bioihbjkbjnl/mcl2 huggingface dataset:
CD34 Selection of the Peripheral Blood Stem Cell Graft for Autologous Transplant
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+
      hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast
      cancer.
    

Detailed description: 
      Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous
      Hematopoietic Support Following High Dose Treatment with BCNU, Cyclophosphamide & Cisplatin
      for Stage IV Breast Cancer & Limited Prior Treatment
    

Intervention name(s): high dose chemo then auto hematopoietic cell transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce
      appetite and hunger given on the same day of testing.
    

Detailed description: 
      Four hours after breakfast a small amount of liquid to drink will be given to a participant
      that will contain either the Appethyl™ or placebo. Participants will be given a lunch of
      about 750 calories and 40% fat prepared by the Metabolic Kitchen and be asked to eat all of
      it. Participants will have food choice testing performed 4 hours after starting their lunch
      meal. This will be done in two ways. Participants will be given a list of two foods that are
      made of carbohydrate like bread and pretzels and be asked which is most preferred.
      Participants will also be given a list of foods that differ in the amounts of fat,
      carbohydrate and protein that they contain and will be asked to mark the ones that appeal to
      them.

      Participants will be presented with a pizza in a quantity more than they could reasonably be
      expected to eat 5 hours after the start of their lunch meal and be asked to eat to their
      satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
    

Intervention name(s): Appethyl™; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. They will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.; Four hours after breakfast, participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. They are not expected to eat all of the pizza.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Combination of Cryosurgery and NK Immunotherapy for Advanced Liver Cancer
Condition: Secondary Malignant Neoplasm of Liver
MeSH terms: Neoplasms; Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      advanced liver cancer.
    

Detailed description: 
      By enrolling patients with liver cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of the combined
      therapy using cryosurgery and nature killer (NK) cells for advanced liver cancer.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK Immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance); Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic liver cancer; Cryosurgery; NK Immunotherapy
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
Condition: HIV Infections; HSV-2 Genital Herpes
MeSH terms: Herpes Genitalis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and
      herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up
      to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this
      study.
    


Intervention name(s): 3% SPL7013 Gel (VivaGel)
Intervention type(s): Drug
Intervention description(s): A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prevention
Single Ascending Oral Doses of SY-008 in Healthy Subjects
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single
      ascending dose trial of SY-008 in healthy subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic /
      pharmacodynamic study of a single oral SY-008 capsule for Chinese healthy subjects. Plan to
      screening total of 54 healthy subjects ， dividing them into 6 dose groups.
    

Intervention name(s): SY-008
Intervention type(s): Drug
Intervention description(s): The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation of the Postprandial Response of Two Different PDO Cheeses on Metabolic Biomarkers
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was the investigation of the postprandial metabolic responses,
      after the intake of a traditional, Ladotyri Mytilinis cheese, compared to corresponding
      responses after an Italian Parmesan cheese consumption, in healthy participants.
    

Detailed description: 
      A pilot cross-over, randomized and single-blinded, intervention-clinical trial was conducted,
      in ten healthy men and women subjects, aged eighteen to thirty years, after random allocation
      into the control and the intervention group, received a high-fat and carbohydrates meal,
      containing Ladotyri Mytilinis (the authentic nonrefrigerated recipe) or Italian Parmesan, PDO
      cheeses. After a washout week, participants consumed the same meals, conversely. Differences
      on postprandial responses of serum total, High Density Lipoprotein (HDL-), Low Density
      Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of
      plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were
      determined between groups in fasting, thirty minutes, one and a half hour, and three hours
      after meal intake.
    

Intervention name(s): Authentic Ladotyri Mytilinis PDO cheese; Control
Intervention type(s): Other; Other
Intervention description(s): Branding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A.; Branding Parmesan PDO cheese from Italy, supplied by LIDL Hellas
Other intervention name(s): Italian Parmesan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In the first trial period, participants in arm a consumed a meal containing 100g of white wheat bread and 80g of Italian Parmesan PDO cheese and arm b participants consumed a meal containing 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese. After a washout week participants consumed the meals, in reverse.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Ladotyri Mytilinis PDO cheese; Postprandial response
Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy
Condition: Diabetes Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      a food collection will be performed in this study with type 1 diabetic patients trained to
      carbohydrate counting, to collect data on the meals consumed daily and their quantities for a
      period of 1 month.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetic patients
      
Keywords: Diabetes; Functional insulin therapy; carbohydrate counting
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Condition: BPH
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This exploratory study will be conducted open label in a single investigational clinical
      unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned
      to receive 4 different treatments with degarelix.
    

Detailed description: 
      The present study aims at exploring the potential of the currently available formulation of
      degarelix to treat BPH with only a short transient lowering of the serum testosterone
      concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing
      regimens (32 and 64 mg administered either as a single administration or as two
      administrations separated by 14 days) will be evaluated for 42 days.
    

Intervention name(s): Degarelix; Degarelix; Degarelix; Degarelix
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.; One dose of 32 mg administered as a single administration will be evaluated for 42 days.; Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.; One dose of 64 mg administered as a single administration will be evaluated for 42 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign Prostate Hyperplasia; BPH; PK/PD; GnRH antagonist
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the original study was to assess whether the protection afforded by
      the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection
      afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a
      computer based modelling analysis of the long term protection afforded by the paediatric
      dose, and to compare this with the standard dose and also with an alternative hepatitis A
      vaccine (Havrix Junior).
    


Intervention name(s): Epaxal 0.25 mL; Epaxal 0.5 mL; Havrix Junior 0.5 mL
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV); 24 IU hepatitis A antigen coupled to IRIV; 720 EU hepatitis A antigen absorbed onto aluminum hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A; Vaccination; Immunisation
Kinetic of Compounds of a Melatonin-based Formulation in Healthy Subjects
Condition: Melatonin Bioavailability
Study type: Interventional

Summary: 
      This study is conducted to clinically document the melatonin and zinc bioavailability of a
      dietary supplement containing delayed release melatonin, zinc and lemon balm
    


Intervention name(s): dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm
Intervention type(s): Dietary Supplement
Intervention description(s): dietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Effect of a Single Dose of Digoxin on the Actions in the Bodies of Healthy Subjects After Having Taken Several Doses of YM178
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on
      YM178, when the latter is taken on a continuous basis, in order to establish that there is no
      risk to patients who may take this combination of drugs.
    

Detailed description: 
      Subjects receive a single oral dose of digoxin on Day 1. A full pharmacokinetic profile of
      digoxin is obtained for up to 144 hours post-dose. On the morning of Day 7, after the
      scheduled assessments are done, the subjects leave the clinic and return on Day 9.

      From Day 10 up to and including Day 23, subjects receive daily oral doses of YM178 q.d. A
      single dose of digoxin is given in combination with YM178 on Day 18 (8 days after the first
      dose of YM178). On this day, a complete pharmacokinetic profile for digoxin is obtained up to
      144 hours post-dose.

      From Day 16 up to and including Day 19, blood samples for bioanalysis of YM178 are taken
      regularly. In addition, vital signs, safety ECG (Electrocardiogram) measurements, safety
      laboratory assessments, adverse events and concomitant medications are monitored throughout
      the investigational period.

      Subjects return for a Post Study Visit 7-14 days after the last dosing occasion.
    

Intervention name(s): YM178 OCAS; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Mirabegron; Myrebtriq; Lanoxin
Intervention MeSH terms: Digoxin; Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Pharmacokinetics; YM178 Oral Controlled Absorption System (OCAS); Digoxin (Lanoxin); DDI (Drug-drug interaction); Open-label; Steady-state; subjects
Paxil CR Bioequivalence Study Brazil
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is prospective, open, randomized, crossover in steady state and the volunteers
      received multiple doses of the drug test and reference (two periods of drug administration).
    

Detailed description: 
      Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride
      25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. -
      Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with
      controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra -
      Puerto Rico (reference formulation), fasted administration in healthy volunteers for both
      genders.

      The study is open, randomized, crossover in steady state and the volunteers received multiple
      doses of the drug test and reference (two periods of drug administration).

      The population is composed of 60 healthy volunteers, adult of both gender, with age between
      18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight
      above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are not
      restrictions regarding the ethnic group.The relative bioavailability of the formulations
      after oral administration in steady state will be evaluated based on statistical comparisons
      of relevant pharmacokinetic parameters obtained from data of concentration of drug in blood.
      The concentration of Paroxetine hydrochloride (controlled release) will be measured by an
      appropriate analytical method and valid after the drug administration.The Pharmacokinetic
      samples will be collected at steady state in each fasting period. The safety assessment will
      include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory
      tests. Adverse events will be monitored throughout the study.
    

Intervention name(s): Test formulation; Reference formulation
Intervention type(s): Drug; Drug
Intervention description(s): Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation); Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fast condition; Paroxetine reference/test; healthy volunteers; Bioequivalence
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on
      Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
    


Intervention name(s): Placebo Vaginal Insert; Prasterone 6.5 mg (0.50%) Vaginal Insert
Intervention type(s): Drug; Drug
Intervention description(s): Daily administration of a placebo vaginal insert.; Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prasterone; DHEA; Menopause; Sexual Disorder
Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if natalizumab in combination with AVONEX is safe
      and effective in delaying progression of individuals diagnosed with relapsing remitting
      Multiple Sclerosis (MS).
    


Intervention name(s): Natalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.; Placebo monthly infusion for up to 116 weeks.
Other intervention name(s): Tysabri
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; MS
A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple
      ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the
      safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in
      healthy adult volunteers.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple
      ascending dose study to determine a maximum tolerated dose (MTD) of IV PGB and to evaluate
      the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV
      APAP in healthy adult volunteers.

      Up to 60 subjects will be enrolled into one (1) of six (6) sequential cohorts (n=10 per
      cohort [8 APAP + PGB and 2 placebo]).

      The dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts,
      the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will
      start with 100 mg TID and then based on tolerability will be either increased or decreased by
      25 mg) based on Safety Monitoring Committee decision.

      The placebo will be the saline solution.
    

Intervention name(s): Pregabalin 100mg; Acetaminophen 1300mg
Intervention type(s): Drug; Drug
Intervention description(s): Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.; Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
Other intervention name(s): PGB; Ofirmev
Intervention MeSH terms: Acetaminophen; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of Single and Repeat Doses of GSK729327 in Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK729327 is a selective positive allosteric modulator of AMPA-type ionotropic glutamate
      receptors, exhibiting equivalent potency at all AMPA receptor subtypes. On the basis of
      preclinical studies it is expected that this compound will improve cognitive measures in
      schizophrenic patients with acceptable safety. This is a First Time in Human Study (FTIH) to
      assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of
      GSK729327 in healthy volunteers. The study will be conducted in 2 parts, with single doses
      being explored in Part A and multiple doses over 28 days in Part B. Part A will be a single
      blind, placebo controlled, single oral dose, dose-rising cross-over study in healthy male
      volunteers. Subjects will be randomized into two cohorts with an alternate panel design.
      There will be up to nine dosing sessions in total in order to investigate up to 7 different
      doses. The initial dose will be 0.25 mg and subsequent doses will be determined based on the
      pharmacokinetic and safety results from the previous dose. Part B will be a randomised,
      single blind, placebo-controlled, parallel group study of repeat oral dosing of GSK729327. Up
      to 4 cohorts of 15 (12 subjects receiving active dose and 3 subjects receiving placebo)
      healthy male and females of (non-childbearing potential) volunteers will be enrolled in Part
      B.
    


Intervention name(s): GSK729327; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; GSK729327 Matching placebo - Tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: AMPA positive modulator, healthy volunteers