bioihbjkbjnl/mcl2 huggingface dataset:
Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Participants will be comparing the sound quality of their own voice and the sound quality of
      streamed music using universal couplings and a custom earmold with a dynamic vent.
    


Intervention name(s): Audeo P90 hearing aid with custom earmolds using dynamic venting; Audeo P90 hearing aid with Open domes; Audeo P90 hearing aid with Vented domes
Intervention type(s): Device; Device; Device
Intervention description(s): Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.; Audeo P90 hearing aid coupled with non-custom, manufacturer open domes; Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a 3-part study with each part being an open-label, fixed-sequence, 2-period study in
      healthy adult participants.
    


Intervention name(s): Danicopan; Cyclosporine; Tacrolimus; Calcium Carbonate; Aluminum/Magnesium Hydroxide/Simethicone; Omeprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet.; Oral capsule.; Oral capsule.; Chewable tablet.; Chewable tablet.; Oral, delayed-release capsule.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; Neoral; Prograf; Antacid; Antacid; Gelusil; Prilosec
Intervention MeSH terms: Cyclosporine; Simethicone; Omeprazole; Anti-Ulcer Agents; Calcium Carbonate; Magnesium Hydroxide; Aluminum hydroxide, magnesium hydroxide, drug combination; Antacids; Tacrolimus; Cyclosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a 3-part study, each part is a fixed-sequence with 2 periods.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Drug Interaction; Cyclosporine; Tacrolimus; Antacids; Omeprazole
Single Dose FSH-GEX™ in Healthy Volunteers
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the current study was the pharmacokinetic and pharmacodynamic characterization of
      a single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female
      volunteers, in comparison with two marketed comparator products.
    

Detailed description: 
      Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in
      three of four possible ascending doses or one dose of two comparators (Bravelle® and
      Gonal-f®) and placebo in random order. The study consisted of three separate treatment
      periods. During each treatment period the subject received one single dose via a subcutaneous
      injection in the lower abdominal wall.
    

Intervention name(s): FSH-GEX™; Gonal-f; Bravelle; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose; 150 IU single dose; 150 IU single dose; single dose
Other intervention name(s): follitropin epsilon; follitropin alfa; urinary FSH
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: in-vitro fertilization; reproductive disorder
Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction
Condition: Fentanyl Adverse Reaction; Caudal Anesthesia
Study type: Observational

Summary: 
      The investigators are measuring fentanyl consumption in micrograms used during anesthesia for
      patients on fast track congenital cardiac surgeries
    

Detailed description: 
      The investigators are measuring fentanyl consumed for both fast track and conventional
      corrective cardiac surgeries and also parents Parental Perceptions satisfaction with early
      child communication in ICU and impact of caudal anesthesia on extubation time our 2ry
      outcomes are the hospital and ICU length of stay
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): amount of fentanyl used in both groups
Intervention MeSH terms: Fentanyl
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with congenital cardiac anomaly for surgical correction from 3months to
        18 years of age
      
Keywords: fast track; congenital cardiac surgery; caudal; fentanyl
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal
      antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will
      receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
      Efficacy and safety parameters will be evaluated.
    


Intervention name(s): BCD-085; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; interleukin 17; monoclonal antibody
Clinical Test Report for Blood Pressure Meter of CH-658
Condition: Blood Pressure
Study type: Observational

Summary: 
      Blood pressure meter model CH-658 was to be assessed against the standard mercury
      sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
      
Keywords: blood pressure
Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in cp
Condition: Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purposes of the current study are to:

      Define and compare between the efficacy of arm ergometer versus stabilization exercises on
      trunk control, hand grip power and upper limb quality of functions in children with diplegia.
    

Detailed description: 
      Studies have shown that the cycle ergometer exercise improves several parameters, such as
      muscle strength and endurance, along with torso control in sitting position. However, these
      results are presented only in a small sample. Studies with the use of cycle ergometer in the
      population with CP are still few and present little information about the physiological
      effects .Previous studies on children with CP focused on the effect of ergometer on the upper
      and lower extremities functions. Limited literature is available regarding the effect of arm
      ergometer on trunk control among this population. The current study will be carried out to
      define the effect of arm ergometer versus stabilization exercises on trunk control, hand grip
      power, upper limb function in children with diplegia.
    

Intervention name(s): Arm ergometer
Intervention type(s): Device
Intervention description(s): The conventional physical therapy program included three sets of exercises as follows:
Flexibility exercises to restore joint mobility of soft tissues. Static and dynamic balance exercise. Functional walking exercises.
Other intervention name(s): Stabilization exercises on BOSU ball
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cerebral palsy / Arm ergometer
Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL)
      with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.
    

Detailed description: 
      The main objective of the study is the evaluation and comparison of the clinical outcomes of
      three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or
      CNA0T0 IOL respectively.

      The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified
      optical design was created to provide improved intermediate vision, comparable distance
      vision and a profile of dysphotopsia similar to other monofocal lenses.

      Considering the modified optical profile of the ICB00 IOL, the primary objective will be the
      evaluation of visual performance at intermediate distance.
    

Intervention name(s): ICB00 IOL; ZCB00 IOL; CNA0T0 IOL
Intervention type(s): Device; Device; Device
Intervention description(s): Bilateral implantation of ICB00 IOL; Bilateral implantation of ZCB00 IOL; Bilateral implantation of CNA0T0 IOL
Other intervention name(s): TECNIS EYHANCE IOL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: IOL; intermediate distance; cataract surgery; enhanced monofocal
Functional MRI Biomarkers of Cognitive Decrements in Diabetes
Condition: Diabetes Mellitus, Type 2; Metabolic Syndrome X; Mild Cognitive Impairment
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2; Cognitive Dysfunction
Study type: Observational

Summary: 
      The exact neuronal mechanism underlying the cognitive decline associated with diabetes
      mellitus type 2 (DM2) still remains to be elucidated. Multi-parametric functional MRI can
      potentially provide functional, micro-structural, micro-vascular, and metabolic information
      on the affected brain at an earlier stage than does conventional structural MRI. The overall
      aim of the current proposal is to obtain a better understanding in the neuronal mechanisms
      that underlie cognitive decline in DM2 and the putative prediabetic condition the metabolic
      syndrome (MetS).
    

Detailed description: 
      Diabetes mellitus type 2 (DM2) is a common chronic metabolic disorder that affects 4.1% of
      the Dutch population. In addition to vascular disease, DM2 is associated with structural
      brain changes visible on MRI, accelerated cognitive decline, and dementia in older
      individuals. The exact pathophysiological mechanisms underlying cognitive decrements in DM2
      still remain to be elucidated. The 'metabolic syndrome' (MetS), defined as a cluster of
      cardiovascular risk factors (including obesity, hypertension, and dyslipidemia) is often
      considered a prediabetic condition. Individuals with MetS display similar cognitive
      decrements as do DM2 patients, but do not share the severity of brain injury. It has been
      indicated that in prediabetic MetS, cognitive problems precede structural brain changes, and
      that MetS and DM2 affect the brain through a shared mechanism in which vascular co-morbidity
      is essential.

      The primary objectives are defined according to a hierarchical design: i) to tailor and apply
      multi-parametric, functional MRI techniques to identify cerebral abnormalities (cerebral
      biomarkers) in DM2 and MetS; ii) to investigate which cerebral biomarkers are shared and
      differ between DM2 and MetS; iii) to assess whether these cerebral biomarkers are associated
      with cognitive decrements.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Matched subjects aged 40-75 years with Diabetes mellitus type 2, metabolic syndrome, and
        healthy controls
Baclofen for Rumination
Condition: Rumination; Supra-gastric Belching
MeSH terms: Rumination Syndrome; Feeding and Eating Disorders of Childhood
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are
      randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high
      resolution impedance manometry measurement, were they receive a solid meal, and recordings
      continue for another hour. Thereafter, they will receive the alternative treatment, after
      which they will undergo a second high resolution impedance manometry measurement. Patients
      are asked to fill out questionnaires during the entire study period.
    


Intervention name(s): Baclofen; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.; placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.
Other intervention name(s): Lioresal
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Cholesterol Education for At-Risk Children
Condition: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia; Coronary Heart Disease Risk Reduction
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Observational

Summary: 
      To evaluate two educational programs that promoted the role of pediatric practices in
      lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through
      dietary modification.
    

Detailed description: 
      BACKGROUND:

      Outcomes of the study provided valuable guidance for pediatricians who wanted to become more
      actively involved in identifying and treating children with elevated blood lipids.

      DESIGN NARRATIVE:

      Pediatricians in five practices in Abington, Pennsylvania conducted a cholesterol screening
      program (capillary bloodsample) for 4-10 year old children in their care. Children who tested
      positive (total cholesterol >176 mg/dl) were offered follow-up evaluations (two fasting
      venous blood samples) to confirm the positive initial test. Those with mean LDL cholesterol
      levels between the 80th and 98th percentiles for age/sex (107-164 mg/dl for boys and 112-164
      mg/dl for girls) and who met other entry criteria were invited to join the study. Children
      with parental permission to participate were randomized to one of three groups: two that
      received dietary education, and a comparison group that received no dietary education. One
      educational program used face-to-face counseling with a registered dietitian and the other
      used a home-based, parent-child autotutorial approach. In addition, a random sample of
      non-hypercholesterolemic children with total plasma cholesterol levels between the 40th and
      60th percentiles for age/sex were invited to join the study as a second comparison group.
      Prior to the education period (baseline) and three times thereafter (3, 6 and 12 months
      post-baseline), all four groups were assessed for consumption of total fat, saturated fat,
      and cholesterol, and their growth and pertinent cognitive psychosocial factors. Also, the
      plasma LDL cholesterol levels of the three hypercholesterolemic groups were assessed at all
      four time points along with blood indicators of iron status at baseline and twelve months.

      To assess the educational programs' effectiveness, changes were compared in assessed
      variables of the hypercholesterolemic groups who did and did not receive dietary education.
      Also, changes in diet, growth, and cognitive/psychosocial factors in these groups were
      compared with those of the non-hypercholesterolemic group that had neither a positive
      diagnosis of elevated blood lipids nor dietary education. Additionally, the
      cost-effectiveness of the two dietary education programs was evaluated.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is to compare meal time glucose control associated with BIOD-531, a rapidly
      absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
    


Intervention name(s): BIOD-531; Humalog Mix 75/25; Humulin R U-500
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Observational [Patient Registry]

Summary: 
      The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first
      multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It
      guarantees its methodology great representativeness and therefore an interesting material for
      the study of risk factors in the population. In addition, it should have little here
      Radiographs of hands for all its patients. It therefore has the opportunity to study a
      possible relationship between tobacco and hip osteoarthritis , knee and hand but also to
      study the relationship between tobacco and structural evolution of hip osteoarthritis and /
      or symptomatic knee.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with osteoarthritis of the hip and patients with knee osteoarthritis
Improved Screening for Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and
      deterioration of bone microarchitecture , leading to increased fracture risk for low trauma,
      such as spinal fractures or femoral neck .

      It is estimated that 3 million people are living in France , particularly women , with an
      incidence that increases with age .

      This disease is a major public health issue in terms of morbidity and mortality , costs and
      risk of recurrence (after a first fracture episode) , including risk factors are identified.

      However, although bone densitometry is a reliable diagnostic tool and preventive treatments
      are at our disposal, screening for osteoporosis is still insufficient .

      The objective of our study is to improve the detection of osteoporosis in Hospital
      Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone
      densitometry or if risk factors are found. Based on the results , the patient will be sent in
      rheumatology consultation for implementation of treatment if necessary .

      Therefore included women hospitalized in medical services , gynecology, surgery and
      orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women
      who could answer a simple questionnaire and those previously treated for osteoporosis or have
      already received a bone density there is less than 3 years old .
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women between 50 and 80 years hospitalized CHD Vendée
The Influence of Fictitious Peers in a Social Media Intervention for Downsizing Portions: The Smart Snacking Studies
Condition: Eating Behavior; Social Psychology
Study type: Interventional

Summary: 
      The 2 interventions aimed to examine whether peer-led nudging on social media may be a way of
      influencing young adults and adolescents to reduce their self-reported ideal portion sizes of
      high energy-dense snacks and sugar-sweetened beverages.
    

Detailed description: 
      Two pilot interventions were conducted which examined the influence of peer-led nudging on
      social media as a way of influencing self-reported ideal portions of high energy-dense snacks
      and sugar-sweetened beverages. In both interventions the peers posted images of 'their'
      snacks and beverages, which constituted the recommended portion, onto an Instagram account.
      The peers also posted images relating to portion sizes, calories and other information
      related to health but not specifically portion size. It was hypothesised that viewing images
      of peers' snacks would influence the participants to reduce their own snack and beverage
      ideal portion sizes.

      Intervention 1 lasted for 2 weeks and recruited young adults and used a within-subjects
      design. Intervention 2 lasted for 4 weeks and recruited adolescents and used a
      between-subjects design. In intervention 2, participants were randomly assigned to either the
      intervention or the control condition. This protocol focusses on intervention 2.

      In both interventions, participants in the intervention condition were added to an Instagram
      account and were required to visit Instagram daily and to like all posts. All participants
      (intervention and control) completed a survey at baseline and at the end of the intervention,
      and completed quizzes at the end of each week.
    

Intervention name(s): Smart snacking intervention
Intervention type(s): Behavioral
Intervention description(s): The smart snacking intervention aimed to examine whether peer-led nudging on social media influenced adolescents to reduce their self-reported ideal portion sizes for a variety of HED snacks and SSBs. In intervention 2, participants were randomly allocated to the intervention or control condition, and their ideal portion sizes were assessed through a survey at baseline and intervention end.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention 2 used a parallel design where participants were either allocated to an intervention or a control group in a between-subjects repeated measures design.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Social influence; Peer influence