bioihbjkbjnl/mcl2 huggingface dataset:
Associations of Vitamin D Receptor ApaI and Tru9I Polymorphisms With the Risk of Primary Open-angle Glaucoma
Condition: Primary Open- Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Observational

Summary: 
      This study investigated whether vitamin D receptor gene polymorphism is altered in primary
      open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients
      and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic
      analysis was studied by polymerase chain reaction-restriction fragment length polymorphism
      technique.
    


Intervention name(s): Vitamin D receptor polymorphic analysis
Intervention type(s): Other
Intervention MeSH terms: Vitamin D
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        primary open-angle glaucoma patients and randomly age-matched people as controls in the Han
        population of Tianjin China
      
Biospecimen description: 
      ApaI and Tru9I Polymorphisms
Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Ablative therapy, as a local treatment modality for tumors, has an immune activating effect.
      To explore the synergistic effect of microwave ablation combined with PD-1 inhibitors, this
      prospective, open-label, multi-cohort, single-center clinical study was conducted. To compare
      the feasibility and safety of preoperative microwave ablation alone, with or without
      camrelizumab in patients with early newly diagnosed breast cancer.
    


Intervention name(s): Microwave Ablation; Camrelizumab; Breast Surgery
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Image-guided microwave ablation 7-10 days prior to surgery; Camrelizumab 200 mg was given a few days after microwave ablation; Standard of care breast conserving surgery or radical mastectmoy
Other intervention name(s): SHR-1210
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ablation; PD-1; Immunotherapy
Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients
Condition: Urinary Bladder, Overactive; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

Summary: 
      The purpose of the study is to assess patient's persistency in maintaining solifenacin
      treatment for overactive bladder.
    


Intervention name(s): Solifenacin
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): YM905; Vesicare
Intervention MeSH terms: Solifenacin Succinate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OAB patients who were treated with solifenacin
      
Keywords: Solifenacin; Overactive bladder; persistency of the treatment; Vesicare
Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)
Condition: Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Chromosome Aberrations
Study type: Observational

Summary: 
      The purpose of the study is the identification of chromosomal aberrations in non-small cell
      lung cancer (NSCLC) .

      The imaging system is intended for diagnostic use as an aid to the pathologist in the
      detection, counting and classifying ALK FISH stained lung samples.
    

Detailed description: 
      The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ
      hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer
      (NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements
      involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction
      with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist
      in the identification of patients eligible for treatment with XALKORI® (crizotinib).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients having non-small cell lung cancer (NSCLC)
      
Keywords: Non-small cell lung cancer (NSCLC); ALK probe; FISH; Chromosomal aberrations
Single Incision Pelvic Floor Mesh Implants
Condition: Intra-operative Complications; Post Operative Complications
MeSH terms: Postoperative Complications; Intraoperative Complications
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is
      feasible, safe and effective for women with moderate pelvic organ prolapse.

      Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a
      single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome
      measures for this study were the operative safety and post-operative pain, adverse effects
      and anatomical as well as functional cure.

      Setting: The operations were performed under general anesthesia according with the reported
      surgical techniques at university and private hospitals.
    

Detailed description: 
      Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures:
      intra operative safety and surgical complications, post operative complications and objective
      as well as subjective cure rates
    

Intervention name(s): Single Incision Mesh
Intervention type(s): Device
Intervention description(s): Single Incision Mesh is implanted for pelvic floor reconstruction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single Incision, Mesh, Complications
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting
      antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as
      ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with
      telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic
      hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously
      treated with pegylated interferon/ribavirin (pegIFN/RBV).
    

Detailed description: 
      A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and
      antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267] and
      ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with
      RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype
      1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin
      (pegIFN/RBV).

      Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and
      ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12
      weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local
      prescribing information).
    

Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin; Pegylated Interferon a-2a (PegINF); Telaprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet; Pre-filled syringe; Film-coated tablet
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial responder; Interferon free; Treatment-experienced; Relapser; Hepatitis C Virus; Null responder; Hepatitis C Genotype 1; paritaprevir; ombitasvir; dasabuvir; ribavirin; Viekira PAK; Chronic hepatitis C
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Condition: Keratoconjunctivitis Sicca; Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1%
      tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the
      signs and symptoms of dry eye.
    


Intervention name(s): Tavilermide ophthalmic solution; Placebo
Intervention type(s): Drug; Other
Intervention description(s): BID topical dosing; BID topical dosing
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Inflammatory Stress and Periodontal Tissue Destruction
Condition: Oxidative Stress; Inflammation
MeSH terms: Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Metabolic syndrome and periodontitis are diseases that lower the quality of life and their
      incidence rates are increasing. Since both of these diseases are associated with systemic
      inflammation and insulin resistance, they may be comorbid. The aim of this study was to
      evaluate the effect of interleukin-20 (IL-20) on periodontal destruction in individuals with
      metabolic syndrome while considering the relationship between metabolic syndrome and
      periodontitis.

      This study included a total of 80 individuals who were systemically and periodontally healthy
      (CG, n=20), were systemically healthy and had periodontitis (PG, n=20), had metabolic
      syndrome and were periodontally healthy (MG, n=20), or had both metabolic syndrome and
      periodontitis (MPG, n=20). Gingival crevicular fluid (GCF) and serum samples were collected
      from all participants for biochemical analyses.
    


Intervention name(s): Gingival crevicular fluid (GCF) and serum samples
Intervention type(s): Other
Intervention description(s): Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The sample size of the study was calculated using the G*Power program with an effect size
        of 0.4, 80% power, and a margin of error of 0.05.
      
Biospecimen description: 
      plasma and gingival crevicular fluid
    
Keywords: Metabolic syndrome; periodontitis; interleukin-20
Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear
      Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half
      will receive placebo.
    

Detailed description: 
      ginger is a plant with lots of phytochemicals which have antioxidant effects. It reduces the
      NF-KB levels in the cells because of its antioxidant effects. It can reduces insulin
      resistance as a result of NF-KB reduction in diabetes.
    

Intervention name(s): Ginger; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks; Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks
Other intervention name(s): Zingiber officinale Roscoe; wheat flour capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: NF-κB; Ginger
The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
Condition: Pain Measurement; Visual Analog Pain Scale
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone
      injection for postoperative pain relief after knee arthroscopic surgery.
    

Detailed description: 
      Sixty patients who were undergoing unilateral knee arthroscopy randomly received unilateral
      spinal anesthesia with 0.5% hyperbaric bupivacaine 6 mg combined with normal saline 0.05 mL
      or hydromorphone 2.5, 5 or, 10 μg/0.05 mL. The verbal numerical rating scale (VNRS) pain
      scores were measured at 30 minutes and 2, 4, 6, 12 and 24 hours postoperatively, and the side
      effects of hydromorphone were recorded.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): 2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      This longitudinal study is being done to understand mechanisms underlying development of
      irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms.
      This information will be used to determine whether temporal changes in gut microbial taxonomy
      and metabolism are associated with changes in symptom severity in IBS, and if targeted
      dietary interventions, including prebiotics, can reverse or moderate these changes.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Motility Clinic, Clinical Research Unit, GI Department
      
Biospecimen description: 
      Plasma, serum, whole blood, stool, colonic mucosal tissue
    
Keywords: IBS
Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma
Condition: Low-Grade Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether oral vinorelbine is effective in the
      treatment of children with progressive or recurrent unresectable low grade glioma.
    

Detailed description: 
      The aim of this study is to determine efficacy of oral vinorelbine in children with
      progressive or recurrent unresectable low grade glioma, in addition to safety,
      pharmacokinetic, pharmacogenetic, medical costs and quality of life.
    

Intervention name(s): ORAL VINORELBINE
Intervention type(s): Drug
Intervention description(s): Orally vinorelbine 60 mg/m2 D1, 8 and 15 Cycle of 28 days For a maximum of 12 cycles The dose of vinorelbine should be increased to 80 mg/m2 from the 2nd cycle If on D8 and D15, the administration conditions are not met, the administration is canceled and not delayed.
Other intervention name(s): NAVELBINE
Intervention MeSH terms: Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
When Will I Feel The First Movements of My Baby?
Condition: Early Pregnancy
Study type: Observational

Summary: 
      This study aims to investigate average gestational week in which mothers feel the
      babies'movements for the first time and maternal-fetal factors affecting this time.
    

Detailed description: 
      Most of the obstetricians face the question; "When Will I Feel The First Movements of My
      Baby?", in daily practice. It becomes a challenge for the obstetrician to answer this
      question. Because, there is not a sufficient data in the current literature on this issue. A
      broad range of weeks for fetal quickening are reported as 16th to 20th weeks, in round
      figures. So, when a woman in the 21st gestational week , asks this question to the
      obstetrician and informed according to aforementioned literature knowledge, the woman will
      ask another question immediately after: "What is the problem with my baby?". But, the
      obstetrician will not be able to give an assuring answer because of the lack of knowledge in
      the current literature.Thus, to cope with such a clinical situation, the investigators
      decided to investigate the average week in which pregnant women in a low risk population,
      felt the babies' movements for the first time and to find out the affects of probable factors
      which may act on this time.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Three groups were formed according to the gestational week in which fetal movements felt by
        mother for the first time. 25th percentile, 50thand 75th percentile values were determined
        .Participants who felt the babies' movements at or before 25th percentile value constituted
        Group1 or early perception group, participants who felt the babies' movements between 25th
        and 75th percentile value constituted Group 2 or average perception group and the
        participants who felt the babies'movements at or beyond 75th value constituted Group 3 or
        late perception group. Subsequently, these three groups were compared regarding maternal
        age, gestational week of inclusion in the study, obstetric features, maternal body mass
        index values, caffeine consumption, smoking status, maternal education status, placental
        localization and fetal gender.
      
Keywords: fetal movement; placenta site; body mass index; maternal education
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Condition: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction); Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the combination of late doses of Infasurf with
      inhaled nitric oxide will interact to improve the surfactant function and thus the
      respiratory status and outcome of treated infants.
    

Detailed description: 
      Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD)
      in persistently ventilated preterm infants. The investigators conducted a multi-center,
      randomized, blinded pilot study to assess the safety and efficacy of late administration of
      surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric
      oxide in preterm infants < 1000 grams birthweight (BW). Calfactant is one of several types of
      exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different
      types.
    

Intervention name(s): Infasurf (ONY Inc.); Sham
Intervention type(s): Drug; Drug
Intervention description(s): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.; Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Other intervention name(s): Infasurf; Air
Intervention MeSH terms: Calfactant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nitric oxide; surfactant; bronchopulmonary dysplasia; prematurity; neonates; iNO; Infasurf; lung function; ventilated infants
Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)
Condition: Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Bariatric Surgery Candidate; Obesity, Morbid
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity, Morbid
Study type: Interventional

Summary: 
      Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition
      where fat accumulates in the liver and can lead to inflammation and scarring. It mostly
      causes no symptoms, however, in the most advanced cases there is an increased risk of liver
      cancer or liver failure.

      NAFLD is currently managed by weight loss and treating associated diseases such as diabetes.
      No medicines have been licensed to directly treat it but bariatric surgery has been shown to
      be usually beneficial, although it is unknown whether some operations are better than others.
      It is also unclear whether this is due to general weight loss or other factors.

      This study will be conducted in a hospital setting and aims to determine what changes in
      liver fat and fat processing occur after pre-operative low calorie diet and the two most
      common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.

      Participants will have ten study visits, four of which may be combined with NHS appointments.
      Participants will undergo investigations including MRI scans to measure changes in NAFLD and
      DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo
      mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be
      added to allow changes in fat processing to be detected. In addition to samples taken as part
      of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal))
      will be used for research. Visits will take place before and after low calorie diet and
      bariatric surgery.
    


Intervention name(s): Roux-en-Y Gastric Bypass (RYGB) surgery; Sleeve Gastrectomy (SG) surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): RYGB operation using surgeons' standard technique; SG surgery using surgeons' standard technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-alcoholic fatty liver disease; bariatric surgery
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the
      afferent branches of the nervus vagus around the human ear. The clinical trial is designed as
      a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve
      stimulation.
    


Intervention name(s): tVNS-Device
Intervention type(s): Device
Intervention description(s): Active treatment with the t-VNS device.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulsatile Tinnitus; Ringing-Buzzing-Tinnitus; Spontaneous Oto-Acoustic Emission Tinnitus; Tensor Palatini Induced Tinnitus; Tensor Tympani Induced Tinnitus; Tinnitus of Vascular Origin; Tinnitus, Clicking; Tinnitus, Leudet; Tinnitus, Leudet's; Tinnitus, Noise Induced; Tinnitus, Objective; Tinnitus, Spontaneous Oto-Acoustic Emission; Tinnitus, Subjective; Tinnitus, Tensor Palatini Induced; Tinnitus, Tensor Tympani Induced; Vascular Origin Tinnitus