bioihbjkbjnl/mcl2 huggingface dataset:
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine
Condition: Healthy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We are examining how morphine (a commonly used pain medication) will alter responses to
      simulated blood loss in humans. To simulate blood loss in our research laboratory,
      participants will complete a test with their lower body in a custom-designed vacuum chamber
      for a brief period of time.
    

Detailed description: 
      Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a
      hemorrhagic injury on the battlefield is virtually always associated with pain, it is
      paramount that the selected pain medication does not disrupt appropriate physiological
      mechanisms that are beneficial towards the maintenance of blood pressure and vital organ
      blood flow during that hemorrhagic insult. Current guidelines for the selection of pain
      medications of a hemorrhaging soldier are based upon limited scientific evidence, with the
      vast majority of supporting studies being conducted on anesthetized animals. Thus, the
      interaction between hemorrhagic shock and pain medications commonly employed on the
      battlefield is yet to be determined in the conscious humans.

      With this background, we will test the hypothesis that morphine will impair the capacity for
      a conscious human to tolerate a hemorrhagic insult.

      The obtained data will provide the necessary scientific evidence in humans to support the
      Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for
      moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data
      will identify the analgesic that least compromises a human's ability to tolerate a
      hemorrhagic insult, ultimately providing critical information to the combat medic on which
      analgesic should be employed for such an injury.
    

Intervention name(s): Morphine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will receive Morphine while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.; Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to investigate

        -  the safety and tolerability of increasing single oral doses of BAY 1830839 versus
           placebo under fasted conditions

        -  the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted
           conditions
    


Intervention name(s): BAY1830839; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation in healthy male subjects; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation with safety assessment following each dose step.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Cytokine Adsorption in Lung Transplantation
Condition: Lung Transplant Failure; Lung Transplant; Complications
Study type: Interventional

Summary: 
      Lung transplantation (LTx) remains the gold standard for treating patients with irreversible
      end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients
      remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as
      defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading
      cause of early mortality and contributes to the development of chronic lung allograft
      dysfunction (CLAD) which is the leading cause of late mortality (2). PGD develops within the
      first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence
      of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for
      PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on
      survival.

      The present study is a randomized controlled pilot study which aims to compare patients
      undergoing LTx with and without the utilization of cytokine adsorption.
    

Detailed description: 
      Early intolerance to the newly transplanted lung starts at the time of transplantation and
      results in PGD driven by an intense inflammatory response. Cytokines play a critical role as
      signaling molecules that initiate, amplify, and maintain inflammatory responses both locally
      and systemically. The use of cytokine filtration devices to target middle- and low-molecular
      weight molecules has been shown to reduce levels of a diverse number of cytokines. These
      results have been demonstrated in the in vitro reduction of pathogen-associated molecular
      pattern molecules (PAMPS) and damage associated molecular patterns (DAMPS) as well as in in
      vivo studies involving orthotopic heart transplantation and kidney transplantation. Cytokine
      adsorption has been used successfully in clinical applications to both heart and kidney
      transplantation.

      The present study is a randomized controlled pilot study which aims to collect preliminary
      data on the efficacy of a medical device through the comparison of patients undergoing LTx
      with and without cytokine adsorption.
    

Intervention name(s): CytoSorb
Intervention type(s): Device
Intervention description(s): Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The model consists of a randomized controlled pilot in human patients using a "cytokine adsorption" device.
Lung transplant recipients are randomized to either the treatment group which undergoes cytokine adsorption using the medical device compared to the control group which has not received the cytokine adsorber.
Masking: None (Open Label)
Primary purpose: Treatment
Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
    


Intervention name(s): IBI305(Bevacizumab Biosimilar); Avastin(Bevacizumab)
Intervention type(s): Biological; Drug
Intervention description(s): 3mg/kg, infusion in 90minutes; 3mg/kg, infusion in 90minutes
Other intervention name(s): avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Waist Circumference Measurements in Schizophrenic Patients
Condition: Waist Circumference Measurements; Schizophrenia; Cardiovascular Risk Factor
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to
      be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients
      with MS have an increased incidence of DM, coronary heart disease and increased mortality
      from cardiovascular diseases. Central adiposity is highly correlated with the presence of
      hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist
      circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD
      than either BMI or waist-to-hip ratio. However, currently there is no standard location for
      the measurement of WC.

      Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the
      iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males
      and females.

      2. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        schizophrenia outpatients
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and efficacy of a single
      treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to
      placebo.
    


Intervention name(s): PRX302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL; Single intraprostatic injection of matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Benign prostatic hyperplasia; BPH; Enlarged prostate; Lower urinary tract symptoms (LUTS)
Quality of Life in Children With Cancer
Condition: Childhood Cancer; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers
      and lymphomas are the most common ones among them. During medical treatment children with
      cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle
      strength, gross and fine motor performance impairment, decreased energy consumption. These
      neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and
      quality of life of the children. Childhood cancers have negative effects on sleep. The aim of
      this study is to identify the status of sleep, fatigue, and quality of life in children with
      various types of cancer and to examine the relationship between these conditions.The general
      situation of children will be determined according to findings from this study.
    

Detailed description: 
      Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers
      and lymphomas are the most common ones among them. Acute lymphoblastic lymphoma (ALL) is the
      most common childhood cancer and 78% of leukemia's reported to be ALL. During medical
      treatment children with leukemia are at risk of neuromuscular and musculoskeletal
      complications such as reduced ankle range of motion, reduced muscle strength, gross and fine
      motor performance impairment, decreased energy consumption, osteonecrosis and osteoporosis.
      These conditions can develop as a result of cancer or its treatment. These neuromuscular and
      musculoskeletal complications can affect dynamic balance, endurance and quality of life of
      the children. Childhood cancers have negative effects on sleep; sleep complaints can develop
      with the diagnosis and continue even after recovery period.The aim of this study is to
      identify the status of sleep, fatigue, and quality of life in children with various types of
      cancer and to examine the relationship between these conditions. In addition, families will
      be assessed about their children's conditions and satisfaction with the health care they
      receive.The general situation of children will be determined according to findings from this
      study.
    

Intervention name(s): Family based assessment
Intervention type(s): Other
Intervention description(s): Family of the children will be assessed with questionnaires about their child health condition.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population will be recruited from children diagnosed as childhood cancer and having
        medical treatment in hospital.
      
Keywords: Cancer; Leukemia
Treatment for Reading and Writing Deficits Following Acquired Brain Injury
Condition: Acquired Brain Injury; Alexia; Agraphia
MeSH terms: Brain Injuries; Agraphia; Wounds and Injuries
Study type: Observational

Summary: 
      Many people with acquired brain injuries have deficits in reading decoding, reading
      comprehension, and written expression. Alexia is a phenomenon in which a person who
      previously could read has trouble doing so after having sustained a brain injury; likewise,
      agraphia is an acquired writing problem affecting one or more aspects of written
      communication. Alexia and agraphia sometimes co-occur with one another and/or with other
      language challenges, but they can also occur as isolated phenomena. Methods to treat alexia
      and agraphia often focus on single intervention techniques that address aspects of reading or
      writing in isolation-such as matching written and spoken letters or letter sounds, performing
      choral reading, tracing letters, etc. Existing research suggests that the effectiveness of
      these techniques is limited. However, when used in combination, such techniques may promote
      improved reading and written communication skills. As such, the purpose of this research is
      to determine the extent to which a multicomponent intervention program improves the reading
      and writing capabilities of people with acquired alexia and/or agraphia.
    


Intervention name(s): Multicomponent reading and writing treatment
Intervention type(s): Behavioral
Intervention description(s): Intervention procedures incorporated into the program include drilling on sight words to improve immediate recognition of common words; engaging in Multiple Oral Reading procedures to increase reading fluency; practicing oral spelling of sight words to improve spelling accuracy; generating written sentences to improve accurate spelling and use of written conventions (e.g., punctuation, capitalization); and summarizing and subsequently writing sentences about read material to establish strategies to enhance reading comprehension and promote written expression.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People enrolled in rehabilitation programs at Quality Living in Omaha, Nebraska, who are
        between the ages of 14 and 70 years and who experience alexia and/or agraphia secondary to
        acquired brain injury.
Impact of Beetroot Supplementation in Athletes
Condition: Healthy
Study type: Interventional

Summary: 
      Several previous studies observed a positive effect of beetroot supplementation on sports
      performance in athletes, mainly in endurance performance. However, less attention has been
      paid to its effects on short-duration performance, especially in youth athletes. Moreover,
      only a few previous investigations performed biochemical analyses, including pro-oxidant
      balance assessments. It is especially important because chronic nitrate intake might directly
      cause the production of reactive nitrogen species and reactive oxygen species in other
      subcellular compartments, leading to more oxidative stress. Additionally, no previous study
      verified the impact of beetroot intake on sleep.
    


Intervention name(s): Beetroot juice supplementation or placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Athletes received 7 days of beetroot juice supplementation with nitrate supplementation (2 × 70 mL of beetroot juice ∼12.9 mmol NO3-; Beet It, James White Drinks, Ipswich, UK) or placebo (2 × 70 mL of water with beetroot powder with negligible nitrate content).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically
      healthy subjects with mild to moderate depressive symptoms who are not taking any
      antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of
      this study.
    

Detailed description: 
      This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically
      healthy subjects with mild to moderate depressive symptoms who are not taking any
      antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of
      this study. Fifty subjects will receive study drug for seven days. Thirty subjects will
      receive ABT-436 and twenty subjects will receive placebo. Blood, urine and saliva samples
      will be obtained, both before and during study drug administration, to measure ABT-436
      pharmacology. Safety will be assessed throughout the study, including at two follow-up visits
      after completion of study drug administration.
    

Intervention name(s): ABT-436; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): QD Days 1-7; QD Days 1-7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
Condition: Acquired Bleeding Disorder; Trauma
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of
      activated recombinant human factor VIIgiven in conjunction with standard therapy in patients
      undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular
      fractures.
    


Intervention name(s): activated recombinant human factor VII; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90 mcg/kg body weight administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused; Administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the
      objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated
      Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
    

Detailed description: 
      The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by
      microcarrier culture in 550 liter bioreactors. The virus suspension was harvested,
      ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV
      were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.

      Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag
      contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.

      This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90
      days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600),
      infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV
      respectively, one month apart.
    

Intervention name(s): Inactivated Poliomyelitis Vaccine (Sabin strains); Inactivated Poliomyelitis Vaccine (Salk strains)
Intervention type(s): Biological; Biological
Intervention description(s): Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.; Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
Other intervention name(s): Sabin IPV; Salk IPV or cIPV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inactivated Poliomyelitis Vaccine; Sabin Strains; poliomyelitis
Thiol/Disulphide Homeostasis and Albumin in Vertigo
Condition: Vertigo, Peripheral; Vertigo, Central Origin; Oxidative Stress; Diagnosis
MeSH terms: Vertigo; Disease; Dizziness
Study type: Observational

Summary: 
      Vertigo is a common complaint in the Emergency Department (ED). The differential diagnosis of
      central and peripheral vertigo is a difficult issue that directly affects mortality. Magnetic
      resonance imaging (MRI) is the preferred diagnostic tool, but may not be suitable in all
      patients due to logistic and economic conditions. In this study, the investigators evaluated
      the role of thiol/disulfide homeostasis (TDH) parameters and ischemia modified albumin (IMA)
      levels to assist in the value of being used instead of MRI.
    

Detailed description: 
      The study was conducted in the ED using a prospective, non-randomized method, and included
      patients with complaints of acute onset vertigo over 18 years of age and who underwent brain
      MRI. Pregnant women, smokers, and those with significant neurological signs were excluded.
      Patients with acute ischemia with MRI were included in the central vertigo group, and
      patients with normal MRI were included in the peripheral vertigo group. Blood samples for
      native thiol (NT), total thiol (TT), disulfide, and IMA were collected from all patients at
      admission. Statistical analyzes were performed with IBM SPSS Statistics for Windows 16.0
      Package Program.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were admitted to the ED with acute onset vertigo of less than 24 hours and who
        underwent brain MRI for differential diagnosis of peripheral or central vertigo
      
Biospecimen description: 
      Venous blood samples
    
Keywords: Vertigo; Central vertigo; Peripheral vertigo; Thiol/disulfide homeostasis; Ischemia modified albumin; Differential diagnosis