bioihbjkbjnl/mcl2 huggingface dataset:
The Study of Polycystic Ovary Syndrome (PCOS) and Questionnaire
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive
      age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic
      criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous
      as the syndrome. This first part of study is determine whether genetic polymorphisms
      influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and
      controls. Furthermore, women with PCOS were reported with high risk of cardiovascular
      disease, the investigators planned to calculate the difference of carotid intima-media
      thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal
      control to determine the premature atherosclerosis of women with PCOS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Polycystic Ovary Syndrome(PCOS)
      
Biospecimen description: 
      whole blood
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
Condition: Diabetes Mellitus, Type 1; Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study has been designed as a prospectively enrolled, randomized sequence, 2-way
      crossover study of device performance, tolerability and safety of an investigational insulin
      infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial
      insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use
      periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a
      wash-out period, subjects will cross over into the investigational or control group,
      respectively.
    


Intervention name(s): coil-reinforced soft polymer indwelling cannula; soft Teflon indwelling catheter
Intervention type(s): Device; Device
Intervention description(s): Insulin infusion set will be used for up to 7 days of continuous use or until failure; Insulin infusion set will be used for up to 7 days of continuous use or until failure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the potential effect of itraconazole on the
      pharmacokinetics of palbociclib.
    


Intervention name(s): Palbociclib Alone; Palbociclib plus itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection; Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.
Other intervention name(s): Palbociclib, PD-0332991; Palbociclib (PD-0332991); Itraconazole (Sporanox)
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Palbociclib
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Palbociclib; Itraconazole; Pharmacokinetics; Drug-Drug Interaction Study; Healthy Volunteers
Dose Response of a Tubule Occlusion Agent
Condition: Dentine Hypersensitivity; Dental Pain
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of two different concentrations of a tubule occlusion agent -
      calcium sodium phosphosilicate in treatment of dentine hypersensitivity
    

Detailed description: 
      Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine
      typically in response to chemical, thermal, tactile or osmotic stimuli. Dentine
      hypersensitivity may be treated by either making the nerve in the tooth less sensitive or by
      occluding the tubules to limit exposure of the nerve to external stimuli. Bioactive and
      biocompatible glasses react with oral fluid to deposit a mineral that is chemically analogous
      to that found in both enamel and dentine thus preventing exposure of the nerve to external
      stimuli.

      A number of controlled clinical trials have been reported indicating that a calcium sodium
      phosphosilicate bioactive glass, when incorporated into a toothpaste formulation,
      significantly reduce pain from dentine hypersensitivity. The aim of this study is to evaluate
      the effectiveness of two currently marketed toothpastes, containing 5% calcium sodium
      phosphosilicate and the other containing 7.5% calcium sodium phosphosilicate in the treatment
      of dentine hypersensitivity compared to a matched placebo control.
    

Intervention name(s): 5% calcium sodium phosphosilicate toothpaste; 7.5% calcium sodium phosphosilicate toothpaste; Placebo toothpaste
Intervention type(s): Device; Device; Device
Intervention description(s): Low concentration calcium sodium phosphosilicate tubule occlusion agent; High concentration calcium sodium phosphosilicate tubule occlusion agent; Placebo toothpaste
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sensitivity; occlusion
24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus
      travoprost when both medications are dosed in the evening. Such a crossover comparison may
      determine the real efficacy of the new fixed combination versus travoprost monotherapy. The
      results should enhance the investigators understanding on the best dosing of TTFC and may
      influence its clinical use in Europe. Finally, the results would better delineate the future
      role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with
      PG analogs and timolol. This study should assist the general ophthalmologist worldwide to
      plan optimal stepwise medical therapy.
    


Intervention name(s): Travoprost/timolol fixed combination, travoprost
Intervention type(s): Drug
Intervention MeSH terms: Timolol; Travoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: travoprost/timolol fixed combination
Resveratrol as a Preventive Treatment of OHSS
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors
    

Detailed description: 
      Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian
      hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving
      hemoconcentration and symptomathology of this condition
    

Intervention name(s): Resveratrol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.; Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Other intervention name(s): Resverasor Plus
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: resveratrol; OHSS; PCOS
Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Obesity; Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have
      increased the generation of overweight or obesity. There is correlation between obesity,
      diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular
      disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema
      effect. Therefore, the purpose of the present study was to design a randomized, double blind,
      control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients
      with obesity.
    

Detailed description: 
      Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into:
      1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2)
      control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of
      starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of
      body mass index (BMI), waist circumferences (WC); secondary outcome measured included the
      changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein,
      low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic
      blood pressure, and meridian energy.
    

Intervention name(s): cassia seed tablet
Intervention type(s): Drug
Intervention description(s): traditional Chinese herbs
Other intervention name(s): cassia obtusifolia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Total of 92 schizophrenia patients with obesity was divided randomly into: 1) control group, received oral administration of Cassia seed placebo (3.0g), once/day for 12 weeks continuously; 2) treatment group, received oral administration of Cassia seed (3.0g), once/day for 12 weeks continuously.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Cassia seed; obesity; Therapeutic effect assessment; clinical trial
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment
      of subjects with chronic nonspecific low back pain.
    


Intervention name(s): Osteopathic Manipulative Treatment; Exercise Therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteopathic manipulative treatment; Chronic nonspecific low back pain; low back pain
Sublingual Immunotherapy In Alternaria-Induced Rhinitis
Condition: Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Respiratory allergy due to Alternaria is a relevant clinical problem, and specific
      immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is
      safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the
      efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double
      blind, placebo controlled fashion.

      Patients with rhinitis with/without intermittent asthma, and ascertained allergy to
      Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10
      months. Symptoms and rescue medication intake are recorded on diary cards from June to
      October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and
      at the end of the study. Alternaria spore count is also performed. Primary outcome is the
      change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue
      medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.
    


Intervention name(s): sublingual immunotherapy; placebo
Intervention type(s): Biological; Biological
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: allergic rhinitis; alternaria alternata; symptom score
Comparison of Two Embryo Culture Media for IVF and ICSI
Condition: Culture, ICSI, IVF
Study type: Interventional

Summary: 
      In this research, the two media used are Global medium and SSM medium with serum), which are
      routinely used in the reproduction biology unit. This study simply consists in setting up a
      methodology to compare these to media. The only constraint placed on patients is to accept
      randomization for the type of medium used.
    


Intervention name(s): global medium; SSM
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
C-Reactive Protein/Albumin Ratio and Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      Objective: Acne vulgaris, an inflammatory disease, was investigated in this study with the
      claim that C-reactive protein (CRP) / albumin ratio and some hematological parameter ratios
      have the potential to be used as inflammatory markers to monitor disease severity and
      prognosis.

      Methods: A descriptive cross-sectional study was conducted with two groups of patients aged
      18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and
      routine hemogram and biochemical parameters were compared. The Global Acne Severity Index was
      used to determine the severity of acne vulgaris.
    


Intervention name(s): Biochemical blood analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Serum CRP and albumin levels
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Acne vulgaris patients and control healthy individuals
      
Keywords: acne vulgaris; CRP albumin ratio
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the amount of lasmiditan that gets into the
      blood stream and how long it takes the body to get rid of it, when given as a
      oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The
      information about any adverse effects experienced will be collected and the tolerability of
      lasmiditan when administered as OD tablet will also be evaluated.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 5 weeks, including screening.
    


Intervention name(s): Lasmiditan
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Protection Against Allergy: Study in Rural Environment - Part IV
Condition: Asthma; Atopy
Study type: Interventional

Summary: 
      PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across
      Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133
      children (farmers in about half of the children) to study the origins of asthma and atopy and
      to develop potential preventive strategies.

      Previous results show a protective effect of farm exposure on allergic risk by livestock
      contacts and microbial exposures and by raw cow milk consumption in early age.

      PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to
      characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis)
      and to explain how early age exposures and particularly milk products consumption contribute
      in the process of allergic illness in childhood. A focus on the characterization of the
      protective biologically active components in raw milk and identification of immunological
      mechanisms are involved.
    


Intervention name(s): blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: farm children; non-farm children
An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will
      be randomized to sequentially receive both sublingual and oral formulations of FDL169.
    

Detailed description: 
      This is a single center, open label study on healthy volunteers. The study will consist of up
      to 2 parts; the decision to proceed to the optional second part will be made following review
      of Part 1 data. Part 1 and optional Part 2 have randomized, 2 period crossover designs.
      Subjects will randomized to 1 of 2 treatment sequences in order to receive 2 single doses of
      FDL169 on separate occasions, one as a sublingual administration and one as an oral
      administration. There will be a minimum washout period of 10 days between FDL169
      administrations. The duration of each part is approximately 7 weeks from screening to follow
      up.
    

Intervention name(s): FDL169
Intervention type(s): Drug
Intervention description(s): Cystic Fibrosis Transmembrane Regulator (CFTR) corrector
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation)
      in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
    

Detailed description: 
      Non small lung cancer will be removed using tumor reducing surgery such as cryosurgery. PBMC
      of the patient will be separated from peripheral blood. After making them potential cancer
      killer γδ T Cell and DC-CIK, they will be infused to the patients as immunotherapy.
    

Intervention name(s): DC-CIK; γδ T Cell; γδ T/DC-CIK cells
Intervention type(s): Biological; Biological; Biological
Intervention description(s): DC-CIK cells will be used against tumor cells.; γδ T cells will be used against non small lung tumor.; γδ T/DC-CIK cells will be used against lung tumor.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: γδ T Cell, non small lung cancer, Without EGFR Mutation
X-3 Polyethylene Survival Outcomes Study
Condition: Arthroplasty, Replacement, Knee; Total Knee Replacement
Study type: Interventional

Summary: 
      A prospective, randomized, blinded clinical trial is proposed to compare Stryker Orthopaedics
      N2Vac Polyethylene to their X3 Polyethylene when used with the Triathlon Posterior Stabilized
      (PS) total knee system.
    

Detailed description: 
      This is a fixed-bearing knee intended for use in patients undergoing cemented total knee
      arthroplasty. The devices to be used are both FDA approved via 510k clearance.

      A total of 572 cases (286 per group) will be entered. Each patient will be assessed
      pre-operatively and post-operatively at three months and two, five, seven and ten years. The
      primary endpoint will be the revision rate at ten years. The result for these will be
      analyzed using an unconditional test of equivalence between two independent binomials.
      Chi-square analysis will be used to compare the instance of mortality, revision surgery, deep
      vein thrombosis, pulmonary embolus, neurovascular complication, and infection. Other outcome
      measures incorporated in the Knee Society Clinical rating scale will undergo appropriate
      generalized linear regression for the type of outcome involved. The primary aim of the study
      is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly
      cross-linked X3) used in a fixed-bearing total knee system in patients undergoing cemented
      total knee arthroplasty. These results will be measured through radiographs at each
      post-operative interval with an independent radiograph review being performed after all
      patients have reached 7 and 10 year follow-up. Secondary results will also be collected and
      will focus on disease-specific (Knee Society Scores), global (SF-12 v1), and outcome
      measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant
      views of the surgical knee will be recorded and analyzed. Completion of the initial
      investigation will occur at the 10-year interval after the last enrolled.
    

Intervention name(s): Stryker X3 crosslink
Intervention type(s): Device
Intervention description(s): Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years.
Other intervention name(s): Stryker X3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to assess the effect of food on the pharmacokinetics of
      an oral tablet formulation of BI 1323495 by investigating the relative bioavailability
      following single dose administration under fed and fasted conditions.
    


Intervention name(s): BI 1323495,
Intervention type(s): Drug
Intervention description(s): single oral doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment