bioihbjkbjnl/mcl2 huggingface dataset:
Prediction of NODAT After Renal Transplantation
Condition: Renal Transplantation
Study type: Observational

Summary: 
      A statistical analysis of the predictive value of OGTT and FPG testing executed as part of
      standard clinical practice after renal transplantation for the diagosis of new-onset diabetes
      mellitus after transplantation.
    

Detailed description: 
      All patients transplanted in our department receive a formal oral glucose tolerance test (and
      thus also fasting plasma glucose concentration) in the first week after renal
      transplantation. This testing for DM or Impaired Glucose Tolerance (IGT) is part of our
      standard clinical protocol and data are collected prospectively in all these patients in an
      electronic patient medical file. The development of diabetes mellitus in all transplant
      patients is documented, including DM therapy.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: NODAT; OGTT; FPG; Renal Transplanation; Risk Factors; Predictive value
Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test
Condition: Anal Canal HPV Infection Diagnosis; Anal Dysplasia Diagnosis; Anal Cancer
MeSH terms: Papillomavirus Infections; Anus Neoplasms; Disease
Study type: Interventional

Summary: 
      This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV
      and whether this aids in identifying individuals are risk for anal cancer or precancerous
      lesions.
    


Intervention name(s): HC2 collection kit with a swab or brush
Intervention type(s): Device
Intervention description(s): We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior
Other intervention name(s): Qiagen HC2 HPV High-Risk DNA Test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Anal HPV; Anal Dysplasia; Ana Cancer
Effects of Wheat Bran Extract on Cognitive and Memory Function
Condition: Cognitive Function 1, Social
Study type: Interventional

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on
      cognitive and memory function. The investigators measured changes in cognitive function
      parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF
    

Detailed description: 
      Based on reports about the neuroprotective effects of water extract from wheat Triticum
      aestivum L. or its bran, the investigators hypothesize that extract of wheat bran (WBE) is
      beneficial to elderly people with age-associated cognitive impairment. The investigators
      investigated the efficacy and safety of WBE on improvement of cognitive function through
      measuring the neuropsychometric assessments in adult with subjective cognitive impairment by
      a randomized clinical trial.

      Seventy participants aged from 50 to 80 years old with subjective cognitive impairment were
      randomly assigned to receive either WBE (3,000 mg/day) in this 12-week, double-blind
      placebo-controlled and parallel trial. Neuropsychological assessments including Computerized
      Neurocognitive function test (CNT), Working Memory Test (WMT), Korean Mini-Mental State
      Examination (K-MMSE), Brief Cognitive Rating Scale (BCRS), Prospective and Retrospective
      Memory Questionnaire (PRMQ), Perceived Stress Scale (PSS), 36-Item of Short-Form Health
      Survey (SF-36) and blood Brain-derived neurotrophic factor (BDNF) were used to assess the
      cognitive function before and after the intervention.
    

Intervention name(s): WBE; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): wheat bran extract (3 g/day); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cognitive function; CNT; memory function; Triticum aestivum L; wheat bran
A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance
      in patients with COPD
    


Intervention name(s): UK-369,003
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Virtual Integrated Environment in Decreasing Phantom Limb Pain
Condition: Phantom Limb
MeSH terms: Phantom Limb
Study type: Observational

Summary: 
      The purpose of this study is to determine if observing a virtual arm decreases phantom limb
      pain (PLP) in upper extremity amputees.
    

Detailed description: 
      Nearly all traumatic limb amputees will experience cognizance of a phantom limb and perceive
      a vivid impression that their lost limb is not only fully present, but also painful. The John
      Hopkins University Applied Physics Laboratory Virtual Integration Environment (VIE) is a
      highly flexible and adaptable virtual reality system that allows patients to observe movement
      of a 3D virtual arm. Using the VIE, recorded signals from the residual limb will be
      correlated to the desired motion of the phantom limb. We hope to correlate the consistency of
      these patterns with PLP to determine if increased control of the phantom limb leads to
      decreased PLP.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Seven unilateral, upper-extremity amputees completed the study. These subjects were either
        trans-radial (n=4) or trans-humeral (n=3) amputees.
      
Keywords: Phantom Limb; Amputation, Traumatic; Electromyography; Visual Analog Pain Scale
Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine
      Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as
      Add-on Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).
    

Detailed description: 
      Study to determine if inhaled nitric oxide (iNO) given through a special delivery device
      (INOpulse® DS) is safe and efficacious in treating Pulmonary Arterial Hypertension (PAH).
      Medical literature and clinical experience suggests that iNO at pulsed doses of 0.013 to 0.1
      mg/kg per hour for 1 month to 2+ years appears safe and suggests efficacy for the treatment
      of pulmonary hypertension.

      There are two parts to this study. In Part 1 (week 0 to week 16), the objectives are to
      determine the safety, tolerability, efficacy, and exploratory objectives of two different
      doses of iNO delivered by a pulsed delivery device in symptomatic subjects with PAH who
      remain symptomatic due to PAH on approved PAH monotherapy or combination approved PAH
      therapy. In Part 2 (week 17 to end of study Part 2 [EOS Part 2]), the objective is to compile
      data on the long-term effects of iNO on safety, tolerability, clinical and hemodynamic
      measures.
    

Intervention name(s): Inhaled Nitric Oxide 0.025 mg/kg IBW/hr delivered via INOpulse DS Device; Placebo delivered via INOpulse DS Device; Inhaled nitric oxide 0.075 mg/kg IBW/hr delivered via INOpulse DS Device
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Cohort 1: 0.025 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (3.0 mg/L [2440 ppm] NO mini-cylinder; change q 24 hours) delivered via INOpulse DS Device and INOpulse DS nasal cannula; Placebo 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (Nitrogen N2, 99.999%) delivered via INOpulse DS Device and INOpulse DS nasal cannula; Cohort 2: 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (6.0 mg/L [4880 ppm] NO mini-cylinder; change q 24 hours) delivered via INOpulse DS Device and INOpulse DS nasal cannula
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inhaled nitric oxide; pulmonary arterial hypertension; pulmonary hypertension; PAH
Vitreo-papillary Traction as an Entity Identified by Optical Coherence Tomography (OCT).
Condition: Tomography, Optical Coherence
Study type: Observational

Summary: 
      Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology.
      This clear and documented imaging identified new diseases/ observations that were not
      previously known.
    

Detailed description: 
      In ophthalmology vitreo-macular adhesion, vitreo-macular traction and posterior vitreous
      detachment were recognized entities for a long time. On the other hand vitreo-papillary
      adhesion/ traction is a fairly new concept in ophthalmology that became known after the use
      of OCT in ophthalmology imaging. Reasons, effects and ways of treatment of vitreo-papillary
      traction will take some time to evolve. The case study in which this traction was documented
      was initiated by an observation of a persistent, tiny single retinal hemorrhage above the
      optic disc of an eye. The patient was completely asymptomatic because of the vitreo-papillary
      traction but the OCT documentation of the case was so clear and striking.
    

Intervention name(s): Optical Coherence Tomography (OCT)
Intervention type(s): Other
Intervention description(s): Optical Coherence Tomography is a fairly new imaging technique in ophthalmology
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        any himan subject that is found to have VPT by OCT.
Comparison of Motor Functions and Quality of Life According to Feeding Type in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to compare motor functions and quality of life of the children, and
      anxiety and depression levels of caregivers according to feeding type of children with
      cerebral palsy.
    

Detailed description: 
      The aim of this study is to compare motor functions and quality of life of the children, and
      anxiety and depression levels of caregivers according to feeding type of children with
      cerebral palsy. Children will be divided into two groups: children with oral feeding and
      children with non-oral feeding, according to Functional Oral Intake Scale. Gross Motor
      Function Classification System will be used for classify children according to gross motor
      function, Gross Motor Function Measurement will be used for evaluate gross motor functions,
      and parent-reported Pediatric Quality of Life Inventory will be used for evaluate quality of
      life of children. To measure caregivers' anxiety and depression levels will be assessed by
      using Beck Depression Inventory and Beck Anxiety Inventory. Parametric or non-parametric
      tests will be applied according to the variables distribution. Through this analyses,
      determination of the difference between feeding type groups and other categorical and
      continuous variables will be decided.
    

Intervention name(s): Gross Motor Function Measurement
Intervention type(s): Other
Intervention description(s): These instruments will be used for determine the gross motor functional level and quality of life of the children with cerebral palsy and anxiety, depression levels of caregivers.
Other intervention name(s): Pediatric Quality of Life Inventory; Beck Anxiety Inventory; Beck depression Inventory; Gross Motor Function Classification System
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with Cerebral Palsy
Early Luteal Progesterone Profile in IVF Patients Triggered With hCG
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Until now very little information exists regarding the early luteal serum progesterone
      profile after Human chorionic gonadotropin (hCG) trigger. This pilot study will help
      characterize the serum progesterone, 17-hydroxyprogesterone profiles in IVF patients and
      correlate progesterone, 17-Hydroxyprogesterone levels to ovarian follicles obtained after
      stimulation with exogenous gonadotropins.
    

Detailed description: 
      The early luteal phase after IVF treatment is only scarcely studied. During IVF treatment the
      early luteinizing hormone (LH) activity deficit induced after ovarian stimulation with
      exogenous gonadotropins will be partly covered by the bolus of hCG used for triggering of
      final oocyte maturation due to the long half-life of hCG. In addition, the luteal phase will
      be covered by exogenous progesterone supplementation. After successful implantation the
      embryo itself will provide the supportive LH activity, securing the function of the corpora
      lutea. However, during the early luteal phase and peri-implantation, recent data suggest that
      an early-mid-luteal hCG/LH deficiency exists after hCG trigger during which the corpus luteum
      lacks an optimal stimulation. Furthermore, the early luteal progesterone profile in IVF
      differs significantly from the progesterone profile of the natural cycle, in which the peak
      is reached around the time of implantation. With this non-invasive trial, we wish to further
      explore the early luteal phase profiles of progesterone, 17-Hydroxyprogesterone and hCG in
      order to optimize current luteal phase support policies in IVF and hopefully increase ongoing
      pregnancy rates.
    

Intervention name(s): Blood collection
Intervention type(s): Diagnostic Test
Intervention description(s): A total of ten (10) blood samples (2ml/each) will be collected during the study.
Blood samples will be collected on the following days for subsequent analysis of LH, Estradiol, hCG, progesterone and 17-Hydroxyprogesterone.
Intervention model: Single Group Assignment
Intervention model description: IVF patients triggered with hCG
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
Condition: Mild Cognitive Impairment; Mild Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease
      or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is
      to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.
    

Detailed description: 
      A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of
      AZD5213 and Placebo in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment
      During 4 Weeks of Treatment, Designed as a Randomized, Double-Blind, Multi-Center, Parallel
      Group, Placebo-Controlled Study
    

Intervention name(s): AZD5213; AZD5213; AZD5213; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): AZD5213 doseA daily; AZD5213 doseB daily; AZD5213 doseC daily; Placebo tablet daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment; Mild Alzheimer's disease; Safety; Tolerability
Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval
Condition: Oocyte Retrieval
MeSH terms: Flushing
Study type: Interventional

Summary: 
      The aim of this study is to compare whether oocyte flushing during retrieval is effective or
      not.
    

Detailed description: 
      In total 300 patients will be randomized for the effectiveness of single or double lumen
      needle during oocyte retrieval. Double lumen needles give an opportunity of washing to the
      follicle with flush. Single lumen needles seem to be faster and no need for flushing. We aim
      to compare to the differences of the use of both needles.
    

Intervention name(s): single lumen needle oocyte retrieval; double lumen needle oocyte retrieval
Intervention type(s): Device; Device
Intervention description(s): single lumen needle use during oocyte retrieval; double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: follicle flushing; oocyte retrieval; needle
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of
      Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be
      administered vaginally.
    

Detailed description: 
      This study is a phase II, 5 arm study with a 12 week active dosing period. The study will be
      conducted in 2 stages. In the first stage, the first 6 women to be enrolled will be treated
      at the 12mg dose level, and in addition to the other required study assessments will be
      monitored with a 24-hour PK assessment on Day 14, and daily trough assessments for the first
      14 days. If, at Visit 3, the Cmax or AUC of any subject treated at 12mg exceeds the mean
      observed for the highest safe oral dose administered in the ZP-204 study, all subjects
      enrolled at the 12mg level will be discontinued, no further patients will be treated at this
      dose level, and the 6mg vaginal dose will be assessed in a similar fashion. In the second
      stage, the remaining subjects will be randomized to a dose of 3, 6, 12 or 24 mg.

      For all subjects there will be a 4-6 week placebo run-in period, to establish baseline
      parameters (bleeding and quality of life) followed by treatment at one of three single-blind
      Proellex doses (3, 6 or 12 mg daily, administered vaginally in capsule form.) The primary
      efficacy endpoint will be bleeding assessed using the Pictorial Blood Loss Assessment Chart
      (PBAC) after 12 or 16 weeks of treatment. The secondary endpoints will be changes in size of
      uterine fibroids assessed by MRI and improvement in quality of life assessed using the
      Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFSQOL0. Safety
      endpoints include significant adverse events, changes in physical examination results, and/or
      clinical laboratory results significantly outside of normal range. For subjects enrolled in
      Stage 2, PK will be assessed after the first and last doses and trough levels every 2 weeks.
    

Intervention name(s): Proellex
Intervention type(s): Drug
Intervention description(s): vaginal suppository, daily, for 12 weeks
Other intervention name(s): Telapristone acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
DSUVIA Early Evaluation of Pain Trial
Condition: Traumatic Injury
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA
      (sufentanil) versus standard care pain management comparing pain treatment outcomes in
      injured patients with moderate to severe pain
    


Intervention name(s): Sufentanil 30 MCG Sublingual Tablet; standard care pain treatment
Intervention type(s): Drug; Drug
Intervention description(s): 30 microgram sublingual tablet administered using sublingual applicator; standard care pain treatment given in Emergency Department
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation
      solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over
      48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent
      asthma.
    


Intervention name(s): Tiotropium low dose QD; Tiotropium high dose QD; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 actuations once daily in the evening; 2 actuations once daily in the evening; 2 actuations once daily in the evening
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of Apatinib in Metastatic Triple-Negative Breast Cancer Patients
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this clinical research study is to discover if the study drug apatinib can
      shrink or slow the growth of pretreated metastatic triple-negative breast cancer.
    

Detailed description: 
      Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor
      (VEGFR), and its anti-angiogenesis effect has been viewed in preclinical tests. The
      investigators' phase I study has shown that the drug's toxicity is manageable and the maximum
      tolerable daily dose is 850 mg. The hypothesis of this clinical research study is to discover
      if the study drug apatinib can shrink or slow the growth of triple-negative breast cancer.
      The safety of apatinib will also be studied. Patients physical state, symptoms, changes in
      the size of the tumor, and laboratory findings obtained while on-study will help the research
      team decide if apatinib is safe and effective in pretreated metastatic triple-negative breast
      cancer patients.
    

Intervention name(s): Apatinib
Intervention type(s): Drug
Intervention description(s): Apatinib was administratered at 750 mg/d in Phase IIa. The actual average dose intensity delivered was 525 mg/d due to toxicities. So, in Phase IIb, the starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
Other intervention name(s): Target therapy
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Apatinib; Triple-Negative Breast Cancer; Metastatic Breast Cancer; ER/PR Negative; Her2/Neu Negative