bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal
Condition: Colorectal Polyps
MeSH terms: Polyps
Study type: Interventional

Summary: 
      European guidelines recommend the use of cold snare polypectomy (CSP) for removal of
      diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP < 4 mm cold biopsy forceps
      (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp
      resection and CSP is associated with a failure of specimen retrieval for histology in up to
      6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF
      for removal of DCP in routine colonoscopy
    


Intervention name(s): Polypectomy of diminutive colorectal polyps will be performed by CBF; Polypectomy of diminutive colorectal polyps will be performed by CSP
Intervention type(s): Procedure; Procedure
Intervention description(s): All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CBF : The CBF will be performed using a standard biopsy forceps (Gluton Life ® Life Partners). Multiple biopsies bites were taken until complete resection (as many as needed).; All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CSP : The CSB procedure will be performed using a 9 mm cold snare (Exacto ® Life Partners). One to two mm of normal surrounding mucosa will be ensnared around the base of the polyp, followed by mechanical excision without electrocautery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polypectomy; Cold biopsy forceps; Cold snare polypectomy; Diminutive colorectal polyp
Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
Condition: Patients Waiting for Elective Coronary Artery Bypass Graft Surgery
Study type: Interventional

Summary: 
      Low levels of physical fitness increase the risk of death in patients with cardiovascular
      disease. Although cardiac rehabilitation programs improve the health of patients after heart
      surgery, most patients are not referred until after surgery. Therefore, the purpose of this
      study was to determine if an exercise "pre-habilitation" (i.e., Prehab) program before heart
      surgery would improve the health of patients before surgery and whether these improvements
      would be maintained after surgery.

      The investigators hypothesized that Prehab would promote the health of patients before heart
      surgery, and these improvements would be maintained three months post-operatively, as
      compared to patients who received standard care.
    

Detailed description: 
      This was a single-centre, parallel randomized controlled trial conducted in Canada to
      determine the feasibility and efficacy of an exercise and education "pre-habilitation" (i.e.,
      Prehab) program before elective coronary artery bypass graft surgery (CABG). We recruited 17
      patients who were scheduled to undergo elective CABG surgery from February 2011-May 2012.
      Enrolled patients were assessed at baseline, one week pre-operatively, and three months
      post-operatively.
    

Intervention name(s): Prehab
Intervention type(s): Behavioral
Other intervention name(s): Pre-habilitation; Preoperative exercise therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Preoperative care; Exercise therapy; Cardiac surgery
Diet and Physical Activity Interactions in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The projects funded by this grant, primarily focus on environmental factors that promote
      weight-gain in the general human population, and how to modify these factors, to prevent
      further weight-gain in the future. In the coming years, the researchers at the University of
      Colorado-HSC hope to gain an understanding as to how small changes in diet and physical
      activity can be achieved and sustained to prevent weight-gain.
    


Intervention name(s): small changes in physical activity and diet
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Prevention
A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme
      (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in
      treatment-naïve pediatric participants without severe symptoms. Participants were to be
      treated for 5 years.
    


Intervention name(s): Agalsidase beta; Agalsidase beta
Intervention type(s): Biological; Biological
Intervention description(s): Powder for concentrate for solution for infusion 1.0 mg/kg/4 weeks; Powder for concentrate for solution for infusion 0.5 mg/kg/2 weeks
Other intervention name(s): Fabrazyme; Recombinant human α-galactosidase A (r-hαGAL); Fabrazyme; Recombinant human α-galactosidase A (r-hαGAL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: α-GAL, α-Galactosidase-A, r-hαGAL
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
Condition: Primary Immunodeficiency Diseases (PID)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to acquire additional data on safety, tolerability and
      immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary
      Immunodeficiency Diseases (PIDD)
    


Intervention name(s): HYQVIA; KIOVIG; Cuvitru
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20); 100 mg/ml solution for Immune Globulin Intravenous Infusion; 200 mg/ml solution for Immune Globulin Subcutaneous Injection
Other intervention name(s): IGI 10% with rHuPH20; IGIV 10%; IGI 10%; IGSC 20%; IGI 20%
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PET Scan in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or
      recurrent prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Measure the pharmacokinetics, whole body retention of isotope, and biodistribution of
           C11-methionine and FDG by PET imaging and serial sampling of blood in men with
           progressive prostate cancer.

        -  Explore metabolism of each PET scan by comparing the sensitivity of C11-methionine or
           FDG by PET scanning in androgen independent prostate cancer metastases with the
           sensitivity of C11-methionine or FDG in androgen dependent metastases on a site by site
           basis.

        -  Compare C11-methionine and FDG PET scanning to standard of care diagnostic studies which
           include the Tc 99m bone scan, computed tomography, and magnetic resonance imaging.

      Patients fast for 6 hours prior to PET imaging with the exception of liberal water intake
      which is encouraged. A two way catheter is placed in the urinary bladder, and continuous
      isotonic saline irrigation is performed throughout scan acquisition to reduce the
      interference in imaging lesions in the pelvic lymph nodes and adjacent pelvic bones caused by
      radiation excreted in urine held in the bladder.

      Each patient receives C11-methionine intravenously. PET imaging begins immediately after
      injection for approximately 60 minutes total using standard imaging procedures. Immediately
      following the completion of imaging after C11-methionine administration, each patient
      receives FDG intravenously. PET imaging begins approximately 45 minutes thereafter for
      approximately 60 minutes using standard imaging procedures.
    

Intervention name(s): positron emission tomography; fludeoxyglucose F 18; methionine C 11
Intervention type(s): Procedure; Radiation; Radiation
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer
Study Evaluating SKI-606 in Subject With Solid Tumors
Condition: Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100,
      200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant
      solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This
      study will also obtain preliminary information on the pharmacokinetics and antitumor activity
      of orally administered SKI-606 in subjects with advanced malignant solid tumors
    


Intervention name(s): SKI-606
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PHASE 1 SKI-606 Solid tumor
Impact of Theta Burst Stimulation Over the Left DLPFC on Language Switching
Condition: Languages
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether theta burst stimulation (TBS) over the
      left dorsolateral prefrontal cortex (DLPFC) influences language switching and cognitive
      flexibility. The experimental paradigm will assess the impact of inhibitory and excitatory
      prefrontal stimulation by TBS versus sham-TBS over the DLPFC in healthy bilinguals.
    

Detailed description: 
      Background:

      Clinical observations and neuroimaging studies seem to confirm the role of executive
      functions and frontal structures in language processing in bilingual subjects.

      Repetitive transcranial magnetic stimulation, such as for example theta burst stimulation
      (TBS), is increasingly being used as a valuable tool for neuroscientists investigating the
      underlying mechanisms of cognitive functions. Case studies have shown a change in language
      switching after bilingual patients received repetitive magnetic stimulation to the left
      DLPFC. However, there is no study investigating the effect of TBS applied to the DLPFC on
      language switching in healthy participants.

      Procedure:

      A planned total of 40 unbalanced bilingual participants will be included. Half of the
      participants will receive inhibitory theta burst stimulation (continuous TBS), the other half
      excitatory theta burst stimulation (intermittent TBS). After TBS, different language and
      nonverbal tasks will be performed while an EEG is measured. Before being stimulated, each
      subject will conduct the same tasks with a sham-TBS as a baseline measure.
    

Intervention name(s): Sham iTBS; Sham cTBS; intermittent theta burst stimulation (iTBS); continuous theta burst stimulation (cTBS)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Placebo stimulation for the iTBS group; Placebo stimulation for the cTBS group; Excitatory theta burst stimulation; inhibitory theta burst stimulation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: theta burst stimulation; Language switching; dorsolateral prefrontal cortex
Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual
      trigger are all retrospective. The investigators therefore aim to perform a prospective
      randomized controlled study in normal responders, comparing cycles triggered with hCG to
      those triggered with hCG+GnRH agonist.
    

Detailed description: 
      A prospective, randomized, double blinded clinical trial. Patients will undergo standard
      clinical and hormonal investigation as usual for IVF. Patients that will be given the
      standard GnRH antagonist IVF protocol will be prospectively randomized into two groups: 1.
      hCG group- will be triggered for final follicular maturation with hCG (Pregnyl 10,000IU) as
      is usual and placebo (normal saline) - 36 hours prior to oocyte aspiration. 2. The Double
      trigger group- will receive GnRH agonist (Suprefact 0.5 mg) and hCG (Pregnyl 10,000IU) 36
      hours prior to the oocyte aspiration. All patients will be supplemented with the usual
      progesterone preparation (vaginal progesterone suppositories) for luteal support.

      In order to increase the rate of MII from to 65% to 80% with an alpha error of 5% and beta
      error of 80% the sample size needed is 276 total patients in both groups or 138 patients in
      each group.
    

Intervention name(s): Buseralin; Placebo; pregnyl
Intervention type(s): Drug; Other; Drug
Other intervention name(s): Suprefact; normal saline; hCG
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Double trigger
Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to understand whether there is any difference in the
      amount of tasimelteon (including its breakdown product) in the blood when taken alone and in
      combination with either rifampin or ketoconazole.

      Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain
      medications. In this study, the effect that this important enzyme has on tasimelteon is being
      studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how they
      are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme
      meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of
      Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme.

      In addition, the safety and tolerability of tasimelteon will also be assessed throughout the
      study.
    


Intervention name(s): tasimelteon; tasimelteon; Rifampin; Ketoconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20mg, oral capsule, once, Days 1 and 12; 20mg, oral capsule, once, Days 1 and 6; 600mg, oral capsules (2 x 300mg), once daily (QD), Days 2-11; 400mg, oral tablets (2 x 200mg), once daily (QD), Days 2-6
Other intervention name(s): VEC-162, BMS-214778; VEC-162, BMS-214778
Intervention MeSH terms: Rifampin; Ketoconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: rifampin,; ketoconazole,; CYP3A4,; tasimelteon,; VEC-162; Pharmacokinetics
Coffee for Optimal Metabolite Profile
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this project is to evaluate metabolite profile after consumption of three types of
      coffee differing in type of bean, degree of roasting and preparation method. Metabolite
      profiles will be evaluated after a) a single dose b) 3-day consumption. The study will be
      carried out as a three-way cross-over design with three different types of coffee. Wash-out
      periods where participants consume their habitual diet are implemented between all
      intervention periods. The first day of intervention (single dose) includes postprandial
      measurements during 13 hours.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Study type: Observational

Summary: 
      The objective of this study is to validate the spanish (from Spain) version of the "Nocturia
      Quality of Life Questionnaire and assess their psychometric properties, using the spanish
      translation provided by the copyright holder.

      Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by
      Intraclass Correlation Coefficient), Convergent Validity (assessed using other already
      validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health
      and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be
      evaluated.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men older than 60 years old suffering from nocturia (one or more voidings overnight)
        without exclusion criteria
      
Keywords: NOCTURIA; SYMPTOMATIC QUESTIONNAIRE; N-QOL
Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis
      B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety,
      tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

      In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose
      of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose
      (MAD) parts, Part B & Part C, subjects with chronic HBV infection will receive two doses of
      VIR-2218 or placebo every 4 weeks administered SC.
    


Intervention name(s): VIR-2218; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VIR-2218 given by subcutaneous injection; Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis
Minimal Invasive Treatment of Inguinal Hernia in Neonates
Condition: Inguinal Hernia; Surgery
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      In this study, preoperative physical examination findings, peroperative findings and data,
      and postoperative follow-up results of newborns who underwent inguinal hernia repair with
      PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively.
    

Detailed description: 
      Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its
      treatment includes high ligation of the patent processus vaginalis by open or laparoscopic
      method. There are many described minimally invasive/laparoscopic repair techniques of
      inguinal hernias in children. One of them is "percutaneous internal ring suturing" or
      "Percutaneous Inner Ring Suturing".

      There are many studies on the PIRS method in children. Two of these studies are prospective
      clinical studies published previously by the investigators of this study: in the first, the
      PIRS method was shown to be a safe and effective method for minimally invasive repair of
      inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in
      anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection
      and anesthesia management in children undergoing laparoscopy.

      Although there are many studies on the repair of inguinal hernia in children with PIRS or
      other minimally invasive methods in the last decade, there are very limited studies on the
      use of these methods in newborns, a special group of childhood patients. In the literature,
      there is no study examining only newborn patients. In this context, the study will be a first
      in the literature.
    

Intervention name(s): Surgery (PIRS)
Intervention type(s): Other
Intervention description(s): Laparoscopic procedure for repair of inguinal hernia as described in:
1) Thomas DT, Göcmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11. PMID: 26777889.
Other intervention name(s): Percutaneous Internal Ring Suturing
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates <28 days of age undergoing PIRS
Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is an urgent need for effective therapies against the novel COVID-19 virus. Studies
      have shown that amiodarone and verapamil can interfere with coronavirus entry and
      amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate
      amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with
      confirmed COVID-19 infection.
    


Intervention name(s): Amiodarone; Verapamil
Intervention type(s): Drug; Drug
Intervention description(s): Ion channel blocker; Ion channel blocker
Intervention MeSH terms: Amiodarone; Verapamil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel group, randomized trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment