bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by
      the body when given to healthy, non smoking males at different dose levels. This is a 2 part
      study, in Part B a single group of subjects will be given both an oral dose and intravenous
      microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.
    


Intervention name(s): AZD5122; Placebo; AZD5122
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of oral suspension; A single dose of oral suspension; A single intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteer; healthy subjects; AZD5122; single oral dose; phase 1; Healthy volunteer phase 1 study
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic
      stroke patients following administration of intravenous tPA.
    


Intervention name(s): NeuroFlo catheter
Intervention type(s): Device
Intervention description(s): NeuroFlo™ catheter 45 minute treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy
      adults.
    


Intervention name(s): EuPCV15; Prevenar13
Intervention type(s): Biological; Biological
Intervention description(s): 15-valent Pneumococcal conjugate vaccine; 13-valent Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with
      inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for
      Asthma (GINA) guidelines.
    


Intervention name(s): fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
Intervention type(s): Drug
Intervention description(s): fluticasone propionate/salmeterol diskus
Other intervention name(s): Advair DISKUS
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer
Condition: Mebo; Lidocaine; Healing; Traumatic Oral Ulceration
MeSH terms: Oral Ulcer
Study type: Interventional

Summary: 
      This study aims to assess topical MEBO application on pain relief and wound healing.
    

Detailed description: 
      One of the conditions that affect the mouth frequently is a traumatic ulcer. Between 3 and 24
      % of the population are affected, which is a significant prevalence. It is symptomatic to
      treat traumatized ulcers. Oral wound healing is a dynamic process and complicated phenomenon
      involving secondary concerns, a succession of overlapping stages of rebuilding cell and
      tissue structure.

      Inflammation, granulation tissue creation, matrix formation, re-epithelialization, and tissue
      remodeling are some of the cellular and physiological activities that occur during wound
      healing.

      Oral wound healing is a dynamic process and complex phenomenon involving secondary issues,
      series overlapping stages of restoring tissue and cellular structures.

      Since 1995, the Moist Exposed Burn Ointment (MEBO), a Chinese burn ointment, has had a
      recognized US patent. Beta-sitosterol, Phellodendron amurense, Scutellaria baicalensis,
      Coptis chinensis, Pheretima aspergillum, Beeswax, and sesame oil are all natural ingredients
      found in MEBO, a pure herbal extract.
    

Intervention name(s): MEBO; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): MEBO (Julphar®, Ras Al Khaimah, United Arab Emirates) was applied using sterile plastic brush daily and the patients were recalled at 2, 5 and 10 days for evaluating the healing of the ulcer.; Lidocaine gel was applied using sterile plastic brush daily and the patients were recalled at 2, 5 and 10 days for evaluating the healing of the ulcer.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in
      healthy male subjects
    

Detailed description: 
      This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared
      with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects
    

Intervention name(s): Raloxifene 60mg/Cholecalciferol 800IU; AD-102
Intervention type(s): Drug; Drug
Intervention description(s): Raloxifene 60mg/Cholecalciferol 800IU tablet; AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Intervention MeSH terms: Cholecalciferol; Vitamin D; Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cerebellum - Cognitive Outcome and Functional Connectivity
Condition: Childhood Cerebellar Tumor
MeSH terms: Cerebellar Neoplasms
Study type: Observational

Summary: 
      Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional
      connectivity level in higher order cognition networks known to interact with the cerebellum.
      Furthermore, to correlate the connectivity level of these networks with the
      neuropsychological performance and functional outcome of the patients.

      The investigator's hypothesis is that the functional connectivity of various cognition
      networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging
      can be impaired after cerebellar tumor surgery and can be correlated with the
      neuropsychological performance. The effect of surgery on the cognition networks and the
      neuropsychological performance is dependent on the tumor location within the cerebellum. Such
      a correlation seems feasible as functional connectivity analysis could be correlated with the
      neuropsychological impairment in various neuropsychiatric disorders. Furthermore,
      investigators were able to depict the maturation of the functional connectivity networks in
      parallel to the neurocognitive development in childhood
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        young adolescent operated on a cerebellar tumor as a child
SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives:

      This study aims to estimate overall treatment benefit (improvement in disability) among acute
      ischemic stroke patients that are randomized to General Anesthesia (GA) compared with
      Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of
      symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural
      complications, reperfusion; and quality of life.

      Hypothesis:

      GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to
      sedation.
    


Intervention name(s): Sedation; General Anesthesia (GA); Intra-arterial Thrombectomy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): The protocol does not specify a particular combination of drugs that must be used for sedation.
The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.; The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed); The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.
Other intervention name(s): Endovascular Therapy
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute stroke; Cerebral Stroke
Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies
Condition: Autonomic Failure; Dysautonomia; Cognitive Impairment; Ehlers-Danlos Syndrome; Postural Tachycardia Syndrome; Pure Autonomic Failure
MeSH terms: Pure Autonomic Failure; Postural Orthostatic Tachycardia Syndrome; Primary Dysautonomias; Autonomic Nervous System Diseases; Tachycardia; Ehlers-Danlos Syndrome; Syndrome
Study type: Interventional

Summary: 
      People with POTS, autoimmune autonomic neuropathy (AAN), pure autonomic failure (PAF), SFN
      and Ehlers Danlos Syndrome (EDS) do not only suffer from orthostatic symptoms such as
      dizziness, headache, neck pain, blurred vision or (pre-) syncope. They also experience
      deficits in attention and concentration (more precisely deficits in selective perspective,
      operating speed, executive functions and memory performance) mainly in upright position. Only
      few studies concerning cognitive impairment in autonomic neuropathies, their frequency,
      aetiology and therapy exist. Many patients concerned, especially with POTS, report attention
      deficits and "brain fog" with problems in their everyday life and work, predominantly in
      upright posture. Specific symptomatic or medical therapies do not exist. Medical treatment
      with Modafinil is discussed and part of a current study at Vanderbilt Autonomic Dysfunction
      Centre (1-5). The investigators want to investigate if problems of concentration, attention
      and/or cognitive dysfunction exist in people with POTS, AAN, SFN and EDS compared to healthy
      controls (HC). Thus the investigators use detailed clinical, autonomic and neuropsychological
      tests in different body positions (lying, sitting and standing) as also acute therapy (leg
      crossing).
    

Detailed description: 
      We are still recruting healthy controls and patients with autoimmune autonomic neuropathy in
      order to perform titl table examination and laboratory testing on day one, ono an empty
      stomach, without morning medication. Cognitive testing is performed on day two after
      randomization in three groups: lying, standing and standing with legs crossed.
    

Intervention name(s): leg crossing
Intervention type(s): Procedure
Intervention description(s): As Counter maneuvre legs will be crossed and cognitive tests will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This prospective pilot trial will evaluate the efficacy, safety, tolerability and
      pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.
    

Detailed description: 
      The most common intervention for Attention Deficit Hyperactivity Disorder (ADHD) is
      pharmacological treatment with methylphenidate (MPH). Effects of MPH on ADHD symptoms in
      children is extremely well-informed. Mazindol is a psychostimulant and a wake-promoter agent
      which may have similar actions to MPH in the central nervous system. However, there is no
      record of the effects, safety, tolerability of Mazindol in children with ADHD. Mazindol (dose
      0.5 or 1.0 mg/day) should prove to be useful in the treatment of ADHD symptoms in children.
      Based on clinical assessments and serum concentrations after oral administration of mazindol
      to children (6-12 years) with ADHD, this prospective pilot trial will evaluate the efficacy,
      safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of
      mazindol.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        childrens
      
Keywords: Attention Deficit Hyperactivity Disorder; Mazindol
Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)
Condition: Irritable Colon
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in
      Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and
      (ii) to obtain reference data for endpoints and dosage and administration of a next phase
      study.
    

Detailed description: 
      The study objectives are to obtain the clinical experience of GR68755 1 mg QD in Japanese
      female subjects with severe d-IBS who have frequent bowel urgency and to obtain exploratory
      efficacy and safety data that can be used as reference for endpoints and dosage and
      administration of a next phase clinical study in Japan.

      After giving a written informed consent, subjects will undergo essential observation and
      examinations during the screening phase and subjects who meet the eligibility criteria will
      enter into the treatment phase. When subjects enter into the treatment phase, the subjects
      will administer GR68755 1 mg tablets QD in the morning every day for 28 days from the next
      day of receiving the investigational products.
    

Intervention name(s): GR68755 (Alosetron hydrochloride) 1 mg tablet
Intervention type(s): Drug
Intervention description(s): 1 tablet (1 mg) once a day
Intervention MeSH terms: Alosetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alosetron hydrochloride; Global Improvement Scale(GIS); Diarrhea-predominant IBS
Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions
Condition: Cardiovascular Response to Epinephrine
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aim to evaluate systemic response of patients when 2 different concentrations of
      Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.
    


Intervention name(s): Epinephrine 1:100,000; Epinephrine 1:200,000
Intervention type(s): Drug; Drug
Intervention description(s): Inferior alveolar nerve block with Epinephrine 1:100.000; Inferior alveolar nerve block with Epinephrine 1:200.000
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The proposed study in an inception cohort of patients with hematological malignancies treated
      with PBSCT is designed to evaluate the effects of a physical exercise intervention on
      muscular-skeletal, physical activity and quality of life outcomes.
    

Detailed description: 
      Peripheral Stem Cell Transplantation is a frequently used therapy option to increase survival
      in hematological and lymphatic malignancies. These malignancies and their treatment are
      associated with numerous physical and psychological symptoms and severe side effects.
      Physical exercise has been proposed as a promising strategy for the treatment of some of
      these physical and psychological complaints, and various exercise interventions are currently
      available after cancer treatment. To date, promising preliminary results concerning exercise
      programs in PBSCT recipients were published with limited sample size populations. Results of
      musculoskeletal outcomes in PBSCT recipients after cancer treatment are lacking.
    

Intervention name(s): Ambulatory Physical Exercise Program
Intervention type(s): Behavioral
Intervention description(s): supervised exercise, 2 x / week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cancer, Exercise, Health Related Quality of Life, PBSCT
Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury
Condition: Severe Burn Injury
MeSH terms: Wounds and Injuries; Burns
Study type: Observational

Summary: 
      This observational study compares the influence of Ringer's Lactate solution and Ringer's
      Acetate solution on organ function scores following severe burn injury.
    

Detailed description: 
      In the early period following severe burn injury volume replacement with high amounts of
      crystalloids is necessary. In this study we compare the organ function scores of a historical
      patient group, treated with Ringer's Lactate solution, with an actual patient population,
      treated with Ringer's Acetate solution.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        patients within a 24-hours period after severe burn injury
      
Keywords: burn injury; volume replacement; Ringer's Lactate solution; Ringer's Acetate solution; volume replacement with crystalloids
The Effect of GCSF in the Treatment of ALS Patients
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor
      (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.
    


Intervention name(s): Granulocyte Colony Stimulating Factor; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Granulocyte Colony Stimulating Factor
Effect of Buffered Numbing Solution on Patients With Toothaches
Condition: Irreversible Pulpitis (Toothache)
MeSH terms: Pulpitis; Toothache
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of buffered lidocaine (a numbing
      solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing)
      solutions have shown promise in some medical and dental research. Patients presenting with
      toothaches will be given either a buffered numbing solution or a nonbuffered numbing
      solution. Neither the patient nor the operator will know which solution they will receive.
      Root canal treatment will be performed on the tooth and the ability of the buffered versus
      non-buffered numbing solutions will be compared.
    


Intervention name(s): buffered lidocaine; nonbuffered lidocaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients
Condition: Hyperlipidemia; Hypertension
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, cross-over study.
      Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively
      assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last
      two months of the 5 months study period. In between the first and second treatment period,
      all patients will enter a Washout Period of 4 weeks and during which time patients should not
      receive any of the study functional fruit drink.
    


Intervention name(s): Shanzha Fruit drink or placebo drink
Intervention type(s): Dietary Supplement
Intervention description(s): The dosage of Shanzha fruit drink or the placebo is 3 cans per day
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment