bioihbjkbjnl/mcl2 huggingface dataset:
Off-site Training in Laparoscopy
Condition: Off-site Training in Laparoscopy
Study type: Interventional

Summary: 
      The study is a randomized study exploring the difference between off-site vs. on-site
      training in laparoscopic skills. The study will be performed using fifty surgical trainees
      from the departments of urology, surgery and gynecology. The participants will be recruited,
      enrolled and randomized during the introductory course in basic laparoscopic techniques held
      six times annually at Center of Clinical Education(CEKU).

      Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual
      Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency
      on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the
      passing level of 358pts on the Training and Assessment of Basic Laparoscopic
      Techniques(TABLT) technical test.

      The intervention group will have a portable trainer available to allow training at their
      convenience, be it at home or at work. The control group will only practice on-site at CEKU
      and at their local hospital.

      Participants will be asked to keep a training log with details of time spend on training and
      number of training sessions. The training log will contain information on any type practice
      involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet
      trainer or training at CEKU. Also time spend in the operation room, assisting or performing
      laparoscopic surgery will be registered.

      To pass the TABLT all participants will book a test session at CEKU for their final test at
      the end of their training. At the test sessions TABLT test scores will be established on site
      by the Chief Investigator and afterwards using video recordings of the test. A blinded rater
      will give scores based on the video recordings and this will be the decisive rating to
      determine whether the participant has passed the test.

      To pass the VRS training an employee at CEKU will monitor a VRS practice session in which
      proficiency level is reached.

      The enrollment of participants is expected to finish June 2015 a data analysis will be
      performed in July 2015.
    


Intervention name(s): Access to a portable trainer for laparoscopic skills
Intervention type(s): Other
Intervention description(s): Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital.
Other intervention name(s): Laptap(R)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Laparoscopy; Training; Off-site; Box trainer; Virtual Reality Simulator
Mifepristone at Same Time Multicenter Study
Condition: Abortion Seekers
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an
      intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate
      in this prospective clinical trial. This study will provide an evaluation of oral
      mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up
      to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7
      and 14 days after misoprostol administration, when using mifepristone 200 mg orally and
      misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up
      to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as
      acceptability will be done using pre and post-study questionnaires, and visual analogue
      scales. Complete abortion rate within 24 hours is expected to be 90%
    

Detailed description: 
      This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an
      intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate
      in this prospective clinical trial. This study will provide an evaluation of oral
      mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up
      to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7
      and 14 days after misoprostol administration, when using mifepristone 200 mg orally and
      misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up
      to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as
      acceptability will be done using pre and post-study questionnaires, and visual analogue
      scales. Complete abortion rate within 24 hours is expected to be 90%.
    

Intervention name(s): mifepristone and misoprostol
Intervention type(s): Drug
Intervention MeSH terms: Misoprostol; Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medical abortion; mifepristone; misoprostol
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics
      (PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and
      of a single dose of ALXN1920 intravenous (IV) in healthy adult participants.
    

Detailed description: 
      This is a first-in-human study in healthy adult participants.

      Eligible participants will be randomly assigned in a 3:1 (ALXN1920:Placebo) ratio in each of
      the treatment cohorts. The first 2 participants randomized to each cohort will be dosed as a
      sentinel pair, with 1 participant on active treatment and 1 participant on placebo. At the
      discretion of the Investigator, up to 3 more participants will be added at least 48 hours
      after the dosing of the sentinel pair, followed by dosing of the remaining participants in
      the cohort no earlier than 72 hours after sentinel pair dosing.

      The study will comprise:

      A Screening Period of up to 28 days; A Dosing Period (single dose through to Follow-up Visit)
      of approximately 28 days; A Final Follow-up period and end of study Visit is planned on Day
      29.

      Each participant will be involved in the study for approximately 56 days.
    

Intervention name(s): ALXN1920; Placebo; ALXN1920; ALXN1920
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.; Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.; Participants will receive a single dose of ALXN1920 by SC infusion.; Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: First-in-human; Single ascending dose; Sentinel dosing; ALXN1920; Safety; Pharmacokinetics; Pharmacodynamics; Japanese Descent
Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs
Condition: Disabilities Multiple
Study type: Interventional

Summary: 
      Adolescent Special need individuals are most need of easy forms of antibacterial agents, so
      in this study, using chemotherapeutic agents like the newly introduced varnish containing
      chlorhexidine seems to be a quite promising tool for local delivery to patients with special
      needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against
      the oral flora while fluorides are well known with their antibacterial ability. This may be
      an excellent way to reduce the risk assessment in adolescent special needs patients.
    

Detailed description: 
      Participants will be divided into two groups according to the tested regimen, where (A1)
      represents participants exposed to risk based conventional protocol, (A2) represents
      participants exposed to chlorhexidine containing varnish and risk based conventional
      preventive protocol. The study will be carried over a period of 10 months (one academic
      year), the study will be divided into three phases Phase I: Information of the Cariogram
      parameters (caries experience, diet content, diet frequency, plaque amount, mutans
      streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be
      collected, which will be used to generate the individual caries profile, based on which the
      participants will be divided into 2 risks groups. Phase II: Risk based preventive program
      will be implemented including the restorative part. Phase III: At the end of 10 months,
      caries profile will be generated again
    

Intervention name(s): preventive protocol; chlorhexidine added to the preventive protocol
Intervention type(s): Behavioral; Behavioral
Intervention description(s): preventive protocol; chlorhexidine varnish added to the preventive protocol
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer; Human Papilloma Virus
MeSH terms: Head and Neck Neoplasms; Papilloma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and
      tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a
      HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as
      MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1
      (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80
      (CD80).

      An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled
      and assessed for safety before additional participants are enrolled.

      The initial safety analysis run-in participants along with an approximate total of 50
      participants with human papilloma virus associated recurrent or metastatic head and neck
      squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor
      efficacy to MEDI0457 in combination with durvalumab.
    


Intervention name(s): MEDI0457; CELLECTRA®5P device; Durvalumab
Intervention type(s): Drug; Device; Drug
Intervention description(s): MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.; MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device.; Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks.
Other intervention name(s): INO-3112; CELLECTRA 2000; MEDI4736
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Squamous Cell Carcinoma; Oropharyngeal Cancer; HPV; Human Papilloma Virus; Cancer Immunotherapy; Check point inhibitors; PD-L1 inhibitor; Recurrent or Metastatic Cancer; Durvalumab; MEDI0457; Antineoplastic agents; Neoplasms
Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This research study will look at brain and symptom differences among women with severe
      premenstrual mood symptoms. One goal of this study is to look at the effects of taking a
      nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in
      emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The
      investigators will also look at whether oxytocin improves premenstrual mood symptoms.
    

Detailed description: 
      Purpose: The primary objective of this pilot study is to use functional neuroimaging
      techniques to begin to identify the central brain networks that may contribute to impairment
      in emotion regulation, interpersonal relationships, and marital and family function in women
      with premenstrual dysphoric disorder (PMDD), particularly for those women who also have a
      history of early life abuse (ELA).

      Based on the evidence that the mammalian neuropeptide oxytocin (OT), best known for its role
      in lactation and parturition, plays a seminal role in social affiliation, emotion regulation,
      attachment, maternal behavior, trust, and protection against stress; and because OT neural
      pathways and receptors are prominently expressed in brain regions involved in emotion
      regulation and maternal/affiliative behavior; the study will: 1) use intranasal OT
      administration as a probe to assess whether it modifies activation of brain regions involved
      in emotion regulation in response to an emotional processing task; and 2) whether daily
      intranasal OT administration during the premenstrual phase improves symptoms in women with
      PMDD with or without a history of ELA.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal Oxytocin spray (40 IU, 3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins; Intranasal Placebo spray (3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Premenstrual Dysphoric Disorder; Premenstrual Syndrome; PMS; PMDD
Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled single center investigation of furosemide's
      effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders
      of pregnancy
    

Detailed description: 
      Hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal
      morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. While
      significant research has been done on the evaluation and management of hypertension during
      pregnancy, studies of postpartum hypertension (PPHTN) are usually limited by their
      retrospective design and focus on inpatients in the immediate postpartum period (2-6 days),
      or patients who were readmitted due to complications related to hypertension. Few studies
      have investigated the incidence and proper management of hypertension in the postpartum
      period. Furthermore, in the United Kingdom, a review of maternal deaths determined that 10%
      were related to hypertensive disorders in pregnancy (HDP) in the postpartum period.
      Postpartum hypertension is also the cause of approximately 27% of readmissions to the
      hospital. These studies clearly show that PPHTN is associated with significant morbidity and
      that it is important to develop interventions that can reduce its effects.

      In patients with HDP, postpartum blood pressure has been shown to decrease in the first 48
      hours postpartum only to then increase in days 3-6 postpartum. This phenomenon is thought to
      be secondary to large fluid shifts, both secondary from fluid retention during the pregnant
      state as well as from fluids given intrapartum. Furthermore, large volumes of sodium are also
      mobilized into the intravascular compartment at this time. Given the latter, furosemide, a
      loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent
      severe range blood pressures and their associated maternal morbidity in the postpartum
      period.
    

Intervention name(s): Oral furosemide; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Furosemide (Lasix), 20 milligram, PO, PO, daily; Placebo, PO, daily
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, randomized, placebo control design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Furosemide; Postpartum; Hypertension
Urology San Antonio MRI/MicroUS Comparison
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI
      targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer.
      Both imaging techniques will be applied to each subject and compared, along with systematic
      biopsy.
    

Detailed description: 
      The investigational protocol describes a study designed to compare ultra-high resolution
      transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities
      are both used clinically to identify targets for prostate biopsy, however little data is
      available to compare their sensitivity. While mpMRI is used clinically to identify targets
      for biopsy, it is not used for real-time biopsy guidance due to challenges performing the
      biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled
      during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often
      using software assisted fusion products. For this investigation, the biopsy procedure will be
      guided by transrectal micro-US (current standard of care at Urology San Antonio), and will
      include systematic (standard, random, extended sextant) plus image-guided prostate biopsies
      among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.
    

Intervention name(s): Micro-ultrasound targeted biopsy; mpMRI targeted biopsy
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system; Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: multiparametric MRI; micro-ultrasound; prostate biopsy
Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
Condition: Accommodation
Study type: Interventional

Summary: 
      An investigational study in the control of the user's accommodative state via visual stimuli.
    

Detailed description: 
      The EyeQue Corporation (EyeQue) is developing devices to measure refraction that can be used
      outside of the clinic. The refraction devices require the user to perform a series of tests
      while looking through it to view a visual display. The current devices do not currently
      account for accommodation and therefore may present inaccurate results for the younger
      population where the accommodation effect is quite significant. This study is aimed at
      enabling future EyeQue refraction measurement products to overcome this issue and provide the
      required tools to allow for accommodation measurement, correction and control. Control of the
      user's accommodative state will allow for measurement of near vision as well as far vision
      based on the refractive measurement.
    

Intervention name(s): Visual Stimuli
Intervention type(s): Device
Intervention description(s): Subjects will be presented various visual stimuli and may be asked to perform tasks. Their accommodative response will be measured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens
      formulated as solution in comparison to a symptomatic standard treatment with add on placebo
      in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with
      or without bronchial asthma.
    

Detailed description: 
      Although highly effective, subcutaneous administration of allergens may cause inconvenience
      in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated
      to find an immunotherapy regimen largely accepted by all groups of patients, including
      children.

      Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of
      immunotherapy. It may be an optimal therapy option especially for children because they often
      fear injections.

      In this study children are to be treated with a preparation of a grass pollen allergen
      extract in a water/glycerol solution with phosphate buffered saline in comparison to a
      symptomatic standard treatment with add on placebo, in order to investigate efficacy and
      safety of the study drug.
    

Intervention name(s): Grass pollen allergens in a water/glycerol solution; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.; Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.
Other intervention name(s): Allerslit forte grasses; Comparator
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: specific immunotherapy; SIT; SLIT; sublingual