bioihbjkbjnl/mcl2 huggingface dataset:
Identification of β Cell Dysfunction in Relatives of Individuals With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Despite the valuable information derived from older studies evaluating type 1 diabetes, the
      diabetes research community has, in large part, overlooked potential contributions of
      baseline abnormalities in β cell function to T1D development. Newer studies focusing on
      higher risk individuals often exclude family members without evidence of positive islet
      autoantibodies. New technologies to assay alternative biomarkers of β cell stress and death
      remain incompletely explored in both Ab negative and Ab positive family members of T1D
      patients. Specifically, modern biomarkers of β cell dysfunction have not been rigorously
      tested in combination with metabolic testing to fully understand their association with
      insulin secretion.

      The investigator's working hypothesis is that individuals at genetic risk for T1D exhibit
      baseline β cell dysfunction, even before development of detectable islet autoimmunity
      (seropositivity for islet Abs).
    


Intervention name(s): There is no intervention
Intervention type(s): Other
Intervention description(s): There is no intervention
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Comparing a population at risk for T1D to healthy controls.
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
Condition: To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Study type: Interventional
Phase: Phase 4

Summary: 
      The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in
      comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.

      The Primary Endpoints for comparison are based on the objective and subjective parameters.

      The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates,
      changes in the endometrial thickness, rate of complications such as infection and anemia and
      discontinuation rates after 2 years.

      The subjective parameters including Quality of Life (QoL) are: pain during insertion,
      menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to
      insertion.

      The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and
      subject satisfaction.
    


Intervention name(s): SCu300A IUB intrauterine device; T380A IUD
Intervention type(s): Device; Device
Intervention description(s): Spherical copper IUD; T-shaped copper IUD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: IUB
Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery
Condition: Kidney Function Tests
Study type: Interventional

Summary: 
      Recent studies have shown an increased incidence of renal replacement therapy after the use
      of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However,
      studies showing detrimental effects of HES have been conducted in mostly non-surgical
      subjects. There are very few studies analyzing the effects of HES on renal function after
      cardiac surgery, a population already at risk of renal dysfunction.
    


Intervention name(s): Hydroxyethylstarch 6% 130/0.4; standard volume therapy
Intervention type(s): Drug; Other
Intervention description(s): Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit
Other intervention name(s): Any volume therapy has been recorded
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy
Condition: Periodontal Diseases; Smoking Cessation
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of smoking cessation on inflammatory markers
      following non-surgical treatment of periodontal disease. This is to assess the period of
      smoking abstinence needed before any periodontal surgery in order to reverse the negative
      effects of the reported increased levels of inflammatory markers (IL-1β and PGE2 in this
      study) associated with smoking on the healing and the periodontium.
    


Intervention name(s): Minimally invasive non-surgical periodontal therapy; Conventional non-surgical periodontal therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Minimally invasive non-surgical periodontal therapy; Conventional non-surgical periodontal therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Smoking Cessation; Periodontal Diseases; Inflammatory Markers; Interleukin-1beta; Prostaglandin E2; Non-surgical therapy; Smoking
Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients
Condition: Renal Function Disorder
Study type: Interventional

Summary: 
      The prospective, double blind randomized, parallel control, and multi-center clinical trial
      will evaluate the safety and efficacy of α-keto acid with restricted protein diet on
      protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD)
      patients.
    

Detailed description: 
      Residual renal function (RRF) is associated with cardiovascular complication, nutritional
      status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients.
      Therefore, RRF is an important determinant of mortality and morbidity in PD patients.

      Previous studies have suggested that dietary protein restriction supplemented with α-keto
      acids may slow the loss of RRF in chronic kidney disease patients. However, these trials are
      small sample and short-time research. In PD patients, there is very few reports to indicate
      the effect of α-keto acid with restricted protein diet on RRF.

      The aim of this study is to evaluate the safety and efficacy of α-keto acid with restricted
      protein diet on protecting residual renal function in continuous ambulatory peritoneal
      dialysis (CAPD) patients.This is a prospective, double blind randomized, parallel control,
      and multi-center clinical study. 160 patients who meet Inclusion/Exclusion criteria will be
      randomized into α-Keto Acid group or control group at the ratio of 1:1. The α-Keto Acid group
      will use compound α-Keto Acid plus restricted protein diet, while control group will use
      placebo plus restricted protein diet.The α-Keto Acid dosage is 100mg/kg/d daily. The
      restricted protein dosage is 1g/kg/d. The safety and efficacy of α-Keto Acid with restricted
      protein diet on RRF will be evaluated after 1 year treatment.
    

Intervention name(s): α-Keto Acid with restricted protein diet; Placebo plus restricted protein diet
Intervention type(s): Drug; Drug
Intervention description(s): α-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day.
Restricted Protein Diet: Diet contain protein 1.0g/kg/d; placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day.
Diet contain protein 1.0 g/kg/d.
Other intervention name(s): Test Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: α-Keto Acid; Restricted Protein Diet; Residual Renal Function
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
Condition: Port Wine Stain
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional

Summary: 
      1. Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin
           involving the superficial vascular plexus that occurs in estimated 3-5 children per
           1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken
           progressively to purple and, by middle age, often become raised as a result of the
           development of vascular nodules. Because most malformations occur on the face, PWS is a
           clinically significant problem in the majority of patients.

        2. The late-stage cobblestoning appearance of PWS subjects is comprised by not only
           pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and
           their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous
           abnormalities. Despite these histologic observations, the specific mechanisms involved
           in PWS nodular formation remains unclear.

        3. In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein
           kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in
           both hypertrophic areas and nodules within the lesion. These observations led us to
           hypothesize that the PI3K pathway may play an important role in nodular formation.
    


Intervention name(s): Pulsed dye laser (PDL)
Intervention type(s): Radiation
Intervention description(s): Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: port wine stain, PI3K, vascular malformation,PDL
Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department
Condition: Angioedema
MeSH terms: Angioedema; Emergencies
Study type: Observational

Summary: 
      Angiotensin-converting enzyme inhibitor ACEi induced angioedema ACEi-AE is defined as
      physical swelling of the deep skin layers or mucous membranes due to increased vascular
      permeability and leakage of fluid into the interstitial space caused while taking an ACEi
    

Detailed description: 
      Angiotensin-converting enzyme inhibitor ACEi induced angioedema ACEi-AE most commonly affects
      the lips, mouth, face, upper airway, and less commonly the gastrointestinal tract. This
      condition may lead to life-threatening airway compromise which would require emergent
      intubation. Currently, strong evidence is lacking to help guide management of ACEi-AE in the
      emergency department (ED).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients must be ≥ 18 years old, be diagnosed with suspected ACEi-AE (with ACEi use). ACEi
        use is defined as patient-reported use or evidence indicating
Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life
Condition: Quality of Life; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of the study was to compare the effect of chemo-mechanical caries removal methods using
      Papacarie-Duo and alternative restorative treatment (ART) on the Oral Health Related Quality
      of Life (OHRQoL) of pregnant women.
    

Detailed description: 
      A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women
      visiting family health centers in Alexandria, Egypt with mild to moderate dental pain due to
      caries. Participants were randomly assigned into Papacarie-Dup group (n=82) and ART group
      (n=80). The outcome variable was percent change in OHRQoL measured by OHIP-14.
    

Intervention name(s): Papacarie; Atraumatic Restorative Treatment
Intervention type(s): Drug; Procedure
Intervention description(s): First, tooth was cleaned with a wet cotton pellet. The gel was inserted using disposable syringe tip into the cavity and its color changed from clear to cloudy indicating the presence of infected tissues. After 40 seconds, the softened carious tissue was removed using excavator by gentle pressure. The remaining gel was removed with a cotton pellet. The procedure was repeated until there was no change in the gel color indicating that there was no more infected tissue.; The tooth was cleaned with a wet cotton pellet to remove debris and plaque and then isolated with cotton rolls to promote a dry environment. Caries was removed using a sharp excavator and the cavity was cleaned using a small wet cotton pellet and dried with a dry cotton pellet.
Other intervention name(s): Papacarie-Duo; ART
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minimally Invasive Caries Removal; Oral Health Related Quality of Life
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
Condition: Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of
      three different strengths of resiquimod gel applied to common wart(s) three times a week for
      four weeks.

      A second purpose is to evaluate the safety of the drug.
    


Intervention name(s): Resiquimod
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Common Wart(s); Pediatric; Wart(s); Children; 3M Pharmaceuticals; Resiquimod
Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate safety of pemetrexed combined with cisplatin for chemo therapy-naive patients
      with malignant pleural mesothelioma
    


Intervention name(s): pemetrexed; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788)
Condition: In Vitro Fertilization
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the induction of multiple follicular growth after single dose administration of
      100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.
    

Detailed description: 
      In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH
      agonist which is known to provide profound suppression of endogenous LH and FSH. It was
      evaluated whether these down-regulated subjects show an appropriate ovarian response to 100
      μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular
      growth was measured by USS, and serum inhibin-B and E2 levels were assessed.
    

Intervention name(s): Org 36286 (corifollitropin alfa)
Intervention type(s): Drug
Intervention description(s): A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing >= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing <= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).
Other intervention name(s): corifollitropin alfa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Pharmacological effects of drugs; Drug therapy; Hormones; GnRH agonist; RecFSH; Corifollitropin alfa; Open-label
Radiological Classification of the Facial Nerve
Condition: Severe to Profound Sensorineural Hearing Loss; Undergoing Cochlear Implant Surgery
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Observational

Summary: 
      Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant.
      Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is
      important to safely perform the posterior tympanotomy. Anatomical variation of facial nerve
      such as lateral or anterior position of vertical segment of facial nerve, will render this
      approach challenging. In this research, investigators proposed a Radiological Classification
      system of the position of vertical segment of facial nerve in relation to the lateral
      semicircular canal to predict difficult cases with narrow facial recess.
    

Detailed description: 
      Cochlear implantation done by mastoidectomy, posterior tympanotomy and round window membrane
      insertion or cochleostomy, if we have to. In cases with very laterally placed vertical
      segment of the facial nerve a trans- mastoid trans- attic approach used with trans canal
      monitoring as an alternative approach. Position of the vertical segment of the facial nerve
      (VFN) determined by coronal view HRCT of temporal bone, bone window of 0.6 mm thickness by
      using the cut posterior to the internal auditory canal at the level of lateral semicircular
      canal (LSCC) and then drawing a line parallel to the bony canal of the VFN and another
      parallel line on the outer bony wall of lateral semicircular canal (LSCC), and comparing
      level of both. The location of the facial nerve classified into normal if the FN is medial,
      same level or lateral to LSCC . Investigators referred the laterally placed FN (LPFN) when
      the whole vertical segment of facial nerve is lateral to LSCC. In addition, distance between
      VFN and LSCC was measured in cases of laterally placed FN.

      Investigators proposed a radiological classification system of the mastoid segment of facial
      nerve to predict round window niche accessibility through posterior tympanotomy
      pre-operatively by using coronal view computed tomography scan of temporal bone. Facial nerve
      position classified into 3 types in relation to LSCC:

        1. TYPE I Medial to LSCC

        2. TYPE II Same level of LSCC

        3. TYPE III Laterally placed to LSCC III a) Less than 2mm III b) More than 2mm
    

Intervention name(s): cochlear implant surgery
Intervention type(s): Other
Intervention description(s): patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        - Patients admitted to otorhinolaryngology department at king Fahad Hospital of University
A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to estimate the bioavailability of amlodipine and enalapril maleate
      fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril
      maleate tablets. The rational for this study is to provide a more convenient dosing regimen
      for patients. This is an open-label, randomized, single dose, two-way crossover study, in
      which 16 healthy adult male and female subjects will be enrolled and dosed under fasting
      conditions. Each subject will participate in two treatment periods of 7 days each. There will
      be at least 14 days of wash out period between the two dosing periods and a follow-up period
      of up to 21 days after treatment period 2. The total duration of study will be approximately
      35 days from the start of the first treatment.
    


Intervention name(s): GSK2944404 FDC; Amlodipine 5 mg; Enalapril Maleate 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Uncoated, round, yellow white bilayer fixed dose combination tablet containing 5 mg amlodipine and 20 mg enalapril for single dose oral administration in each period.; Emerald-shaped white 5 mg amlodipine table for single dose oral co-administration with enalapril maleate tablet in each period.; Peach triangle shaped 20 mg enalapril maleate tablet for single dose oral co-administration with amlodipine in each period.
Intervention MeSH terms: Amlodipine; Enalapril; Enalaprilat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; enalapril maleate; healthy volunteers; amlodipine; pharmacokinetics
Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea
Condition: Sickle Cell Anemia; Sickle Cell Thalassemia
MeSH terms: Thalassemia; Anemia, Sickle Cell
Study type: Observational

Summary: 
      Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with
      significant decrease in the frequency of vaso-occlusive crises and other crises related to
      SCA. Several studies were published with relative short term follow up in pediatric and young
      adult age. The purpose of this study is to assess the long term follow up in a group of
      patients that initiated Hydroxyurea treatment in childhood.
    

Detailed description: 
      Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with
      significant decrease in the frequency of vaso-occlusive crises and other crises related to
      SCA. Several studies were published with relative short term follow up in pediatric and young
      adult age. The purpose of this study is to assess the long term follow up in a group of
      patients that initiated Hydroxyurea treatment in childhood.

      A long term follow up will be recorded in a cohort of twenty SCA patients treated by
      Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute
      chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively.
      Also the mean hgb level and hgb F percentage will be summarized.
    

Intervention name(s): Clinical follow up and laboratory analysis
Intervention type(s): Other
Intervention description(s): Clinical follow up and laboratory analysis
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving
        Hydroxyurea
      
Keywords: Sickle cell anemia; Sickle cell thalassemia; Hydroxyurea