bioihbjkbjnl/mcl2 huggingface dataset:
Parallel Effects of Schizophrenia and N-methyl-D-aspartate (NMDA) Antagonism
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the common features of electrophysiological measures in schizophrenia
      and effects of NMDA antagonist ketamine in healthy volunteers.
    


Intervention name(s): ketamine
Intervention type(s): Drug
Intervention description(s): For healthy volunteer arm of study, NMDA antagonist ketamine will be administered. 0.23 mg/kg over 1 minute, followed by 0.58 mg/kg/hour for 30 minutes, followed by 0.29 mg/kg/hour for 50 minutes.
No drug administration for patients with schizophrenia
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: NMDA; glutamate; schizophrenia
Water Exchange Versus Carbon Dioxide for Colonoscopy
Condition: Colorectal Cancer; Colorectal Adenomas; Colorectal Polyps; Pain
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional

Summary: 
      Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of
      colonoscopy involving the use of water as the sole modality to aid colonoscope insertion,
      water exchange, has been described in recent research papers to decrease patient discomfort
      and pain, and to reduce the need for sedation during colonoscopy when compared with standard
      air insufflation. Carbon dioxide insufflation has been described to decrease patient
      discomfort after colonoscopy. No randomized trial has so far compared the use of water
      exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less
      discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients
      undergoing screening colonoscopy in two centers in Norway, one center in Poland and one
      center in The Netherlands will be enrolled and randomized to examination of either of the two
      methods.
    

Detailed description: 
      Single blinded randomized controlled trial.
    

Intervention name(s): Water exchange colonoscopy; Carbon dioxide insufflation
Intervention type(s): Other; Other
Intervention description(s): Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.; Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
Other intervention name(s): Water exchange; Carbon dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Colonoscopy; Colorectal cancer; Colorectal adenomas; Pain
A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis
      C Genotype 2 or 3.
    

Detailed description: 
      A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon
      (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With
      Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3
    

Intervention name(s): Albuferon; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Chronic; Genotype 2 or 3; Treatment naive
Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients
Condition: Lung Transplantation
Study type: Interventional

Summary: 
      Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and
      for surveillance in the diagnosis of acute rejection using standard transbronchial forceps.
      It is recognized that standard forceps biopsies underestimate the presence or degree of
      airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been
      shown in the literature to provide larger samples without crush artifact in a safe fashion in
      lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is
      superior to standard transbronchial forceps biopsies in regards to sample size, architecture
      and the diagnosis of early rejection in lung transplant recipients which if discovered
      earlier may improve survival.
    


Intervention name(s): Cryoprobe biopsy; Forceps Biopsy
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lung Transplantation; Acute Rejection
The Safety and Tolerability of PF-05089771 Will be Investigated in Healthy Subjects Over a 14 Day Dosing Period.
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is primarily to determine the safety and toleration and
      pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.
      Dosing will either be administered twice or three times daily. Secondary objectives will be
      to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on
      the PK of PF-05089771.
    


Intervention name(s): PF-05089771; PF-05089771; PF-05089771; PF-05089771
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-05089771 will be dosed as a suspension twice daily; PF-05089771 will be dosed as a suspension twice daily; PF-05089771 will be dosed as a suspension either twice or thrice daily; PF-05089771 will be dosed as a suspension either twice or thrice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics; PF-05089771
The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is testing the safety, tolerability and effectiveness of NVX-108
      administered via intravenous infusion in combination with standard radiation and
      chemotherapy.

      NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is
      hoped to increase the effectiveness of radiation therapy.
    


Intervention name(s): NVX-108
Intervention type(s): Drug
Intervention description(s): 0.2% emulsion administered i.v.
Other intervention name(s): Dodecafluoropentane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma; multiforme; radiation; radiation therapy
Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Condition: Respiratory Syncytial Virus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of presatovir on respiratory
      syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant
      (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of
      presatovir on development of lower respiratory tract complication, being free of any
      supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety,
      and tolerability of presatovir.
    


Intervention name(s): Presatovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube; Tablets administered orally or via nasogastric tube
Other intervention name(s): GS-5806
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus (RSV); Antiviral; Hematopoietic Cell Transplant (HCT); Upper respiratory tract infection
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031
      versus a placebo control in subjects with non-constipating irritable bowel syndrome.
    


Intervention name(s): LX1031 High Dose; LX1031 Low Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A high dose of LX1031; daily oral intake for 28 days; A low dose of LX1031; daily oral intake for 28 days.; Matching placebo dosing with daily oral intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae
Condition: Pneumococcal Infections; Pneumonia, Pneumococcal
MeSH terms: Pneumonia; Pneumococcal Infections; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be
      randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will
      receive up to 3 doses at 4 week intervals.

      Following the third dose, subjects will be inoculated intranasally with S. pneumoniae
      serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained
      pre-inoculation, and then 2, 7 and 14 days after inoculation.

      Subjects will also be monitored for safety and tolerability throughout the dosing period, and
      then for 12 months after their last dose.

      The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing
      colonization rates and magnitude of colonization following the S. pneumoniae challenge.
    


Intervention name(s): GEN-004 with Aluminum Hydroxide Adjuvant; Placebo; Streptococcus pneumoniae inoculation
Intervention type(s): Biological; Biological; Biological
Intervention description(s): GEN-004: 100 µg of each antigen, with adjuvant, 350 µg aluminum hydroxide, administered as a 0.5 mL intramuscular (IM) injection.
GEN-004 is a recombinant S. pneumoniae protein subunit vaccine consisting of 3 recombinant T cell antigens:
GB104: ABC transporter, substrate-binding protein
GB144: Maltose/maltodextrin binding protein, ABC transporter
GB152: Hypothetical protein
GEN-004 is filled in 2 mL vials containing 0.5 mL (350 µg/mL of each antigen).
Aluminum hydroxide adjuvant is filled in 2 mL vials containing 1 mL at a concentration of 5 mg/mL.; Placebo: normal saline, 0.5 mL per dose, IM.; Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.
Other intervention name(s): GEN-004; Saline; Normal saline; S. Pneumoniae
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: GEN-004; Aluminum hydroxide; Vaccine; Streptococcus pneumoniae; Pneumococcal Infections; Strep pneumoniae; Pneumonia
Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
Condition: Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The investigators hypothesized that positive end expiratory pressure (PEEP) would increase
      the regional oxygen saturation (rSO2).
    

Detailed description: 
      The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery
      by improving oxygenation.
    

Intervention name(s): zero end-expiratory pressure; positive end expiratory pressure
Intervention type(s): Procedure; Procedure
Intervention description(s): positive end expiratory pressure 0 cm H2O during peumoperitoneum; PEEP 0 cmH2O
Other intervention name(s): ZEEP; ZEEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cerebral oxymetry; laparoscopy; PEEP
Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children
Condition: Cancer Childhood
Study type: Observational

Summary: 
      This study aims to translate the original English version of Resilience Scale for Children
      (RS10) into traditional Chinese. It will then test the psychometric properties of the newly
      translated RS10.
    

Detailed description: 
      It has been well documented that cancer and its treatment may have adverse effects on the
      physical and psychological well-being of children with cancer. Such adverse effects may start
      from diagnosis and continue for months or even years after the completion of therapy. Cancer
      and its treatments may also have long-term effects on the psychological well-being of
      children with cancer, such as decreased self-esteem, increased anxiety and depression that
      can adversely affect their quality of life.

      Numerous studies indicated that resilience effectively prevents the development of mental
      health problems and is associated with positive mental health outcomes in children and
      adolescents, such as reduced levels of anxiety, depression and obsessive compulsive symptoms.
      Assessing resilience in children with cancer is therefore crucial for a thorough
      understanding of their responses to stress and adversity, which is an essential prerequisite
      for the design of an appropriate psychological intervention to enhance their resilience and
      foster the development of their coping mechanisms and positive mental well-being.

      This study aims to translate the original English version of Resilience Scale for Children
      (RS10) into traditional Chinese. It will then test the psychometric properties of the newly
      translated RS10. In addition, the factorial structure of RS10 will be examined using
      confirmatory factor analysis (CFA).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children should be ages between 7 and 14; diagnosed with cancer within the previous 6
        months and currently undergoing active treatments, and able to speak Cantonese and read
        Chinese.
Energy Expenditure Responses to Acute Exercise in Older Women (Calorie Expenditure and Exercise)
Condition: Aging
Study type: Interventional

Summary: 
      In older, normal-weight women (60-75 yrs, BMI=18-28 kg/m2), an acute bout of higher-intensity
      (60% of maximum effort) aerobic exercise, in comparison to an isocaloric bout of
      lower-intensity (45% of maximum effort) exercise (caloric expenditure of 3.5 kcal/kg body
      weight for both), will result in differential:

        1. decline in non-exercise activity calorie expenditure in the subsequent 48 hours after
           exercise;

        2. increase in resting metabolic rate 48 hours after exercise;

        3. increase in serum free triiodo-L-thyronine (free T3) concentrations immediately
           following exercise;

        4. decline from pre-exercise in plasma leptin and serum free T3 concentrations 48 hours
           after exercise.
    


Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): exercise sessions at 45% and 60% of maximum effort
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: older; NEAT; exercise; RMR; energy expenditure
The Effect of Reiki Application on Pain, Fatigue and Sleep Quality in Elderly Persons Staying in Nursing Homes
Condition: Pain; Tiredness; Sleep Quality
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      A person's life is a stage that passes in the time interval that ends with his birth when he
      opens his eyes to the world and his death when he closes his eyes to the world. Old age is a
      forced end for all people. Sleep is one of the most important and basic human needs. It
      prepares the individual for a new day by resting the body, strengthening and regulating the
      cerebral functions and repairing the brain. While a change in sleep pattern and quality
      affects a person's daily life activities, long-term persistence of this change may lead to
      deterioration of body and mental health.During Reiki practices, the hands are held in each
      position for 3-5 minutes by touching the head, neck, chest, abdominal cavity and groin. In
      problem areas, this time can be extended to 10-20 minutes. The duration of treatment lasts an
      average of 30-90 minutes. During the application, the person is in a lying or lying position
      and does not need to take off his clothes.
    

Detailed description: 
      In the elderly, the pathology of fatigue has not yet been fully elucidated. Natural changes
      and the disadvantages of age can be the cause of fatigue. Decrease in muscle strength,
      sarcopenia, pain, inactivity, changes in body composition due to malnutrition, decrease in
      physical fitness, insufficient energy systems, cardiovascular and respiratory problems,
      medications used can cause fatigue in the elderly. It has been shown that 27-50% of the
      elderly suffer from moderate to severe fatigue. Increasing the severity of fatigue reduces
      the daily activity performance of the elderly (6). Today, in many areas, in addition to
      medical treatment to reduce the symptoms of chronic diseases, alternative and complementary
      medicine are also used. Reiki, which constitutes our research subject; one of the energy
      approaches, in Japan at the end of the 19th century, Dr. It is a complementary medicine
      application discovered by Usui in Sanskrit inscriptions, which has been shown to be effective
      on pain, depression, insomnia and fatigue symptoms. Reiki is generally safe and no serious
      side effects have been reported. Reiki practice in the last 10 years; it increases among
      physicians, nurses and other health workers.
    

Intervention name(s): pain
Intervention type(s): Behavioral
Intervention description(s): reiki
Other intervention name(s): tiredness; sleep quality
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: reiki
Masking: Single (Participant)
Primary purpose: Supportive Care
Study Evaluating Etanercept in Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg
      given twice weekly in subjects with moderate to severe persistent asthma.
    


Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Anti-Asthmatic Agents; Receptors; Tumor Necrosis Factor
Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back
      pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.
    

Detailed description: 
      This pilot study will evaluate the feasibility of the experimental protocol and provide
      sufficient pilot data to estimate statistical power and sample size requirements. The study
      will include 30 individuals (15 per group) diagnosed with persistent low back pain who will
      receive a standard protocol of Scrambler therapy or sham treatment. Participant data will
      include subjective measures of low back pain, pain sensitivity using quantitative sensory
      testing, and mRNA expression levels of pain sensitivity candidate genes at baseline (prior to
      treatment) and 1 and 3 weeks post-treatment.
    

Intervention name(s): Scrambler
Intervention type(s): Device
Intervention description(s): Electrotherapy
Other intervention name(s): Calmare
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nonspecific low back pain; chronic low back pain
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury
Condition: Pain; Burn Injury
MeSH terms: Wounds and Injuries; Burns
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of transcranial direct current
      stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The
      investigators hypothesize that the active tDCS group will show a significant pain/itch
      reduction when compared to sham stimulation.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): Subjects will undergo tDCS stimulation. For both active and sham stimulation we will use electrodes at 35cm^2, with an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex, and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be active for the duration of 20 minutes. For sham stimulation, the current will only be active for 30 seconds, simulating the sensations of active stimulation.
Other intervention name(s): low intensity 1x1 direct current stimulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Transcranial Direct Current Stimulation
Potential Influence of Pantoprazole on the Pharmacokinetics of Pritelivir
Condition: HSV Infection
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV),
      and to investigate the safety and tolerability of PTV.
    

Detailed description: 
      This was a single-center, open-label, 2-period, fixed-sequence Phase 1 trial in 16 healthy
      adult male and female subjects (at least 7 subjects per sex). In the first period, subjects
      received treatment 1 (T1; single dose of 100 mg PTV on Day 1). In the second period, subjects
      received treatment 2 (T2: 40 mg qd ESO from Day -3 to Day 1 followed by a single dose of 100
      mg PTV on Day 1). The wash-out period between PTV administrations in T1 and T2 was at least 4
      weeks.
    

Intervention name(s): Pritelivir; ESO and pritelivir
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Intervention MeSH terms: Pritelivir
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequence for all subjects:
Treatment 1: single dose of 100 mg PTV followed by Wash out period (4weeks) followed by Treatment 2: single dose of 100 mg PTV Day 1 and 40 mg/day ESO from Day -3 to Day 1
Masking: None (Open Label)
Primary purpose: Other