bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Efficacy of Different Dosages Vitamin K2
Condition: Carboxylation Level; Vitamin K-dependent Proteins
Study type: Interventional

Summary: 
      Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green
      vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher
      menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet
      about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of
      essential proteins). Therefore, this study was undertaken to study effects of different
      dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.
    

Detailed description: 
      Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green
      vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher
      menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Higher menaquinones
      not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2
      vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas
      K1 is preferentially transported to the liver. Nothing is known yet about the efficacy of
      bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). This
      study describes a dose-response experiment for different dosages of bacterial K2 which are
      compared with one selected dose of K1 and placebo. The efficacy is concluded from the
      carboxylation of the bone Gla-protein osteocalcin and of the vascular Gla-protein matrix-Gla
      protein (MGP).
    

Intervention name(s): placebo; vitamin K1; vitamin K2; vitamin K2; vitamin K2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 placebo sachet per day containing only sucrose during 12 weeks; 15 µg vitamin K1 per day during 12 weeks; 15 µg vitamin K2 per day during 12 weeks; 30 µg vitamin K2 per day during 12 weeks; 45 µg vitamin K2 per day during 12 weeks
Intervention MeSH terms: Vitamins; Vitamin K; Vitamin K 2; Vitamin K 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Condition: Alagille Syndrome
MeSH terms: Liver Diseases; Alagille Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this extension study is to determine the long-term safety and tolerability of
      an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who
      have completed participation in a core LUM001 treatment protocol. Efficacy will be assessed
      by evaluating the effect of LUM001 on pruritus, biochemical markers of pruritus, as well as
      biochemical markers of cholestasis and liver disease.
    


Intervention name(s): LUM001 (Maralixibat)
Intervention type(s): Drug
Intervention description(s): Dosing of LUM001 also known as Maralixibat (MRX) with the objective of achieving optimal control of pruritus at a dose level that is tolerated by the participant and up to a maximum daily dose of 560 micrograms per kilogram (mcg/kg).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
Condition: Tear Protein Lacritin in Human Tears
Study type: Observational

Summary: 
      Purpose: to build a library of normal tear lacritin values by collecting tears from normal
      adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay
      will provide more sensitive indicators of eye disease for clinicians and determine if a
      particular therapy, such as recombinant lacritin drops, is of benefit.
    


Intervention name(s): Tear Collection
Intervention type(s): Procedure
Intervention description(s): The tear sample will be collected from the left eye of each subject. Subjects wearing contact lenses will be instructed to remove their lenses and wait at least 5 minutes before proceeding with the tear collection procedure. The patient will then be instructed to sit with eyes gently closed for two minutes after instilling one (1) drop of 0.5% proparacaine on the cornea and conjunctiva. Tear collection was accomplished by using a polyester fiber rod wick. This wick will be placed in contact with the tear fluid at the lower cul-de-sac for a minimum time to obtain fluid without irritating the subject's eye approx. for 3 to 5 minutes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Military health care beneficiary between the ages of 21-55.
      
Keywords: Lacritin
Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following DMEK Using Ultra-high Resolution OCT
Condition: Fuchs' Endothelial Dystrophy
MeSH terms: Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
Study type: Interventional

Summary: 
      Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss
      of endothelial cells, thickening of Descemet's membrane and deposition of extracellular
      matrix in the form of guttae. This result in failure of the endothelium to support corneal
      deturgescence leading to corneal edema. Affected patients complain about blurred vision at
      early stages of the disease which can progress to blindness. The pathophysiology of the
      disease is still unclear, but several studies point towards a genetic susceptibility.
      Additional risk factors that have been identified are female sex, smoking and older age.

      While for a long time penetrating keratoplasty (PKP) was the only therapy available for
      affected patients, in the recent years less invasive methods such as descemet's membrane
      endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane
      and the endothelium is removed and replaced with the corresponding parts from a donor's
      cornea. For FECD, this brings the advantage that only the diseased part of the cornea is
      replaced. Graft detachment has been identified as the main complication following DMEK.

      In the investigators' study, an ultra high resolution OCT system will be used to detect graft
      detachment in patients with FECD after DMEK. With this technique, even small detachments can
      be visualized. The area of graft detachment will be evaluated at predefined time points after
      surgery and correlated to visual acuity. A follow-up of one year will be performed in order
      to investigate the predictive value of graft adherence status at several time points for
      visual outcome.
    


Intervention name(s): Ultrahigh resolution Spectral Domain OCT
Intervention type(s): Device
Intervention description(s): The area of graft detachment will be measured by a customized ultra high-resolution OCT for the cornea.
A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fuchs' Endothelial Dystrophy, DMEK
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
Condition: Chronic Kidney Failure; Anaemia
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy
      Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian
      Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon
      Multidose solution on Day 1.
    

Detailed description: 
      Ethnic comparison studies are becoming common research requirements in order to identify
      differences in response to drugs in various ethnic populations. This study will investigate
      the pharmacokinetic parameters and pharmacodynamic response in healthy Caucasian and Japanese
      male subjects after a single subcutaneous administration of 50IU/kg Epoetin beta

      This is a Phase I single centre, open label trial to investigate the bioequivalence of a
      single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese and Caucasian
      Male subjects.

      The primary objectives are 1) to establish the pharmacokinetic parameters of Epoetin beta in
      healthy Japanese and Caucasian males, and 2) to compare the pharmacokinetic parameters AUCinf
      and Cmax in healthy Japanese and Caucasian males. The secondary objective is to establish the
      pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian
      males.

      Subjects will receive a single subcutaneous administration of 50IU/kg on one occasion only.
      The planned study duration is approximately 1 month.
    

Intervention name(s): Epoetin Beta
Intervention type(s): Drug
Intervention description(s): Epoetin Beta. A single subcutaneous dose of 50IU/kg on Day 1. The body weight recording on day -1 will be used to calculate the dosage
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: NeoRecormon®; Caucasian; Japanese; Bioequivalence; Ethnic
Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Single and 14 Day Repeat Topical Application of GSK1940029
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan
      will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and
      safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),
      after topical administration on healthy subjects and acne patients. Study SCD117226 will be a
      randomized, single-blind, dose-rising study to evaluate the safety, tolerability and
      preliminary pharmacokinetics of single and 14 day repeat topical applications of GSK1940029
      gel on the intact skin of healthy human subjects. Part 1: (single-dose) subjects will receive
      0.3% or 1% GSK1940029 (or matching vehicle), as a single approximately (App) 24 hour (h)
      (22.5h) application to a surface area of 400 square centimeter (cm^2) (0.3%), 400 cm^2 (1%)
      or 1200 cm^2 (1%), respectively, in each of three sequential cohorts. Part 2: (repeat-dose)
      subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily App24h (22.5h)
      application to a surface area of 400 cm^2 (0.3%), 400 cm^2 (1%) or 1200 cm^2 (1%),
      respectively, in each of three sequential cohorts. Parts within Study SCD117225 and Study
      SCD117226 will have interdependencies. No significant primary irritation signal in Study
      SCD117225 Part 1 (primary irritation) would allow initiation of Study SCD117226 Part 1. Once
      safety, tolerability and exposure information are determined in Study SCD117226 Part 1, then
      Part 2 (cumulative irritation) of Study SCD117225 may be initiated along with Part 2 of Study
      SCD117226. No significant cumulative irritation signal (study SCD117225 Part 2) in
      combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of
      Part 3 (facial irritation) of Study SCD117225.
    


Intervention name(s): 0.3% GSK1940029 gel; 1% GSK1940029 gel; 0.3%/1% vehicle gel only
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Will be supplied as gel for topical application; Will be supplied as gel for topical application; Will be supplied as gel for topical application
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SCD1; Topical Administration; Acne; Gel
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Condition: Chemotherapy Induced Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in
      anemic cancer patients undergoing chemotherapy
    


Intervention name(s): recombinant human erythropoietin; recombinant human erythropoietin placebo
Intervention type(s): Drug; Drug
Intervention description(s): 36000IU（0.5mL）s.c./week for 8 weeks; 0 IU(0.5mL)s.c./week for 8 weeks
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
Condition: Intrauterine Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Using American Fertility Society classification of intrauterine adhesions, the efficacy of a
      new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation
      and curettage for delayed miscarriage in women without previous dilatation and curettage was
      examined.
    

Detailed description: 
      Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing
      intrauterine adhesions formation after dilatation and curettage.

      Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health
      care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed
      miscarriage without previous dilatation and curettage.

      Interventions: Women were randomly assigned into either dilatation and curettage alone group
      or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1
      allocation.

      Measurements and Outcomes: All patients were evaluated using American Fertility Society
      classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after
      dilatation and curettage procedure. The primary outcome was the number of women with IUAs,
      and the secondary outcome was the adhesion scores and the severity of IUAs.
    

Intervention name(s): new crosslinked hyaluronan gel
Intervention type(s): Device
Intervention description(s): At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
Other intervention name(s): MateRegen Gel
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intrauterine adhesion; Delayed miscarriage; hyaluronan gel
Single-file Pulpectomy in Primary Molars
Condition: Pulpal Necrosis
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      The current study evaluates the rotational One Shape single-file system regarding clinical
      and radiographic outcomes in root canal treatment of infected primary molars.

      This randomized clinical trial was carried out on 94 primary molars on children in the age
      group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2
      groups according to the used endodontic preparation system. Group I: 47 primary molars were
      instrumented with One Shape rotational single-file system. Group II: 47 primary molars were
      instrumented with stainless steel K-files. All teeth were evaluated clinically and
      radigraphically for 12 months with periodic recall at 3, 6 and 12 months.
    


Intervention name(s): One Shape Single-file rotary system; manual stainless steel K-file
Intervention type(s): Other; Other
Intervention description(s): rotational single file system used for mechanical debridement of root canals; sequential manual filing with stainless steel K-files
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulpectomy; Pediatric Dentistry
Effects of Acute Dietary Sodium on Cerebrovascular Reactivity and Blood Pressure Reactivity
Condition: Blood Pressure; Cerebrovascular Reactivity
Study type: Interventional

Summary: 
      Americans eat more salt than is recommended by the American Heart Association. This is
      important because consuming a high-salt diet is associated with an increased risk of
      cardiovascular events, like strokes and heart attacks. In fact, consuming one high-salt meal
      temporarily reduces blood vessel function and it is not uncommon for Americans to consume
      high-salt meals. Therefore, our laboratory is interested in determining if a single high-salt
      meal affects 1) brain blood vessel function at rest and 2) blood pressure responses during
      exercise.
    

Detailed description: 
      Excess dietary salt increases the risk of cardiovascular events like strokes and heart
      attacks, independent of resting blood pressure. Recent data found that consuming one
      high-salt meal temporarily reduces endothelial function in the periphery. This decrease in
      endothelial function can lead to an exaggerated blood pressure response during exercise and
      may also attenuate cerebrovascular reactivity at rest. This is essential, because an
      exaggerated cardiovascular response to exercise and a decrease in brain blood vessel function
      at rest are risk factors for future cardiovascular events. The long-term goal is to determine
      how dietary salt adversely affects BP and cerebrovascular regulation. The objective of this
      proposal is to evaluate the impact of an acute dietary salt meal on BP response during
      exercise and cerebrovascular reactivity at rest. The investigators have 2 specific aims: 1)
      Aim 1 will test the hypothesis that high dietary salt will reduce cerebrovascular reactivity,
      2) Aim 2 will test the hypothesis that high dietary salt will augment blood pressure
      reactivity during exercise. The findings of this project will shed light on how acute dietary
      salt affects the risk of cardiovascular events during a bout of exercise and long-term risk
      for cardiovascular disease and stroke.
    

Intervention name(s): Low Sodium Meal (138 mg sodium); High Sodium Meal (1,495 mg sodium)
Intervention type(s): Other; Other
Intervention description(s): One Low Sodium Meal; One High Sodium Meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Study to Evaluate the Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of Prednisone in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a
      single dose of prednisone
    


Intervention name(s): BIIL 284 BS; Prednisone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the
      autoinjector and pre-filled syringe of SB4 in healthy male subjects.
    


Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention description(s): 50 mg/mL PFS and AI
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Herbal Treatment for Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The
      conventional therapies are effective in alleviating symptoms but the efficacy are limited and
      not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese
      herbal formula, has been used for AR for centries. Our study purpose is to evaluate the
      clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis
      (PAR).

      Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and
      change some immunological parameters in the peripheral blood when comparing with the placebo.
    

Detailed description: 
      It is a randomized, double-blind, placebo-controlled trial.
    

Intervention name(s): Shi-Bi-Lin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 4 weeks of treatment, dose of 1 g (two capsules), twice daily; 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
Other intervention name(s): Modified from the classic formula Cang-Er-Zi-San.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perennial Allergic rhinitis; Traditional Chinese Medicine