bioihbjkbjnl/mcl2 huggingface dataset:
MISA to NRDS：a Multicenter Study in China
Condition: Bronchopulmonary Dysplasia; Patent Ductus Arteriosus; Intraventricular Hemorrhage; Necrotizing Enterocolitis; Periventricular Leukomalacia
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Bronchopulmonary Dysplasia; Leukomalacia, Periventricular; Ductus Arteriosus, Patent; Hemorrhage
Study type: Interventional

Summary: 
      BACKGROUND Treatment of neonatal respiratory distress syndrome with exogenous surfactant and
      mechanical ventilation made millions of preterm infants survived in neonatal intensive care
      unit (NICU). Endotracheal intubation surfactant administration is related to invasive
      intubation and short periods of positive pressure ventilation and implies the risk of lung
      injury. Continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure
      ventilation) with surfactant but without intubation may work synergistically. This randomized
      trial investigated a minimal invasive surfactant administration (MISA). To test the
      hypothesis that MISA increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks'
      gestational age in very low birth weight infants.

      DESIGN, SETTING, AND PARTICIPANTS The Minimal Invasive Surfactant Administration (MISA) was a
      multicenter, randomized, clinical, parallel-group study conducted between July 1st, 2017, and
      November 30, 2018, in 8 level III neonatal intensive care units in Beijing, Tianjin, and
      Hebei province, China. The final follow-up date was March 30, 2019. Participants enrolled
      spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age
      with signs of respiratory distress syndrome. In an intention-to-treat design, infants were
      randomly assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane
      Pharmaceutical Co., China) either via a 5Fr nasogastric tube during CPAP/NIPPV-assisted
      spontaneous breathing (minimal invasive surfactant administration group, MISA group) or after
      conventional endotracheal intubation during mechanical ventilation (endotracheal intubation
      surfactant administration group, EISA group).

      INTERVENTION MISA via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps.
    


Intervention name(s): Minimal Invasive surfactant administration
Intervention type(s): Procedure
Intervention description(s): Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. Preterm infants of the MISA (Minimal invasive surfactant administration) group were assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps during CPAP/NIPPV-assisted spontaneous breathing.
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, clinical, parallel-group study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The primary goal of the study is to see if the PET/CT will be able to determine the precise
      location of the Y-90 particles within the liver and within the tumors. We hope to use this
      information in order to see if these particles distribute evenly throughout large tumors or
      if the particles go into the tumor which is located in the portal vein.

      The secondary goals are threefold. First correlate the distribution of Y90 particles (as
      demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a
      difference in the Y90 particle's distribution when a low particle load (1-3 million
      particles) is used compared to when a high particle load (6-8 million particles) is used.
      Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being
      used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production
      PET research imaging.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients (18-85 years old), who have hepatocellular carcinoma with tumors that are greater
        than 5 cm or have tumor-associated portal vein thrombosis. The patients are currently
        undergoing treatment with Yttrium-90 Radioembolization, as part of their clinical care.
      
Keywords: PET, Yttrium-90
HIV Persistence and Viral Reservoirs
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it
      does not to completely restore health. Patients doing well on otherwise effective HAART
      remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other
      "non-AIDS-defining" events. While complete eradication may never be feasible, a "functional
      cure" in which patients are able to maintain undetectable viral loads indefinitely without
      therapy may be possible. The best evidence for this are the so-called "elite" controllers,
      whom we define as individuals who are HIV-seropositive, with plasma HIV RNA levels below the
      level of conventional detection without treatment. Controllers may be conceptualized as a
      naturally occurring model of a functional cure (or "HIV remission"), and are ideal patients
      in which to study HIV persistence and the possibility of eradication.

      We propose to conduct a pilot study to better characterize the reservoirs that lead to viral
      persistence in a group of well-characterized controllers. We propose two specific aims: 1) to
      characterize the dynamics of viral production in blood and gut-associated lymphoid tissue
      (GALT) in controllers; and 2) to prospectively treat 10 controllers with raltegravir,
      tenofovir/emtricitabine for 24 weeks and study the effects of HAART on viral dynamics and
      host inflammatory responses.

      Our primary hypotheses are: 1) viral replication is ongoing in untreated controllers, 2)
      HAART will reduce viral replication in blood and GALT and decrease immune activation, and 3)
      higher levels of immune activation are associated with greater measures of microbial
      translocation and distribution of virus to more differentiated T cell subsets.
    


Intervention name(s): Raltegravir, tenofovir/emtricitabine
Intervention type(s): Drug
Intervention description(s): 16 controllers will be treated with open-label raltegravir/tenofovir/emtricitabine for 24 weeks.
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; HIV persistence; HIV reservoirs
Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
Condition: Skin Aging; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if dietary consumption of Revival Soy can improve
      the appearance of the skin, hair, and finger nails and support weight loss in overweight,
      premenopausal women.
    

Detailed description: 
      The researchers hypothesize that supplementation of Revival® Soy products to overweight
      premenopausal women as part of a soy-based meal replacement diet plan will:

        -  Improve the health and appearance of the skin by normalizing skin pigmentation and
           reducing wrinkles,

        -  Improve the health and appearance of hair by enhancing sheen and ease of combing, and

        -  Improve the health and appearance of nails by enhancing shine, flexibility, and
           strength.

        -  Stimulate a loss in weight and a reduction in the Body Mass Index (BMI),

      For this study, obese (BMI = 30-40 kg/m2) premenopausal women (25-45 years of age) with mild
      to moderate photoaging (n=40) will receive either a Revival® soy shake (20 grams soy protein
      with 160 mg total isoflavones; n=20) or a placebo shake (20 grams of milk protein with 0 mg
      isoflavones; n=20) daily for 6 months. The subjects will be asked to come into the office for
      a total of seven visits, at baseline and at monthly intervals for 6 months. At baseline,
      month 3, and month 6, the subjects will be asked to complete a questionnaire in order to
      provide self-reported improvements related to hair, skin, and nail health. Following
      completion of the questionnaire, the investigator and the dermatology clinic staff will
      examine the subjects to assess the health and appearance of their skin, hair, and nails at
      baseline, month 3, and month 6.

      After acceptance into the study, a registered dietitian will instruct the study subjects in
      the use of a low-energy (1,200 - 1,500 kcal/day) diet that incorporates 2 soy-based daily
      meal replacements (shakes, ~500 kcal), a minimum of 5 daily servings of fruits and vegetables
      (~300 kcal), and one entrée (~400 - 500 kcal). Subjects will be required to keep a dietary
      food intake record of all food and supplement use during the trial. Anthropometric data
      (height, body weight, waist circumference and hip circumference) will be collected at
      baseline and at monthly intervals.
    

Intervention name(s): Revival Soy Dietary Supplement
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Soy; Dermatology; Skin; Hair; Finger Nails; Weight Loss; Body Mass Index; Photoaging of Skin; Skin Wrinkling
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy
Condition: Macular Retinoschisis; Macular Detachment; Normal Tension Glaucoma
MeSH terms: Optic Nerve Diseases; Low Tension Glaucoma; Retinoschisis; Dissociative Disorders
Study type: Observational

Summary: 
      Clinical features, optical coherence tomography findings and surgical outcome in eyes with
      macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit
      or high myopia were evaluated.
    


Intervention name(s): Optical coherence tomography
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients with macular retinoschisis and detachment associated with normal tension
        glaucoma
      
Keywords: Macular retinoschisis; Macular detachment; vitrectomy
Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability
Condition: Scapholunate Interosseous Ligament; Torn Wrist Ligaments
Study type: Observational

Summary: 
      Damage to the ligaments of the wrist occurs frequently, however, it is not well publicized or
      understood. Our previous and current biomechanical studies have shown that damage to certain
      wrist ligaments is the likely cause of wrist instability and pain. Based on our three
      dimensional models and animations of actual cadaver motions with various ligaments intact or
      sectioned, we have identified several changes in how the carpal bones move and are positioned
      relative to the radius with various levels of instability. Using this information, we have
      developed a mathematical model that can predict in cadaver wrists which groups of ligaments
      have been injured. We started, under IRB approval, a prospective clinical study to evaluate
      the reliability of this mathematical model. During the past 5 years we have studied 13
      patients with suspected wrist ligament injuries who were previously scheduled for surgical
      treatment. CT scans have been performed of the injured wrist and for comparison purposes, the
      contralateral, uninjured wrist. During these 5 years, there were no problems with the conduct
      of the study. During these 5 years the only changes to the original study application were

        -  a) to include a CT scan of the contralateral wrist for comparison purposes

        -  b) a paper handout given to potential subjects

        -  c) to add additional people to the study team.

      The principal investigator, blinded to the results of the CT scan, surgically explores and
      treats these patients in the same manner that he would for any patient with suspected wrist
      ligament injuries. During the surgery, the investigator determines the integrity of the
      various wrist ligaments. The prediction of which ligaments are damaged, based upon the CT
      scan information and mathematical model is compared to the actual surgical findings. The
      importance of this study is to develop a tool that will allow one to rapidly and non
      invasively diagnose wrist instability and initiate treatment before further damage is done.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have suffered ligamentous injuries to their wrists will be recruited for this
        study
      
Keywords: scapholunate instability; neural networks; scaphoid; lunate; Suspected torn scapholunate interosseous ligament; Suspected other torn wrist ligaments
Fruit and Vegetable Intake Promotion. "The UVa Community Eats Healthy" Study Protocol (University of Valladolid)
Condition: Fruit and Vegetable Consumption
Study type: Interventional

Summary: 
      The goal of this randomized controlled trial is to increase the consumption of fruit and
      vegetables of the University of Valladolid (UVa) community employing three different online
      methodologies: facebook (FB), virtual campus (VC) and, instagram (IG).
    

Detailed description: 
      In order to use different methodologies, the sample was randomly divided in four groups,
      three took the nutrition educational program and the other one was a control group.

      All four groups had access to the virtual campus of the UVa which uses the teaching platform
      Moodle Learning Management System (LMS). In this platform, a course entitled "The UVa
      community eats healthy" was created with four sections. Each of the sections corresponded to
      one of the four groups, the names of the sections were: I-campus (VC group), C-campus
      (control group), F-campus (FB group), and G-campus (IG group).

      To make the intervention more effective, this program was theory-based designed, based on the
      theory of planned behaviour (TPB).

      In order to assess the effectivity of social media use for nutrition education compared to
      more traditional interventions, the program was adapted to three platforms: virtual campus,
      private account of IG and private group of FB. The topics of the intervention groups were the
      same but with adapted activities.
    

Intervention name(s): Increase of fruit and vegetable consumption
Intervention type(s): Behavioral
Intervention description(s): Week 1 Presentation of the program. Healthy eating Week 2 Fruit and vegetable: nutritional value, types, seasonality, benefits for health Week 3 Shopping Fruit and vegetable: tips, places, conservation methods Week 4 Healthy menu planning with "My Plate" Week 5 How to cook Fruit and Vegetable avoiding food waste Week 6 Healthy snacks using Fruit and vegetable Week 7 Batch cooking
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy
Condition: Macular Disease
Study type: Observational

Summary: 
      We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with
      idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings
      will affect postoperative visual outcome.
    

Detailed description: 
      We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with
      idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings
      will affect postoperative visual outcome.
    

Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The eyes with macular hole or lamellar macular hole
      
Keywords: macular hole; lamellar macular hole
A Study of Soticlestat Tablets in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim is to see how soticlestat tablets of different strengths work and to compare how
      it works alone in contrast to administration along with food.

      In the study will be 2 groups of participants (part A and part B). Participants in part A
      will receive 300 mg of soticlestat administered in different kind of tablets (regular
      tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg
      of soticlestat in tablets but with food and crushed tablets with applesauce.

      Participants will complete several assessments including clinical laboratory evaluations,
      physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment,
      electrocardiographs (ECGs), and vital signs.
    

Detailed description: 
      The drug being tested in this study is called soticlestat (TAK-935). The study will assess
      the bioequivalence, effect of food and tablet crushing, safety and tolerability following
      single oral dose of 3 different soticlestat oral tablet formulations in healthy participants.

      The study will enroll approximately 96 participants. This study will be conducted in two
      parts (Part A and Part B) having 6 treatment sequences each. Participants will be randomly
      assigned (by chance, like flipping a coin) to one of the study parts as per treatment
      sequence:

        -  Part A, Sequence 1: Treatment B + Treatment A + Treatment C

        -  Part A, Sequence 2: Treatment A + Treatment C + Treatment B

        -  Part A, Sequence 3: Treatment C + Treatment B + Treatment A

        -  Part A, Sequence 4: Treatment B + Treatment C + Treatment A

        -  Part A, Sequence 5: Treatment A + Treatment B + Treatment C

        -  Part A, Sequence 6: Treatment C + Treatment A + Treatment B

        -  Part B, Sequence 1: Treatment E + Treatment D + Treatment F

        -  Part B, Sequence 2: Treatment D + Treatment F + Treatment E

        -  Part B, Sequence 3: Treatment F + Treatment E + Treatment D

        -  Part B, Sequence 4: Treatment E + Treatment F + Treatment D

        -  Part B, Sequence 5: Treatment D + Treatment E + Treatment F

        -  Part B, Sequence 6: Treatment F + Treatment D + Treatment E

      This single center trial will be conducted in the United States. The overall duration of the
      study is approximately 51 days. Participants will be followed up for 14 days after the last
      dose of study drug for a follow-up assessment.
    

Intervention name(s): Soticlestat; Soticlestat; Soticlestat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Soticlestat T4 tablets.; Soticlestat T3 mini-tablets.; Soticlestat commercial tablets.
Other intervention name(s): TAK-935; TAK-935; TAK-935
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Fetoscopic Open Spina Bifida Repair Using the SAFER Technique
Condition: Open Spina Bifida; Myelomeningocele; Meningomyelocele; Chiari Malformation With Spina Bifida; Chiari Malformation Type 2
MeSH terms: Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica; Arnold-Chiari Malformation; Congenital Abnormalities
Study type: Observational

Summary: 
      Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER
      (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate at 30
      months or more, regarding ambulation, neurodevelopment, urinary and fecal status.
    

Detailed description: 
      Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER
      (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate the
      neuropsicomotor development at 30 months of chronological age. The mental evaluation will use
      the Bayley III and thePEDI neurodevelopmental scale. The motor development will use the
      difference between anatomic and motor level of the lesion. Urinary and fecal continence will
      be evaluated using clinical and ultrasonographic parameters. For the anatomical level
      determination, immaging of the spine at the lesion level will be used. Motor level and
      ambulation will be evaluated through standard clinical examination.
    

Intervention name(s): Neuropsicomotor developmental test
Intervention type(s): Other
Intervention description(s): Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children submitted to prenatal repair of open spina bifida using the fetoscopic
        percutaneous repair technique - SAFER
      
Keywords: myelomeningocele; spina bifida; meningomyelocele; fetal surgery; fetoscopy; fetal disease; fetal treatment
Acupuncture and Auditory Evoked Potentials
Condition: Evoked Potentials; Healthy Volunteers
Study type: Interventional

Summary: 
      To investigate whether body acupuncture of acupuncture points specific for hearing influences
      the auditory avoked potentials in comparison to puncture of non-specific acupuncture points
    


Intervention name(s): Acupuncture
Intervention type(s): Behavioral
Intervention description(s): Body acupuncture of 1 specific point per trial session
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science