bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies
Condition: Fetal Sex Determination
Study type: Observational

Summary: 
      Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56
      days as confirmed by artificial reproductive technology (ART). The samples will be used to
      develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal
      plasma or urine.
    

Detailed description: 
      This is an observational study whereby samples will be tested to determine the presence or
      absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw and
      urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender
      will be requested at or soon after delivery. The accuracy of the test and the optimal time to
      perform the test during pregnancy will be assessed by comparing the test results from
      maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal
      sex results obtained at birth.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Women who are pregnant via assisted reproductive technology between days 36 and 56
        gestational age
      
Biospecimen description: 
      Maternal whole blood and urine will be collected. Whole blood will be processed to plasma and
      buffy coat.
    
Keywords: Assisted Reproductive Technology; circulating cell free fetal DNA; First trimester
The Role of Glucagon in the Effects of Dipeptidyl Peptidase-4 Inhibitors and Sodium-glucose Co-transporter-2 Inhibitors
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      In normal physiology, glucagon from pancreatic alpha cells plays an important role in
      maintaining glucose homeostasis via its regulatory effect on hepatic glucose production.
      Patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state,
      and in response to ingestion of glucose or a mixed meal.glucagon, glucagon concentrations
      fail to decrease appropriately and may even increase. This diabetic hyperglucagonaemia may
      therefore contribute importantly to the hyperglycaemia of the patients.

      Several glucose-lowering treatment modalities have been shown to affect glucagon levels in
      patients with type 2 diabetes, but the role of glucagon in the glucose-lowering effects of
      these treatment modalities has been difficult to discern. By using a glucagon receptor
      antagonist (GRA) the investigators will exploit glucagon receptor antagonism to delineate the
      role of glucagon during treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors and
      dipeptidyl peptidase 4 (DPP-4) inhibitors, which have been shown to increase and decrease
      plasma glucagon levels, respectively.
    


Intervention name(s): LY2403021; LY2403021 placebo; Standardised liquid meal; Linagliptin; Linagliptin placebo; Empagliflozin; Empagliflozin placebo
Intervention type(s): Drug; Drug; Procedure; Drug; Drug; Drug; Drug
Intervention description(s): Glucagon receptor antagonist; DPP-4-inhibitor; SGLT2-inhibitor
Other intervention name(s): Trajenta; Jardiance
Intervention MeSH terms: Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Communication Intervention for Toddlers With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The goal of this study is to conduct an efficacy trial to determine whether an early
      communication intervention which blends two evidence-based interventions, Enhanced Milieu
      Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER),
      improves social communication in toddlers with Autism Spectrum Disorder (ASD).
    

Detailed description: 
      This study tests the blended intervention (J-EMT) in a parent-plus-therapist-implementation
      model that has been demonstrated to be effective with other populations.

      The J-EMT communication intervention is tailored to the specific social communication
      characteristics of children with ASD and is delivered during a critical period in early
      communication development for these children.

      In this study, the investigators compare this blended intervention (J-EMT) to a business as
      usual (BAU) comparison group. Children assigned to the J-EMT group will receive a total of
      48, 1-hour direct intervention sessions over six months that will include teaching their
      parents to implement J-EMT procedures across daily activities.

      The investigators will examine social communication and child vocalizations, expressive and
      receptive language, symbolic play, and symbol-infused joint engagement to determine whether
      J-EMT changes both a primary functional outcome and the underlying specific skills that
      contribute to effective social communication in children with ASD.

      Results from this study will indicate the efficacy of this variation of
      parent-plus-therapist-implemented EMT (i.e., J-EMT) specifically tailored to the
      characteristics of young children with ASD.
    

Intervention name(s): J-EMT for Toddlers with Autism
Intervention type(s): Behavioral
Intervention description(s): Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.
Other intervention name(s): Communication Intervention for Toddlers with Autism
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the clinical outcomes after implantation
      of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate
      Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
    

Detailed description: 
      The purpose of this study is to evaluate and compare the clinical outcomes after implantation
      of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate
      Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will
      last for 12 months.
    

Intervention name(s): Silicone plate Ahmed Glaucoma Valve (Model FP7); Porous Plate Ahmed Glaucoma Valve (Model M4)
Intervention type(s): Device; Device
Intervention description(s): This intervention is conducted as a surgical intervention.; This intervention is conducted as a surgical intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory Glaucoma; Intractable Glaucoma; Primary Open Angle Glaucoma; Neovascular Glaucoma
Postprandial Response of Individuals to Dietary Inorganic Phosphate
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The study aims to compare the postprandial response of plasma phosphate and cardiometabolic
      relevant factors to phosphate intake in defined diet(s).
    

Detailed description: 
      It is a monocentric, controlled intervention trial. The study will be carried out in
      cross-over design. This design was chosen because of a moderately strong individual metabolic
      response to the test meal.

      Two interventions are planned in which the subjects will receive a test meal with phosphate
      supplement or with placebo in random order on 2 days. Subjects will be randomized to one of
      the 2 treatment arms.

      On the two intervention days (T1 and T2), the subjects are placed a venous indwelling
      cannula. Immediately after the first blood sample the subjects take the fat and
      carbohydrate-rich test meal along with 700 mg of phosphorus or a placebo, both in the form of
      capsules. Phosphorus is administered as sodium phosphate . The placebo used is sodium
      chloride with equivalent amounts of sodium. The filler should be silica and mannitol. The
      capsules are made of hard gelatin and dissolve in about 10 minutes. The capsules are taken
      with 300 ml of water. The verum and placebo capsules are produced by the central pharmacy of
      the University Hospital.

      The test meal consists of a pasta dish with oily tomato sauce. It is freshly prepared by the
      study staff and packaged airtight in individual portions before being handed out to the
      subjects. The test meal should be consumed within 10 - 12 minutes. The time is documented by
      the study staff. The next blood sample is taken immediately after the end of consumption
      (time 0), all other 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes
      thereafter. All blood samples are taken in a lying position. The first 3 hours after eating
      the test meal the subjects should spend reclining. In the following 5 hours subjects are free
      to move in the study center with each patient taking a recumbent position 10 minutes before
      the next blood draw. Immediately before all blood samples are taken the measurement of blood
      pressure and pulse is provided for which the opposite arm is to be used. Furthermore the
      collection of urine samples is provided every hour. Subjects are encouraged to take 200 ml of
      water every hour on the intervention day. At the end of the intervention, a snack will be
      provided.
    

Intervention name(s): inorganic phosphate; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sodium phosphate; Sodium chlorid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: inorganic phosphate; postprandial response; fibroblast growth factor-23; health individuals
Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults
Condition: Stress; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a three-day mindfulness meditation
      retreat (vs. a three-day relaxation retreat) in stressed, unemployed, community adults on
      brain function, brain structure, and overall health and immunity.
    

Detailed description: 
      Chronic stress has been shown to be a significant risk factor for increased morbidity and
      mortality. Eight-week Mindfulness-Based Meditation programs (MBSR) have been shown to improve
      participants' health and well-being, including reducing inflammation and slowing the
      progression of chronic diseases such as HIV. The purpose of this study is to evaluate the
      potential benefits of a three-day mindfulness-based meditation retreat program (vs. an active
      rest and relaxation retreat control condition) on a highly stressed, unemployed, community
      adult population.

      Participants are recruited from the Pittsburgh area and are randomly assigned to either the
      mindfulness-based retreat program or the rest and relaxation retreat program. All
      participants complete a psychosocial survey, blood work, and a baseline fMRI before
      completing the intervention. Participants complete a second fMRI immediately following the
      intervention and then additional blood work and psychosocial surveys at a four month
      follow-up timepoint. At each fMRI appointment, participants will complete neuroimaging tasks
      (where they will be presented with words, picture, and sounds) that will assess
      neuroreactivity, regulation responses, and brain volume before and after mindfulness
      meditation training.
    

Intervention name(s): Mindfulness-Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): three-day mindfulness-based meditation retreat program
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: MBSR; mindfulness; stress
Incentive Programs for Female Substance Abusers Who Smoke - 3
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to examine the effects of incentive programs for the treatment
      of nicotine dependence in women who have problems with substance dependence.
    

Detailed description: 
      This study will determine the influence of voucher-based CM on reducing smoking (and other
      drug) use during pregnancy or in post-partum women with children under 1 year of age living
      with them, or in non-pregnant females who smoke. We are targeting smoking cessation since
      cigarette use is so prevalent in our service. We will compare a control group to two
      different voucher-based contingent-reinforcement procedures: one that targets smoking
      abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis
      results.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: nicotine dependence
Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the influence of
      omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral
      semaglutide in healthy subjects.
    


Intervention name(s): semaglutide; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide.; Will be given daily with oral semaglutide.
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic
      patients with stage 1 or stage 2 hypertension
    


Intervention name(s): Nebivolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration; Matching placebo tablets, oral administration
Other intervention name(s): Bystolic (TM)
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nebivolol; Bystolic ™; Hypertension; Hispanic; Hypertension in Hispanic patients
Functional Changes in the Brain After Tibial Nerve Stimulation: a Pilot Study
Condition: Spinal Cord Injuries; Bladder, Neurogenic
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic
Study type: Observational

Summary: 
      The lower urinary tract is innervated by the autonomous (sympathetic, parasympathetic) and
      the somatic nervous system. Afferent information from the lower urinary tract (LUT) (e.g.
      filling state and volume of the urinary bladder) is conducted via the dorsal roots to the
      sacral spinal cord and from there to the pontine micturition center (PMC) in the brain stem.
      The PMC has several connections to other cortical areas. These complex interactions with the
      cortex enable voluntary control of the LUT and are crucial for urinary continence. The
      integrity of this neuronal circuit is crucial for an undisturbed function. Deterioration of
      the nerve fibers due to a systemic neurological disease (e.g. spinal cord injury) can affect
      LUT function. Neurogenic lower urinary tract dysfunction can lead to urgency, urge
      incontinence, reduced bladder capacity and secondary deterioration of the upper urinary tract
      (i.e. kidneys). First-line therapy of neurogenic detrusor overactivity contains
      antimuscarinic treatment. In case of side effects or remaining detrusor overactivity, nerve
      stimulation (e.g. sacral neuromodulation and in effect nerve tibialis stimulation) is an
      accepted therapy option. The precise mechanism of action of these neuro-modulatory procedures
      is still unknown. Utilizing state-of-the-art neuroimaging techniques, we intend to
      investigate the functional activation pattern after afferent tibialis nerve stimulation as
      well as the association with the architecture of the sacral roots. We aime to get a better
      insight into functional neuromodulation and central nervous processing. The study aim is to
      evaluate the feasibility in healthy subjects as a pilot study for the application of these
      method in patients with chronic, incomplete spinal cord injury.
    


Intervention name(s): magnetic resonance imaging
Intervention type(s): Other
Intervention description(s): functional magnetic resonance imaging and diffusion tensor imaging after tibialis nerve stimulation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy volunteers
Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Condition: Breast Neoplasms; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is
      evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further
      determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the
      changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor
      celecoxib.

      In a single-centre double-blinded phase II study, breast cancer patients were randomised to
      receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three
      weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical
      excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray,
      which allows to study the genome-wide changes at the transcriptional level.
    


Intervention name(s): celecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pre-operative celecoxib (400 mg) twice daily for two to three weeks; pre-operative placebo twice daily for two to three weeks
Other intervention name(s): celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Celecoxib; Clinical trial, Phase II; Oligonucleotide Array Sequence Analysis
Does Reducing Spasticity Permit an Increase in Strength?
Condition: Spastic Diplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy,
      resulting in numerous treatment strategies that target various parts of the motor system.
      However, in many children weakness may be a greater contributor to disability than
      spasticity. Recent results suggest a correlation between spasticity and weakness, but it is
      not known if reduction of spasticity can improve strength.

      We suggest a simplified model in which spinal mechanisms (including reflex contributions to
      spasticity) and supraspinal mechanisms (including voluntary contributions to strength)
      combine to activate muscle. The model implies that the supraspinal contribution cannot
      increase unless the spinal contribution decreases. We therefore hypothesize that reduction of
      spasticity improves the ability to increase voluntary strength.

      We propose a double-masked placebo-controlled clinical trial combining treatment using the
      oral anti-spasticity medication baclofen with a 6-week program of strength training. We will
      enroll 20 ambulatory children with spastic diplegic cerebral palsy. Prior to and following
      the intervention, we will obtain quantitative measures of spasticity, strength, and gait. We
      predict that the children taking baclofen will have a greater increase in strength than the
      children taking placebo. We predict that the increase in strength will be reflected in
      improved performance on gait analysis, and it will correlate with a reduction in quantitative
      measures of spasticity and spinal reflex excitability.

      If the hypothesis is correct, it will provide important new information on the relationship
      between spasticity and strength in children with cerebral palsy. It will provide the first
      measurements of the effect of baclofen on voluntary muscle activation in children. It will
      support the short-term use of combined anti-spasticity medication and strengthening as a new
      clinical treatment for ankle weakness in children with spastic diplegia. A successful result
      will have immediate and significant implications for treatment of children with cerebral
      palsy.
    


Intervention name(s): baclofen
Intervention type(s): Drug
Intervention MeSH terms: Baclofen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The stapedius reflex protects the ear from the loud noise. The measurement of the
      intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric
      cochlear implants (CIs) is used to confirm that the implant is functioning correctly and
      determine the maximum comfortable level . Total intravenous anesthesia (TIVA) with propofol
      and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT.
      However, high doses of remifentanil exacerbates postoperative pain and increased opioid
      consumption.
    

Detailed description: 
      Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for
      pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil
      exacerbates postoperative pain and increased opioid consumption.
    

Intervention name(s): Lidocaine; Na CL 0.9%
Intervention type(s): Drug; Other
Intervention description(s): Before induction of anesthesia; children in group LID received an iv bolus dose of LIDOCAINE 1 mg/kg over 5 minutes followed by 1 mg Kg-1 h-1 ivi until the start of skin closure.; Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of LIDOCAINE.
Other intervention name(s): Xylocaine; isotonic saline solution
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care