bioihbjkbjnl/mcl2 huggingface dataset:
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)
Condition: Human Papilloma Virus Infection
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Observational

Summary: 
      The aim of the study is to develop robust analytical protocols for first-void urine sample
      preparation and antibody assays to monitor natural and/or vaccine induced immunity against
      HPV (Human Papillomavirus).
    

Detailed description: 
      In total 57 women will be included in this trial: 38 vaccinated with an prophylactic HPV
      vaccine and 19 not vaccinated with a prophylactic HPV vaccine. These women are asked to
      collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood
      sample of 5-10 cc is collected. The collected urine and blood samples will be used for the
      development and optimisation of robust analytical protocols for sample preparation and
      antibody assays.
    

Intervention name(s): First-void urine collection; Blood draw
Intervention type(s): Other; Other
Intervention description(s): One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).; One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccinations (CEV).
Other intervention name(s): FV urine; Blood
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In total 57 women will be included in this trial. During their study visit, participants
        are asked to collect a first-void urine sample with the Colli-PeeTM device. Hereafter, a
        blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill
        in a questionnaire.

        For this pilot study, our study population is based on unequal groups with twice as many
        cases (vaccinated women) then controls (non-vaccinated women) (k = 2) because our focus is
        to develop analytical protocols and assays for anti HPV antibodies. This results in a total
        sample size of 57, including 19 controls (non-vaccinated women) and 38 cases (vaccinated
        women).
      
Biospecimen description: 
      First-void urine samples and Blood samples
    
Keywords: Antibodies; Vaccination; Self-sampling; First-void urine; Serum
A Novel Approach for Transmuscular Quadratus Lumborum Block
Condition: Transmuscular Quadratus Lumborum Block Hip Surgery
Study type: Interventional

Summary: 
      a novel approach for TQL (anterior Q.L) block aiming mainly for terminal branches of lumbar
      plexus. The technique is described as Para-Spinous Saggital Shift Q.L block, done at L4
      transverse process level in saggital orientation.
    

Detailed description: 
      With this approach, we think it has advantages of easy identification, better caudal LA
      spread till under fascia iliaca, with the psoas major muscle provides a better protective
      barrier against accidental needle entry into the peritoneal cavity, the endpoint is injection
      within a fascial plane, rather than a specific motor response contact where the lumbar plexus
      stimulation is not sought, so there is minimal risk of nerve injury, inadvertent dural cuff
      puncture and intrathecal spread of local anesthetic. And finally optimal insertion of
      catheter in long axis of Q.L and psoas major if continuous analgesia is planned.
    

Intervention name(s): transmuscular quadratus lumborum block
Intervention type(s): Procedure
Intervention description(s): transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The investigators compared the perioperative, oncological, functional and immunological
      outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for
      treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain
      induced, endoscopic submucosal dissection is expected to be less invasive when compared to
      laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show
      that endoscopic submucosal dissection is associated with a significantly better perioperative
      recovery and less immunological disturbance. Moreover, it will also induce a better long term
      outcomes as the stomach can be preserved, hence the digestive function is maintained to
      prevent long term functional morbidities of the gastrointestinal tract.

      This study will be the unique first study in the literature to show that intramucosal early
      gastric cancer can be adequately treated by endoscopic submucosal dissection with better
      perioperative, functional and quality of life outcomes when compared to laparoscopic assisted
      gastrectomy.
    


Intervention name(s): Endoscopic Submucosal Dissection; Laparoscopic assisted Gastrectomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeating Patterns of Sleep Restriction and Recovery
Condition: Healthy
Study type: Interventional

Summary: 
      Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient
      sleep increases susceptibility to a variety of disease states by progressively compromising
      the integrity of stress response systems.
    


Intervention name(s): Repeated sleep restriction and recovery; Control sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Repeated cycles of sleep restriction and sleep recovery; Regular amounts of sleep across study protocol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy individuals
Kinetic Study of Lp(a) and PCSK9 in Humans
Condition: Cholesterol; Metabolic Disorder; Lipoproteinemia
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The aim is to study the relationship between lipoprotein(a) [Lp(a)] and PCSK9 (Proprotein
      Convertase Subtilisin/Kexin type 9) in humans with a kinetic study of lipoproteins in
      patients with dramatic increase of Lp(a) and controls.
    

Detailed description: 
      Elevated plasma levels of lipoprotein(a) [Lp(a)] are independently associated with an
      increased risk of cardiovascular diseases (CVD). Recently an unexpected and significant 15 to
      30 % reduction of Lp(a) was reported with PCSK9 (Proprotein Convertase Subtilisin/Kexin type
      9) inhibitors. The relation between Lp(a) and PCSK9 are unclear and debated.

      Kinetic studies of lipoprotein are an important tool to decipher the complexity of
      apolipoprotein metabolism in human. The comparison of apoprotein(a) and PCSK9 kinetic
      parameters of patients with extreme lipid disorder link to PCSK9 and apo(a) will allow to
      better understand the impact of PCSK9 on apo(a). From one previous in vitro study, the
      hypothesize is that PCSK9 increases the production rate and the assembly of Lp(a).

      The objectives are to explore the relationship between the plasma concentration of PCSK9 and
      apo(a) production rate as well as the impact on the catabolic rate. Patients with extreme
      Lp(a) levels and healthy controls will be explored by performing a continuous infusion of
      deuterated leucine for 14 hours. LC/MS-MS will be used to analyze the samples and kinetic
      data of apo(a) and PCSK9 will be generated from a compartmental model. Tracer enrichment
      analysis could be complicated for proteins with low plasma concentrations as PCSK9. This
      issue will be solved with SPE and/or immune affinity concentration techniques.
      Non-parametrical test and multivariate analysis will be use to describe the relationship
      between these two variables.

      This study will provide new knowledge on Lp(a) and PCSK9 metabolism and their interactions in
      humans.
    

Intervention name(s): infusion of tracer [5,5,5-2H3] -L-leucine
Intervention type(s): Other
Intervention description(s): A bolus of 6ml of [5,5,5-2H3] -L-leucine tracers will be performed followed by an infusion of 90 ml of [5,5,5-2H3] -L-leucine infused over 14 hours. This tracer participates in protein synthesis and especially in the synthesis of all apolipoproteins and PCSK9. Blood samples will be taken at T0, T2min, T5min, T10 minutes, T30 minutes and then every hour until 14 hours (a total of 240 ml of blood will be collected) to measure the stable tracer enrichment in the proteins of interest.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Kinetic study of lipoprotein metabolism with stable isotope tracers.
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
Condition: Acute Lymphoblastic Leukemia; Philadelphia Chromosome
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Imatinib is safe and effective in
      association with intensive treatment of Ph+ALL in children.
    

Detailed description: 
      Recent advances in treatment have increased the cure of childhood ALL to 75% or better.
      However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have
      been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently
      being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia
      patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric
      patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type
      chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in
      particular on the Disease Free Survival (DFS).
    

Intervention name(s): Standard chemotherapy + Imatinib
Intervention type(s): Drug
Intervention description(s): Patients receive Imatinib together with the standard chemotherapy regimen of phase IB and after each of three consecutive blocks of the standard chemotherapy in the consolidation phase
Other intervention name(s): Glivec; Gleevec
Intervention MeSH terms: Imatinib Mesylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy; Leukemia; Children; Philadelphia chromosome; Protein-tyrosine kinase inhibitor
Rectus Musle Reapproximation During Cesarean Section
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In
      group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the
      rectus muscles and bowel functions will be evaluated.
    

Detailed description: 
      Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be
      opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1
      rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be
      closed. Postoperative pain scores, distance between the rectus muscles and bowel functions
      will be evaluated.
    

Intervention name(s): Cesarean Section
Intervention type(s): Procedure
Intervention description(s): Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg
      and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
    

Detailed description: 
      Vilanterol trifenatate (VI) is a potent and selective long-acting β2 agonist; Umeclidinium
      bromide (UMEC) is a long-acting, inhaled, muscarinic receptor antagonist (LAMA). Both
      compounds are in development once daily for the treatment of Chronic Obstructive Pulmonary
      Disease (COPD).

      This study is a randomized, open label, three-period crossover, balanced incomplete block
      study which will assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg
      and 125µg) and VI (25µg) as monotherapies and combinations in 20 healthy Chinese subjects.
      Each subject will receive three of five possible treatments for 10 days each.

      Blood samples for PK analysis will be taken at designed timepoints. Safety will be assessed
      by measurement of ECG QTcF, heart rate, blood pressure, and safety laboratory data and review
      of adverse events.
    

Intervention name(s): UMEC/VI 125/25 mcg; UMEC/VI 62.5/25 mcg; UMEC 125 mcg; UMEC 62.5 mcg; VI 25 mcg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Combination in high dose; Combination in low dose; LAMA mono in high dose; LAMA mono in low dose; LABA mono
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Music Pacing in Pediatric Exercise Testing
Condition: Exercise Testing With Music Pacing
Study type: Interventional

Summary: 
      Study hypothesis: Music pacing improves the quality of exercise testing in children.

      Children tend to cycle in a non-constant pace during exercise testing, which might make the
      test less reliable.

      20 boys will perform two exercise tests on a cycle ergometer. One test will be done with
      constant tempoed music, and the other without. Different parameters will be checked including
      pedaling cadence, aerobic fitness, level of work load obtained.
    


Intervention name(s): Music listening
Intervention type(s): Other
Intervention description(s): Listening to tempo music while cycling in an exercise test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Keywords: exercise testing; music; VO2 max
Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery
Condition: Atelectasis; Atelectases, Postoperative Pulmonary
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      In this study researchers aim to evaluate effect of different ventilation modalities on the
      developments of atelectasis by using ultrasound.
    

Detailed description: 
      Patients undergoing laparoscopic surgery will be randomly assigned either volume controlled
      ventilation group or pressure controlled volume guaranteed ventilation group. All patients
      will be performed lung ultrasonography pre and postoperatively to evaluate the development of
      lung atelectasis and effect of different ventilation modalities on the development of
      atelectasis.
    

Intervention name(s): VCV; PCV-VG; lung ultrasonography
Intervention type(s): Procedure; Procedure; Diagnostic Test
Intervention description(s): after induction for anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode; after induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode; all patients will be performed lung ultrasonography pre and postoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: postoperative atelectasis; mechanical ventilation; laparoscopic surgery; lung ultrasonography; volume controlled ventilation; pressure controlled
Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, third-party open (ie, participant-blind,
      investigator-blind and sponsor-open), placebo-controlled, dose escalating clinical study to
      evaluate the safety, tolerability, immunogenicity, PK and PD of PF-06480605 in Japanese
      healthy adult participants.
    

Detailed description: 
      Approximately 16 participants are planned to be enrolled into the study. The study consists
      of 2 cohorts, and approximately 6 participants will be randomized to PF-06480605 and
      approximately 2 participants will be randomized to placebo in each cohort. Each participant
      will receive PF-06480605 or placebo subcutaneously.
    

Intervention name(s): PF-06480605; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-06480605 150 mg and 450 mg SC dosing; Placebo SC dosing
Other intervention name(s): Cohorts 1 and 2 Active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
ToleroMune Ragweed Follow up Study
Condition: Ragweed Allergy; Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In
      the third National Health and Nutrition Examination Surveys54.3% of the population had
      positive test responses to one or more allergens, with the prevalence for short ragweed being
      26.2%

      The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis
      symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing
      visits and the post treatment challenge (PTC) visit in study TR002 approximately one year
      after the start of treatment.
    

Detailed description: 
      Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC
      will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4
      visits on successive days. Following the final EEC visit a follow-up visit will be performed
      3-10 days later.
    

Intervention name(s): Placebo; ToleroMune Ragweed
Intervention type(s): Biological; Biological
Intervention description(s): No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.; No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects previously randomised in study TR002 and completed all dosing visits and the Post
        Treatment Challenge (PTC).
      
Keywords: Ragweed allergy; ToleroMune ragweed; immunotherapy
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
Condition: Cataract
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery
      Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
    


Intervention name(s): LAL (Light Adjustable Lens) and Light Deliver Device (LDD); Monofocal control IOL
Intervention type(s): Device; Device
Intervention description(s): LAL implanted and adjusted with LDD; Commercially available monofocal intraocular lens (IOL)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 3 medical device study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome
Condition: Knee Pain Chronic
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      We performed a prospective case series study of 48 patients who suffered Lateral patellar
      compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and
      failed conservative management and underwent isolated arthroscopic lateral patellar
      retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private
      Hospital between December 2016 and August 2019.
    


Intervention name(s): Lateral patellar release
Intervention type(s): Procedure
Intervention description(s): Arthroscopic lateral patellar reticular release
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lateral patellar compression syndrome; Arthroscopic lateral release; Lysholm score