bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine:

      Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of
      50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral
      administration of 160 milligram (mg) mobocertinib.

      Period 2 (absorption, distribution, metabolism, and elimination [ADME]): the mass balance and
      metabolic profile of mobocertinib in plasma, urine, and feces, to characterize the PK of
      mobocertinib and its metabolites (AP32960 and AP32914) in plasma, whole blood, and urine, and
      total radioactivity concentration equivalents in plasma and whole blood following a single
      oral administration of 160 mg (approximately 100 mcCi) [14C]-mobocertinib solution.
    

Detailed description: 
      The drug being tested in this study is called mobocertinib. The study will determine ABA of
      mobocertinib following single microdose of 50 mcg [14C]-mobocertinib and single oral
      administration of 160 mg mobocertinib and will assess the mass balance and metabolic profile
      of mobocertinib in plasma, urine, and feces following a single oral administration of 160 mg
      [14C]-mobocertinib solution, and will characterize the PK of mobocertinib and its metabolites
      in plasma, whole blood, and urine, and total radioactivity concentration equivalents in
      plasma and whole blood following a single dose of 160 mg [14C]-mobocertinib.

      The study will enroll approximately 6 participants. The study is designed to consist of 2
      periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1, all
      participants will receive single unlabeled oral 160 mg dose of mobocertinib as capsules. At
      3.75 hours post oral dosing, participants will receive 15-minute intravenous infusion of a
      microdose of 50 mcg (approximately 2mcCi) [14C]-mobocertinib. In Period 2, participants will
      receive single dose of 160 mg (approximately 100 mcCi) [14C]-mobocertinib as an oral
      solution.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 65 days including screening period. Participants
      will be contacted approximately 30 days after the last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): Mobocertinib
Intervention type(s): Drug
Intervention description(s): Mobocertinib capsule, [14C]-Mobocertinib intravenous infusion, [14C]-Mobocertinib oral solution.
Other intervention name(s): TAK-788
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Food Effects on Milademetan Pharmacokinetics in Healthy Participants
Condition: Food Effects on Pharmacokinetics
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objectives of this trial are:

        -  To evaluate the effect of a high-calorie, high-fat meal on the single-dose
           pharmacokinetics (PK) of milademetan

        -  To evaluate the effect of a standard meal on the single-dose PK of milademetan

      The key secondary objective is to evaluate the safety and tolerability of single-dose
      milademetan in all treatments.

      The duration of the study for each individual participant will be approximately 8 weeks from
      the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the
      final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit
      (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights).

      Participants will receive 3 single doses of study drug (at least 1 week apart) over the
      course of 15 days.

      At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2
      days) after final dose of study drug for a follow-up visit.

      The end of the study is defined as the date of final follow-up visit of the last subject
      undergoing the study.
    


Intervention name(s): Milademetan Treatment A; Milademetan Treatment B; Milademetan Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions; Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal; Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
Other intervention name(s): Experimental product; Experimental product
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be assigned to 1 of 6 treatment sequences (Sequences ABC, ACB, BAC, BCA, CAB, or CBA), according to a pre-generated randomization scheme.
Masking: None (Open Label)
Primary purpose: Basic Science
Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions
Condition: Macula Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Study type: Interventional

Summary: 
      The aim of this study is to compare formulated Posterior Subtenon Triamcinolone acetonide
      (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone in the management of
      macular edema secondary to non-ischemic retinal vein occlusions, either central or branch.
    


Intervention name(s): Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate; Triamcinolone Acetonide alone
Intervention type(s): Drug; Drug
Intervention description(s): formulated with sodium hyaluronate and chondroitin sulfate; Triamcinolone Acetonide alone
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hyaluronic Acid; Triamcinolone diacetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to compare the change from baseline in hemoglobin A1C
      achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin
      XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral
      administration of double-blind treatment. The safety of treatment with dapagliflozin will
      also be assessed in this study
    


Intervention name(s): Dapagliflozin; Metformin XR; Metformin XR; dapagliflozin matching Placebo; metformin HCl Modified Release matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 10 mg, once daily, 24 weeks; Tablets, Oral, up to 2000 mg, once daily, 24 weeks; Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks; Tablets; Tablets
Other intervention name(s): Farxiga™; Glucophage®; Glucophage®
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Metformin; Dapagliflozin; Hypoglycemic Agents; Pharmacologic Actions; Physiological Effects of Drugs
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Condition: Advanced Solid Malignancies; Malignant Lymphoma
MeSH terms: Lymphoma; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a
      maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when
      given daily to patients with advanced solid malignancies including malignant lymphoma
    

Detailed description: 
      A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics
      and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced
      Solid Malignancies including Malignant Lymphoma
    

Intervention name(s): AZD1208
Intervention type(s): Drug
Intervention description(s): Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced solid malignancies; Malignant lymphoma
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety
      of two different subcutaneous hMG preparations when administered to patients undergoing
      controlled ovarian stimulation for IVF.
    


Intervention name(s): Menotropins; Menotropins
Intervention type(s): Drug; Drug
Intervention description(s): Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.; Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Virtual Reality in Burn Pain Management
Condition: Burns; Pain
MeSH terms: Burns
Study type: Interventional

Summary: 
      To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn
      patients experiencing severe procedural pain during wound care.
    

Detailed description: 
      This is a prospective, randomized cross-over study of the safety and effectiveness of the use
      of a virtual reality distraction intervention to management procedural pain during burn wound
      care. Up to 20 subjects will be enrolled until 12 complete the study.
    

Intervention name(s): Pain management; Standard of care/no virtual reality game
Intervention type(s): Procedure; Other
Intervention description(s): Pain mamagement for burn care procedures.; no intervention for standard of care
Other intervention name(s): Snow World or Standard of care; Standard of care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: wound care
Plant Protein Supplementation Within a Healthy Lifestyle Modulates Plasma Circulating Amino Acids and Improves the Health Status of Overweight Individuals
Condition: Obesity; Metabolic Syndrome; Metabolic Disorder; Inflammation; Immune System and Related Disorders
MeSH terms: Overweight; Metabolic Syndrome; Metabolic Diseases; Inflammation
Study type: Interventional

Summary: 
      A dietary pattern based on Mediterranean diet has been reported as healthy for humans, as
      well as doing aerobic exercise regularly, diminishing the development of potential
      inflammation in subjects. Protein intake has been proposed as nutritional strategy to further
      improve these positives outcomes in terms of preventing inflammation diseases. In this work,
      overweight patients followed a Mediterranean diet together with aerobic exercise according to
      WHO-guidelines and were supplemented with 20 g of hemp protein/day, for twelve weeks.

      Anthropometric and biochemical measures (including analysis of oligoelements), as well as
      plasma circulating amino acids were evaluated in each patient at the end of the intervention,
      to assess whether biologically relevant changes could be observed.
    


Intervention name(s): Mediterranean diet supplement with 20 g / day of hemp protein.
Intervention type(s): Dietary Supplement
Intervention description(s): All participants followed a low-energy diet (1315 kcal/daily) based on Mediterranean diet for 12 weeks, supplement with 20 g / day of hemp protein. The specific menu was designed by a trainee nutritionist. The program prescribed five meals a day, with the time customized to fit the lifestyle of each patient. Based on the baseline metabolism, the energy and nutritional parameters of every patient were computed. Patients reported the dietary intake data daily.
The intervention included face to face visit every two weeks, individual nutrition counseling and education sessions.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
Condition: Mucosal Immunity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the safety and effectiveness of the influenza
      vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a
      muscle). The investigators will measure the systemic (through out the body) and mucosal
      immune responses (how your body recognizes and defends itself against bacteria) to nasally
      administered influenza vaccine, and determine if nasal immunization results in immunity (your
      body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral
      and reproductive), in comparison with intramuscular administration and placebo (inactive
      substance given in the same form as the active drug).
    


Intervention name(s): Fluzone; Fluzone
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 ml/15 micrograms; 0.5 ml/60 micrograms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Vaccination; Mucosal Immunity; Nasal Immunization
Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers the disease.

      Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's
      also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has
      beneficial effects on glucose and lipids metabolism, blood pressure and body weight.

      The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome,
      insulin sensitivity and insulin secretion.

      The investigators hypothesis was that the administration of resveratrol modifies the
      metabolic syndrome, insulin sensitivity and insulin secretion.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients
      with a diagnosis of metabolic syndrome in accordance with the International Diabetes
      Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and
      acid uric were evaluated after a 75 g of dextrose load.

      12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.

      The remaining 12 patients received placebo with the same prescription.

      Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion
      (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin
      sensitivity (Matsuda index).

      This protocol was approved by a local ethics committee and written informed consent was
      obtained from all volunteers.

      Results are presented as mean and standard deviation. Intra and inter group differences were
      tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was
      considered significant.
    

Intervention name(s): Resveratrol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.; Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Other intervention name(s): Trans resveratrol; 3, 5, 4' -trihidroxiestilbeno; Calcined magnesia
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabolic syndrome; central obesity; resveratrol; insulin secretion; insulin sensitivity
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Condition: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study IS to

        -  explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents,
           particularly focusing on genetics, infections/immunology, endocrinology, autonomic
           control and cognitions

        -  to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity)
           in adolescent CFS.
    


Intervention name(s): Clonidine; Lactose capsula
Intervention type(s): Drug; Drug
Intervention description(s): Day 1-56 (week 1-8): 25 microgram (1 capsula) x 2/day for patients < 35 kg; 50 microgram (2 capsula) x 2/day for patients > 35 kg.
Day 57-63 (week 9): 25 microgram (1 capsula) x 1/day for patients < 35 kg; 25 microgram (2 capsula) x 2/day for patients > 35 kg.; Day 1-56 (week 1-8): 1 capsula x 2/day for patients < 35 kg; 2 capsula x 2/day for patients > 35 kg.
Day 57-63 (week 9): 1 capsula x 1/day for patients < 35 kg; 1 capsula x 2/day for patients > 35 kg
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; Clonidine; Autonomic nervous system; Stress
Determine Pacritinib Pharmacokinetics in Impaired Hepatic Patients and Healthy Subjects
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel-group, single-dose study of the PK and safety of 400 mg
      pacritinib administered orally to patients with stable chronic liver disease and healthy
      control subjects.
    

Detailed description: 
      All study participants will undergo screening evaluations to determine eligibility for the
      study. All screening evaluations must be performed within 28 days of pacritinib dosing (Day
      1). Assignment of patients to each hepatic impairment group will be defined by Child-Pugh
      Clinical Assessment Score at the time of Screening. Group 3 patients will not be dosed until
      at least 2 patients combined from Groups 1 and 2 have completed the study (Day 8). Healthy
      subjects will be enrolled after hepatic impairment accrual is complete to allow for age-,
      gender- and body mass index- (BMI) matching with the hepatic impairment population.
      Participants will be admitted to the study site on Day -1 (i.e., Check-in). On Day 1, upon
      receipt of all baseline safety evaluation results and confirmation of eligibility, study
      participants will be administered a single dose of 400 mg pacritinib orally under fasting
      conditions. Fasting will start 10 hours prior to pacritinib administration and continue for
      an additional 4 hours after administration. Following administration of pacritinib,
      participants will remain confined to the study site for 168 hours (8 days) after pacritinib
      dosing for collection of blood for PK and safety assessments.
    

Intervention name(s): Pacritinib
Intervention type(s): Drug
Intervention description(s): Pacritinib 400 mg (4 capsules of 100 mg each), single dose, oral administration
Other intervention name(s): Pacritinib 400mg capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants
Condition: Streptococcus Pneumoniae
MeSH terms: Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to determine the minimum of doses of a new nine valent
      pneumococcal conjugate vaccine required to protect UK infants and toddlers
    

Detailed description: 
      A new vaccine against pneumococcal infection is now available in the UK and has already been
      in routine use in the US for five years. The purpose of the trial is to determine the minimum
      number of does required to protect UK infants and toddlers, and to assess the compatibility
      of the pneumococcal vaccine with the other vaccines given in the UK childhood immunisation
      programme. The vaccine used in the US protects against seven strains of pnemococcus whereas
      the vaccine used in this trial protects against nine strains. Infants received either two
      doses at two and four months or three doses at two, three and four months of age, the latter
      comprising the routine infant schedule for other paediatric vaccines in the UK. The infants
      also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and Hib
      together with meningitis C vaccine which is currently only used in the UK and a few other
      countries worldwide. A group of toddlers aged twelve to fifteen months also took apart and
      received either one or two doses of pneumococcal vaccine around the same time as their MMR
      vaccine. All children in the study received a booster dose some months later. The response to
      the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal
      strains in blood samples taken at various times during the immunisation schedule.
    

Intervention name(s): 9 valent pneumococcal con jugate vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention