bioihbjkbjnl/mcl2 huggingface dataset:
Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Evaluation of the endometrial cavity is an important step in the infertility work-up,
      particularly if assisted reproductive therapy is planned. The aim is to identify possible
      endometrial abnormalities that may impair implantation.Undiagnosed endometrial abnormalities
      are present in 11 to 45% of women scheduled for in vitro fertilization (IVF).Traditionally,
      two dimensional transvaginal ultrasound (2D TVUS) and hysterosalpingography (HSG) are the
      basic methods for assessment of the endometrial cavity. However, these imaging modalities
      have shown high false negative rates among infertile women, a finding that could confine
      their rule to initial screening rather than definite diagnosis.

      Office hysteroscopy (OH) is the gold standard for evaluation of the endometrial cavity.
      Although the endoscopic approach has been proven to increase pregnancy rate in women who
      experienced prior implantation failure, evidence on treatment of unsuspected
      hysteroscopically-diagnosed endometrial lesions, to improve IVF outcome, is still lacking.
      Nevertheless,clinicians tend to use OH routinely prior to IVF because the psychological and
      financial burden that infertile couples may experience as a consequence of failed IVF cycle
      is unjustifiable.Yet, costs and invasiveness of OH counteract its global implementation to
      all women prior to IVF.
    


Intervention name(s): three dimensional ultrasound; Office hysteroscopy
Intervention type(s): Radiation; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Assisted reproductive technology
Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1b trial will assess the dose-related safety and PK profile of different doses of
      NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV
      DNA levels and other virologic efficacy parameters will be assessed.
    

Detailed description: 
      The Phase 1b assessments of the dose-related safety, PK, and initial antiviral efficacy of
      NVR 3-778 in hepatitis B patients will also be conducted at approximately 14 different sites
      to meet enrollment goals of 54-84 chronic hepatitis B patients.

      To promote objective safety and tolerance assessments during this trial, study subjects, and
      site personnel administering the study drug and performing the clinical assessments on the
      subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or
      placebo doses), for all treatment cohorts in the study. Study advancement to subsequent
      patient cohorts will require satisfactory interim reviews of available cumulative safety data
      by the Safety Review Committees (SRC), using the safety criteria and review procedures
      described in the protocol. Also, there will be one interim review of safety data by an
      independent Safety Monitoring Board (SMB), as described in the protocol.
    

Intervention name(s): NVR 3-778; Placebo for NVR 3-778; Pegasys
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sugar pill manufactured to mimic the NVR 3-778 capsule
Other intervention name(s): peginterferon alfa-2a
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis B
Dynamic FDG PET/CT: Optimization and Validation of Data Acquisition
Condition: Positron-Emission Tomography
Study type: Interventional

Summary: 
      Quantification of the metabolic rate of glucose from Dynamic Whole-Body PET examinations
      requires measurements of the time course of the radioactivity concentrations in arterial
      blood by blood sampling, and in the tissue of interest by dynamic PET. Invasive arterial
      blood sampling cannot be part of a standard examination, and therefore the blood samples need
      to be replaced by activity concentrations derived from the PET images, usually from small
      volumes in the descending aorta or left ventricle.

      Newly developed scanner software (Siemens) allows automated CT-based identification of blood
      pool regions and extraction of an image-derived blood input function from the corresponding
      PET data.

      However, this automated method needs validation, as it could be prone to systematic errors
      caused by limited spatial resolution, patient movement, and image reconstruction. We will use
      invasively measured arterial blood samples as a reference for validation of methods to
      extract non-invasive PET image-derived input functions and quantify any systematic errors
      that could propagate to the resulting parametric images.
    


Intervention name(s): Dynamic Whole-Body parametric PET/CT
Intervention type(s): Diagnostic Test
Intervention description(s): Dynamic whole-body PET/CT imaging protocol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
Condition: Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by
      reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.
    


Intervention name(s): Axitinib (AG-013736)
Intervention type(s): Drug
Intervention description(s): AG-013736 5mg twice daily [BID]
Intervention MeSH terms: Axitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; PK; Biomarker
Development of a Novel Human In Vitro Sarcoidosis Model
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Observational

Summary: 
      There is currently no experimental model that accurately represents sarcoidosis. The lack of
      a useful research model significantly slows progress towards developing new treatments for
      sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will
      test the model to see if it helps us understand how sarcoidosis develops and if it is useful
      for testing new treatments.
    

Detailed description: 
      Sarcoidosis is a systemic granulomatous disease of unknown cause, most commonly affecting the
      lungs, which tends to afflict young adults in the prime of their lives. Recent data
      indicating that sarcoidosis mortality rates are rising in the U.S. (1) and Europe (2)
      highlight the inadequacy of current therapies. As noted in a recent NIH-sponsored sarcoidosis
      workshop, the lack of relevant animal, computer or in vitro models represents a bottleneck
      for progress towards understanding disease mechanisms and developing highly effective
      sarcoidosis treatments (3). The lack of useful disease models likely contributes to the
      current lack (zero) of investigator-initiated (RO1) projects supporting sarcoidosis research.

      The long-term goal of this proposal is to develop a novel human sarcoidosis research model to
      fill the current void in the field, thereby expediting exploration of basic disease
      mechanisms and pre-clinical testing of novel therapies. The objective of this application,
      which is the first step towards achieving the long-term goal, is to develop a novel in vitro
      human granuloma model to represent abnormal granuloma formation in the context of
      sarcoidosis. In this regard, a growing body of evidence indicates that mycobacterial antigens
      are commonly harbored in sarcoidosis tissues, to which these patients are sensitized (4, 5).
      Our central hypothesis is that the pathological mechanisms of sarcoidosis can be modeled in
      vitro, as represented by abnormal granuloma formation in response to mycobacterial and other
      ubiquitous environmental antigens. The feasibility of our proposed model is supported by
      preliminary studies showing that subjects sensitized to Mycobacterium tuberculosis antigens
      (latent TB tuberculosis with a positive TB skin test) form well-organized granulomas readily
      in response to challenge with TB antigens, compared to healthy controls. This project is
      highly innovative and we feel has an excellent likelihood of leading to a critical
      breakthrough in the field of sarcoidosis research.
    

Intervention name(s): No intervention, observational study only
Intervention type(s): Other
Intervention description(s): No intervention. We are collecting blood for an ex vivo study
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Biospecimen description: 
      Blood
Sugammadex and Smoker's Neuromuscular Block
Condition: Neuromuscular Blockade; Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      We compared the durations of antagonizing and of the severity of effect of sugammadex used in
      antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of
      Four(TOF) neuromuscular monitorization.
    

Detailed description: 
      40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at
      least 10 years or non-smokers, who will undergo elective surgery were included in this
      randomized prospective study. Patients underwent routine monitoring and neuromuscular
      monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction.
      After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The
      patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 +
      50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four)
      counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the
      operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.
    

Intervention name(s): sugammadex
Intervention type(s): Drug
Intervention description(s): At the end of the operation, at least 15 minutes after the last dose of rocuronium, sugammadex 2 mg / kg was administered both of groups
Other intervention name(s): bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sugammadex; smoking; neuromuscular blockade
The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers
Condition: Children Who Underwent Minor Surgery
Study type: Interventional

Summary: 
      This study aimed to accomplish the following objectives:

        1. Develop a family-centered preoperative preparation program.

        2. Evaluate the effectiveness of this program in terms of children's preoperative emotional
           behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.
    


Intervention name(s): preoperative preparation
Intervention type(s): Behavioral
Intervention description(s): Participants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship Between Vitamin D, Fingernail Thickness and Bone Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Vitamin D deficiency is common in the elderly and contributes to the increased incidence of
      falls, hip fracture and depression in this population. An unknown number of elderly have
      vitamin D resistance resulting in a functional vitamin D deficiency state. Because there are
      no simple procedures or blood tests that identify vitamin D resistance, its prevalence and
      contribution to disability in the elderly is unknown. Our inability to screen for this
      condition precludes our ability to initiate and monitor treatment.

      Previous studies indicate that fingernail thickness correlates with vitamin D status and may
      therefore provide a simple cost effective procedure to not only identify patients with
      vitamin D deficiency but also, those with vitamin D resistance. This procedure may also
      provide a way to monitor an individual's response to treatment.

      This study is designed to demonstrate the association between fingernail thickness and
      vitamin D status.
    


Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Masking: Double
Primary purpose: Diagnostic
Keywords: Vitamin D resistance
Treatment of Functional Dyspepsia With Acupuncture
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders
      affecting humans. Existing therapies for FD are still far from satisfactory and new therapies
      are constantly being sought. Acupuncture has been used for the alleviation of functional
      gastrointestinal symptoms in several non-controlled studies. This study aims to investigate
      the therapeutic efficacy of acupuncture in patients with FD.
    


Intervention name(s): Acupuncture; Sham acupuncture
Intervention type(s): Other; Other
Intervention description(s): Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists; Patients will be given sham acupuncture treatment at dummy acupuncture points
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Functional Dyspepsia; Acupuncture; Traditional Chinese Medicine
Endoscopic Retrograde Cholangiopancreatography(ERCP)-Related Discussion Through a Mobile Social App by a Group of Doctors
Condition: Healthy
Study type: Observational

Summary: 
      Group chat through the platform of mobile social networking provides an easily accessible,
      real-time and interactive channel for communication. With the help of mobile social app, a
      group of doctors with similar interests can share valuable cases, important papers and
      opinions through multiple media types (texts, images, and videos). It remains unknown what
      activities of Endoscopic Retrograde Cholangiopancreatography(ERCP) doctors on a group-chat
      platform are.

      In the beginning of 2013, a chatting group on Wechat (the most popular mobile social app in
      China), focusing on ERCP, was created. All the doctors who received and finished their ERCP
      training in Xijing Hospital of Digestive Diseases were invited to join in the platform. The
      contents in the chatting group were analyzed. The relationships between the chatting
      activities of ERCP doctors and the performance of ERCP (such as case volume, cannulation
      success rate and PEP etc.) were investigated.
    


Intervention name(s): joining in the platform
Intervention type(s): Other
Intervention description(s): The activities (contents, chatting frequency etc.) of ERCP doctors on the chatting group were retrospectively extracted. The data related to the performance of ERCP (such as case volume, cannulation success rate and PEP etc.) by ERCP doctors were collected by a questionaire.
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Doctors who received and finished their ERCP training in Xijing Hospital of Digestive
        Diseases and joined in a chatting group through a mobile social app
      
Keywords: Endoscopic Retrograde Cholangiopancreatography; social networking; group chat
Ankle Fracture Treatment in the Elderly
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Observational

Summary: 
      The purpose of this study is to track surgical outcomes and post-operative course in patients
      55 years of age or older treated for ankle fractures.
    

Detailed description: 
      This study seeks to describe and track surgical outcomes associated with the use of a
      minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55
      years of age or older
    

Intervention name(s): Fracture union
Intervention type(s): Other
Intervention description(s): Retrospective records review post-operatively until fracture resolved.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        At-risk population, at least 55 years of age at time of surgery receiving treatment for
        ankle fractures.
      
Keywords: Ankle; Fracture; Elderly; At-risk Population; Ankle Fracture in at-risk elderly population
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
Condition: IgA Nephropathy; CKD Associated With Type 1 Diabetes; Focal Segmental Glomerulosclerosis; Autosomal Dominant Polycystic Kidney
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Glomerulonephritis, IGA; Polycystic Kidney, Autosomal Dominant; Glomerulosclerosis, Focal Segmental; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy
      of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases
      (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental
      glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients
      will be enrolled in disease specific cohorts within the trial, and effectiveness of
      bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD.

      All patients in the study will follow the same visit and assessment schedule. Following
      randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks
      1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients
      will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks
      after the end of treatment.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Bardoxolone methyl capsules
Intervention type(s): Drug
Intervention description(s): Bardoxolone 5 mg capsules
Other intervention name(s): RTA 402
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IgA Nephropathy; CKD associated with type 1 diabetes; Focal segmental glomerulosclerosis; Autosomal dominant polycystic kidney disease; IgAN; FSGS; ADPKD; Bardoxolone methyl; CDDO-ME; RTA 402
Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to to assess the nutritional status of children diagnosed
      with cystic fibrosis between the ages of 2-14, to determine the changes in the nutrition
      education given to the mothers of the patients on the nutritional status of the children and
      the nutritional knowledge of the mothers, and to compare them with the control group.. The
      main questions it aims to answer are:

        1. Will be better the nutritional status of children of mothers in the education group will
           be better compared to the control group?

        2. Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of
           children with cystic fibrosis in education group increase after nutrition education?

        3. Will the nutrition knowledge test scores of mothers of children with cystic fibrosis in
           education group on "Nutrition in Cystic Fibrosis" increase after nutrition education?

      Mothers of children diagnosed with cystic fibrosis will participate in the study as a result
      of the call of the Cystic Fibrosis Association in Turkey. Mothers participating in the study
      will be divided into 2 groups. While the mothers in the first group will be given nutrition
      education 3 times a week, 1 hour a day, no education session will be given to the mothers in
      the control group. The nutritional status and nutrient consumption of children in the
      training group and the control group will be compared.
    


Intervention name(s): Nutrition Education
Intervention type(s): Behavioral
Intervention description(s): All mothers in this group will be given 3 nutrition education sessions including detailed informations on Nutrition Therapy in Cystic Fibrosis. In addition to the education sessions, an informational booklet and a high-energy sample recipe booklet will be given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cystic fibrosis; nutrition education; nutritional status