bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes Randomized Controlled Trial
Condition: Birth Weight; Birth, Preterm
MeSH terms: Pregnancy Complications; Premature Birth; Birth Weight
Study type: Interventional

Summary: 
      The main objective of this study is to determine whether the provision of non-surgical
      periodontal therapy to pregnant women with periodontitis is effective in reducing the
      incidence of low birth weight, preterm birth and still birth when compared to pregnant women
      with periodontitis but who will be provided with oral hygiene instructions alone.
    

Detailed description: 
      Approximately two-thirds of pregnant Pakistani women suffer from periodontal disease a common
      inflammatory disease of the soft tissues surrounding the tooth. It was demonstrated that
      periodontitis among pregnant women is significantly associated with preterm birth and low
      birth weight. Pakistan has a high prevalence of these adverse birth outcomes therefore;
      identifying an intervention is of prime importance and may have social and economic benefits.

      Non-surgical periodontal therapy is affordable and amenable to people and thus seems to be an
      intervention which may prove to be of benefit in a population where the dental services are
      available. It has been recommended in systematic reviews and Meta analysis that Randomized
      Controlled Trials are now required to establish whether the removal of inflammatory factors
      by scaling and root planning are effective in reducing adverse pregnancy outcomes such as
      preterm birth and low birth weight.
    

Intervention name(s): NSPT plus oral hygiene; Oral hygiene alone
Intervention type(s): Procedure; Other
Intervention description(s): Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus; It includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given.
Other intervention name(s): scaling, dental scaling, de-scaling; periodontal prophylaxis, periodontal debridement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It's an assessor blinded, parallel group, randomized controlled trial aimed at determining the superiority of non-surgical periodontal therapy over no dental treatment among pregnant women.
The main objective of this trial is to determine whether the provision of NSPT to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to the pregnant women who were subjected to no NSPT. Outcomes of interest are pre-term birth (<37 weeks) gestation, low birth weight (<2500g) or still birth with either one occurring being considered as a positive outcome.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Metabolic Impact of Intermittent CPAP
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown
      mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid
      metabolism during sleep, which over time could lead to diabetes and cardiovascular disease.
      This study examines metabolic changes during sleep in patients with obstructive sleep apnea.
      Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to
      undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights.
      During sleep, blood samples are obtained so that metabolic function can be compared between
      sleep apnea and CPAP nights.
    

Detailed description: 
      Participants with a history of moderate severe sleep apnea (AHI>20) will be enrolled if
      participants meet inclusion/exclusion criteria. Investigators will report to the sleep
      laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for
      3 nights. The order of observation will be randomized. A standard research dinner is provided
      before each study. IV's are placed so that blood can be sampled at frequent (30 min)
      intervals throughout the night. In the morning after each study, a glucose tolerance test and
      endothelial function study (endoPAT) are performed. Serum samples will be analyzed for
      glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.
    

Intervention name(s): CPAP withdrawal
Intervention type(s): Other
Intervention description(s): CPAP is discontinued for 3 nights.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obstructive sleep apnea; CPAP; metabolism
Mifepristone for Treatment of Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objectives of this study are to estimate the efficacy and safety of the daily
      administration of mifepristone 5 mg versus 10 mg for three months for the treatment of
      uterine fibroids.

      The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in
      about 40% after 3 months of treatment.
    

Detailed description: 
      Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids
      were randomly assigned to receive 5 mg or 10 of mifepristone.

      The diminishing of prevalence of symptoms attributable to uterine fibroids is the most
      important goal to achieve under both treatments. The possible side effects of mifepristone
      are slight and women's adherence to treatment is remarkable. Also the reduction of the
      volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
    

Intervention name(s): Mifepristone; Mifepristone
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of Mifepristone 10 mg daily for three months; Oral administration of Mifepristone 5 mg, daily for three months
Other intervention name(s): Low doses of antiprogestins to treat uterine fibroids.
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uterine fibroids; mifepristone; antiprogestins
A Deep Learning Framework for Pediatric TLE Detection Using 18F-FDG-PET Imaging
Condition: Epilepsy, Temporal Lobe
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Observational

Summary: 
      This study aims to use radiomics analysis and deep learning approaches for seizure focus
      detection in pediatric patients with temporal lobe epilepsy (TLE). Ten positron emission
      tomograph (PET) radiomics features related to pediatric temporal bole epilepsy are extracted
      and modelled, and the Siamese network is trained to automatically locate epileptogenic zones
      for assistance of diagnosis.
    

Detailed description: 
      Purpose:The key to successful epilepsy control involves locating epileptogenic focus before
      treatment. 18F-FDG PET has been considered as a powerful neuroimaging technology used by
      physicians to assess patients for epilepsy. However, imaging quality, viewing angles, and
      experiences may easily degrade the consistency in epilepsy diagnosis. In this work, the
      investigators develop a framework that combines radiomics analysis and deep learning
      techniques to a computer-assisted diagnosis (CAD) method to detect epileptic foci of
      pediatric patients with temporal lobe epilepsy (TLE) using PET images.

      Methods:Ten PET radiomics features related to pediatric temporal bole epilepsy are first
      extracted and modelled. Then a neural network called Siamese network is trained to quanti-fy
      the asymmetricity and automatically locate epileptic focus for diagnosis.The performance of
      the proposed framework was tested and compared with both the state-of-art clinician software
      tool and human physicians with different levels of experiences to validate the accuracy and
      consistency.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with Temporal Lobe Epilepsy
      
Keywords: Deep Learning; Temporal Lobe Epilepsy; Positron-Emission Tomography
Safety of Insulin Detemir in Children With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin
      detemir and insulin NPH in children with type 1 diabetes.
    


Intervention name(s): insulin detemir; insulin NPH
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Lead Levels and College Achievement Scores
Condition: Lead Poisoning
MeSH terms: Poisoning; Lead Poisoning
Study type: Observational

Summary: 
      This project studies the relationship between lead exposure and academic achievement in
      college students. Most studies of the neurobehavioral effects of lead have focused on
      performances at the low end of the distribution. There is evidence that lead affects outcome
      across the entire distribution. This is a retrospective cohort study of subjects whose
      cognitive function is adequate to gain admission to college. We will use x-ray fluorescence
      to measure bone lead concentrations in undergraduate college students and test the hypothesis
      that achievement scores are related to early lead exposure. Early lead exposure has been
      shown to have measurable effects on academic performance and neurobehavioral outcomes at 18
      years of age. Should an effect be found in this study, the spectrum of lead toxicity would be
      expanded to include subjects with above average function.
    


Time perspective: Retrospective
Keywords: Lead exposure; Bone lead; Cognitive function; Academic achievement; Neurobehavior
Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will be a closely monitored trial of a small number of subjects to
      establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations:
      ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be
      the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the
      comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of
      study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same
      assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive
      ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9
      patients will be enrolled in this study, allowing for up to 3 replacement or additional
      patients.
    


Intervention name(s): mesalamine; ALTH12-1:4; ALTH12-2:4
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily; ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine; ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine
Other intervention name(s): Rowasa; 5-ASA; 5-aminosalicylic acid; mesalamine; 5-ASA; N-acetylcysteine; NAC; enema; mesalamine; 5-ASA; N-acetylcysteine; NAC
Intervention MeSH terms: Acetylcysteine; Aminosalicylic Acid; Mesalamine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: colitis; inflammatory bowel disease; ulcerative colitis; rectal administration; enema; mesalamine
NORepinephrine-Maintaining-individuaALIZEd Blood Pressure
Condition: Perioperative Myocardial Injury; Blood Pressure; Non-cardiac Surgery
Study type: Interventional

Summary: 
      This study compares the effect of individualized vs standard blood pressure management on
      postoperative myocardial injury in high-risk patients undergoing non-cardiac surgery by
      measuring the hs-cTnT levels. Continuous norepinephrine infusion is used to target a mean
      pressure of greater than 65mmHg and a systolic pressure less than 160mmHg in the standardized
      group while the target is 20% within the ward blood pressure in the individualized group. The
      pre- and postoperative hs-cTnT levels to detect myocardial injury are compared between the
      two groups.
    

Detailed description: 
      Managing the blood pressure preoperatively is important in high-risk patients because
      hypotension can lead to perioperative myocardial injury. It has been reported that a systolic
      pressure of less than 50-55mmHg or greater than 40% decrease can lead to cardiac
      complications. The mechanism of hypotension leading to postoperative myocardial injury is due
      to hypoperfusion and ischemic reperfusion injury.

      In this randomized controlled study, the blood pressure for participants in the standardized
      group is maintained as follows: mean blood pressure greater than 65mmHg and systolic blood
      pressure less than 160mmHg. The individualized group participants' blood pressure is
      maintained at a target of 20% within the preoperative ward blood pressure. Anesthesia and
      intraoperative management are the same in both groups to target a bispectral index level of
      50. In order to quantitatively measure the myocardial injury, high sensitive cardiac troponin
      T (hs-cTnT) will be measured pre- and postoperatively. A level greater than 14ng/dl has been
      reported to be associated with myocardial injury and mortality. The objective of this study
      is to show that the standardized protocol of maintaining a mean pressure greater than 65mmHg
      is non inferior to the individualized management in terms of postoperative myocardial injury.
    

Intervention name(s): standardized blood pressure management; Individualized blood pressure management
Intervention type(s): Other; Other
Intervention description(s): Standardized blood pressure management of a mean blood pressure > 65mmHg and a systolic blood pressure of < 160mmHg using norepinephrine continuous infusion; Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
The Spatiotemporal Gait Parameters in LDH Patient
Condition: Lumbar Disc Herniation; Pain
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The aim of this study was to assessment on the interaction of spatial and temporal gait
      parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15
      days after surgery.
    

Detailed description: 
      The participants were divided into LDH and healthy control groups. The analysis of the
      spatiotemporal gait parameters was performed using the "Win-Track" gait analysis platform
      system for two groups. In addition, the analysis of spatiotemporal gait parameters of 60
      participants who had the planned lumbar discectomy surgery, was tested before and 15 days
      after surgery. The pain intensity of the patients was recorded by the Visual Analog Scale
      (VAS) immediately before performing the analysis. After then participants completed ten
      passes on the "Win-Track" Gait Analysis Platform at their self-selected walking speed. The
      arithmetic mean of the three flawless walking data was used for analysis. The gait symmetry
      index was used to calculate the walking asymmetry.
    

Intervention name(s): All of the spatial and Temporal Gait parameters
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Gait analysis; Lumbar Disc Herniation; Spatiotemporal gait parameters; Gait asymmetry
Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.
Condition: IUD Insertion
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether vaginal dinoprostone administered before intrauterine device (IUD)
      insertion reduces failed insertions, insertion-related complications, and pain in multiparous
      women.
    

Detailed description: 
      Women may experience pain and technical difﬁculties may be encountered when insertion of an
      intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related
      complications and side effects are more common among women who had never delivered vaginally.
      Pain can be perceived during all steps of IUD insertion including the application of the
      tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through
      the cervical canal inside the uterine cavity
    

Intervention name(s): Dinoprostone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.; one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence
Condition: Pre-diabetes; Diabetes Risk Score; Motivation
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this randomized, controlled study is to evaluate whether the knowledge of a
      personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle
      change program in prediabetic patients. The intervention group will receive diabetes risk
      score results at the beginning of the twelve weeks, and the control group will not receive
      these results. Both groups will review their baseline and 12-week diabetes risk score results
      at the conclusion of the program and will be followed for an additional twelve weeks.
      Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c,
      fasting blood glucose, cholesterol, and diabetes risk score will be compared between the
      groups.
    


Intervention name(s): diabetic risk score
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pre-diabetes; diabetes risk score; motivation; Air Force; Military; Lifestyle change
A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory
      diabetic macular edema.
    

Detailed description: 
      Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the
      main cause of decreased visual acuity is macular edema.

      According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice
      for diabetic macular edema (DME) is laser therapy, which may be neither effective nor
      curative in some patients.There are many cases which are refractory to laser treatment or not
      suitable candidates for it.

      Corticosteroids might have a beneficial effect on DME. They have been used with different
      doses and routes (periocular,intravitreal,and slow released implants) for a variety of
      retinal diseases.

      Recently, a few prospective randomized studies, concerning the effect of intravitreal
      triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies
      et al. concluded that IVT improved vision and reduced macular thickness in eyes with
      refractory diabetic macular edema. They showed that this beneficial effect persisted for up
      to 2 years with repeated treatment.

      We also conducted a randomized placebo-controlled clinical trial to determine the safety and
      efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this
      intervention on angiographic findings of these patients.
    

Intervention name(s): Triamcinolone acetonide
Intervention type(s): Drug
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cystoid macular edema; Diabetic macular edema; Hard exudates; Intravitreal triamcinolone; Macular thickness