bioihbjkbjnl/mcl2 huggingface dataset:
A Possible Therapeutic Role for Adenosine During Inflammation
Condition: Endotoxemia
MeSH terms: Endotoxemia; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The adenosine receptor is known for its anti-inflammatory actions and could therefore be a
      potential target in the treatment of sepsis and septic shock. Stimulation of the adenosine
      receptor could potentially lead to a decrease in inflammation and tissue damage.

      Under normal conditions adenosine is formed either by an intracellular 5'nucleotidase, which
      dephosphorylates AMP, or by the hydrolysis of S-adenosylhomcysteine by hydrolase. An
      alternative pathway of AMP degradations is provided by the cytosolic enzyme AMP deaminase
      (AMPD), which catalyses the irreversible deamination of AMP to inosine monophosphate and
      ammonia.

      In humans four AMPD isoforms have been described, named after the source from which they were
      initially purified; M (muscle), L (liver), E1 and E2 (erythrocyte), encoded by AMPD1, AMPD2
      and AMPD3. Approximately 15-20% of Caucasian and African American individuals are
      heterozygous or homozygous for the 34C>T variant of AMPD1.

      We hypothesize that healthy volunteers who have the polymorphism for AMPD1 have a less severe
      inflammatory response to LPS and show less (severe) organ failure. This hypothesis is based
      on the expected higher levels of adenosine in patients with the AMPD1 polymorphism. This
      hypothesis is strengthened by the fact that patients with coronary artery disease and the
      AMPD1 polymorphism show improved cardiovascular survival (Anderson JL et al. J Am Coll
      Cardiol 2000; 36: 1248-52) possibly based on higher adenosine levels by reduced AMPD
      activity. Furthermore the polymorphism predicts improved clinical outcome in patients with
      heart failure (Loh E et al. Circulation 1999) also based on a hypothetical elevation of
      adenosine.

      We hypothesize that:

      The C34T-polymorphism of the enzyme AMP-deaminase leads to a decreased inflammatory respons
      and thereby a decrease of LPS-induced tissue damage.

      A second hypothesis is based on the antagonism of the adenosine receptor, by caffeine;

      Antagonism of the adenosine receptor by caffeine leads to an increased LPS-induced
      inflammatory reaction and an increase in (subclinical) tissue damage?
    


Intervention name(s): AMPD1 polymorphism; Caffeine infusion; placebo
Intervention type(s): Genetic; Drug; Drug
Intervention description(s): Endotoxin 2ng/kg to subjects with a AMPD1 polymorphism; Endotoxin 2ng/kg combined with caffeine. Caffeine (4mg/kg) is used as an adenosine receptor antagonist.; Endotoxin 2ng/kg combined with saline infusion (0.9%)
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Endotoxin; Adenosine; Caffeine; AMPD1 polymorphism
A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the effect of selpercatinib on the levels of
      dabigatran in the blood stream and how long it takes the body to remove dabigatran. This
      study will also look at how safe and well-tolerated of dabigatran when administered in
      combination with selpercatinib in healthy participants. This study will last approximately 22
      to 25 days.
    


Intervention name(s): Dabigatran; Selpercatinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3527723
Intervention MeSH terms: Dabigatran
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing
Condition: Wound Healing
Study type: Interventional

Summary: 
      The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag
      Surgical Dressing (treatment group) as compared to prepackaged island wound dressings
      consisting of traditional tape and gauze (control group) for total hip and total knee
      arthroplasty.
    


Intervention name(s): Postop Dressing; Postop Dressing
Intervention type(s): Procedure; Procedure
Intervention description(s): The AQUACEL® Ag Surgical Dressing is a silver impregnated, waterproof, adhesive dressing that sticks to the skin around the wound and blocks bacteria from the outside.; A standard island dressing consists of adhesive tape and gauze.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interaction Between NGF and Acute Exercise-induced Ischemia
Condition: Hyperalgesia; Pain Response; Healthy Subjects
MeSH terms: Hyperalgesia; Ischemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate pain evoked responses and facilitation of
      NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced
      ischemic condition in a NGF-sensitized muscle.
    

Detailed description: 
      Assessing evoked pain responses and muscle hyperalgesia following contractions during acute
      ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF
      sensitization and acidic stimulation exist.

      It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in
      contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses,
      and 2) facilitate NGF-induced muscle hyperalgesia.
    

Intervention name(s): NGF; Isotonic saline
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection; Intramuscular injection
Other intervention name(s): Beta-Nerve Growth Factor, Human; Control
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: NGF-induced pain; Ischemia-induced pain; Hyperalgesia; NGF pain model
Comparison of TLH and LAVH With Over Than 500g
Condition: Hysterectomy, Benign Uterine Diseases
MeSH terms: Uterine Diseases
Study type: Interventional

Summary: 
      Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic
      surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer
      complications and shorter hospitalization compared to total abdominal hysterectomy.

      However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of
      the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show
      the postoperative complications were less frequent (3) and the postoperative recovery (4) and
      return to daily life were faster than total abdominal hysterectomy (3) even if it took longer
      operation time.

      Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and
      indications are increasing. However, there has not yet been a direct comparison between TLH
      and VALH for large uterine surgery. In this study, we compared the results including the
      complications, hospitalization period and so on., in undergoing operation and post-operation
      between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.
    


Intervention name(s): TLH vs LAVH
Intervention type(s): Procedure
Intervention description(s): TLH: The subjects undergoing laparoscopic hysterectomy with a giant uterus of 500 g or more
LAVH: The subjects undergoing Laparoscopic Assisted Vaginal Hysterectomy with a giant uterus of 500 g or more
Other intervention name(s): TLH: Total Laparoscopic Hysterectomy, LAVH: Laparoscopic Assisted Vaginal Hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and bioequivalence of a single oral dose of
      carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa
      combination plus a single oral dose of entacapone under fasting conditions in healthy
      volunteers.
    


Intervention name(s): ELC200 (carbidopa+levodopa+entacapone)
Intervention type(s): Drug
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; bioavailability; carbidopa; levodopa; entacapone; fasting; Healthy volunteers study
SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth.

      PURPOSE: This phase II trial is studying how well SB939 works in treating patients with
      recurrent or metastatic prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the efficacy, as measured by PSA response and progression-free survival, of
           HDAC inhibitor SB939 in patients with recurrent or metastatic castration-resistant
           prostate cancer.

      Secondary

        -  To determine the objective response and response duration in patients with measurable
           disease at baseline.

        -  To determine the tolerability and toxicity of this drug in these patients.

        -  To determine the number of circulating tumor cells at baseline and after 6 weeks (and 12
           weeks if patient is still on study treatment).

        -  To explore potential molecular factors predictive of response by assessment of archival
           prostate tumor tissue.

        -  To explore ERG and PTEN expression on circulating tumor cells as a potential prognostic
           and predictive marker for response to this drug.

        -  To determine time to PSA and time to objective progression in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral HDAC Inhibitor SB939 once daily on days 1, 3, 5, 8, 10, 12, 15, 17, and
      19. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease
      progression or unacceptable toxicity.

      Blood samples are collected periodically for correlative studies. Blood samples and Archival
      tumor tissue are analyzed for TMPRSS2-ERG fusion and PTEN deletion status by FISH;
      TMPRSS2-ERG fusion by RT-PCR; and for the number of circulating tumor cells.

      After completion of study therapy, patients are followed up at 4 weeks and then every 3
      months thereafter.
    

Intervention name(s): HDAC inhibitor SB939
Intervention type(s): Drug
Intervention description(s): SB939 given orally every other day 3 times a week (i.e. Monday /Wednesday /Friday, or Tuesday /Thursday / Saturday) for 3 consecutive weeks followed by one week off-dosing. A treatment cycle is 4 weeks (28 days).
Intervention MeSH terms: Histone Deacetylase Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hormone-resistant prostate cancer; recurrent prostate cancer; stage IV prostate cancer; stage III prostate cancer; adenocarcinoma of the prostate
Website for Adolescents About Pediatric Clinical Trials
Condition: Healthy; Chronic Illnesses, Multiple
MeSH terms: Chronic Disease; Multiple Chronic Conditions
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effectiveness of DigiKnowIt News: Teen with
      parent-adolescent pairs.
    

Detailed description: 
      Parent-adolescent pairs (N=180) will be recruited to participate in a randomized controlled
      trial. Parent consent and parent permission and youth assent will be sought. Participant
      pairs will be randomized into one of two study arms: intervention and wait-list control. All
      participants will complete a web-based pre-test questionnaire. Youth and parents in the
      intervention group will then receive access to DigiKnowIt News: Teen for one week.
      Approximately one week after completing the pre-test questionnaire, all participants will
      complete a web-based post-test questionnaire (the post-test for the intervention group will
      include Consumer Satisfaction Questions). Youth and parents in the wait-list control group
      will then receive access to DigiKnowIt News: Teen for one week. After one week, they will be
      asked to complete a Consumer Satisfaction Questionnaire.
    

Intervention name(s): DigiKnowIt News: Teen
Intervention type(s): Behavioral
Intervention description(s): Participants will interact with a multimedia educational website that will teach them about pediatric clinical trials, including topics such as participant rights and safety and different types of procedures used in trials, and will provide strategies for parent-teen shared decision-making about clinical trials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor
Condition: Healthy; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker
      Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range
      of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal
      is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed
      sensors.
    

Detailed description: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive
      pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements
      from a laboratory blood gas analyzer.

      It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse
      oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for
      the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and
      then at one of 3 levels, e.g. 95%, 85%, and 75% saturation for about 30-60 seconds at each
      level), thereby demonstrating an acceptable SpO2 accuracy performance specification.
    

Intervention name(s): STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Intervention type(s): Device
Intervention description(s): Reprocessed noninvasive pulse oximeter sensors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pearl Index Study With Low Dose Combined Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and
      safety of SH D00342A. Subjects participating in the study will be treated with an oral
      contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Minisiston (SH D00342A)
Intervention type(s): Drug
Intervention description(s): Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval
Intervention MeSH terms: Ethinyl Estradiol-Norgestrel Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study
Condition: Conditions Influencing Health Status; Bipolar Disorders
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      This research project follows two main objectives: 1) Assess anatomical and functional
      cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes
      after the application of a psychoeducational program in these patients. Specifically, this
      project aims to assess neurophysiological (fMRI - activation and functional connectivity) and
      neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar
      disorders and the therapeutic response to the psychoeducation. The results of this thesis
      project would also contribute to the validation of a pathophysiological model of the bipolar
      disorder.
    


Intervention name(s): psychoeducation
Intervention type(s): Behavioral
Intervention description(s): Bipolar disorders are educated to learn about their pathology
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorders; euthymic; psychotherapy; Functional magnetic resonance imaging
Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
Condition: Liver Metastasis; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
Study type: Interventional

Summary: 
      The correlation between the values of angiogenesis-related growth factors in plasma and
      efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity
      or resistance to treatment will be examined exploratively.
    

Detailed description: 
      The correlation between the values of angiogenesis-related growth factors in plasma and
      efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity
      or resistance to treatment will be examined exploratively.
    

Intervention name(s): Bevacizumab; Cetuximab; L-OHP; l-LV; 5-FU; 5-FU
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Other intervention name(s): Avastin; Erbitux; Oxaliplatin; Levofolinate; Fluorouracil; Fluorouracil
Intervention MeSH terms: Bevacizumab; Cetuximab; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver only metastasis from KRAS Exon 2 wild type; Liver only metastasis from RAS wild type
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the safety and tolerability of multiple doses
      of AMG 598 administered alone or in combination with liraglutide in adults with obesity.
    


Intervention name(s): AMG 598; Placebo; Liraglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AMG 598 administered by subcutaneous injection; Placebo matching to AMG 598 administered by subcutaneous injection; Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5.
Other intervention name(s): Saxenda®
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
EC50 of Anesthetics During Microelectric Recording
Condition: Deep Brain Stimulation
Study type: Observational

Summary: 
      The investigators determine the half maximum effective concentration (EC50) of the Cet value
      of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for
      the maintenance of general anesthesia during microelectrode recording in the deep brain
      surgery in patients with Parkinson's disease.
    

Detailed description: 
      General anesthesia is sometimes required for DBS (deep brain stimulation) surgery in those
      with excessive fear, anxiety, reduced cooperation, or severe movements due to ' off drug'
      state. Dexmedetomidine and propofol are both used individually in the sedation for DBS
      surgery, and were reported to affect the MER (microelectrode recording) to some extent,
      especially in the higher zone of the dose range. In this study, the investigators plan to use
      the combination of dexmedetomidine and propofol for the maintenance of general anesthesia in
      patients with Parkinson's disease. In this study, dexmedetomidine is given with a loading
      dose of 0.5 mcg/Kg, and continuous infusion with the dose of 0.4 mcg/Kg/hr. Propofol is given
      within 0.8~1.8 mcg/Kg during the MER recording (based on institutional guideline). MER
      recording will be observed and correlated wtih the dose of propofol. The Dixon "up-and-down"
      sequential allocation method was used to determine the EC50 of the value of Cet of propofol.
      The study aims to determine the dose that is adequate for maintaining general anesthesia with
      endotracheal intubation and least interference with the MER recording.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients, aged 20-85, with clinical diagnosis of Parkinson's disease, who are
        undergoing deep brain stimulation for which gnenral anesthesia with endotracheal intubation
        is required.
      
Keywords: effective concentration