bioihbjkbjnl/mcl2 huggingface dataset:
The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A
Condition: Cannabis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a
      hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a
      1:1 ratio.
    

Detailed description: 
      The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of a
      novel hemp-derived oral cannabinoid product, at various doses, in healthy adults. The study
      will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design. Drug
      administration will be double blind (the participant and research staff will be unaware of
      the dose administered). Upon enrollment, participants will complete 4 dosing conditions
      (placebo, 1 mg/kg, 2 mg/kg, 4 mg/kg of cannabinoids). Each condition will consist of a single
      acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and
      pharmacokinetic (PK) drug effects. Biological specimens (blood and urine) will be obtained
      throughout these 8 hours to characterize the pharmacokinetics of CBD, CBD-A,
      delta-9-Tetrahydrocannabinol (THC), and THC-A, as well as other relevant cannabinoids and
      metabolites. Pharmacodynamic assessments including subjective drug effects, cognitive
      performance testing, and vital signs will also be collected for 8 hours post-drug
      administration. For each of the two days after each experimental session, participants will
      be asked to return to the lab for brief visits (~20 min) to provide additional biospecimens
      (~24 and ~48 hrs after dosing) to allow for further PK analysis. These procedures will be
      completed 4 separate times by each participant (sessions will be separated by at least 1 week
      to allow for sufficient drug washout between doses).
    

Intervention name(s): CBD 1mg/Kg; CBD 2mg/Kg; CBD 4mg/Kg; Placebo CBD
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will ingest soft gel tablets containing CBD 1mg/Kg; Participants will ingest soft gel tablets containing CBD 2mg/Kg; Participants will ingest soft gel tablets containing CBD 4mg/Kg; Participants will ingest soft gel tablets containing placebo for CBD
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will complete all dose conditions (study arms) in a randomized order
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
Condition: Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of
      multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072
      in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.
    

Detailed description: 
      This was a Phase 2a, randomized, blinded, placebo-controlled, dose-ranging study in
      chronically, hepatitis C virus (HCV) genotype 1-infected participants designed to explore the
      safety, tolerability, pharmacokinetics, antiviral activity, as well as the evolution and
      persistence to resistance of ABT-450/r, ABT-333, or ABT-072. Participants were treated with
      ABT-450/r, ABT-333, or ABT-072 monotherapy for 3 days, followed by 81 days (12 weeks minus 3
      days of monotherapy) of ABT-450/r, ABT-333, or ABT-072 combined with pegylated
      interferon/ribavirin (pegIFN/RBV), followed by 36 weeks of pegIFN/RBV alone. Participants
      randomized to an ABT-450/r treatment group who achieved rapid virologic response (RVR) and
      had HCV ribonucleic acid (RNA) levels < 25 IU/mL at all subsequent visits were eligible to
      stop pegIFN/RBV therapy on or after Week 24.
    

Intervention name(s): ABT-450; ABT-072; ABT-333; Ritonavir; Peginterferon alpha-2a; Ribavirin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): 50 mg capsules co-administered with ritonavir; 50 mg tablet; 400 mg tablet; 100 mg capsules co-administered with ABT-450; Syringe, 180 µg/0.5 mL for subcutaneous injections; 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day; Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level
Other intervention name(s): Dasabuvir; ABT-538; Norvir
Intervention MeSH terms: Ritonavir; Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients
Condition: HIV Infections; Hepatitis C, Chronic; Treatment Failure
MeSH terms: Infections; Hepatitis A; Hepatitis C; HIV Infections; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C.
      Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have
      previously been treated with a first line anti-HCV treatment. The purpose of the study is to
      evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with
      chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin.
      The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of
      ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained
      virological response, defined as an undetectable HCV RNA level 24 weeks after the end of
      anti-HCV treatment.
    


Intervention name(s): Peginterferon alfa2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; HCV infection; HIV infection; Treatment Failure; PEG interferon; Interferons/therapeutic use; Interferon Alfa-2a/adverse effects; Ribavirin/therapeutic use; Ribavirin/adverse effects; Drug Therapy, Combination; Treatment Experienced; Treatment Naive
Effects of High and Low Frequency TENS on Sympathetic Skin Response and Skin Temperature
Condition: Effects of TENS on Sympathetic Skin Response
Study type: Interventional

Summary: 
      The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous
      electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic
      skin response (SSR) and skin temperature.
    

Detailed description: 
      15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in
      this study.

      All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a
      control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a
      10-minute follow up period.

      Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin
      temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15
      seconds before, just 15 seconds after, and 10 minutes after application of interventions.
    

Intervention name(s): transcutaneous electrical nerve stimulation
Intervention type(s): Device
Intervention description(s): All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.
Other intervention name(s): TENS
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: TENS, sympathetic skin response, skin temperature
Comparing Smoking Treatment Programs for Lighter Smokers - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to compare two different types of Food and Drug Administration
      (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in
      conjunction with two levels of counseling. It was hypothesized that the higher level of
      counseling would have the highest rates of treatment completion and highest rates of
      abstinence.
    

Detailed description: 
      The study compared a minimal level counseling model to a higher level counseling model plus
      one of two types of FDA approved smoking cessation products (bupropion or the nicotine
      patch)used to achieve long term abstinence among lighter smokers. Each participant received
      both products under blinded conditions meaning that neither the participant nor the counselor
      knew which product was real or a placebo. The primary goal was to determine the combination
      or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or
      the nicotine patch) that were most effective for lighter smokers. The main hypothesis was
      that higher level counseling would contribute to improved outcomes meaning that more
      counseling would be associated higher abstinence rates following the completion of treatment
      and at longer term follow-up.
    

Intervention name(s): nicotine transdermal system; bupropion; Medication Management; Mayo Counseling; placebo patch; placebo bupropion
Intervention type(s): Drug; Drug; Behavioral; Behavioral; Drug; Drug
Intervention description(s): starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.; 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks; Brief manual based therapy; four 15 minute session over 10 weeks.; Manual based therapy; Weekly 30 minute sessions for 10 weeks; placebo patch containing no nicotine; placebo pills
Other intervention name(s): Nicoderm; Zyban
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: light smokers, smoking cessation treatment programs
Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the
      laboratory may help doctors predict how well patients will respond to treatment.

      PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from
      older patients with acute myeloid leukemia treated with cytarabine-based therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To validate a pre-specified proteomic classifier to predict the likelihood of complete
           response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3
           acute myeloid leukemia.

      Secondary

        -  To identify signaling nodes associated with risk of relapse among these patients who
           achieve a CR to induction chemotherapy.

      OUTLINE: This is a multicenter study.

      Previously collected bone marrow and peripheral blood samples are analyzed to validate the
      association of a pre-specified proteomic signature with clinical response via flow cytometry.
    

Intervention name(s): proteomic profiling; flow cytometry; laboratory biomarker analysis
Intervention type(s): Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E3999 and E3993 from whom samples were submitted for
        research
      
Keywords: adult acute myeloid leukemia in remission; recurrent adult acute myeloid leukemia; adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)
Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery
Condition: Surgery
Study type: Interventional

Summary: 
      This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to
      standard Intravenous lipid emulsion on fatty acid composition and inflammatory response
      (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish
      oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the
      inflammatory response.
    

Detailed description: 
      This study is conducted in infants post gastrointestinal surgery that requires parenteral
      nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received
      standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and
      omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%,
      respectively, both administered for three consecutive days after surgery (72 hours) in 1-4
      gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid
      composition are checked from blood plasma. Blood examination is done before the surgery and 3
      days after the surgery.
    

Intervention name(s): SMOFlipid 20%; Lipofundin 20%
Intervention type(s): Other; Other
Intervention description(s): Fish oil-enriched intravenous lipid emulsion; MCT/LCT standard intravenous lipid emulsion
Intervention MeSH terms: SMOFlipid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parenteral nutrition; Interleukin-1b; Interleukin-8; Lipid emulsion
Effect of Short-term Chinese Tea-flavor Liquor Consumption
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term
      Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and
      CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented
      from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor
      fermented from above 5 grains plus green tea.

      Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled
      randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with
      meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids,
      inflammation biomarkers and CVD risk factors.

      TFL could significantly decrease systolic blood pressure of males, but increase diastolic
      blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for
      females. Both liquor significantly decrease serum uric acid and glucose in males and females.
      The effect of the two liquors on inflammation biomarkers were complicated and needs further
      research work.

      TFL may possess more beneficial effect on CVD risk factors than GML probably because of the
      special fermentation products of green tea with other grains.
    


Intervention name(s): Tea-flavor Liquor; Guizhou Meijiao Liquor
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30 mL of Tea-flavor Liquor(45% alcohol content); 30 mL of Guizhou Meijiao Liquor (45% alcohol content)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: short term consumption; Chinese liquor; serum lipids; uric acid; inflammation biomarkers
Comparison of Pericapsular Nerve Group Block With Suprainguinal Fascia Compartment Block in Hip Fractures
Condition: Hip Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular
      Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip
      surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip
      fracture patients will be evaluated. Postoperative opioid consumption and quality of recovery
      will also be evaluated.
    

Detailed description: 
      The study was conducted as a retrospective cohort feasibility design within a tertiary
      hospital. Patient records and electronic data systems were used to gather the required data
      for analysis. Before surgery, a carefully selected cohort of patients who underwent PENG
      block and PENG block added SIFCB were included in the study.
    

Intervention name(s): PENG block; PENG block+ SIFCB
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients underwent ultrasound-guided PENG Block for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.; Patients underwent ultrasound-guided PENG Block+ SIFCB for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.
Other intervention name(s): Drug; Drug
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Data of patients underwent hip surgery under spinal anesthesia between 31.01.2023 and
        01.10.2023.
      
Keywords: Anesthesia; Lower extremity; pericapsular nerve group block; suprainguinal fascia compartment block
Total Knee Arthroplasty (TKA) Cemented Versus Cementless
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of the study is to analyse and to compare the quality of fixation of a femoral
      implant with or without cement.

      One hundred thirty patients will be operated on and included with 2 groups, the first one
      with TKA all cemented and the second one with TKA with a cementless femoral implant. The
      study criteria include the IKS (International Knee Society) score and the analysis of a
      radiolucent line at the femur.

      Patients will be reviewed at 2, 6 and 12 months.
    


Intervention name(s): cement Palacos R40 and LV40
Intervention type(s): Device
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Knee arthroplasty; Femoral loosening; Total Knee Arthroplasty
A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused
      by viruses that belong to the enterovirus genus of the picornavirus family. Although most
      HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71
      (EV71) can present with a high rate of neurological complications, including
      meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by
      EV71 has become a major emerging infectious disease in Asia and the highly pathogenic
      potential of EV71 clearly requires the attention of world medical community.

      The development of vaccine against EV71 is active and ongoing in Asian countries now. Several
      studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal
      model. A wide range of experimental EV71 vaccine approaches have been studied including
      heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1
      recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing
      domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated
      virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the
      most important factors in prevention of the severe EV71 infection. Recently, an inactivated
      vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase
      Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.
    


Intervention name(s): vaccine against EV71 of 320U/0.5ml; vaccine against EV71 of 640U/0.5ml; vaccine against EV71 of 160U/0.5ml; vaccine against EV71 of 320U/0.5ml; vaccine against EV71 of 640U/0.5ml
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines; inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28; inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day; inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28; inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccines Adverse Reaction