bioihbjkbjnl/mcl2 huggingface dataset:
Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
Condition: Fine Needle Aspiration Cytology; Thyroid Diseases
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Interventional

Summary: 
      Thyroid gland diseases are the second most common endocrine disease following diabetes
      mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in
      adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy,
      cost-effective test for cancer diagnosis, and its use has markedly decreased the number of
      unnecessary thyroid surgeries(2).
    

Detailed description: 
      it should be noted that FNAC cannot differentiate between benign and malignant follicular
      neoplasms.differentiation between follicular adenoma and follicular carcinoma is only
      possible after thyroid lobectomy.[2,3] In addition, a study of FNAC showed that 68% of the
      cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of
      papillary carcinoma, indicting a considerable overlap between benign and malignant
      neoplasms.[4] Incidental findings of thyroid nodules have increased exponen¬tially in recent
      years, mostly due to the widespread application of high-resolution ultrasound (US) to the
      thyroid [5].Several in¬ternational scientific societies have established clinic-radiolog¬ical
      guidelines for the diagnosis and the management of thy¬roid nodules [2,3]. The American
      College of Radiology identifies 5 radiological risk levels and recommends US-guided
      fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and
      of nodules with a low risk for malignan¬cy only if larger than 25 mm [2]. According to the
      European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features
      (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and
      FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should
      undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious [3].
    

Intervention name(s): Fine Needle Aspiration Cytology
Intervention type(s): Procedure
Intervention description(s): Comparison between FNAC and post operative specimen after thyroid surgery
Other intervention name(s): Thyrodectomy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FNAC; thyroid nodules; thyroidectomy
Minimally Invasive Liver Surgery for Metastases From Colorectal Cancer: Oncologic Outcome and Prognostic Factors
Condition: Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators
Study type: Observational

Summary: 
      Only few reports exist on long-term survival after minimally invasive liver surgery (MILS for
      colorectal liver metastases. No data are available assessing prognostic factors in the era of
      current modern treatment strategies. The aim of the current study is to analyze the long-term
      oncologic outcome after MILS for metastases from colorectal cancer and determine prognostic
      indicators.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients sufering from colorectal liever metastases (CRLM) who undergo
        minimally invasive liver surgery (MILS) or open liver surgery (OLS)
      
Biospecimen description: 
      Tissue samples for histopathology diagnosis & staging
    
Keywords: liver metastases; colorectal cancer; surgery; prognosis
Effect of PBI-4050 on the Pharmacokinetics of Midazolam in Heathy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of
      PBI-4050 combined with midazolam in healthy adult subjects.
    

Detailed description: 
      This is a Phase 1, single-center, open-label, 2-period, fixed sequence study to investigate
      the effect of multiple doses of PBI-4050 on the PK of midazolam, a cytochrome P450 (CYP) 3A
      substrate, in healthy adult men and healthy women of non-childbearing potential (WONCBP), and
      to determine the safety and tolerability of PBI-4050, when co-administered with midazolam.

      On Day 1 of Period 1, subjects will receive a single oral dose of midazolam followed by PK
      sampling of midazolam and its metabolite 1-hydroxymidazolam (1-OH-midazolam). In Period 2,
      subjects will receive multiple daily doses of PBI-4050 for 5 consecutive days (Day 1 to Day
      5) with a single oral dose of midazolam co-administered on Day 5. PK sampling for midazolam
      and 1-OH-midazolam will be collected for 24 hours following dosing on Day 5. PK sampling for
      PBI-4050 and its major metabolite will be collected at pre-dose on Days 3, 4, and 5.

      There will be a washout period of at least 2 days between midazolam dose in Period 1 and the
      first PBI-4050 dose in Period 2.
    

Intervention name(s): PBI-4050 and midazolam
Intervention type(s): Drug
Intervention description(s): A single oral dose of midazolam (1 mL of 2mg/mL syrup) will be given to all subjects in Period 1 and on Day 5 of Period 2. 1200 mg of PBI-4050 (3 X 400 mg tablets) will be administered for 5 days (Day 1 to Day 5) of Period 2 and a single dose of midazolam (1 mL of 2mg/mL) on Day 5.
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PBI-4050; drug-drug interaction; CYP3A; midazolam; healthy subjects
Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of
      pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing
      hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the
      hematological system, the cardiovascular system and the feto-placental unit. In its most
      severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and
      even death.
    

Detailed description: 
      The key aspects in the pathophysiology of pre-eclampsia are placental oxidative stress (and
      hypoxia), placental release of the anti-angiogenic factors Soluble Fms Like Tyrosine Kinase
      -1 and soluble endoglin and maternal endothelial dysfunction. A drug that can counter these
      pathological steps could be a strategy to treat pre-eclampsia.

      If an affordable and safe treatment was available it could temporize the disease progression
      of pre-eclampsia thereby delaying delivery to gain gestation. This could save the lives of
      many infants and decrease the hospital burden caused by iatrogenic prematurity.

      Currently, there are trials investigating the possible use of pravastatin to treat
      pre-eclampsia, and to prevent it There are no other significant trials of orally available
      small molecules to treat pre-eclampsia that we are aware of.

      The Translational Obstetrics Group at Melbourne University has generated strong preclinical
      evidence suggesting esomeprazole as one of the proton pump inhibitors may have potent actions
      giving it significant potential as a treatment for pre-eclampsia

      Proton pump inhibitors have been commonly used in pregnancy to treat gastroesophageal reflux
      disorders and more serious gastrointestinal complications like Helicobacter pylori-infection,
      peptic and duodenal ulcers and Zollinger-Ellison syndrome.

      Esomeprazole counters three key steps in pre-eclampsia pathogenesis, by up-regulating heme
      oxygenase-1 ( strongly decreasing the release of antiangiogenic factors Soluble Fms Like
      Tyrosine Kinase -1 and soluble endoglin and quenching endothelial dysfunction.
    

Intervention name(s): Esomeprazole 40 mg Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): once daily oral tablets; once daily oral tablets
Other intervention name(s): Nexium; inert
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old
Condition: Influenza, Human; Vaccination; Infection; Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M
      vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children
      aged 6 months to 9 years (at the time of the first vaccination).
    

Detailed description: 
      The trial includes 2 stages (stage I, II). At stage I children aged 3-9 years will be
      included. Based on findings from tolerability and safety assessment in respect of the Flu-M
      vaccine vs. the Vaxigrip® vaccine for the first 7 days after vaccination of volunteers during
      Stage I, an intermediate report will be prepared. The report will be submitted to the
      supervisory executive authorities alongside the notice of commencement of Stage II of the
      trial - the continuation of trial on children aged 3-9 years and the commencement of trial on
      children aged between 6 months and 35 months. During Stage II, the trial for Stage I
      volunteers will continue in full and also children aged between 6 and 35 months will be
      included in the trial.
    

Intervention name(s): Flu-M, Inactivated split influenza vaccine 0.5 mL; Vaxigrip, Inactivated split influenza vaccine 0.5 mL; Flu-M, Inactivated split influenza vaccine 0.25 mL; Vaxigrip, Inactivated split influenza vaccine 0.25 mL
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Solution for intramuscular injection Сhildren were vaccinated with the Flu-M vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL; Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL; Solution for intramuscular injection Children were vaccinated with the Flu-M vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL; Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Flu; Vaccine; FLU-M; SPbSRIVS; Vaxigrip; Children
Effects Of Deep Neck Flexor And Extensor Exercises
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Deep cervical flexor and extensor muscles show decreased strength in patients with Mechanical
      neck pain. Exercises involving deep cervical muscles has improved coordination and motor
      control. This study aim to determine the effects of deep flexor muscle exercises along with
      deep extensor muscle exercises on pain, range of motion and muscle strength in mechanical
      neck pain.
    

Detailed description: 
      This study will be a randomized controlled trial and will be conducted in Riphah
      Rehabilitation Clinic Lahore and Physiotherapy outpatient department of WAPDA Teaching
      Hospital Lahore. Non-probability consecutive sampling will be used to collect the data.
      Sample size of 36 subjects with age group between 18-40 years will be taken. Data will be
      collected from the patients having present complaint of Mechanical Neck pain. Outcome
      measures will be taken using Numeric pain rating scale (NPRS) for pain, Manual Muscle Testing
      (MMT) for muscle strength and Universal Goniometer (GU) for Range of motion. An informed
      consent will be taken. Subjects will be selected on the basis of inclusion and exclusion
      criteria and will be equally divided into two groups by random number generator table. Both
      the Groups will receive Hot Pack, superficial neck muscles stretching and Neck isometrics,
      while Group A will receive deep neck flexor and extensor exercises, and Group B will receive
      conventional treatment. Outcome measures will be measured at baseline and after 4 weeks. Data
      analysis will be done by SPSS version 25.
    

Intervention name(s): Deep Neck Flexors & Extensors exercises
Intervention type(s): Other
Intervention description(s): Deep neck flexor exercises (2 set of 10 repetitions) that includes:
Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine
Deep Neck Extensor exercises (2 set of 10 repetitions) that includes:
Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck muscles; Neck Pain; Muscle strength; Range of Motion
Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety
      and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South
      Korea.
    


Intervention name(s): V114
Intervention type(s): Biological
Intervention description(s): V114 0.5 mL sterile suspension for intramuscular injection.
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase II Study of ABI-007 for Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for
      recurrence or unresectable gastric cancer patients who have received one prior regimen
      containing fluoropyrimidine and developed disease progression or recurrence.
    


Intervention name(s): ABI-007
Intervention type(s): Drug
Intervention description(s): ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Intervention MeSH terms: Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension
Condition: Hypertension; Blood Pressure, High; Blood Pressure, Resistant; Blood Pressure, Uncontrolled
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in
      patients with treatment-resistant or uncontrolled hypertension.
    


Intervention name(s): ROX COUPLER
Intervention type(s): Device
Intervention description(s): The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; High blood pressure; Resistant blood pressure; Uncontrolled blood pressure
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. The aim of this research is to assess the safety of
      continuous treatment with insulin detemir following participation in trial NN304-1689
      (NCT00435019) on antibody development.
    


Intervention name(s): insulin detemir; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.; Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to determine the health effects of the 4 weeks daily intake of a
      drink manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood
      markers of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism,
      together with general hematology and blood coagulation will be assessed at baseline time (day
      0) and after drink ingestion (day +14 and +28).
    

Detailed description: 
      The main objective of the present study is to verify the hypothesis that the intake of the
      drink based on lupine peptides is safe and has beneficial effects on the immune and oxidative
      status.

      The secondary objectives are:

        -  Assess the effect of the drink on biological parameters of the carbohydrate, lipid,
           renal and hepatic metabolism as well as hematology analysis.

        -  Assess whether the new product is well tolerated.

        -  Evaluate the effect of the drink on the general health of the volunteers through the
           Short Form-36 health survey.

        -  Determine the degree of drink acceptability through the acceptability Likert test.
    

Intervention name(s): Drink manufactured from lupine peptides
Intervention type(s): Dietary Supplement
Intervention description(s): Comparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study tests whether GLYX-13 - an experimental drug that acts on a brain
      receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment
      study. Results from this study will allow doctors and researchers to better understand if you
      and others with OCD may respond to a class of medications that target the NMDA brain
      receptor.
    


Intervention name(s): Rapastinel (formerly GLYX-13)
Intervention type(s): Drug
Intervention description(s): 10 mg/kg IV Rapastinel (formerly GLYX-13)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The
      purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a
      single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a
      single-dose, parallel group design comprising 2 groups of healthy subjects assessing the
      effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose
      administered in Part 2 will be determined from emerging safety and PK data from Part 1 and
      Study TFR110951.
    

Detailed description: 
      This study will be a randomised, placebo-controlled study to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of single doses of inhaled GSK1995057 in
      healthy subjects. The study consists of 2 parts with a total of 6 cohorts. Part 1 will be
      conducted singleblind and Part 2 will be conducted single-blind with restrictions (i.e.
      subject and investigator only). The GSK Study Team and site pharmacist will remain unblinded
      to treatment allocation. Cohorts 1, 2, 3 and 4 (in Part 1) will receive a single inhaled dose
      of GSK1995057 or placebo. Cohort 5 will receive a single inhaled dose of GSK1995057 and in
      addition will have a bronchoalveolar lavage (BAL) sampling procedure conducted approximately
      30 minutes post GSK1995057 dose. Subjects in Cohort 6 (Part 2) will be randomised to receive
      a high dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling
      procedure. Subjects will be required to visit the clinic over the course of 28 days after
      their dosing period for a follow up. Further visits for immunogenicity sampling may be
      conducted at 56 and 84 days post-first dose for subjects who show changes indicating a
      positive ADA response after dosing. Doses levels stipulated within the protocol are target
      doses based on predictions using the PK/PD model described in Section 1.2.2 of the clinical
      protocol. Part 1 will commence first and following acceptable safety and tolerability data
      will allow initiation of Part 2. All cohorts will participate in a single study session only.
    

Intervention name(s): GSK1995057; bronchoalveolar lavage; LPS; Placebo
Intervention type(s): Drug; Procedure; Drug; Drug
Intervention description(s): inhaled dose (volume based on cohort); BAL; 50 μg; Sucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose)
Intervention MeSH terms: Dimercaprol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Infection, Quality of Life, lung injury