bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements
Condition: Healthy
Study type: Interventional

Summary: 
      This is an open-label study in adults to assess at-home Project: EVO Monitor measurements
      over repeat play cycles. The study has three arms:playing multiple times per day, once daily,
      and once weekly for 4 to 8 weeks.
    

Detailed description: 
      This is an open-label study in adults ages 40 to 55 to assess Project: EVO Monitor
      measurements over repeat play cycles. The study has three arms: adults playing multiple times
      per day, adults playing once daily, and adults playing once weekly. The investigators plan to
      evaluate 76 participants (N = 30 in the daily and weekly arms, and N=16 in the multiple times
      per day arm) in two sites over a 4 to 8 week study period. The study period includes 2
      in-clinic sessions and scheduled, at-home game play of the short (less than 7 minutes)
      Project: EVO Monitor.
    

Intervention name(s): Project: EVO Monitor
Intervention type(s): Other
Intervention description(s): Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Medical Gas Humidification During Noninvasive Mechanical Ventilation
Condition: Respiration, Artificial; Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      In this study, the investigators aimed to study the role of medical gas humidification during
      noninvasive mechanical ventilation.
    

Detailed description: 
      The medical gases are usually dry and cold thus when they are used during invasive mechanical
      ventilation they must be conditioned. No data are present on the necessity to condition the
      medical gases during non invasive mechanical ventilation. In this study the investigators
      studied the humidity and the temperature of the medical gases with and without any
      conditioning during non invasive mechanical ventilation in a group of healthy subjects and
      critically ill patients.
    

Intervention name(s): MR730
Intervention type(s): Device
Intervention description(s): humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: temperature; humidity; non invasive mechanical ventilation
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Condition: Non-Hodgkin's Lymphoma; Lymphoma, Large Cell; Diffuse, Mantle Cell Lymphoma, Lymphoma; Follicular Lymphoma; Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of SyB L-0501 in combination with
      rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
    

Detailed description: 
      Primary Objective is to determine the efficacy, as measured by overall response rate on the
      basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m^2/day on
      day2 and 3 in combination with rituximab at 375 mg/m^2 on day 1 of each 21-day cycle in
      patients with relapsed/refractory diffuse large B-cell lymphoma.
    

Intervention name(s): SyB L-0501; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule.
SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation.; The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
Other intervention name(s): Bendamustine hydrochloride
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin's lymphoma; Lymphoma, Large B-Cell; Diffuse, Mantle cell lymphoma, Lymphoma; Follicular, Lymphoma; Large B-Cell, Diffuse
Procalcitonin Level and Kinetics in Children With Bacterial Infections
Condition: Bacterial Infections; Bacteremia; Meningitis; Urinary Tract Infection; Mastoiditis; Lobar Pneumonia; Septic Arthritis; Cellulitis; Osteomyelitis
MeSH terms: Infections; Communicable Diseases; Pneumonia; Urinary Tract Infections; Bacterial Infections; Bacteremia; Osteomyelitis; Cellulitis; Arthritis, Infectious; Mastoiditis; Meningitis
Study type: Observational

Summary: 
      The purposes of this study are:

        1. To determine whether procalcitonin level at admission of pediatric patients with
           bacterial infections can be used as a marker for prediction of defervescence and
           hospitalization length

        2. To examine the kinetics of procalcitonin in pediatric patients with bacterial infections
           and persistent fever
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hospitalized patients at date of admission
      
Biospecimen description: 
      whole blood
    
Keywords: UTI
Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Ths purpose of this study is to determine whether "near" activities enhance the effect of
      patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared
      with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in
      children 3 to <7 years old.
    

Detailed description: 
      The value of "near visual activities" while patching for amblyopia is controversial. Some
      pediatric eye care providers currently recommend that the child perform near visual tasks
      while wearing a patch over the sound eye, while other pediatric eye care providers do not
      prescribe any specific visual tasks to be performed while the patch is worn.

      In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye
      Disease Investigator Group, near visual activities were incorporated into the prescribed
      treatment regimes. Although different doses of patching, combined with near visual
      activities, were successful in improving visual acuity in most children, it is unclear
      whether concurrent near visual activities enhanced the effect of patching.

      This study is designed as an efficacy study, making effort to maximize adherence to treatment
      group assignments.

      The study has been designed as a simple trial that, other than the type of amblyopia therapy
      being determined through the randomization process, approximates standard clinical practice.
      The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily patching
      combined with near visual activities while patching and 2)2 hours of daily patching combined
      with distance visual activities while patching.
    

Intervention name(s): Eye Patch; Near activities; Distance activities
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): 2 hours daily patching; near visual activities while patching; distance visual activities while patching
Other intervention name(s): Coverlet, 3M Opticlude, Ortopad®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amblyopia; patching; visual activities
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
Condition: Rhinitis; Conjunctivitis; Asthma
MeSH terms: Rhinitis; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking
      factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ
    


Intervention name(s): subcutaneous immunotherapy
Intervention type(s): Biological
Intervention description(s): 7 injections
Other intervention name(s): AVANZ
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allergen immunotherapy; allergy to grass pollen
Pain in Single Incision Laparoscopic Surgery Cholecystectomy
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new
      techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision
      Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but
      there are not any publications to study a possible different pain score in new techniques
      versus classic laparoscopic cholecystectomy. In this randomized controlled study the
      researchers have investigated the pain scores, the incidence of nausea and vomiting and
      analgesics request after the procedure.
    


Intervention name(s): Laparoscopic Cholecystectomy; SILS
Intervention type(s): Procedure; Procedure
Intervention description(s): Four ports classic laparoscopic cholecystectomy; Single transumbilical incision laparoscopic cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: minimally invasive surgery; scarless cholecystectomy; new techniques in laparoscopy; invisible scar; single port access; abdominal pain; shoulder pain
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, single dose, open-label, three-treatment period crossover study in
      healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the
      level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.
    

Detailed description: 
      The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization
      Phase will have 2 periods: Screening and Baseline. The Randomization Phase will consist of
      three 6-day long Treatment Periods with each Treatment Period separated by a 1-day long
      Baseline. Sixty participants will be evenly randomized to 1 of 6 possible treatment sequences
      (A, B, C, D, E, or F). The 3 treatments vary by the level of crystalline polymorph Type-C
      present in the drug product batch used in each arm, respectively: Treatment 1 - low Type-C
      crystal level less than 12%; Treatment 2 - reference Type-C crystal level 12% to 26%; and
      Treatment 3 - high Type-C crystal level greater than 26%.
    

Intervention name(s): Lenvatinib 10 mg
Intervention type(s): Drug
Intervention description(s): Treatment 1: low Type-C crystal level <12%
Treatment 2: reference* Type-C crystal level 12% to 26%
Treatment 3: high Type-C crystal level >26%
Other intervention name(s): E7080;Lenvima
Intervention MeSH terms: Lenvatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lenvatinib; Healthy Volunteers; Lenvima; E7080
Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Condition: Attention Impairment
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil
      in children with persistent attention impairment that is present at least 12 months after the
      completion of cancer treatment.
    

Detailed description: 
      This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who
      have persistent attention impairment following treatment for cancer. This trial has three
      phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind,
      placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a
      12-week, blinded extension phase during which all subjects will receive active drug.
    

Intervention name(s): Donepezil hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.
During the Blinded Extension Phase, all subjects will receive active treatment (donepezil).; During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.
During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention; cancer; chemotherapy; donepezil; acetylcholinesterase; inhibitor
Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.
Condition: Endometrioma; Endometriosis; Surgery
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      This retrospective case-control study was performed in an Academic centre for the diagnosis
      and treatment of endometriosis. It included patients with recurrent unilateral endometriomas
      who were previously operated for the same condition (cases) and patients without recurrency
      who previously underwent surgery for unilateral endometrioma (controls). The primary outcome
      of the study was to assess the impact on ovarian reserve of second surgery for recurrent
      unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum
      anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta
      estradiol level and antral follicle count (AFC).
    


Intervention name(s): Anti-mullerian hormone (AMH) level dosage.; Follicle-stimulating hormone (FSH) level dosage.; Antral follicle count (AFC).
Intervention type(s): Other; Other; Other
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        In this study were recruited women referred to an academic centre for the diagnosis and
        treatment of endometriosis.

        Cases were patients undergoing second surgery for recurrent unilateral endometrioma.

        Controls were patients previously operated for unilateral endometrioma.
Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients
Condition: Obese
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      Upper airway obstruction (UAO) during induction of general anesthesia is a frequently
      occurring complication. The mechanism of UAO during anesthesia shares many similarities with
      the upper airway obstruction observed during obstructive sleep apnea (OSA). Obesity is major
      risk factors for OSA and obese patients have a higher prevalence of UAO during anesthesia.
      The change of body position improved upper airway stability during sleep in patients with
      OSA.We hypothesis that the 30˚ reverse trendelenburg body position maintain airway patency in
      obese patients during general anesthesia.
    

Detailed description: 
      This is a prospective, observational study. Fifteen subjects with BMI limited in the range of
      30 kg/m2 to 50 kg/m2, between 18-65 years of age meeting ASA physical status classification
      I-III requiring general anesthesia for elective surgery will be recruited from the main
      operating room of the Massachusetts General Hospital. We will start the recruiting process at
      least 12 hours ahead of the surgery at a pre-admission test area.

      The PI/Co-I who approaches a potential subject who has expressed interest will not be the
      anesthesiologist providing anesthesia care for the subjects. In addition the PI/Co-I
      approaching the patient will reinforce that she or he does not have to participate and that
      the decision not to participate will not affect their care at anytime.

      The Principal Investigator or Co-Investigator will participate in the informed consent
      process in operative holding area. Subjects to be recruited will be given a thorough review
      of the informed consent, as well as the study purpose and procedures, and its risks,
      discomforts, and potential benefits. When the subject is comfortable with and knowledgeable
      about the protocol, he or she will sign the consent form in the presence of the investigator.
      Investigator will also sign the informed consent form. All subjects will be given ample time
      to read the consent form and consider participating in the trial. Any complaint or problems
      related to our recruitment plan will report in real time to the IRB.
    

Intervention name(s): Head up
Intervention type(s): Procedure
Intervention description(s): 30˚ reverse trendelenburg body position
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fifteen patients with BMI limited in the range of 30 kg/ m2 to 50 kg/ m2, between 18-65
        years of age meeting ASA physical status classification I-III requiring general anesthesia
        for elective surgery
      
Keywords: Obese patients; Upper airway patency
The Aortic Valve DECalcification (AVADEC) Trial
Condition: Aortic Valve Stenosis; Multidetector Computed Tomography; Vitamin K 2; Randomised Clinical Trial
MeSH terms: Aortic Valve Stenosis
Study type: Interventional

Summary: 
      Aortic stenosis is a common heart valve disease and due to the growing elderly population the
      prevalence is increasing. The disease is progressive with increasing calcification of the
      valve cusps. A few attempts with medical preventive treatment have failed, thus presently the
      only effective treatment of aortic stenosis is surgery. This study will examine the effect of
      menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). The
      investigators hypothesize that MK-7 supplementation will slow down the calcification process.
    


Intervention name(s): Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Half of the patients are randomized to supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day).; Half of the patients are randomized to placebo treatment (no active treatment).
Intervention MeSH terms: Vitamin D; Vitamin K 2; Vitamin K; Menaquinone 7
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:1 after stratiﬁcation for site, AVC score (300-599 or ≥600) and statin-use. Each site will be provided with sequentially numbered, opaque and sealed envelopes containing randomly generated treatment allocations. Four different types of envelopes are provided; 1) AVC 300-599, no statin-use; 2) AVC 300-599, statin-use; 3) AVC ≥600, no statin-use; and 4) AVC ≥600, statin-use.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Essure Transvaginal Ultrasound (TVU) Study
Condition: Contraceptive Usage
Study type: Interventional
Phase: Phase 4

Summary: 
      The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first
      permanent birth control method that can be performed in the comfort of a physician's office
      without hormones, cutting, burning or the risks associated with general anesthesia or tubal
      ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix
      without incisions. Over the next three months, the body forms a natural barrier around the
      micro-inserts to prevent sperm from reaching the egg. Three months after the Essure
      procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is
      called a hysterosalpingogram and evaluates the location of the inserts and whether the
      fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to
      evaluate the location of the inserts.

      The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective
      method of confirming micro-insert location.
    

Detailed description: 
      This study has previously been posted by Conceptus, Inc. (USA).

      After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
    

Intervention name(s): TVU
Intervention type(s): Device
Intervention description(s): Use of transvaginal ultrasound to determine location of micro-insert
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment