bioihbjkbjnl/mcl2 huggingface dataset:
Disposition of Intravenous Paracetamol in Young Women
Condition: Pain
Study type: Observational

Summary: 
      Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was
      significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due
      to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a
      proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal
      clearance (1.15 vs 0.75 l.h-1, 53 %) [KUlo et al, Int J Obstet Anesth]. This increase in
      glucuronidation clearance may in part be driven by oestradiol, and may explain within and
      between individual differences in paracetamol metabolism (e.g. oral contraceptives,
      follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.

      Based on a pooled analysis, investigators aimed to further explore the impact of these
      covariates on paracetamol metabolism based on plasma and urine collections in women at
      delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral
      contraceptives (OC) following intravenous (iv) paracetamol administration.
    

Detailed description: 
      This study aims to perform a pooled analysis of:

        1. Paracetamol PK data recently published in 47 pregnant women. In these cases, iv
           paracetamol was administered q6h after delivery (caesarean) for 24 h. 8 were recruited a
           second time for an additional single dose pK study in postpartum (Kulo et al, Br J Clin
           Pharmacol 2013).

        2. The PK data as initially published by Gregoire et al, but limited to female volunteers,
           all on oral contraceptives (n=14) (Gregoire et al, Clin Pharm Ther 2007)

        3. A dataset in 8 young women not on oral contraceptives, iv paracetamol, single dose.
    

Intervention name(s): intravenous paracetamol (acetaminophen)
Intervention type(s): Drug
Intervention description(s): paracetamol disposition in young women, exploring the impact of covariates (pregnancy, postpartum, oral contraceptives) in this population.
Other intervention name(s): Perfusalgan, paracetamol Fresenius,
Intervention MeSH terms: Acetaminophen
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pooled analysis of different cohorts of young women who all underwent PK study on
        paracetamol disposition after iv paracetamol administration.
      
Keywords: pharmacokinetics; pregnancy; oral contraceptives; oestradiol
Biological Mesh Repair of Complex Hernias in High Risk Patients
Condition: Hernia
MeSH terms: Hernia
Study type: Observational

Summary: 
      Complex ventral hernia repair is a significant surgical challenge with high frequencies of
      both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in
      2010 recommendations regarding grading and technique of repair, which we have followed since
      November 2011.The purpose of the this study was to evaluate our results after biologic mesh
      repair of complex hernias.
    

Detailed description: 
      Obervational study

      Primare outcome: Surgical site occurence

      Secondary outcome: Hernia recurrence

      Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and
      contaminated hernia.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        16 consecutive patients with biological mesh repair
      
Keywords: biological mesh; contaminated hernia; abdominal wall reconstruction
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
Condition: Bile Salt Export Pump (BSEP) Transporter; Polysorbate 80
Study type: Interventional
Phase: Phase 4

Summary: 
      The study employs two-sub-studies that share a common placebo arm.

      The objective of one sub-study is to assess the impact of metformin on pravastatin and
      chenodeoxycholic acid pharmacokinetics. We hypothesize that metformin represses the bile salt
      export pump (BSEP) in the liver, which excretes pravastatin and chenodeoxycholic acid from
      the liver into the bile.

      The objective of the other sub-study is to assess the impact of polysorbate 80 on
      valacyclovir, chenodeoxycholic acid, and enalaprilat pharmacokinetics. We hypothesize that
      polysorbate 80 inhibits uptake transporters in the intestine, which absorb valacyclovir and
      chenodeoxycholic acid in the gut via the peptide transporter 1 (PepT1) and apical sodium-bile
      acid transporter (ASBT), respectively. Enalaprilat is passively absorbed but with low
      permeability, and thus serves as a passive absorption reference.
    


Intervention name(s): pravastatin and chenodeoxycholic acid, after metformin and placebo; valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg; single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg
Intervention MeSH terms: Metformin; Valacyclovir; Enalaprilat; Enalapril; Chenodeoxycholic Acid; Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteer; pharmacokinetics; excipient; transporter
Avastin for Post-Photocoagulation Macular Edema
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg),
      against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance
      in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative
      diabetic retinopathy (PDR) and good vision
    


Intervention name(s): Bevacizumab; Panretinal Photocoagulation
Intervention type(s): Drug; Procedure
Intervention description(s): Intravitreal administration; Panretinal Photocoagulation
Intervention MeSH terms: Bevacizumab
Primary purpose: Treatment
Keywords: Panretinal Photocoagulation; Macular Edema; Intravitreal Bevacizumab
Lipid Emulsions and Liver Function - Results After 5 Years.
Condition: Liver Failure; Parenteral Nutrition-Related Hepatitis
MeSH terms: Liver Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but
      also one of the key risk factors for development of intestinal failure associated liver
      disease (IFALD). The aim of the study was to analyse the influence of ILEs on liver function
      during long term PN.
    

Detailed description: 
      Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but
      also one of the key risk factors for development of intestinal failure associated liver
      disease (IFALD). Despite of many commercially available ILEs with hypothetically different
      impact on liver, a direct comparison of them has never been performed. Therefore the aim of
      the study was to analyse the influence of ILEs on liver function during long term PN. Ths
      study is a continuation of the previous trial, NCT03044639.
    

Intervention name(s): Intravenous Lipid Emulsion
Intervention type(s): Drug
Intervention description(s): Various types of intravenous lipids
Intervention MeSH terms: Fat Emulsions, Intravenous
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, clinical trial
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Compare Two Different Anti-HIV Drug Regimens
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares 2 different anti-HIV drug regimens to determine which is the most
      effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study
      are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase
      inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor
      (nevirapine).

      These drug combinations have been previously studied in adults, but there is limited
      information on how well they work in HIV-infected children. It is important to develop drug
      combinations which are effective at suppressing the HIV virus in children.
    

Detailed description: 
      The use of combination therapy with 2 or more antiretroviral agents has been strongly
      supported by recent studies in both children and adults. However, as of yet, few combinations
      of antiretrovirals have been studied in large cohorts of stable HIV-1 infected,
      antiretroviral-experienced children. Evidence suggests that viral suppression may be more
      difficult to achieve in children. Therefore, it is important to develop new drug combinations
      which can maximally suppress plasma HIV-1 RNA concentrations in children.

      Patients are stratified by prior antiretroviral treatment (zidovudine [ZDV]/lamivudine [3TC]
      versus d4T/other treatment) and by age (under 24 months versus 24 months and older). Patients
      are then randomized to 1 of 4 treatment groups.

      Arm A1: ddI/NFV/RTV (for prior ZDV/3TC-treated patients). Arm A2: ddI/NFV/RTV (for prior
      d4T/other-treated patients). Arm B1: d4T/NFV/NVP (for prior ZDV/3TC-treated patients). Arm
      B2: d4T/NFV/NVP (for prior d4T/other-treated patients). Treatment is administered for 48
      weeks. At Weeks 2, 4, and then every 4 weeks thereafter, patients undergo physical
      examinations, and blood samples are drawn to measure viral load. [AS PER AMENDMENT 4/27/00:
      Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks.
      While on the treatment extension, patients must continue their current schedule for study
      drug administration and completion of study visits. Patients in Arms A1 and A2 who have
      reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this
      24-week extension. Patients who were enrolled in Arms A1 or A2 and who were taken off study
      after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number
      of weeks they have been off study.]
    

Intervention name(s): Ritonavir; Nelfinavir mesylate; Nevirapine; Stavudine; Didanosine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Nelfinavir; Nevirapine; Stavudine; Didanosine
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; HIV Protease Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents
Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Randomized, double-blind, placebo-controlled pilot study to evalaute viral load in saliva of
      COVID19+ patients using quantitative PCR, before and after use of active or placebo rinses
    


Intervention name(s): CHX0.12+CPC0.05 oral rinse (PerioAidActive Control); placebo rinse
Intervention type(s): Other; Other
Intervention description(s): rinse 15 ml during 1 min during 5 days, twice daily; destilled water rinse 15 ml during 1 min during 5 days, twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Risk Evaluation and Education for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the characteristics of those who obtain genetic
      susceptibility testing for Alzheimer's disease with APOE disclosure and to study the
      psychological and behavioral consequences of providing this information.
    

Detailed description: 
      Advances in genetic research have led to an increased number of testing procedures to
      determine future risk of disease among at-risk individuals. An increasing number of genes are
      being identified that confer susceptibility for a given disease rather than inevitably
      causing it. Given that such genes may provide risk information for common diseases (e.g.,
      stroke, depression), there is a growing need to understand how at-risk populations might
      respond to the option of genetic susceptibility testing. A prominent case in point is
      Alzheimer's disease (AD).

      Participation in this study requires an initial phone call which will elicit some medical and
      family history information about the participant. A first in-person visit to the clinic will
      consist of an education session and the administration of some tests to assess memory and
      thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later,
      participants will return to have their blood drawn for genetic testing. Participants will
      then be randomized to one of two groups. Those in the experimental arm will receive
      information on their risk based on their family history and APOE genotype, while those in the
      active comparator arm will receive information on their risk for developing Alzheimer's
      disease based on their family history alone. Participants will be followed for 1 year
      following disclosure of results with 2 additional clinic visits.
    

Intervention name(s): APOE Disclosure
Intervention type(s): Behavioral
Intervention description(s): Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Mild Cognitive Impairment; disease/disorder proneness/risk; family genetics; genetic counseling; genetic marker; genetic polymorphism; genetic susceptibility
The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a neurodevelopmental disorder and is the most common childhood
      disability. CP is characterized by abnormal development, impaired motor function, and
      muscular and skeletal abnormalities. Due to their diminished musculoskeletal function,
      individuals with CP suffer a high rate of moderate to severe bone fractures, which can lead
      to further immobility. Optimizing muscle and bone health with exercise may be important in
      minimizing fractures from limited mobility, and fundamental for maximizing health-related
      quality of life. The main purpose of this research is to investigate the effect of exercise
      training on musculoskeletal system in individuals with CP, with the goal of reducing the
      incidence of falls and fractures. To accomplish these aims, musculoskeletal health will be
      assessed using various physiological techniques (e.g., Dual energy X-ray Absorptiometry,
      Humac Norm Isokinematic System, Biodex Balance System) before, during, and after one year of
      exercise training in individuals with CP. In addition, various functional mobility tests to
      quantify fitness levels will be performed. Findings may lead to the development of novel
      therapeutic interventions targeted at improving musculoskeletal health in individuals with
      CP.
    


Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Oral PF614 Relative to OxyContin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A)
      and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts
      of the study will be conducted in healthy adult subjects.
    

Detailed description: 
      This study is intended to evaluate the pharmacokinetics of OxyContin (oxycodone ER) and
      PF614, as well as PF614 fragments, following administration of multiple ascending doses of
      PF614, and to compare to steady-state pharmacokinetics to those of OxyContin. (Part A)

      In addition, oral bioavailability of oxycodone derived from single doses of PF614 of the
      to-be-marketed capsule formulation will be compared to that of the reference drug, OxyContin,
      in the fasted and fed condition. A pivotal food effect assessment will be incorporated into
      the study to determine the impact of a high fat meal on the bioavailability of oxycodone,
      following oral single-dose administration of PF614 (Part B).
    

Intervention name(s): PF614; Naltrexone Hydrochloride; OxyContin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF614 is an oxycodone prodrug; Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers; Bioequivalence single-dose comparison to OxyContin
Other intervention name(s): oxycodone prodrug; ReVia; OxyContin 40 mg Extended-Release Tablet
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A will utilize a randomized, open label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects per group.
Part B will utilize an open-label, single-dose, randomized, 4-way crossover design with 13 subjects in each treatment sequence.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prodrug; PF614; OxyContin; oral
Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the present study was to investigate the long-term effects on blood glucose
      concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP).
      This is a plant growing in the mountain regions of Northern Vietnam and previously being used
      in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed
      patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12
      weeks. All patients received instructions regarding diet and physical exercise. Oral glucose
      tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken
      with the purpose to monitor lipids, kidney and liver function, body weight and blood
      pressure.
    

Detailed description: 
      In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic
      patients, but effects of these extracts have not been studied adequately. Based on previous
      results in experimental animals, we have selected the plant Gynostemma pentaphyllum (GP),
      which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect
      on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin
      secretion. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in
      diabetic Zucker fatty rats.

      The present study aimed at investigate effects of GP extract, administered as a "tea", and
      compared with placebo in a randomized, double-blind trial in drug-naive patients with newly
      diagnosed type 2 diabetes. All patients also received instructions about diet and physical
      exercise. In addition to monitoring effects on plasma glucose regulation, we also studied
      possible effects on plasma lipids, kidney and liver function as well as body weight and blood
      pressure.
    

Intervention name(s): Gynostemma pentaphyllum tea; Placebo tea
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 grams twice daily, orally; 3 grams twice daily, orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Herbal medicine; Type 2 diabetes; Insulin sensitivity; Insulin secretion
Bioequivalence Study of Nefopam Hydrochloride 30mg Tablets vs Acupan® 30mg Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of Nefopam Hydrochloride 30mg
      Tablets (test product) and Acupan® 30mg Tablets (reference product).
    


Intervention name(s): Nefopam Hydrochloride 30mg Tablets; Acupan® 30mg Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Iressa v BSC (Best Supportive Care) in First Line NSCLC
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to determine if the addition of Iressa to Best Supportive Care
      treatment will increase the progression free survival of chemo-naïve, poor performance status
      patients, with stage IIIB or IV NSCLC.
    


Intervention name(s): Gefitinib; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment