bioihbjkbjnl/mcl2 huggingface dataset:
Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
Condition: Obesity; Bariatric Surgery
MeSH terms: Obesity
Study type: Observational

Summary: 
      This study aimed to examine the effects of obesity and bariatric surgery on gut microbiota in
      a Turkish population, and to contribute to the literature by bringing multi-dimensional
      parameters including dietary intake, metabolic and inflammatory markers. This case-control
      study was conducted between June 2015 and August 2019. All participants were followed during
      the six-month period. Face-to-face interviews and physical examinations were held, and blood
      and fecal samples were collected at the baseline (M0) and at the end of 3 (M3) and 6 months
      (M6). Dietary intakes of subjects were assessed using 24-h dietary recall method in each
      interview and a detailed quantitative food frequency questionnaire that involved 85 food
      items. Subjects were recruited to the study as three groups: 15 patients who had bariatric
      surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as
      control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as
      control group-2. All subjects in the study group had sleeve gastrectomy. Subjects in control
      groups were selected as age and gender matched with the participants in the study group.
      Individuals were excluded if (a) they were under 19 or above 65 years old, (b) they had an
      acute or chronic inflammatory disease, (c) they were diagnosed with infectious diseases,
      cancer or alcohol addiction, (d) they used antibiotics in last 3 months before the screening.
    


Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): A procedure for morbidly obese patients whose body mass index (BMI) is higher than 40 kg/m2 or 35 kg/m2 and having comorbidities of obesity.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery
        as study group, 8 morbidly obese participants who did not have bariatric surgery as control
        group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control
        group-2.
      
Keywords: obesity; bariatric surgery; gut microbiome; diet
Efficacy and Safety of Burosumab (KRN23) Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)
Condition: X-Linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in
      improving rickets in children with XLH compared with active control (oral phosphate/active
      vitamin D).
    


Intervention name(s): burosumab; Oral Phosphate Supplement; active vitamin D
Intervention type(s): Biological; Drug; Drug
Intervention description(s): solution for subcutaneous (SC) injection; oral tablet; oral solution; oral powder; tablet, oral solution
Other intervention name(s): KRN23; Crysvita ®; UX023
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ketogenic Diet for Refractory Status Epilepticus
Condition: Status Epilepticus; Seizure; Epilepsy; Refractory Status Epilepticus; Medically Resistant Status Epilepticus
MeSH terms: Epilepsy; Seizures; Status Epilepticus
Study type: Interventional

Summary: 
      This research is being done to observe the safety, tolerability, side effects, and
      effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus)
      being treated in a neurointensive care unit.
    


Intervention name(s): Ketogenic diet
Intervention type(s): Dietary Supplement
Intervention description(s): 4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
Other intervention name(s): KetoCal 4:1 liquid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: status epilepticus; seizure; epilepsy; ketogenic diet; modified Atkins diet
Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect, pharmacokinetics and dose
      proportionality of buprenorphine when administered to non-dependent opiate users. 1) To
      evaluate whether plasma concentrations of buprenorphine increase proportionally to
      buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects
      of buprenorphine; and 3) To determine the safety of buprenorphine.
    

Detailed description: 
      This will be an open-label, single dose-escalation trial. A total of 24 opiate experienced,
      but not dependent subjects will receive four ascending doses of buprenorphine, 4, 8, 16, and
      24 mg, respectively, with an at least a 14 day washout interval between treatments. The four
      treatments are sublingual administration of:

        1. two 2-mg buprenorphine sublingual tablets,

        2. one 8-mg buprenorphine sublingual tablet,

        3. two 8-mg buprenorphine sublingual tablets; and

        4. three 8-mg buprenorphine sublingual tablets.

      The dose proportionality in plasma profiles of buprenorphine and dose response of the
      buprenorphine sublingual tablets are evaluated at buprenorphine dose range of 4 to 24 mg.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: opiate dependence
Intranasal Oxytocin for the Treatment of Children and Adolescents With ASD (OXY)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      Extensive data has been accumulated to suggest that central release of oxytocin is important
      for social cognition and function, as well as likely involved in anxiety modulation and
      repetitive behaviors. The principal investigators of this study have previously documented:
      1) an association between Autism Spectrum Disorder and a single nuclear polymorphism of the
      oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme
      immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in
      the treatment of social deficits and repetitive behaviors in adults with autism. A medication
      treatment targeting the core deficits of Autism Spectrum Disorder in childhood is highly
      valuable because it could influence the developmental trajectory and make further
      psychosocial interventions possible. In this context, we propose a small dose finding study
      to confirm that the dose used in the adult study is not more than the maximum tolerated dose
      in youth. '
    


Intervention name(s): Intranasal Oxytocin
Intervention type(s): Drug
Intervention description(s): We are selecting morning and afternoon dosing to try to influence most hours where youth are in settings with increased potential for social interaction (school, after school). Medication will be administered by the parents before school and early afternoon. All patients will receive their first dose by the study physician to educate parents and themselves on proper administration and determine safety of first dose.
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum disorder; Oxytocin; Clinical Trial; Children; Pharmacology
Treatment of Oral Premalignant Lesions With 5-ALA PDT
Condition: Leukoplakia; Erythroplakia
MeSH terms: Precancerous Conditions; Leukoplakia; Erythroplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if
      not treated. There is no good treatment for these lesions, apart from surgery which is
      associated with significant side effects and physical deformation of the treated area.

      The investigators hypothesized that photodynamic therapy can be used safely and effectively
      to induce significant regression of oral leukoplakia.
    

Detailed description: 
      This is a combined Phase I/II non-randomized prospective study designed to determine the
      safety and assess the clinical efficacy of PDT in the treatment of oral leukeplekia with
      5-ALA and 585-nm PDL with 1.5 ms pulse time. In the first part of the study we determined the
      maximum tolerated dose (MTD) of the PDL radiant exposure in combination with 5-ALA. In the
      second phase of the study, this dose is used to treat subjects at the MTD in order to
      determine the efficacy of the treatment by documenting the regression of the treated lesions.
    

Intervention name(s): PDL-585, ScleroPLUS laser; 5-Aminolevulinic Acid (Levulan KerastickTM); Fluorescence Diagnosis Imaging
Intervention type(s): Device; Drug; Procedure
Intervention description(s): PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue; Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze; FD Image taken prior to PDL-585 usage
Other intervention name(s): 5-ALA
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      The study is to compare the performance of a CPAP (continuous positive airway pressure)
      device to a clinical polysomnography (PSG) in identifying breathing events in patients with
      obstructive sleep apnea.
    

Detailed description: 
      Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with
      manually scored events on PSG. The PAP device was modified to produce a square wave voltage
      output identifying when apneas, hypopneas, and snoring events were detected. Recording this
      event signal on the PSG performed with the patient using the PAP device allowed an
      event-by-event comparison between manually scored PSG events and AED events. In addition, the
      AHI, AI, and HI derived from the manually scored PSG were compared with the respective
      measures reported by the PAP device used during the PSG.

      Study Objectives: Compare automatic event detection (AED) of respiratory events using a
      positive airway pressure (PAP) device with manual scoring of polysomnography (PSG) during PAP
      treatment of obstructive sleep apnea (OSA).

      Design: Prospective PSGs of patients using a PAP device.

      Setting: Six academic and private sleep disorders centers.

      Interventions: A signal generated by the PAP device identifying the AED of respiratory events
      based on airflow was recorded during PSG.
    

Intervention name(s): Analysis with AED and manual PSG scoring
Intervention type(s): Device
Intervention description(s): The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.
Intervention model: Single Group Assignment
Intervention model description: Participants wore a PAP device and had a PSG at the same time. These participants had their PSG data compared to the PAP data.
Masking: None (Open Label)
Primary purpose: Diagnostic
The Detection of Circulating Tumor Cells (CTCs) in Patients With Liver Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Condition: Neoplastic Cells, Circulating
MeSH terms: Liver Neoplasms; Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      liver cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers. In view of these facts, the
      investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting
      human tumor cells of liver cancer in normal peripheral blood after cryosurgery with or
      without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators
      also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)
      method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with liver cancer and healthy volunteers. The blood of the healthy volunteers will be used to
      evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage liver cancer come to Fuda Hospital for treatment.
      
Keywords: Liver Neoplasms; Circulating Tumor Cells
Vitality Acupunch Exercise Program for Sarcopenia Older Adults
Condition: Activities of Daily Living; Functional Fitness
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      This project was aimed to test the effects of a six-month VA program on the activities of
      daily living (ADL) and functional fitness of institutional older adults with sarcopenia.
    

Detailed description: 
      A cluster-randomized controlled trial was conducted to test the effects of a six-month VA
      program on ADL and functional fitness (lung capacity, body flexibility, range of the joint's
      motion, and muscle endurance) of institutional older adults with sarcopenia. Using
      convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and
      then cluster-randomized by the facility to a VA experimental or a control group. The
      experimental group received the VA program led by certified instructors 3 times per week and
      40 minutes per session for six months; the control group continued with their regular daily
      activities. One pre-test and two post-tests, three months apart, were conducted.
    

Intervention name(s): Vitality acupunch (VA) exercise program; Control
Intervention type(s): Other; Other
Intervention description(s): The VA had three phases and took 40 minutes to complete.; Participants maintained their daily activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of
      Carboxymethyl β-Glucan treatment in high-risk HPV+ patients
    

Detailed description: 
      To evaluate the effectiveness of local treatment with carboxymethyl-b-glucan and
      polycarbophil on the clearance time of human papillomavirus (HPV), as well as on the
      normalisation of cytological alterations identified at study inclusion.
    

Intervention name(s): carboxymethyl β-glucan
Intervention type(s): Dietary Supplement
Intervention description(s): It is a vaginal spray gel designed for the prevention and treatment of cervical lesions caused by HPV. This is achieved by controlling the physiological conditions of the transformation zone of the cervico-vaginal mucosa. The composition of the gel, which includes polycarbophil and carboxymethyl-beta-glucan, effectively shields the cervico-vaginal mucosa from the damaging effects of external agents due to its bioadhesive capacity. Additionally, it contributes to the re-epithelialization and regression of cervical lesions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The data will be collected from patients who meet the selection criteria.
      
Keywords: HPV
Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction
Condition: Left Ventricular Noncompaction; Isolated Noncompaction of the Ventricular Myocardium
MeSH terms: Isolated Noncompaction of the Ventricular Myocardium
Study type: Observational

Summary: 
      The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC)
      have been well established for echocardiography and cardiac magnetic resonance, such
      validation is lacking for computed tomography (CT). Such criteria are of great clinical
      relevance as a growing number of patients undergo a cardiac CT scan in daily clinical
      routine.

      The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC
      from lesser degrees of trabecular layering seen in potential differential diagnoses such as
      cardiomyopathies and left ventricular hypertrophy or dilation.

      The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can
      be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac
      CT.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the Department of Cardiology and Cardiac Imaging Division.
        They will be asked if they want to participate in this study.
      
Keywords: isolated left ventricular non-compaction; cardiac computed tomography; cardiac magnet resonance imaging; echocardiography
Vitamin D Supplementation in HIV
Condition: HIV-infection/Aids
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in
      children, adolescents and young adults with Human Immunodeficiency Virus and acquired
      immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind,
      placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on
      evidence from the Vit D Dose Finding Study-IRB 09-007332.
    

Detailed description: 
      Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune
      function, growth, muscle, bone, and inflammatory status in children, adolescents and adults
      with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy
      using clinically important outcomes, and this will overcome the critical barrier for use of
      vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit
      D supplementation may prove to be an effective and feasible treatment for symptoms and
      prevention of side effects for people of all ages living with HIV/AIDS in the US and around
      the world.

      The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit
      D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB
      09-007332 in 58 subjects with both Perinatally Acquired (PA) and Behaviorally Acquired (BA)
      HIV/AIDS to assess the long-term safety in terms of serum calcium and 25OHD concentrations,
      and efficacy in terms of the effect of vit D supplementation on 25OHD, cathelicidin, growth
      (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory
      status and HIV/AIDS disease severity and progression.

      Primary Hypotheses:

      H1: Vit D supplementation is safe and does not result in an increased incidence of elevated
      serum calcium (above age-specific range) associated with elevated serum 25OHD (>160 ng/mL) in
      treated subjects compared with the subjects receiving placebo.

      H2: Vit D supplementation is significantly associated with both increased 25D and
      cathelicidin in treated subjects compared with subjects receiving placebo.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7000IU per day of vitamin D3 for 12 months.; Once a day for 12 months.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV/AIDS; Nutrition