bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients
      with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812)
      or placebo. Each patient's participation will last approximately 41 weeks.
    


Intervention name(s): AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): 0.5 mg/kg AAB-003, IV; 1 mg/kg AAB-003, IV; 2 mg/kg AAB-003, IV; 4 mg/kg AAB-003, IV; 8 mg/kg AAB-003, IV; Placebo, IV
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Safety Study; Adaptive; Double Blind
Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate whether the blood concentrations of eletriptan administered using two
      test formulations of oral disintegrating tablets are comparable to those observed with the
      standard commercial tablet.
    


Intervention name(s): Commercial tablet with water; ODT #1 without water; ODT #2 without water; ODT #1 with water; ODT #2 with water
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40 mg tablet, given once to each subject; 40 mg tablet given once to each subject; 40 mg tablet given once to each subject; 40 mg tablet given once to each subject; 40 mg tablet given once to each subject
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; eletriptan; bioavailability; oral disintegrating tablet
Brimonidine vs ALTP in Progressing Human Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is evaluating possible non-intraocular pressure (IOP) related effects of the
      alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic
      neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.
    

Detailed description: 
      Patients with open angle glaucoma and a history of relative stability of the visual field are
      followed for 18 months. A visual field is measured every 3 months for a total number of n = 6
      eligible fields at the end of this phase. Then, those eyes showing progression of the field
      (i.e. deterioration of th eexisting glaucoma), are randomized to receive either 0.2%
      brimonidine tartrate eyedrops b.i.d. or 360° argon laser trabeculoplasty in one session.
      Either treatment will be put "on top" of the pre-existing anti-glaucoma therapy. Then, a
      further 18-month phase is planned, with a sequnece of field taken at the same pace as the
      previous phase. Progression is detected (and measured) acording to a trend-analysis (i.e.
      regression vs time of single points and of clusters of adjacent points).
    

Intervention name(s): brimonidine; laser trabeculoplasty
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Brimonidine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: neuroprotection; alpha one agonists; glaucoma; visual field
Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in
      Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it
      has not been adapted to Turkish language. The aim of this study is to adapt the Sitting
      Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to
      examine the validity and reliability of the Turkish version of the scale.
    

Detailed description: 
      Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's
      classified with GMFCS and MACS.

      Evaluation will be applied to the volunteer participants after the translation steps of the
      Sitting Evaluation Assessment are completed. The validity of the scale will be examined in
      terms of construct validity and content validity. All evaluations will be performed in the
      clinic with the specialist physiotherapist.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cerebral Palsy will be participate the study between the ages of 2 and 18 years.
      
Keywords: Cerebral Palsy; Validity
Hemp Seed Protein and Bioactive Peptides Consumption for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This clinical trial is being conducted to study the effect of whole hemp seed protein, hemp
      seed protein hydrolysate derived bioactive peptide and casein protein consumption on systolic
      and diastolic ambulatory blood pressure. This study is will be conducted in 35 hypertensive
      participants aged between ≥18 and ≤75 yrs who have systolic blood pressure higher than 130
      mmHg or diastolic blood pressure ≤ 110 mmHg. The study will consist of 3 periods of 42 days
      each during which participants will consume assigned treatment. Consumption of treatments
      will be from days 1 to 42. There will also be a washout period of a minimum of 14 days
      between the 3 treatment periods where the participants can consume their habitual diets. The
      entire study is designed to take 22 weeks from start to completion. The participants will
      consume the assigned treatment twice a day. The treatments are in the form of a smoothie and
      the smoothies will consist of frozen fruit, fruit juice, frozen yoghurt/sorbet, and 25 g of
      protein from treatment protein powder which is 25 grams of casein protein, 25 grams of hemp
      seed protein, or 22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein
      hydrolysate derived bioactive peptides. On days 1 and 42 of each treatment period of the
      trial, body weight, waist and hip circumference, blood pressure, pulse wave velocity (PWV)
      and augmentation index (AI) will be measured. Ambulatory blood pressure (ABP) over 24 hours
      will also be measured on day 1 of phase 1 and day 42 of each treatment period of the trial.
    


Intervention name(s): Whole hemp seed protein; Whole hemp seed protein plus bioactive peptides; Casein protein
Intervention type(s): Other; Other; Other
Intervention description(s): The intervention was provided in the form of a smoothie.; The intervention was provided in the form of a smoothie.; The intervention was provided in the form of a smoothie.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemp seed protein; Protein hydrolysate; Bioactive peptides; Cannabis sativa; High blood pressure
Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Condition: Mild to Moderate Diabetic Sensorimotor Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on
      peroneal motor nerve conduction velocity relative to placebo in subjects with mild to
      moderate diabetic sensorimotor polyneuropathy.
    


Intervention name(s): Ranirestat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ranirestat 40 mg tablets; Placebo tablets
Intervention MeSH terms: Ranirestat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Condition: Endovascular Repair of Aortic Aneurysm; Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities
MeSH terms: Aneurysm; Aortic Aneurysm; Arteriosclerosis; Arteriosclerosis Obliterans
Study type: Interventional
Phase: Phase 4

Summary: 
      Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis
      obliterans of lower extremities are two kinds of common surgeries in the investigators'
      hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive
      function, are not clear. In this study investigators propose to measure postoperative
      cognitive function and other outcome of patients who are undergoing these two kinds of
      surgeries, and try to identify whether there is an association between different kinds of
      anesthetics and postoperative outcome. Investigators will also observe whether changes in
      plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative
      delirium or cognitive change.
    


Intervention name(s): Sevoflurane; Propofol; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sevoflurane-based general anesthesia; total intravenous anesthesia
Intervention MeSH terms: Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and
      electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine
      (intranasal administration) and supratherapeutic exposures of esketamine (intravenous
      administration) in healthy adults.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), placebo- and
      positive-controlled, double-blind (Periods 1 to 3), and open-label (Period 4), single-dose,
      crossover study in up to 60 healthy adults. The study has a Screening Phase and a Treatment
      Phase. Participants will be randomly assigned to 1 of 6 treatment sequence groups and will
      receive the 4 treatments (1 treatment per period); Treatment A (intravenous placebo,
      Intranasal placebo and Oral placebo tablet matched to the moxifloxacin tablet), Treatment B
      (intravenous placebo, 84 milligram (mg) of intranasal esketamine as 4 devices, each with 28
      mg esketamine and Oral placebo tablet matched to the moxifloxacin tablet), Treatment C
      (intravenous placebo, Intranasal placebo and 400 mg oral moxifloxacin tablet) and Treatment D
      (0.8 milligram per kilogram of intravenous esketamine, Intranasal placebo and Oral placebo
      tablet matched to the moxifloxacin tablet ). The first 3 periods will be double-blinded and
      the fourth period will be open-label. Periods 1, 2, 3, and 4 will be separated by 5 to 7
      days. Primarily the effects of esketamine on QT/QTc intervals and electrocardiogram (ECG)
      morphology will be evaluated. Safety of the participants will be monitored throughout the
      study.
    

Intervention name(s): Intranasal Esketamine; Intravenous Esketamine; Moxifloxacin; Oral Placebo; Intravenous Placebo; Intranasal Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.; Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.; Participants will receive 400 mg Moxifloxacin orally.; Participants will receive matching placebo orally.; Participants will receive placebo 40 minutes, intravenous infusion.; Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Intervention MeSH terms: Moxifloxacin; Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Esketamine; Healthy; Pharmacokinetics; Electrocardiogram; Repolarization
Different Insulin Regimens and Postprandial Coagulation Activation
Condition: Type 2 Diabetes; Cardiovascular Risk; Hemostasis; Inflammation; Endothelial Function
MeSH terms: Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study in patients with type 2 diabetes was to investigate the acute
      effect of postprandial blood glucose levels modified by two different insulin treatment
      regimens on coagulation activation, inflammation and endothelial cell function. The
      investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial
      postprandial effect on coagulation, endothelial dysfunction and inflammation compared with
      the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.
    


Intervention name(s): Standardised meals
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperglycaemia; Postprandial; Type 2 diabetes; Cardiovascular risk markers
Effect of Goji Berry Consumption on Biochemical Parameters
Condition: Healthy; Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Goji Berry as a functional food have been shown to reduce risk of hyperlipidemia, type 2
      diabetes, etc. However, human studies are limited in this area. In this study, it has been
      aimed to evaluate the effect of goji berry consumption on some biochemical parameters in
      healthy individuals.
    

Detailed description: 
      Healthy individuals have been divided into control and study groups. Individuals in both
      group have same characteristics such as age, gender, and body mass index (Control Group: 35
      individuals - Study Group: 35 individuals). Both group were asked to maintain their normal
      diets. In addition, the study group consume 20 g of dried goji berry per day and did not
      consume any fruit with a similar antioxidant content during the 8 weeks study period. The
      control group was asked to exclude goji berry and similar fruits with high antioxidant
      content from their diet during the 8 weeks study period. The 20 g goji berry for per day was
      given weekly to each individual in a study group in transparent bags. At the beginning of the
      study and every 15 days, food consumption record for 3 consecutive days (2 weekdays and 1
      weekend), a 3-day physical activity record, and anthropometric measurements (weight, height,
      waist and hip circumferences, body composition analysis) were taken. Blood parameters (total
      cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low density
      lipoprotein (VLDL), triglyceride, glucose, insulin, homeostatic model assessment of insulin
      resistance (HOMA-IR), HbA1c) of individuals were taken at the beginning and the end of the
      study.
    

Intervention name(s): Goji Berry
Intervention type(s): Dietary Supplement
Intervention description(s): As a functional food goji berry contains 19 amino acids, 21 minerals, a wide range of carotenoids (β-Carotene, Neoxanthin, Cryptoxanthin, Zeaxanthin), polysaccharides, flavonoids, phytosterols, vitamin A, C and E.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Functional Food; Goji Berry; Serum Lipids; Serum Fasting Glucose
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of
      the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed
      vaccine Fluarix® (TIV) in young children 6 to 35 months of age.
    

Detailed description: 
      The subjects will be randomized (1:1) in the 2 treatment groups to explore responses to
      vaccination in a sub-group analysis based on age (6 to 17 months, 18 to 35 months).
    

Intervention name(s): Quadrivalent influenza GSK2282512A vaccine; Fluarix
Intervention type(s): Biological; Biological
Intervention description(s): 1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.; 1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; Children; Safety; Seasonal influenza; Fluarix
Endostar Combined With Paclitaxel and Nedaplatin in Treating Patients With Recurrent or Metastatic Esophageal Cancer
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with
      paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or
      metastatic esophageal squamous cell cancer.
    

Detailed description: 
      The prognosis of recurrent or metastatic esophageal squamous cell cancer is poor. However,
      there is still no standard chemotherapy regimen recommended for this disease because of the
      lack of trails. Currently, anti-angiogenesis therapy had been proved to improve the survival
      successfully in colorectal cancer, non-small cell lung cancer, breast cancer, glioma and
      kidney cancer. Recent studies showed that the high level of VEGF was negative correlated with
      the prognosis of esophageal cancer. Endostar, as a novel endogenous angiogenesis inhibitors,
      was proved to significantly inhibited the proliferation and metastasis in esophageal cell
      lines and animal models. A retrospective study also reported the safety and efficacy of the
      combination therapy of paclitaxel liposome and recombinant human endostatin. Based on the
      basis above, we designed this phase Ⅱ study to evaluate the efficacy and safety of endostar
      combined with paclitaxel and nedaplatin as first-line therapy in treating patients with
      recurrent or metastatic esophageal squamous cell cancer.
    

Intervention name(s): Paclitaxel+Nedaplatin+Endostar
Intervention type(s): Drug
Intervention description(s): Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14
Other intervention name(s): Paclitaxl; Nedaplatin; Endostar; Recombinant Human Endostatin Injection
Intervention MeSH terms: Paclitaxel; Endostar protein; Endostatins; Nedaplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 4

Summary: 
      The endoscopic discectomy has rapidly developed and increased need by patients. This
      procedure is widely performed by interventional pain physicians as well as by spine surgeons
      because it requires no general anesthesia or admission to a hospital. Many studies were
      reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar
      discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy
      is lacking.
    

Detailed description: 
      To examine whether corticosteroid administered epidural space in patients undergoing
      endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain
      relief, improves functional disability comparing to placebo
    

Intervention name(s): 40 mg Triamcinolone acetate 1 cc; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg Triamcinolone acetate 1 cc; no injected agent
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Label Extension to Bridging Study CTBM100C2303
Condition: Pseudomonas Aeruginosa; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label, single arm (uncontrolled) study in participants suffering from cystic
      fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who
      were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into
      CTBM100C2303.
    


Intervention name(s): Tobramycin inhalation powder
Intervention type(s): Drug
Intervention description(s): Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.
Intervention MeSH terms: Tobramycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents
An Observational Study of the Functional Capacity of Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This is an observational study of the functional capacity of patients with Heart failure with
      Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical
      treatment.
    

Detailed description: 
      This observational study will evaluate the functional capacity (ability to walk and distance
      walked) of patients with Heart failure with Reduced Ejection Fraction (HFrEF) in
      approximately 50-70 patients who present with Acute Heart Failure to approximately 5-6
      hospital sites in the USA. All enrolled patients will be evaluated for their baseline
      functional capacity. Patients will receive standard Acute Heart Failure therapy and will be
      serially assessed for change in their functional capacity.
    

Intervention name(s): 6 Minute Walk Test
Intervention type(s): Procedure
Intervention description(s): Evaluation of walking distance on standardized 6 minute walk test
Other intervention name(s): Walk Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Heart failure; 6 Minute Walk Test