bioihbjkbjnl/mcl2 huggingface dataset:
Molecular Imaging of Lymphoma Using Labeled Technetium-99m 1-Thio-D-Glucose
Condition: Hodgkin Lymphoma, Adult; Non-Hodgkin Lymphoma, Adult
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients
      with Hodgkin Lymphoma and Non Hodgkin Lymphoma.

      The primary objective are:

        1. To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at
           different time intervals.

        2. To evaluate dosimetry of 99mTc-1-thio-D-glucose.

        3. To study the safety and tolerability of the drug 99mTc-1-thio-D-glucose after a single
           injection in a diagnostic dosage.

      The secondary objective are:

      1. To compare the obtained 99mTc-1-thio-D-glucose SPECT imaging results with the data of CT
      imaging and/or 18F-FDG positron emission tomography (PET) and immunohistochemical (IHC)
      studies in Lymphoma patients.
    

Detailed description: 
      The overall goal is to study the effectiveness of SPECT imaging Hodgkin Lymphoma and Non
      Hodgkin Lymphoma Using technetium-99m labeled 1-thio-D-glucose.

      Phase I of the study:

      Biodistribution of 99mTc-1-thio-D-glucose in patients with Hodgkin Lymphoma and Non Hodgkin
      Lymphoma.

      The main objectives of the study:

        1. To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in
           patients with Lymphoma at different time intervals.

        2. To evaluate dosimetry of 99mTc-1-thio-D-glucose based on the pharmacokinetic parameters
           of the drug after a single intravenous administration.

        3. To study the safety of use and tolerability of the drug 99mTc-1-thio-D-glucose after a
           single intravenous administration in a diagnostic dosage.

      Additional research tasks:

      1. To conduct a comparative analysis of the diagnostic information obtained in the
      visualization of Lymphoma by SPECT using 99mTc-1-thio-D-glucose with data obtained by CT
      and/or positron emission tomography (PET) and immunohistochemical (IHC) research of
      postoperative material.

      Methodology:

      Open-label, exploratory, single centre study. The subjects will receive a single injection of
      the labeled tracer.
    

Intervention name(s): SPECT with 99mTc-1-thio-D-glucose
Intervention type(s): Diagnostic Test
Intervention description(s): One single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hodgkin Lymphoma; Non Hodgkin Lymphoma; 99mTc-1-thio-D-glucose; SPECT
Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of posaconazole
      intravenous solution in Chinese participants at high risk for invasive fungal infections.
      Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or
      myelodysplastic syndromes will be enrolled in the study. The primary hypothesis is to
      evaluate the pharmacokinetic parameters of intravenous (IV) posaconazole (POS) solution in
      Chinese participants at high risk of invasive fungal infections and determine the percentage
      of Chinese participants who reach steady-state concentration averages of POS in blood plasma
      of 500 ng/ml and higher. Two subgroups were evaluated: Subgroup 1 from serial PK blood draw
      sampling and Subgroup 2 from sparse limited PK blood draw sampling.
    


Intervention name(s): Posaconazole
Intervention type(s): Drug
Intervention description(s): Posaconazole 18 mg/mL IV solution; posaconazole 40 mg/mL oral suspension
Other intervention name(s): MK-5592; Noxafil
Intervention MeSH terms: Posaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
Condition: Irritable Bowel Syndrome With Constipation; Constipation-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional

Summary: 
      Single centre, open-label, non-randomized study is planned to proof the concept of safety and
      efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage
      based on kombucha, enriched with inulin and vitamins in patients with constipations
    

Detailed description: 
      This single-center open-label non-randomized study is planned to proof the concept on safety
      and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage
      based on kombucha, enriched with inulin and vitamins in patients with irritable bowel
      syndrome with constipations.
    

Intervention name(s): kombucha-based beverage
Intervention type(s): Dietary Supplement
Intervention description(s): kombucha-based beverage: drinking water, black tea, kombucha, inulin, vitamins (B1, B2, B6, niacin, folic acid). Nutritional value in 100 ml: carbohydrates - 2.57 g (including sucrose - 0.22 g, glucose - 1.32 g, fructose - 1.03 g), inulin - 1.15 g (46%*), vitamin B1 - 0.4 mg (29%*), B2 - 0.21 mg (13%*), B6 - 0.48 mg (24%*), niacin - 2.74 mg (15%*), folic acid - 24.0 mcg (12%*). Energy value/Caloric content - 54 kilojoules/13 kcal (* - % of the recommended daily allowance, according to the Technical regulations of the Customs Union #022/2011). Flavours, identical by nutrient's content and nutrients density: black currant berries & juniper berries, or strawberries & lime leaves, or passion fruit & mango.
Portion's volume - 220 ml. Daily intake: 1 portion
Other intervention name(s): Kombucha enriched with inulin, vitamins and flavours
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: specialized food product; kombucha; safety; efficacy; constipation; functional food
Assessment of V0018 1.5 mg Effect on Craving
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the reduction of craving after administration of
      V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.
    


Intervention name(s): V0018; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oromucosal - Single dose; Oromucosal - Single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotine replacement therapy; craving; Healthy moderately dependant smokers
Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic
      antitumor activity. The purpose of the present study is to investigate the safety and
      pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following
      single-dose administration.
    


Intervention name(s): deuteporfin; deuteporfin; deuteporfin; deuteporfin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): deuteporfin 1 mg/kg IV as a single dose; deuteporfin 2.5 mg/kg IV as a single dose; deuteporfin 5 mg/kg IV as a single dose; deuteporfin 7.5 mg/kg IV as a single dose; Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: deuteporfin; safety; tolerability; pharmacokinetics; healthy volunteers
Effects of Walnuts on Endothelial Function in Overweight Adults With at Least One Factor of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of walnut consumption on endothelial
      function and lipid markers in overweight patients with at least one factor of metabolic
      syndrome as compared to the control group.
    

Detailed description: 
      The prevalence of obesity in both adults and children in the United States has increased
      significantly over the past 50 years. More than 66% of adults in the US are now overweight or
      obese and at least 17% of children in the population at large are now considered
      overweight.Obesity may be a factor predisposing patients to a myriad of comorbidities that
      increase the associated mortality rate.Several large prospective trials have documented that
      obesity is an independent risk factor for mortality from cardiovascular disease (CVD).
      Considering the major metabolic and biochemical changes that occur in obesity, such as
      atherogenic dyslipidemia, insulin resistance and hyperinsulinemia, endothelial dysfunction,
      and chronic inflammatory and prothrombotic states, obesity plays a role in the pathogenesis
      of systemic atherosclerosis and its clinical complications.

      Walnuts are rich in alpha-linolenic acid, an essential omega-3 fatty acid, L-arginine and
      antioxidants. Polyunsaturated fatty acids and antioxidants have anti-oxidative effects and
      are thought to help preserve the endothelium's capacity to generate nitric oxide (NO), which
      acts to promote vasodilation, stabilize platelets, and promote the anti-inflammatory
      abilities of the endothelium. Evidence of this anticipated effect would have implications for
      strategies to prevent or retard type 2 diabetes mellitus and cardiovascular disease.
      Endothelial function testing using high frequency ultrasound imaging of the brachial artery
      to assess endothelium-dependent flow-mediated dilatation (FMD) offers a non-invasive,
      uniquely valuable means of assessing aggregated influences on cardiac risk by gauging a
      physiologic response of the vascular endothelium. Proposed, therefore, is a randomized,
      controlled, cross-over clinical trial, to assess the effects of walnuts on endothelial
      function in overweight adults with elevated waist circumference and at least one risk factor
      of metabolic syndrome.
    

Intervention name(s): Walnut Supplementation; No walnut supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Eight weeks of walnut supplementation; Eight weeks without walnut supplementation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; walnuts; endothelial function
A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate pharmacokinetics, including dose
      proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy
      Chinese subjects.
    


Intervention name(s): Spesolimap
Intervention type(s): Drug
Intervention description(s): Spesolimap
Other intervention name(s): BI 655130
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
Condition: Peripheral Artery Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional

Summary: 
      The aim of this study was to analyze the effects of resistance exercise and training on
      cardiovascular function of peripheral artery disease patients.
    

Detailed description: 
      Several studies have shown that strength training can promote important benefits for the
      cardiovascular system in healthy subjects and patients with chronic diseases. However, the
      effects of resistance exercise on cardiovascular function in intermittent claudication
      patients are unclear. In addition, it also do not know the chronic effects on cardiovascular
      function in these patients.
    

Intervention name(s): Resistance training; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Resistance training exercises; Stretching exercises
Other intervention name(s): Physical training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Nicotine Lozenge Bioequivalence Study
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bio equivalence of new nicotine lozenge formulation with the reference
      nicotine lozenge so as to deliver the same nicotine blood profile.
    


Intervention name(s): Nicotine (2 mg); Nicotine (4 mg)
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg nicotine lozenge in two formulations; 4 mg nicotine lozenge in two formulations
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: nicotine lozenge; nicotine; nicotine replacement therapy
Salbutamol Tolerance Onset
Condition: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness
      (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the
      long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The
      onset of tolerance to salbutamol is not known.
    


Intervention name(s): salbutamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200mcg twice daily for a total of 7 doses; 200mcg twice a day for a total of 7 doses (3.5 days).
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
Condition: Wrinkles
Study type: Interventional

Summary: 
      This single-center, the clinical trial is being conducted over the course of 90 days followed
      by 1-month and 6-month post-treatment visits in order to assess the efficacy and tolerability
      of the Sponsor's SkinPen device when used by men and women with the wrinkles of the neck.
    

Detailed description: 
      A total of 32 subjects completed study participation.

      At visit 1 (baseline), subjects were screened for eligibility criteria, and those who
      qualified either completed day 1 procedures at the same visit or returned to the clinic up to
      14 days after visit 1 to complete day 1 procedures at visit 2.

      On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the
      testing facility (henceforth referred to as "clinic") treated each subject's wrinkles of the
      neck with SkinPen Precision System at depths of up to 2.5mm.

      During the post-treatment period, Clinical evaluations were conducted at visit 2 (day 1),
      visit 3 (day 30), visit 4 (day 60), visit 5 (day 90), visit 6 (1month post-treatment), and
      visit 7 (3 months post-treatment)
    

Intervention name(s): SkinPen Precision
Intervention type(s): Device
Intervention description(s): Surgical instrument motors and accessories/attachments/Hydrogel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular
      multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden.

      II. Compare the relative protection of each vaccine against atypical or subclinical pertussis
      infection.

      III. Analyze possible laboratory correlates to vaccine protection.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution.

      The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT)
      and filamentous hemagglutin (FHA).

      The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and
      agglutinogen 3.

      The third group receives a whole-cell pertussis vaccine. The fourth group receives a
      diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular
      injection, at 2-3, 4, and 6 months of age.

      Close surveillance of infants and families continues for 2-3 years.
    

Intervention name(s): whole-cell pertussis vaccine; diphtheria-tetanus vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: bacterial infection; immunologic disorders and infectious disorders; pertussis; rare disease
Anesthesia Depth Increases Delirium Incidence
Condition: Delirium; Anesthesia Awareness
MeSH terms: Delirium; Intraoperative Awareness
Study type: Interventional

Summary: 
      This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light
      anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and
      mortality but higher rates of awareness and complications than a standard of care anaesthesia
      blinded to depth monitoring.
    

Detailed description: 
      Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical
      center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission
      II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical
      Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson
      Prof W. Striebel) on Mai 12th 2008.

      Patients: n=130, aged > 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care
      (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative
      cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal
      working&short term, figural working&short term memories and well as attention level) Second
      aims: mortality, complications
    

Intervention name(s): BIS guidance of anesthesia; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics; Anesthesia is administered as usual
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised-controlled, double blind study, monocentric
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: bispectral index monitoring; anesthesia depth
Oxidative Stress in Patients With Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      First, to quantify, by means of comet assay analysis, systemic oxidative stress in patients
      with non-exudative and exudative age-related macular degeneration (AMD) and compare results
      to healthy controls.

      Second, to quantify systemic oxidative stress in patients with exudative AMD prior to and
      after photodynamic (PDT) therapy.
    

Detailed description: 
      Oxidative stress is the major factor that plays a role in the pathogenesis of age-related
      macular degeneration (AMD), which is a leading cause of blind registration in the developed
      world. The term oxidative stress refers to reversible damage to molecules, such as for
      example DNA, by reactive forms of oxygen (eg. free oxygen radicals). This damage is repaired
      is normally repaired in our body.

      AMD is classified in two forms: the dry (non-exudative) and wet (exudative) form. The
      exudative form of AMD occurs when new blood vessels form to improve the blood supply to
      retinal tissue. However, the new blood vessels are very delicate and break easily, causing
      bleeding and serious vision loss. The standardized method used to treat exudative AMD is
      photodynamic therapy (PDT). This treatment is based upon the infusion of a drug that can be
      activated by light and produces free radicals that destroy these newly formed vessels. In
      other words, these new vessels are destroyed by an iatrogenic source of oxidative stress.
      This means that the factor that originally caused the disease AMD, namely oxidative stress,
      is finally used as a form of treatment- to destroy these newly formed blood vessels.

      In the present study we would like to quantify in a first step the level of systemic
      oxidative stress in patients with non-exudative and exudative AMD and compare to healthy
      controls. In a second step we would like to test whether the treatment (PDT) for patients
      with exudative AMD additionally increases systemic oxidative stress. Oxidative stress is
      quantified in our laboratory by means of single cell gel electrophoresis or comet assay.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with macular degeneration
      
Biospecimen description: 
      plasma
    
Keywords: exudative age-related macular degeneration (AMD); non-exudative age-related macular degeneration (AMD); oxidative stress; photodynamic therapy
Food Effect Study PF-04136309
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food intake on PF-04136309
      pharmacokinetics (PK) following a single dose at 1000 mg.
    

Detailed description: 
      The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has
      been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food
      on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in
      the multiple dose setting in patients, will provide information to guide the dose
      administration in regards to food intake at relevant therapeutic dose levels for further
      studies in patients.
    

Intervention name(s): PF-04136309
Intervention type(s): Drug
Intervention description(s): Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets.
Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: food effect; healthy volunteers; pharmacokinetics; CCR2i