bioihbjkbjnl/mcl2 huggingface dataset:
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
Condition: Smoking Cessation; Harm Reduction
Study type: Interventional
Phase: Phase 1

Summary: 
      In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users
      will be given repeated doses of four different types of portion snus: "General", "Catch",
      "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen
      (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific
      nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation
      of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco
      specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
    

Detailed description: 
      Comparisons:

      A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

      B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per
      portion.

      C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine
      per portion.

      D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg
      nicotine per portion.

      Swedish portion snus will be administered once every hour (4 administrations/brand) and will
      be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
    

Intervention name(s): Buccal Administration of nicotine; Buccal Administration of nicotine; Buccal Administration of nicotine; Buccal Administration of nicotine
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Oral pouch 1g, single dose. One pouch administered over 30 minutes.; Oral pouch 1g, single dose. One pouch administered over 30 minutes.; Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.; Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Other intervention name(s): Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP; Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP; Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP; Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: smokeless tobacco; Nicotine; Cadmium; lead; Tobacco Specific Nitrosamines
31P Magnetic Resonance Spectroscopy Fructose Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of an oral fructose challenge on liver
      adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a
      potential measure measure of liver health.
    

Detailed description: 
      This study uses 31P spectra acquired from the liver in healthy subjects following a fructose
      drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver
      lipid levels
    

Intervention name(s): Fructose
Intervention type(s): Dietary Supplement
Intervention description(s): Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NAFLD; Oral Fructose Challenge; 31P MRS; Liver; Subjects
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency
Condition: Idiopathic Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily
      dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of
      anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No
      investigational medicinal product will be administered in connection with this follow-up
      study. Eligible patients will attend one visit in this follow-up study.
    


Intervention name(s): Blood sampling
Intervention type(s): Procedure
Intervention description(s): Blood sample will be collected at a single visit
Validation of the PNQ for CIPN Patients.
Condition: Chemotherapy-induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      The Patient Neurotoxicity Questionnaire (PNQ) represents a diagnostic tool concerning
      patients with Chemotherapy Induced Peripheral Neuropathy (CIPN). Application of such a tool
      in the Greek clinical praxis requires validation.

      Validation consists of three stages: translation, reverse translation, and patient
      application. 100 oncologic patients were assessed by comparing the PNQ to the NCI-CTCAE at
      the chemotherapy onset and 2nd, 4th, and 6th sessions. Specific requirements of the
      diagnostic tool (compliance, validity, concordance, sensitivity, specificity, reliability)
      were statistically evaluated.

      Differences between translated texts and between the reverse translation and the original
      were considered negligible. At the 2nd, 4th and 6th session compliance was 98%, 95% and 93%
      while Cronbach's α was 0,57 0,69 and 0,81 respectively. Cohen's weighted κ was 0,67 and 0,58,
      Spearman's ρ was 0,7 and 0,98 while AUC of the ROC was 1 and 0,9 for the sensory and the
      motor part respectively. The variance's linear regression analysis confirmed CIPN worsening
      over time (p-value<0,0001).

      The Greek version remains close to the original. Compliance rates reflect easy PNQ
      application. Cohen's κ values highlight the physicians' tension to underestimate the
      patients' condition. Spearman's ρ, Cronbach's α and AUC values reflect good validity,
      reliability and specificity of the PNQ respectively. Finally, the linear analysis confirmed
      the PNQ sensitivity over time.

      The PNQ validation in Greek adds a crucial tool in the physicians' armory. It can now draw
      the necessary information to modify the chemotherapy and analgesic treatment schemes at both
      preventive and acute levels.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        100 male or female patients from the oncology clinic of the General Hospital of Rhodes,
        Greece, regardless of cancer type
      
Keywords: chemotherapy; peripheral neuropathy; questionnaire
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of food on the pharmacokinetics (PK) of pediatric
      formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine
      [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in
      healthy adult participants. Additionally, safety and tolerability of these formulations will
      also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of
      companies.
    


Intervention name(s): TRIUMEQ; DOVATO
Intervention type(s): Drug; Drug
Intervention description(s): TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion.; DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion.
Intervention MeSH terms: Abacavir, dolutegravir, and lamivudine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, single-dose, 2-cohort, 2-period crossover study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TRIUMEQ; DOVATO; Pharmacokinetics; Food effect; Dolutegravir; Abacavir; Lamivudine
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the influence of renal impairment on the pharmacokinetics and metabolism of
      Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
    

Detailed description: 
      Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted
      conditions
    

Intervention name(s): 20 mg HC-ER; 20 mg HC-ER; 20 mg HC-ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1-72 hours; 1-72 hours; 1-72 hours
Other intervention name(s): Zohydro ER; Zohydro ER; Zohydro ER
Intervention MeSH terms: Hydrocodone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Multifocal Contact Lens on Ocular Tissue
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
    


Intervention name(s): etafilcon - PVP (multi-focal)
Intervention type(s): Device
Intervention description(s): The investigational contact lens must be worn at least six hours daily.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cryolipolisis for Abdomen and Flank Fat Reduction
Condition: Subcutaneous Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment
      groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion
      Cryolipolysis. The region will be treated according to the individual need, in the region of
      abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60
      and 90 days after randomization. Blood collections will also be performed at baseline and
      between 14 and 21 days after randomization for evaluation of lipid profile and liver
      function.
    


Intervention name(s): Conventional Cryolipolysis; Contrast Cryolipolysis; Reperfusion Cryolipolysis
Intervention type(s): Device; Device; Device
Intervention description(s): Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.; Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.; Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2
      vaccine (CoronaVac）manufactured by Sinovac Research & Development Co., Ltd. The purpose of
      this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of CoronaVac
      in healthy adults aged 26-45 years.
    

Detailed description: 
      This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45
      years to evaluate the lot-to-lot consistency, immunogenicity and safety of the
      commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was
      manufactured by Sinovac Research & Development Co.,Ltd. A total of 1080 healthy subjects aged
      26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups
      in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.
    

Intervention name(s): Inactivated SARS-CoV-2 Vaccine (Vero cell）
Intervention type(s): Biological
Intervention description(s): 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other intervention name(s): CoronaVac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
Condition: Premature Birth; Neonatal Hypoxic Conditions
MeSH terms: Premature Birth; Hypoxia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent
      events in premature infants born between 32.0 and 33.6 weeks of gestational age.
    

Detailed description: 
      A weekly screening will be done on all new hospitalized infants at the neonatal care unit of
      the CHUS born between 32.0 and 33.6 weeks of gestational age. At the beginning of their 2nd
      week in the neonatal care unit, infant's medical record will be consulted for inclusion and
      exclusion criteria. At this moment, no information will be noted. Then, team research will
      discuss with neonatologist to have their opinion concerning the inclusion of a patient in the
      study. If they agree, the doctor or the nurse having a therapeutic link with the infant will
      ask parents' infant if they agree to meet the research team to discuss about the research
      project. Once the agreement will be obtained, parents will be approached by a member of the
      research team. Project will be explained, questions will be answered and consent form will be
      obtained. When an infant will be enrolled in the study, a code will be attributed to him and
      a randomization will established the order of the intervention.

      Option A) night 1: a 12h cardiorespiratory recording with vanilla, night 2: no recording and
      night 3: a 12h cardiorespiratory recording without vanilla OR Option B): night 1: a 12h
      cardiorespiratory recording without vanilla, night 2: no recording and night 3: a 12h
      cardiorespiratory recording recording with vanilla.

      All data will be entered in a secured database and a double checked will be done by team
      members to assess the accuracy.
    

Intervention name(s): Vanilla scent
Intervention type(s): Other
Intervention description(s): A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements will be performed while the infant is exposed to vanilla scent (from vanilla solution on the infant's pyjamas).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Late preterm; Vanilla; Hypoxic intermittent events
Imaging Possible Appendicitis With CT
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      Pain in the right lower abdomen is one of the commonest reasons patients present to general
      surgeons as an emergency. Whether or not such patients have appendicitis is crucial to their
      assessment. In UK practice, when the diagnosis is unclear, ultrasound scanning (US) is
      commonly used to investigate the problem. US is very safe but it will only visualise the
      appendix in the minority of cases. As a result, the sensitivity for diagnosing appendicitis
      in this setting is probably only 5-30%. Alternatively, computed tomography (CT) is an
      accurate way of diagnosing appendicitis in over 90% of cases. CT scans are readily available
      and with modern scanners, high quality images can be achieved with lower radiation doses.
      Unenhanced scanning avoids the use of contrast media and permits further reductions in
      ionising radiation exposure.
    

Detailed description: 
      Pain in the right lower abdomen is one of the commonest reasons patients present to general
      surgeons as an emergency. Whether or not such patients have appendicitis is crucial to their
      assessment. In UK practice, when the diagnosis is unclear, ultrasound scanning (US) is
      commonly used to investigate the problem. US is very safe but it will only visualise the
      appendix in the minority of cases. As a result, the sensitivity for diagnosing appendicitis
      in this setting is probably only 5-30%. Alternatively, computed tomography (CT) is an
      accurate way of diagnosing appendicitis in over 90% of cases. CT scans are readily available
      and with modern scanners, high quality images can be achieved with lower radiation doses.
      Unenhanced scanning avoids the use of contrast media and permits further reductions in
      ionising radiation exposure.
    

Intervention name(s): unenhanced abdomino-pelvic CT scan; abdominal ultrasound
Intervention type(s): Other; Other
Intervention description(s): unenhanced abdomino-pelvic CT scan; abdominal ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
Condition: Influenza; Orthomyxovirus Infections; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To further characterize the immune responses induced after an influenza vaccination performed
      either via the ID or the IM routes in two clearly distinct populations.

      Objectives:

        -  To describe the immune response per age group and vaccine group after vaccination.

        -  To describe the safety of the vaccines per age group and per vaccine group after
           vaccination.
    


Intervention name(s): Inactivated, split-virion, influenza vaccine; Inactivated, split-virion, influenza vaccine; Inactivated, split-virion influenza vaccine; Inactivated, split-virion influenza vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.1 mL, Intradermal; 0.5 mL, Intramuscular; 0.1 mL, Intradermal; 0.5 mL, Intramuscular
Other intervention name(s): Vaxigrip®; Vaxigrip®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Myxovirus Infection; Inactivated Split-virion influenza vaccine; Adults; Elderly
A Study to Evaluate the Effect of Genotype on LY2216684
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine
      on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be
      documented.
    

Detailed description: 
      The human cytochrome P450 2C19 (CYP2C19) enzyme is a polymorphic enzyme yielding ultrarapid
      metabolizer, extensive metabolizer (EM), intermediate metabolizer, and poor metabolizer (PM)
      phenotypes. Enrollment in the study was limited to participants predicted to be CYP2C19
      extensive metabolizers or CYP2C19 poor metabolizers, as determined by genotyping analysis.
    

Intervention name(s): LY2216684; Quinidine
Intervention type(s): Drug; Drug
Other intervention name(s): Quinidine sulfate controlled release (CR)
Intervention MeSH terms: Quinidine; Quinidine gluconate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in
      treating patients who have soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the response in patients with resectable soft tissue sarcoma of the
      extremity treated with neoadjuvant intra-arterial cisplatin and IV doxorubicin followed by
      limb-sparing procedure or amputation, adjuvant IV cisplatin and IV doxorubicin, and
      radiotherapy. II. Determine the chemotherapeutic response in tumor specimens of patients
      treated with this regimen.

      OUTLINE: Neoadjuvant chemotherapy: Patients undergo arterial cannulation followed by
      cisplatin intra-arterially over 4 hours on day 1 and doxorubicin IV (beginning 15 minutes
      after completion of cisplatin infusion) on days 1-3. Treatment continues every 3 weeks for 2
      courses in the absence of unacceptable toxicity. Patients undergo amputation or limb-sparing
      wide excision, as feasible, approximately 4 weeks after the second course. If surgery cannot
      be scheduled at this time for logistical reasons, a third course may be administered.
      Patients with an estimated tumor kill of at least 50% receive adjuvant chemotherapy as
      outlined below. Patients undergoing limb-sparing wide excision receive post-operative
      radiotherapy as outlined below. Adjuvant chemotherapy: Beginning 3-4 weeks after surgery,
      patients receive cisplatin IV over 4 hours on day 1 and doxorubicin as above on days 1-3.
      Treatment continues every 3 weeks for 4 courses in the absence of disease progression, stable
      disease, or unacceptable toxicity. Patients undergoing radiotherapy receive the final 3
      courses of chemotherapy after completion of radiotherapy. Post-operative radiotherapy:
      Beginning after the first postoperative chemotherapy course and within 8 weeks after surgery,
      patients receive radiotherapy 5 days a week for 7-8 weeks. An interstitial implant using
      iridium Ir 192 may be used to administer the final doses of radiotherapy.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
    

Intervention name(s): cisplatin; doxorubicin hydrochloride; isolated limb perfusion; conventional surgery; brachytherapy; radiation therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Radiation; Radiation
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Primary purpose: Treatment
Keywords: stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma
14C-ARN-509 Microtracer Label AME and Absolute BA Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is study in healthy human volunteers to determine the absorption, metabolism, and
      excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).
    

Detailed description: 
      Two cohorts of 6 healthy volunteers will be enrolled for the AME and absolute BA parts,
      respectively. The dose for both cohorts is 240 mg. The expected exposure of the dose is
      7-fold lower than the steady state reached in patients with castration-resistant prostate
      cancer.
    

Intervention name(s): ARN-509
Intervention type(s): Drug
Intervention description(s): Single oral dose of 240 mg ARN-509
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; mass balance study; Pharmacokinetics