bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Cilostazol in Patients With Mild Cognitive Impairment (COMCID)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Epidemiological, clinicopathological and animal studies show that vascular disease in various
      forms contributes to cognitive decline. Increasing age is the strongest risk for dementia
      irrespective of whether it results from a vascular etiology or neurodegenerative disease
      processes such as in Alzheimer's disease (AD). AD and vascular cognitive impairment, the two
      most common causes of dementia, represent two extremes of a spectrum of disorders; however, a
      number of entities, which possess varying degrees of neurodegenerative and vascular
      pathologies, occur in between. The pure forms of the disorders are preferred for convenience
      to label, treat or manage but conditions within the spectrum are the norm rather than the
      exception as dementia advances. Therefore, combinatorial therapy directed at both vascular
      and neurodegenerative aspects of dementia is a promising approach for the treatment of
      dementia in the elderly.

      Cilostazol acts as an antiplatelet agent and has other pleiotropic effects based on
      phosphodiesterase-3-dependent mechanisms. Increasing evidence suggests that cilostazol offers
      endothelial protection, via pleiotropic effects. Intriguingly, cilostazol has been shown to
      decrease amyloid beta (Abeta) accumulation and protect Abeta-induced cognitive deficits in an
      experimental model. In a pilot study of 10 patients with moderate AD (mean MMSE score, 11.9
      points) who received donepezil, cilostazol add-on treatment for 5-6 months demonstrated
      significantly increased MMSE score in comparison to baseline. Moreover, cilostazol was shown
      to be effective in preventing cognitive decline in patients with AD with cerebrovascular
      diseases, mild cognitive impairment (MCI), and mild dementia who received donepezil.

      These results highlight the need for a comprehensive prospective cohort study to analyze the
      effect of cilostazol on the preservation of cognitive function in patients with early-stage
      cognitive impairment, namely MCI.
    


Intervention name(s): Cilostazol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the comparative bioavailability of edaravone oral suspension administered
      orally and via a nasogastric tube in healthy adult subjects
    


Intervention name(s): MT-1186
Intervention type(s): Drug
Intervention description(s): Suspension
Other intervention name(s): Edaravone
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Landing Biomechanics Following Fatigue in Athletes With and Without a History of Patellar Tendinopathy
Condition: Patellar Tendinitis; Fatigue
MeSH terms: Tendinopathy; Fatigue
Study type: Observational

Summary: 
      In this case-control study, two- and three-dimensional landing biomechanics, by means of
      lower limb joint angles and moments (opto-electronic system with synchronised force plate),
      will be compared between 30 male volleyball/basketball players with a history of patellar
      tendinopathy and 30 healthy controls.
    


Intervention name(s): Biomechanical analysis; Fatigue protocol
Intervention type(s): Diagnostic Test; Other
Intervention description(s): 3D analysis of landing manoeuvres.; A circuit of different tasks (e.g. jumping, sprinting forward and backward, side-stepping exercise) was performed to induce fatigue.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Players from sports with repetitive jump-landing manoeuvres.
      
Keywords: Biomechanics; Landing
Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the mass balance recovery and metabolite profile, and will identify
      metabolite structures following a single oral dose of 14C-CORT125281 in healthy participants.
    


Intervention name(s): 14C-CORT125281
Intervention type(s): Drug
Intervention description(s): 14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth
Condition: Lung Injury
MeSH terms: Lung Injury
Study type: Interventional

Summary: 
      In this clinical trial the Investigators aimed to assess the Adrenomedullin (AM) release in
      urine and plasma in preterm infants undergoing Sustained Inflation or Positive Pressure
      Ventilation at birth to manage respiratory failure.
    

Detailed description: 
      Background and objectives: The respiratory management in the DR may play an important role in
      the development and prevention of lung injury. The sustained lung inflation (SI) is a
      promising approach to facilitate cardio-respiratory transition, but currently, although it
      has been shown to decrease the duration of MV, seems not to guarantee relevant benefits
      compared to Positive Pressure Ventilation (PPV). In order to clarify the impact of these two
      different approaches on lung tissues, this study measures Adrenomedullin (AM), which is a
      biomarker involved in lung development.

      Methods: we conducted a prospective case control-study in a cohort of very low birth weight
      (VLBW) infants (< 1500 g) of 28+0-30+6 weeks of gestational age (GA), who received SI or PPV
      during stabilization in DR.

      Exclusion criteria were major malformations (i.e. congenital heart disease, cerebral, lung
      and abdominal malformations), fetal hydrops, lack of parental consent and need for
      endotracheal intubation at birth.

      Blood samples for AM measurement were collected at birth from the arterial umbilical cord
      before resuscitation maneuvers, then at 1 hour from birth and at 24 hours from birth.
      Moreover, urine samples were collected, in correspondence with the first urine emission while
      in NICU and at 24 hours of life.
    

Intervention name(s): Sustained Inflation; Positive Pressure Ventilation
Intervention type(s): Procedure; Procedure
Intervention description(s): Application of positive pressure by face mask with T-piece resuscitator for a prolonged period of 15 seconds at a peak pressure of 25 cmH20 followed by PEEP set at 5 cmH2O; Application of positive pressure by face mask with T-piece resuscitator at a peak pressure of 25 cmH20, PEEP set at 5 cmH2, for 40 inflations/minute
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Feasibility of Telemedicine Medical Abortion
Condition: Pregnancy
Study type: Observational

Summary: 
      This pilot study is designed to obtain data on the safety, acceptability, and feasibility of
      providing abortion by direct-to-patient telemedicine and mail.
    


Intervention name(s): medical abortion
Intervention type(s): Drug
Intervention description(s): medical abortion
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People seeking abortion
Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects
Condition: Vitamin D Insufficiency; Secondary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and non-Japanese Healthy
      Subjects
    

Detailed description: 
      An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101
      (Calcifediol) Extended-release Capsules in Japanese and non-Japanese Healthy Subjects
    

Intervention name(s): CTAP101 Capsules
Intervention type(s): Drug
Intervention description(s): Calcifediol Extended-Release Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Assessment of Tremor Using SNUMAP Motion Sensing System
Condition: Tremor
MeSH terms: Tremor
Study type: Interventional

Summary: 
      The purpose of this study is to record and measure tremor using portable six-axis (tri-axial
      accelerometer and tri-axial gyroscope) motion sensing system.
    

Detailed description: 
      SNUMAP system is portable, finger-worn, battery powered device that contains MEMS
      (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and
      three-axis gyroscope). The SNUMAP device consists of a wrist module and finger module, which
      attaches to an patients's finger and transmits three dimensional motions to a wrist module
      for storage and further analysis. The aims of this study is to assess tremor severity using
      tri-axial accelerometry and gyroscope to determine the reliability and the correlation with
      clinical measurements.
    

Intervention name(s): SNUMAP
Intervention type(s): Device
Intervention description(s): Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system
Other intervention name(s): Hybrid (accelerometer and gyroscope)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tremor; SNUMAP; accelerometry; gyroscope; clinical rating scale
To Study Different Levels of MK0493 for Safety, Efficacy, and Tolerability in Obese Patients (0493-017)(COMPLETED)
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.
    


Intervention name(s): MK0493
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems
Condition: Healthy
Study type: Interventional

Summary: 
      Trace elements, bioactive secondary metabolites and vitamins are among the most important
      quality parameters in plants. Yet, very little information is available on their content,
      bioavailability and health effects of organically grown plant food products. The main
      objective of the project is to study the impact of different agricultural management
      practises relevant for organic farming on the ability of cereal and vegetable crops to absorb
      trace elements from the soil and to synthesise bioactive compounds (secondary metabolites,
      antioxidant vitamins and phytates) with health promoting effects. Field experiments with a
      rigidly controlled design will be implemented together with state-of-the-art analytical
      techniques allowing solid conclusions to be drawn on the variability and optimum levels of
      bioactive compounds. The multitude of analytical data from plant and soil samples will be
      analysed by multivariate statistical methods in order to reveal differences between the
      cultivation systems used. Finally, the relationship between bioavailability of the nutrients
      studied and the elemental fingerprint of plants will be extracted by the statistical methods.
    


Intervention name(s): Organic or conventional diet; Diet (organic or conventional)
Intervention type(s): Other; Other
Intervention description(s): 12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet; organic or conventional diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: diet, organic, health; healthy people
Local Infiltration Analgesia for Hip Arthroscopy
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic
      solution around the hip joint will provide effective pain control after hip arthroscopy.
    


Intervention name(s): Infiltration of local anesthetic; Normal Saline Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): 30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.; injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: hip arthroscopy; post operative analgesia
A Study of Carbon-14-Labelled [14C] LOXO-305 (Pirtobrutinib) in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the absorption, metabolism, and excretion (AME)
      profiles of pirtobrutinib (LOXO-305), to identify and characterize metabolites of
      pirtobrutinib (LOXO-305), and to assess the safety and tolerability of [14C] LOXO-305 in Part
      1. To determine the absolute bioavailability of pirtobrutinib (LOXO-305), to evaluate the
      plasma concentration of total radioactivity, to evaluate the urinary excretion of [14C]
      LOXO-305 and total radioactivity, to evaluate the fecal excretion of [14C] LOXO-305 and total
      radioactivity, and to assess the safety and tolerability of pirtobrutinib (LOXO-305), and
      [14C] LOXO-305 in Part 2. Blood tests will be performed to check how much pirtobrutinib
      (LOXO-305) and [14C] LOXO-305 gets into the bloodstream and how long it takes the body to
      eliminate it.

      The study will last up to approximately 60 days for Part 1 and approximately 47 days for Part
      2.
    


Intervention name(s): [14C]-LOXO-305; LOXO-305; [14C]-LOXO-305
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered IV
Other intervention name(s): LY3527727; Pirtobrutinib; LY3527727; LY3527727
Intervention MeSH terms: Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 2-part study.
Masking: None (Open Label)
Primary purpose: Basic Science
C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Observational

Summary: 
      The goal of this study is to determine whether markers of vascular inflammation (such as
      c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated
      dilation) in postmenopausal women with glucose intolerance compared to normal controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Two groups of healthy postmenopausal women who do not smoke. One group includes women with
        either pre-diabetes or diet-controlled diabetes. The control group includes women with
        normal glucose tolerance
      
Keywords: c-reactive protein; endothelial dysfunction; glucose intolerance
Managing Diabetes Mindfully Study
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction
      (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure,
      perceived stress, depression, patient self-efficacy and quality of life; and to estimate the
      effect of a MBSR program for patients with DM. It is expected that MBSR program participants
      will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and
      standardized measures of diabetes self-management, perceived stress, depression,
      self-efficacy, and quality-of-life.
    

Detailed description: 
      Primary Objective: Evaluate the feasibility of conducting a trial of a MBSR program for
      patients with diabetes on measures of HbA1c, blood pressure, perceived stress, depression,
      patient self-efficacy and quality of life. Feasibility will be assessed via: a) the interest
      of patients in taking part in an MBSR program; c) the effectiveness of strategies for
      recruiting patients with diabetes into the study; d) rates of participant compliance with the
      MBSR; and, e) patient compliance with the program evaluation plan.

      Estimate the effect of a MBSR program for patients with diabetes. It is expected that MBSR
      program participants will evidence a trend toward better clinical outcome measures of HbA1c,
      blood pressure, and standardized measures of diabetes self-management, perceived stress,
      depression, self-efficacy, and quality-of-life.

      Secondary Objective: To explore the experience of people with diabetes who participate in an
      MBSR course through the use of semi-structured interviews.
    

Intervention name(s): Mindfulness-Based Stress Reduction (MBSR)
Intervention type(s): Behavioral
Intervention description(s): An 8-9 week MBSR course led by an experienced instructor in a group format. Participants learn mindfulness meditation techniques and simple yoga exercises. Subjects receive four phone support calls.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness-Based Stress Reduction; Diabetes Management; Stress Reduction; Diabetes Testing
Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      After administration of besifovir preparations different from each other to healthy subjects,
      the investigators evaluate equivalence of bioavailability of LB80331.
    

Detailed description: 
      The purpose of this study is to evaluate equivalence of bioavailability of LB80331
      preparations different. Following the randomly allocated sequence group administer the
      relevant test drug for 1 time according to the determined schedule of Treatment A and
      Treatment B in each of the periods.
    

Intervention name(s): Treatment A; Treatment B
Intervention type(s): Drug; Drug
Intervention description(s): administration of 1 time administration of the test drug (Treatment A); administration of 1 time administration of the reference drug (Treatment B)
Other intervention name(s): LB80380 maleate made by IDP; LB80380 maleate made by LGLS
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      This study aims to compare and contrast the effects of two different aquatic exercises on
      postural control and hand functions in people with multiple sclerosis.
    

Detailed description: 
      Impaired limits of stability causes falls in people with Multiple sclerosis (pwMS) whereas a
      well-controlled posture provides improved upper limb functions which are limited in almost
      75% of pwMS due to weakness, spasticity or tremor. It is an already known fact that hand
      dexterity is an indicator of fall risk due to neuromuscular causes and/or abnormalities in
      the corpus callosum in pwMS.

      Aquatic therapy (AT) provides a safe and effective environment for many therapeutic purposes.
      It is important to understand the effects of each type, intensity, and duration of the
      aquatic interventions to accomplish most suitable aquatic exercise program.

      Halliwick method, neuromotor treatment approach which uses fluid and mechanical properties of
      water, is based on postural control by mobilizing and controlling body parts through the Ten
      Point Program.

      During Aquatic Plyometric Exercises, proximal part of the body needs to be stabilized to
      generate a sudden and powerful contraction at the distal part and stabilization of the
      proximal joints is necessary for maintaining distal movements in a coordinated way.

      It is important to understand the effects of each type, intensity, and duration of the
      aquatic interventions to accomplish most suitable aquatic exercise program. This study aims
      to compare and contrast the effects of two different aquatic exercises on postural control
      and hand function.
    

Intervention name(s): Halliwick; Aquatic Plyometric Exercises
Intervention type(s): Other; Other
Intervention description(s): The exercise program was progressed by increasing the speed and the range of motion of the movements. Patients were asked not to accelerate the exercise and to focus on their alignment. Mental adjustment, sagittal rotation, transverse rotation, and combined rotation controls, balances in stillness steps of the Halliwick concept were included.; The APE programme was progressed by increasing speed and the range of motion of the movements. Patients were carefully informed not to deform the exercise just to emulate the speed. The three phases of each exercise; eccentric (or loading) phase, the amortization phase, and the concentric (or unloading) phase explained thoroughly at the beginning of every exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aquatic therapy; Limits of stability; Halliwick; aquatic plyometric exercises