bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and
      immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the
      eligibility of Japanese patients in subsequent clinical studies.
    


Intervention name(s): QGE031; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.; Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Allergy,; Asthma,; Atopic dermatitis,; Japanese,; QGE031,; IgE
Probiotic Administration and Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic, Perennial; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the
      quality of life in adult subjects suffering from perennial allergic rhinit.
    


Intervention name(s): Lactobacillus paracasei probiotic strain; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dust mite; Perennial allergic rhinitis
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of two investigational
      drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with
      hypertension (high blood pressure).

      This is an early phase trial and some specific protocol information is proprietary and not
      publicly available at this time. (Full information is available to trial participants).
    

Detailed description: 
      Participants enrolled in the study will be separated into 2 strata based on baseline body
      mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will
      include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12
      weeks in duration.
    

Intervention name(s): MK0736; MK0916; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the Menstrual Cycle
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Iron supplementation is the first line of treatment of iron deficiency in most women, but we
      do not know when the best time is to supplement in the context of the menstrual cycle. With
      this study, we aim to measure and compare iron status, hepcidin, inflammatory markers,
      hormones estrogen and progesterone and changes in iron absorption at various points
      throughout the menstrual cycle, with a long-term view to determine best time for iron
      supplementation in relation to the menstrual cycle.
    

Detailed description: 
      To date, very few studies have assessed iron absorption in relation to a woman's menstrual
      cycle. Although oral iron supplementation is considered the first line of treatment for iron
      deficiency in most women, there is no knowledge on the relationship between this intervention
      in the context of the menstrual cycle, and more specifically there is no knowledge on its
      potential implications for the most appropriate timing of iron supplementation. A better
      understanding of iron absorption during the menstrual cycle as well as kinetics of key
      parameters could allow the design of adapted and/or new interventions (e.g., timing of iron
      supplementation in relation to different phases of the menstrual cycle) to mitigate iron
      deficiency in menstruating women and can inform programs aimed at addressing iron deficiency
    

Intervention name(s): Test meal labelled with 54Fe; Test meal labelled with 57Fe; Test meal labelled with 58Fe
Intervention type(s): Other; Other; Other
Intervention description(s): Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe; Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe; Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Anemia; Micronutrients; Iron; Trace elements; Menstruation; Hormones
Does the Volume of the Embryo Culture Medium During Embryo Transfer Affects the IVF Outcomes?
Condition: Clinical Pregnancy Rate
Study type: Interventional

Summary: 
      The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used
      for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled
      the inclusion criteria and agreed to participate in the study, were randomized, on the day of
      the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)
    

Detailed description: 
      The volume of culture medium used for embryo transfer is a variable that has been speculated
      to affect the IVF outcome. It is known that ultra high volume (>100 μl) of medium during
      embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy.
      Similarly, some authors advocate that ultra low volume of transferring medium (<10 μl) may
      negatively affect pregnancy and implantation rates.

      However small differences in the volume of the culture medium may favor the outcome of the
      embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS
      20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF
      cycles.
    

Intervention name(s): Volume of medium during embryo transfer
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: embryo transfer; volume; culture medium; loading the catheter; clinical pregnancy rate
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
Condition: Aging
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effects of protein consumption before sleep
      or immediately after exercise during 12 weeks of resistance exercise training in older
      adults. The main questions it aims to answer are:

      Are there differences in muscle growth or strength during 12 weeks of resistance training
      when 40 grams of protein is consumed either before sleep or immediately after exercise? Are
      there differences in cognitive performance during 12 weeks of resistance training when 40
      grams of protein is consumed either before sleep or immediately after exercise?

      This study is a randomized double-blind placebo-controlled study. Participants will be
      randomly allocated into 1 of 3 groups. All three groups will perform the same 12-week
      resistance exercise training program two times per week and consume 40 g of protein: 1)
      Immediately post-exercise, 2) 30 minutes prior to sleep, or 3) no supplemental protein
      (control). Test of muscle growth and strength, and cognitive performance will be measure
      before, during, and after the exercise training program.

      Researchers will compare the 3 conditions to determine if consume protein after exercise or
      before sleep during 12 weeks of resistance exercise training affects muscle growth and
      strength, and cognitive performance.
    


Intervention name(s): Protein; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Post-exercise protein group consumed protein immediately after exercise sessions.
Pre-sleep protein group consumed protein 30 minutes before sleep.; Resistance exercise training only group did not consume supplemental protein.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Hypertrophy; Strength; Power
A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the efficacy and safety of 2 different treatment durations of
      peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on
      study treatment is 1-2 years, and the target sample size is greater than (>) 500 individuals.
    


Intervention name(s): Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\n; Ribavirin is available as 200 mg tablets
Other intervention name(s): Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a four-period crossover study to assess the glycemic effects of a single dose of
      oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus
      (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4
      treatment periods, with a 7-day wash-out between each treatment period. The primary
      hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or
      better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly
      enhancing insulin secretion.
    


Intervention name(s): Oxyntomodulin; Liraglutide 0.6 mg; Liraglutide 1.2 mg; Placebo for Oxyntomodulin; Placebo for Liraglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1); Single subcutaneous dose in the evening of the day before the GGI (Day-1); Single subcutaneous dose in the evening of the day before the GGI (Day-1); IV infusion in the morning of the day of GGI (Day 1); Single subcutaneous dose in the evening of the day before the GGI (Day-1)
Other intervention name(s): Victoza®; Victoza®
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2,
      to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery
      outcome by prevention of excessive scarring and trabecular meshwork transformation.
    

Detailed description: 
      The transforming growth factor beta (TGF-β) is known to play a key role in glaucoma.
      Increased levels of TGF-β2 in the eye have been linked to trabecular meshwork transformation,
      increased intraocular pressure and direct optic nerve damage.

      Trabeculectomy is the standard surgical intervention to reduce intraocular pressure in
      subjects no longer sufficiently responding to pressure-lowering medications. Scarring of the
      surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the
      intraoperative use of Mitomycin C to prevent this). TGF-β2 has been described to play a
      distinct role in the fibrotic process of bleb closure.
    

Intervention name(s): TGF-β2 antisense oligonucleotide; Trabeculectomy
Intervention type(s): Drug; Procedure
Intervention description(s): intravitreal injection; Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control
Other intervention name(s): ISTH0036
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glaucoma; trabeculectomy
Safety of the HIV Vaccine 732462 in HIV Infected Subjects Aged 18 to 55 Years Old
Condition: AIDS
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to evaluate the safety of GSK Biologicals'
      investigational HIV vaccine 732462, administered as two doses approximately 1 month apart, in
      a small group of HIV infected people.
    

Detailed description: 
      This multicenter observer-blind study will determine the safety and reactogenicity of GSK
      Biologicals' investigational HIV vaccine 732462 in two sequentially enrolling cohorts of
      HIV-infected subjects treated with HAART (highly active antiretroviral therapy) and HIV
      infected treatment naïve subjects, respectively.
    

Intervention name(s): HIV Vaccine 732462; Placebo vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month.; Two doses of placebo, injected intramuscularly, at an interval of approximately one month
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: immunogenicity; HIV; reactogenicity; safety; vaccine; HIV Infections
Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Observational

Summary: 
      Pancreatic cancer often spreads through local invasion into local structures, including fat,
      blood vessels, nerves, and nearby organs (stomach, duodenum, spleen, bile duct). Local
      microscopic invasion is associated with recurrence of pancreatic cancer after pancreatic
      resection, such that even if the original cancer is surgically removed, microscopic areas of
      cancer often remain. Data on the patterns of local invasion by pancreatic cancer have not
      been published. In this study, The investigators hope to investigate the frequency of the
      various methods of local invasion of pancreatic adenocarcinoma. This would help the
      investigators better understand how pancreatic cancer spreads, and determine what cancers are
      not resectable.
    

Detailed description: 
      Pancreatic cancer is the eighth most common malignancy, and the fifth leading cause of
      cancer-related death, in the United States. Unfortunately, patients often present late in the
      course of the disease. Accordingly, the 1- year survival rate is approximately 20%, and the
      5-year survival rate is less than 4%. Even in patients with local disease who are surgical
      candidates, survival at five years remains only 10-25%. Staging for pancreatic adenocarcinoma
      typically utilizes the TNM classification, where "T" represents tumor size, "N" represents
      regional lymph node metastasis, and "M" represents distant metastasis. This type of staging
      can usually only be done after operative resection. Unfortunately, up to 25% of patients are
      found to be unresectable at the time of surgical exploration. This is most often due to local
      invasion or metastatic disease. Local microscopic invasion is associated with recurrence of
      pancreatic cancer after pancreatic resection. Comprehensive data on the patterns of local
      invasion by pancreatic cancer have not been published. The investigators believe that it
      would be beneficial to investigate the frequency of the various methods of local invasion of
      pancreatic adenocarcinoma. A clearer understanding of the natural history of local invasion
      could potentially lead to a better determination of what constitutes unresectability.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will include patients who have been diagnosed with pancreatic
        adenocarcinoma and who are undergoing surgical resection at CUMC.
      
Keywords: Pancreatic adenocarcinoma; Local invasion by pancreatic adenocarcinoma; Recurrence of pancreatic cancer; Surgical resection of pancreatic cancer
A Study of LY3451838 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study has two parts. In Part A, single increasing doses of LY3451838 will be administered
      intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered
      subcutaneously (just under the skin).
    


Intervention name(s): LY3451838; Placebo; Placebo; LY3451838
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One dose administered (IV); Administered IV; Administered SC; One dose administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide
      250 Diskus when repeatedly dosed to Asthmatic patients.
    


Intervention name(s): HCP0910; Seretide Diskus
Intervention type(s): Drug; Drug
Intervention description(s): 250/50, BID for 2 weeks; 250/50, BID for 2 weeks
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Condition: Microdialysis; Ischemia; Anastomotic Leakage
MeSH terms: Ischemia; Anastomotic Leak
Study type: Interventional

Summary: 
      Postoperative surveillance of local metabolism of the surgical reconstruction after
      esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven
      postoperative Days. Results analysed in a blinded fashion and related to the clinical
      outcome. Primary endpoint: anastomotic leakage
    

Detailed description: 
      The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring
      method for the early diagnosis of complications after surgery in the gastrointestinal tract.
      Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data
      on surgical procedures in gastrointesinala tract. These parameters are: Patient general
      condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive
      protein), white blood cells, blood gases.The patients are their own controls when the purpose
      is to see if you can detect early complications with Onzurf probe and also identify how many
      people gets complications after surgery in the gastrointestinal tract. The patients' clinical
      routine tests (blood tests, etc.) will serve as control samples, which then will be compared
      with results from sampling of Onzurf probe. No interventions will be carried out on the
      patient.
    

Intervention name(s): OnZurf Probe
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Application Value of Deep Learning-Based Nomograms in Benign-Malignant Discrimination of TI-RADS Category 4 Thyroid Nodules
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Observational

Summary: 
      This retrospective study focuses on benign and malignant classification of thyroid nodules
      using deep learning techniques and evaluates the value of deep learning based nomograms in
      the classification of TI-RADS category 4 thyroid nodules to improve the accuracy of benign
      and malignant identification of TI-RADS category 4 thyroid nodules.

      Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong
      First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their
      general clinical features, information on preoperative ultrasound diagnosis, and
      postoperative pathologic data were reviewed.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study collected data on a total of 500 TI-RADS category 4 thyroid nodules from 500
        patients who attended the First Affiliated Hospital of Shandong First Medical University
        from April 2022 to November 2023.
      
Keywords: TI-RADS category 4 thyroid nodules; YOLOv3 model; nomograms
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
Condition: Tinea Corporis
MeSH terms: Tinea
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of
      luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to
      17 years of age (inclusive) with tinea corporis.
    


Intervention name(s): Luliconazole Cream 1%; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Luliconazole cream will be applied per schedule specified in the arm.; Vehicle cream will be applied per schedule specified in the arm.
Other intervention name(s): Product 33525
Intervention MeSH terms: Luliconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment