bioihbjkbjnl/mcl2 huggingface dataset:
Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, randomized, three period, placebo- and positive-controlled,double-blind,
      double-dummy, crossover study will be performed with approximately 80 healthy male and female
      subjects. The effects of single doses of exenatide (10 μg, subcutaneous), moxifloxacin (400
      mg, oral) or placebo(subcutaneous or oral) on QT interval will be assessed.
    


Intervention name(s): exenatide; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneously injected, 10 mcg, single doses; oral, 400 mg tablet, single doses; Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Amylin; Eli Lilly; exenatide; moxifloxacin
Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      pain control in pediatric renal transplant is a major concern. the main goal during
      anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to
      that of the adult donor. epidural analgesia is thought to be very effective in pain control.
      this study emphasises the ease of application of epidural catheter via the caudal route to
      the lower thoracic level; avoiding possible complications that may arise from lumbar or
      thoracic routes, and its effects on hemodynamics when using analgesic doses of local
      anesthetics and narcotics.
    


Intervention name(s): B-Braun, Perifix® ONE Paed, Germany; Pethidine; Propofol; Bupivacaine; Fentanyl
Intervention type(s): Device; Drug; Drug; Drug; Drug
Intervention description(s): caudal epidural catheterization bupivacaine fentanyl; pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia; fentanyl propofol atracurium besylate
Intervention MeSH terms: Fentanyl; Meperidine; Bupivacaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: caudal; epidural; pediatric; renal; transplant; hemodynamics
tDCS-Augmented Exposure Therapy for Pathological Fear
Condition: Specific Phobias
Study type: Interventional

Summary: 
      This double-blind randomized controlled clinical trial aims to test whether transcranial
      direct current stimulation (tDCS) can be used to modulate fear extinction learning during
      exposure therapy for pathological fear, including fear of spiders, snakes, or germs /
      contamination. Participation takes place over three laboratory visits, including (1) a
      pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1 month follow-up
      visit. During treatment, participants will receive either 20 minutes of active or sham tDCS,
      followed by 30 minutes of in vivo exposure therapy.
    

Detailed description: 
      In a trans-diagnostic sample with marked pathological fear and behavioral avoidance, this
      study aims to: (1) evaluate whether excitatory tDCS of the mPFC and inhibitory tDCS of right
      dlPFC enhances exposure therapy relative to sham tDCS; (2) determine whether tDCS effects are
      moderated by baseline negative prognostic indicators; and (3) determine whether tDCS effects
      are mediated by pre-post changes in vigilance to threat, in-session fear reduction, and
      contextual memory for the exposure context. If successful, the project may discover a
      potentially effective exposure therapy augmentation, and may enhance knowledge of the
      behavioral, cognitive, affective, and neurobiological factors that moderate and mediate acute
      treatment response and maintenance of treatment gains. This knowledge may inform treatment
      development efforts for more debilitating forms of pathological fear.
    

Intervention name(s): Transcranial Direct Current Stimulation (tDCS); In vivo exposure therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.; Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive either (a) excitatory tDCS of the medial prefrontal cortex and inhibitory tDCS of right dorsolateral prefrontal cortex, or (b) sham tDCS
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arachnophobia (fear of spiders); Ophidophobia (fear of snakes); Germaphobia (fear of germs, dirtiness, and contamination)
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
Condition: Hyperlipidemia; Mixed Dyslipidemia
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Dyslipidemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after
      a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal
      impairment or end-stage renal disease (ESRD) receiving hemodialysis.
    


Intervention name(s): Evolocumab
Intervention type(s): Biological
Intervention description(s): Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subjects with normal renal function or severe renal impairment (RI) or end stage renal disease (ESRD) receiving hemodialysis
A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
Condition: Depression, Anxiety; Cognitive Training; Emotion Training; Emotion Regulation
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The research proposes to use an innovative solution to shape brain circuits that support
      executive function and emotion reactivity -using targeted neurobehavioral intervention.
    

Detailed description: 
      Participants will be recruited locally in the San Francisco Bay area with certain symptoms of
      anxiety and depression. They will complete a clinical assessment and then take part in a
      cognitive-emotion training delivered online.
    

Intervention name(s): Computerized neurobehavioral intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will complete the intervention by logging into a secure online website and complete computerized neurobehavioral tasks. Tasks will train the following - cognitive control, working memory and task shifting with two different tasks that engage these skills and positivity biases.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Polyphenols, Prebiotics, the Gut Microbiome and Stress
Condition: Stress, Psychological; Gut Bacteria
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is to evaluate how different combinations of prebiotics and polyphenols
      affect the gut microbiota and perceived cognitive state. 40 volunteers will take part in this
      study who will be randomised into 4 different groups. One group will consume a placebo,
      whereas the other groups will consume prebiotics, polyphenols, or a combination of the two.
    

Detailed description: 
      -  All participants will be asked to fill out a health screening questionnaire and
           inclusion/exclusion criteria will be reviewed for volunteer eligibility

        -  Valid informed consent will be obtained from the volunteer.

        -  Once the study begins, participants will be randomly allocated into 1 of 4 groups each
           assigned a different polyphenol or prebiotic product. the prebiotic content is dosed as
           follows: Inulin at 5g/d, GOS at 5g/d and Resistant Starch at 20g/d.

        -  Participants will be asked to consume their assigned product once per day. The length of
           the intervention is 14 days

        -  Participants will provide two stool samples: one on day 0 and one on day 14 of the study
           to identify changes in gut microbiota composition

        -  Urine samples will also be provided at day 0 and at day 14 looking for changes in
           urinary metabolites

        -  Participants will also be asked to fill out various mood related questionnaires on days
           0 and 14 of the study.

        -  You will take your own blood pressure and heart rate on day 0 and day 14 and at least 3
           times per week to try and link changes in gut microbiota composition with vascular
           health.

        -  Volunteers will be given containers and specimen pots to take home for initial and final
           faecal and urine collections. No treatment will be issued until initial stool and urine
           sample has been provided

        -  Maintenance of normal dietary patterns throughout the study is essential and
           participants will be required to complete food and drink logs throughout the study via a
           web-based app - on three consecutive days with one of the days being a weekend
    

Intervention name(s): Blueberry, cranberry, green tea extract, cocoa; GOS, Inulin, RS2; prebiotics and polyphenols; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): tablet supplements, available readily.; Prebiotic combination, Inulin, GOS and RS2; combination of the same prebiotics and polyphenols as above; maltodextrin, 10g per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Grass Pollen Immunotherapy Using a Cluster Regime for Seasonal Rhinitis and Asthma
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess the effects of grass pollen immunotherapy on
      symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma.
      Hay fever symptoms and medication use, health-related quality of life, and measurements of
      non-specific bronchial responsiveness were recorded during the study period.
    

Detailed description: 
      This was a single centre, randomized, double-blind, placebo-controlled, parallel group study.
      The main aim of this study was to assess the effects of grass pollen immunotherapy on
      symptoms, bronchial hyperresponsiveness, and quality of life in seasonal rhinitis and asthma.
      Forty-four patients with severe summer hay fever (of whom 36 reported seasonal chest symptoms
      and 28 had seasonal bronchial hyperresponsiveness) participated in a randomised double-blind,
      placebo-controlled, parallel group study. After symptom monitoring for one summer,
      participants matched placebo injections (n=22) in a rapid up-dosing cluster regimen for 4
      weeks, followed by monthly injections for 2 years. Outcome measures included hay fever
      symptoms and medication use, health-related quality of life, and measurements of non-specific
      bronchial responsiveness.

      Results: Significant reductions were observed in immunotherapy group compared with the
      placebo group in hay fever symptoms (49%, 15%: P = 0.1), medication scores (80%, 18%;
      P=.007), and seasonal chest symptoms (90%, 11%; P < .05). Impairment of overall quality of
      life (mean score of 7 domains) during the pollen season was less in the immunotherapy group
      than in the placebo group (median difference [95% CI], 0.8 [0.18-1.5]; P=.05=2]. During the
      pollen season, there was no change in airway methacholine PC20 (provocation concentration
      producing a 20% fall in FEV1) in the immunotherapy-treated group (P=5), compared with an
      almost 3 doubling-dose decrease in the placebo-treated group (P=.5), compared with an almost
      3 doubling dose decrease in the placebo-treated group (P=.01, between-group difference).
      There were no significant local or systemic side effects during the study.

      Conclusion: Grass pollen immunotherapy improves quality of life in seasonal allergic rhinitis
      and reduces seasonal asthma symptoms and bronchial hyperresponsiveness.

      Note: Ongoing mechanistic studies and nasal biopsies studies until 2008
    

Intervention name(s): Subcutaneous Alutard SQ grass pollen (Phleum pratense); Venepuncture: 20 ml blood sample taken on 2 separate visits
Intervention type(s): Biological; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hayfever; Subcutaneous Immunotherapy; Grass pollen immunotherapy; Seasonal Allergic Rhinoconjunctivitis
Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      There is a necessity for the development of new malaria drugs. Some antibiotics are also
      effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be
      effective against malaria, although it cannot achieve a total cure in all patients. Previous
      small studies have shown that in combination with clindamycin, an commonly used antibiotic,
      it is highly effective and safe when given for three days, leading to a total cure in most
      patients. The current study will evaluate its efficacy in a larger population in Gabon, and
      compare its effect with the generally used drug, sulfadoxine-pyrimethamine.
    

Detailed description: 
      Fosmidomycin-clindamycin (30 mg/kg and 10 mg/kg) given twice daily for three days is an
      effective and safe combination of antibiotics which demonstrated good activity against
      malaria parasite in previous phase II studies in African children. In this phase III trial,
      the efficacy and safety of the combination will be evaluated in African children with
      uncomplicated P. falciparum malaria. A single dose of sulfadoxine-pyrimethamine, the standard
      antimalarial in Gabon, is used as comparator.
    

Intervention name(s): Fosmidomycin; clindamycin
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg/kg; 10 mg/kg
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Fosmidomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Fosmidomycin; Clindamycin; Chemotherapy; Gabon
Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
Condition: Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after
           single oral doses.

        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how
           the study drug enters and leaves your body and how your body acts on the study drug) of
           AZD5213 in your blood and urine.

      One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of
      AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and
      then return to the clinic to receive AZD5213 after eating a high fat breakfast.
    


Intervention name(s): AZD5213; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AZD5213; Phase 1; Safety
The Effect of Backward Walking Treadmill Training on Balance in Patient With Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this research was to discuss the effect of backward walking treadmill training
      on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic
      stroke.
    

Detailed description: 
      Walking training is a good method and strategy to improve postural stability, balance, gait
      symmetry, and increase walking ability. Generally, there are many walking training theories
      and methods for patients with chronic stroke and treadmill walking training is applied in
      recent years. Previous studies showed that patients with stroke improve the walking abilities
      and speed after the walking treadmill training. However, most studies have demonstrated that
      forward walking treadmill training improved balance and walking ability in patients with
      stroke, but fewer studies have investigated the effects on backward walking treadmill
      training. However, no studies to date have investigated the effects of backward walking
      treadmill training for patients with chronic stroke.
    

Intervention name(s): backward walking treadmill training; conventional physical therapy
Intervention type(s): Other; Other
Intervention description(s): subjects accepted 30 minutes backward walking treadmill training. a week for four weeks.; subjects accepted 30 minutes traditional physical therapy three times a week for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Chronic Stroke; cardiopulmonary; Berg Balance Scale (BBS)
Metabolic Effects of High-amylose Wheat-based Breads
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The amylose-amylopectin ratio influences starch properties. A higher amylose content is
      associated with slower starch digestion thus reducing the postprandial plasma glucose
      response and improving the overall postprandial metabolism. So far, limited evidence is
      available on the metabolic effect of wheat-based foods rich in amylose. This randomised
      controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads
      in overweight subjects focusing on potential mechanisms.
    


Intervention name(s): Test meal
Intervention type(s): Other
Intervention description(s): Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.
After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the "second meal effect" from breakfast to lunch.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Sulphate Accumulation in Prostate
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences
      in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made
      between participants randomised to the broccoli-rich diet and those randomised to the
      non-intervention arm.
    

Detailed description: 
      Epidemiological studies provide evidence for a negative correlation between prostate cancer
      and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing
      intervention trials carried out at the IFR suggest that dietary changes can directly
      influence the metabolic profile of prostate tissue. The most significant result observed to
      date is that of sulphate accumulation within the prostate. The additional sulphate is likely
      to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a
      process which would consume energy from ATP. A significant rise in levels of both ADP and
      phosphate has also been observed in prostate tissue from these studies, supporting the
      potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP
      accumulation is negatively correlated with prostate cancer progression.

      The investigators now propose to undertake a two arm parallel un-blinded study to test the
      hypothesis that a short-term intervention with broccoli soups will lead to the accumulation
      of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites
      indicating a change in redox status, and therefore functional status, of specific genes
      involved in tumour suppression (PTEN) will also be investigated.

      Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP
      is specific to the prostate gland through the metabolic analyses of both prostate and
      non-prostate tissues.
    

Intervention name(s): Dietary intervention; Normal diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.; Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prostate; Sulphate; ATP; PTEN
A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes
      and Resistance With Moderate to Severe COPD.
    

Detailed description: 
      Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI
      first and then crossed over to receive the opposite intervention. The study consisted of 2
      treatment periods of 14 days separated by a washout period of 5-21 days.
    

Intervention name(s): GFF MDI (PT003) 14.4/9.6μg; Placebo MDI
Intervention type(s): Drug; Drug
Intervention description(s): Glycopyrronium and Formoterol Fumarate; Comparator: Placebo MDI which contains no active ingredients
Other intervention name(s): GFF; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment