
      
Keywords: Chart must reveal the following procedures:; Heart rate variability,; Deep Breathing Test,; Valsalva maneuver,; Table test,; Thermoregulatory Sweat Testing,; Quantitative Sudomotor Axon Reflex Test (QSART),; Vital signs,; postural changes in heart rate and blood pressure,; composite autonomic score