bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis
Condition: Thyrotoxicosis; Graves Disease; Thyroiditis
MeSH terms: Graves Disease; Thyroiditis; Thyrotoxicosis
Study type: Observational

Summary: 
      The study is a single-center prospective cohort study of clinical application of continuously
      monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose
      of the study is to evaluate the association between parameters of pulse rate, activity, and
      sleep from wearable activity trackers and the thyrotoxic status along with the treatment.
    

Detailed description: 
      Activity trackers to be used: Fitbit Charge HR (TM)

      Data which ware provided by Fitbit app (TM) will be analyzed in this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults (20 to 60 years) undergoing newly developed or recurrent thyrotoxicosis who can use
        wearable activity trackers and smartphone applications
      
Keywords: wearable activity tracker; thyrotoxicosis
Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles
Condition: Pregnancy
Study type: Observational

Summary: 
      This study aims to investigate the impact of serum progesterone concentrations on the day of
      embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary
      outcomes, the investigators will investigate if endometrial volume measured by
      three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone
      levels and with chances of pregnancy.
    


Intervention name(s): Progesterone 25-75; Progesterone <25, >75
Intervention type(s): Other; Other
Intervention description(s): Impact of serum progesterone concentrations [25-75] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy; Impact of serum progesterone concentrations (<25, >75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy
Intervention MeSH terms: Progesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile patients undergoing their first or second egg donation cycle
      
Biospecimen description: 
      Blood sample
Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
Condition: Pediatric Urinary Disorders
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation
      induction.
    


Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): intravenous propofol with sevoflurane inhalation induction
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Condition: Tinea Capitis
MeSH terms: Tinea; Tinea Capitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily
      in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules
      and pruritus are the primary clinical signs which can be associated with tinea capitis. The
      infection is caused by a relatively small group of dermatophytes in the genera Trichophyton
      and Microsporum.

      Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study
      will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
    


Intervention name(s): Terbinafine hydrochloride (HCl); Griseofulvin
Intervention type(s): Drug; Drug
Intervention description(s): Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration; Griseofulvin pediatric suspension o.d. administration
Other intervention name(s): Lamisil; Grilfulvin V
Intervention MeSH terms: Terbinafine; Griseofulvin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Terbinafine, Tinea capitis, pediatric, antifungal
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Condition: Acute Otitis Media; Otitis Media; Ear Infection
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this pilot study is to evaluate the efficacy of treatment with montelukast
      as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
    

Detailed description: 
      Otitis media (OM) is one of the most common childhood disorders requiring physician care and
      has been associated with an alarming rise in prevalence. Certain children are prone to
      recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis
      media with effusion (COME). Because medical therapy with antibiotics, antihistamines,
      decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is
      surgical intervention, which is quite expensive and exposes patients to risks of general
      anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with
      montelukast as compared to placebo in the prevention of recurrence of acute Otitis media
      (AOM)
    

Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ear Infections; Otitis Media
Estimating and Predicting Hemodynamic Changes During Hemodialysis
Condition: Hemodialysis
Study type: Observational

Summary: 
      Machine learning techniques and algorithms originally developed for use in the field of
      robotics can be applied to continuous, noninvasive physiological waveform data to discover
      hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) estimate
      acute blood loss volume, 2) monitor and estimate fluid resuscitation needs, 3) predict
      cardiovascular collapse well ahead of any clinically significant changes in standard vital
      signs, and 4) estimate intracranial pressure. We hypothesize that these same methods can be
      used to monitor volume loss during hemodialysis, as well as predict intradialytic
      hypotension, well before it occurs.
    

Detailed description: 
      1. Collect physiological waveform data from patients undergoing hemodialysis at the
           University of Colorado Hospital, Children's Hospital Colorado, and Fresenius Medical
           Centers using non-invasive monitoring techniques.

        2. Combine the physiological data from patient monitors with clinical and demographic data,
           including age, gender, race, problem list, reason for dialysis, estimated dry weight,
           volume removed, arterial and venous pressures, etc. for use in developing mathematical
           models of hemodialysis.

        3. Develop robust, real-time, computational models for:

             -  estimating acute intravascular volume loss during hemodialysis

             -  predicting an optimal, individual specific, intravascular volume to be removed
                during a hemodialysis session

             -  predicting intradialytic hypotension

        4. Determine:

             -  which non-invasive signals are relevant to each model type

             -  which features extracted from these signals are relevant

             -  which algorithms are capable of using the extracted features for each decision type
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult and pediatric patients undergoing hemodialysis at Fresenius Medical Centers,
        University of Colorado Hospital or Children's Hospital Colorado will be the population base
        for enrollment in this study. Patients may have acute kidney injury or end stage renal
        disease. Subjects may be inpatients or outpatients.
      
Keywords: Hemodialysis; Hemodynamics
Treadmill Training and Orthotic Use in Infants With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study determines the effect of orthotic use in combination with treadmill training on
      the development of gross motor skills and walking onset in infants with Down syndrome.
    

Detailed description: 
      The goal of this study is to determine if orthotic use impacts the development of walking and
      upright play skills over and above the impact that treadmill training alone has. Infants with
      Down syndrome who can pull to stand but not walk will be recruited and assigned to a group
      that receives treadmill training and orthoses or just treadmill training. The infants are
      followed monthly until they have one month of walking experience. During the monthly visits,
      the infants' gross motor development is tested and their upright play behavior is observed.
      At the end of the study each infants gait is evaluated. We believe that the orthoses will
      lead to a decreased age at walking onset, an improvement in gait patterns, and an improvement
      in upright play ability.
    

Intervention name(s): Treadmill Training; Supramalleolar Orthoses
Intervention type(s): Behavioral; Device
Intervention description(s): Parents hold their infants on an infant treadmill for 8 minutes a day, 5 days a week. The treadmill speed is set at 0.2 m/s.; In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.
Other intervention name(s): Orthoses; Orthotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Down syndrome; Gait; Motor Development; Orthoses
The Effects of Rye Crisp Bread on Appetite and Metabolic Function
Condition: Appetite Regulation
Study type: Interventional

Summary: 
      The aim of this study is to contribute to a better understanding of how dietary fibre in rye
      affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads
      affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We
      will also investigate microstructural properties of the crisp breads with microscopy, as well
      as to characterize the food products with respect to the content of dietary fibre and certain
      bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are
      related to changes in insulin and glucose levels, appetite related hormonal signals and
      microstructural properties to verify findings from previous studies.
    

Detailed description: 
      The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective
      appetite and metabolism will be evaluated using a randomized cross-over study design. Each
      participant will consume three different breakfasts consisting of two different rye crisp
      breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out
      period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by
      using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min
      before breakfast. Blood samples will be collected before breakfast and at regular intervals
      throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate
      will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will
      be related to subjective appetite and to differences in composition of the breakfasts.
    

Intervention name(s): Rye crisp bread A; Rye crisp bread B; Wheat crisp bread C
Intervention type(s): Other; Other; Other
Intervention description(s): In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.; In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.; In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Rye; Dietary Fibre; Bread; Crisp bread; Appetite; Satiety; Hunger; Desire to eat; Metabolism; Glucose; Insulin; Gut hormones; Gastric emptying rate
Immunogenicity and Safety Evaluation of QIS in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the antibody response to each of the four influenza
      vaccine strains included in the study vaccine, as measured by hemagglutination inhibition
      (HAI) at 4 weeks after the last dose of the study vaccine in young subjects aged between 3
      years old and 17 years old.
    


Intervention name(s): AdimFlu-S (QIS)
Intervention type(s): Biological
Intervention description(s): This was an open study to demonstrate the use of AdimFlu-S (QIS) (2016-2017 season) vaccine in young subjects aged between 3 years old to 17 years old. All subjects were divided into two subgroups. That were subjects aged 3 to 8 years old, who received 2 doses of 0.5 mL vaccine separated by 4 weeks, and subjects aged 9 to 17 years old, who received one dose of 0.5 mL vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza Vaccine; Immunogenicity
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa
      may interfere with the growth of cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon
      alfa in treating patients who have metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response in patients with metastatic renal cell carcinoma treated with
           tretinoin liposome and interferon alfa-2b.

        -  Determine the toxicity of this regimen in these patients.

        -  Study retinoic acid receptor expression on tissue obtained from selected patients who
           have tumor biopsies.

      OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual
      dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.)

      Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b
      subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in
      the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum
      tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at
      which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined
      additional patients are accrued and treated at that dose. (Phase I closed to accrual as of
      9/24/03.)

      During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose
      escalations. After week 3, patients continue at the highest acceptable dose level of
      interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.)

      Patients are followed at 30 days after the last treatment.

      PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this
      study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued
      into the phase II portion of this study.
    

Intervention name(s): recombinant interferon alfa; tretinoin liposome
Intervention type(s): Biological; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Tretinoin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; recurrent renal cell cancer
PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Condition: Care Giver; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm
MeSH terms: Neoplasms; Recurrence
Study type: Interventional

Summary: 
      This trial studies how well a web-based legacy intervention works in improving the quality of
      life in caregivers and younger patients with cancer that has come back (recurrent) or does
      not respond to treatment (refractory). Legacy-making, defined as doing or saying something to
      be remembered, may reduce the suffering of children with cancer and their caregivers.
      Currently, there is little information about what kinds of legacy-making activities are
      helpful from the perspective of children. Using a web-based digital storytelling
      intervention, this study may help researchers examine what children think about these
      legacy-making activities and what kinds of activities might be helpful to them.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To examine the impact of legacy-making on coping strategies and adjustment outcomes among
      children with refractory or relapsed cancer.

      II. To examine the impact of legacy-making on coping strategies and adjustment outcomes among
      parent caregivers.

      III. To examine the process of implementing a web-based legacy-making intervention for
      children with refractory or relapsed cancer and their parent caregivers by obtaining parent
      self-reports (e.g., What did you and your child-like/not like about the intervention? How
      difficult was it to complete the intervention? What made it difficult? What else you would
      like to teach us?).

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I: Patients participate in a web-based legacy intervention by answering questions about
      themselves and uploading videos, photographs, and music to create a digital story within 2
      weeks.

      GROUP II: Patients receive standard of care. Patients have the option to participate in the
      web-based legacy intervention after 2 months.
    

Intervention name(s): Internet-Based Intervention; Best Practice; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Complete web-based legacy intervention; Receive standard of care; Ancillary studies; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Intrathecal Dexamethasone and Labor Analgesia
Condition: Effects of; Anesthesia, in Labor and Delivery
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in
      combined spinal epidural (CSE) analgesia during vaginal delivery.
    

Detailed description: 
      This prospective double-blind trial included 80 primigravidas during vaginal delivery with a
      cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups;
      Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal
      levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of
      analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the
      epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The
      primary outcome measure was the duration of spinal analgesia. Secondary outcome measures
      include time from spinal analgesia to delivery, total amount of epidurally administered
      levobupivicaine, adverse effects of neuraxial block and neonatal outcome.
    

Intervention name(s): Dexamethasone; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg; levobupivacaine 2.5 mg
Other intervention name(s): decadron; chirocaine
Intervention MeSH terms: Dexamethasone; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
Condition: Minimally Invasive Surgery
Study type: Observational

Summary: 
      Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning
      curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy
      procedure should be contrasted with the open procedure.
    

Detailed description: 
      Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic
      oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The
      Second Hospital of Shandong University. Eight of these 214 patients were converted to
      thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to
      a history of left upper lobectomy, and the other seven patients were due to bleeding
      controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE
      group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014
      to August 2016, and these patients were defined as the open group. The data from the patients
      in the open group were compared with those of the patients who underwent
      thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were
      preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine
      thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography
      to evaluate the clinical TNM stage. The operations were performed by a single surgical team.
      This study was approved by the ethics committee and Medical Administration Division of the
      Second Hospital of Shandong University. Written informed consent was obtained from each of
      the enrolled patients. All methods performed in the investigator's study were conducted in
      accordance with the relevant guidelines and regulations.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy.