bioihbjkbjnl/mcl2 huggingface dataset:
Bone Adaptation to Impact Loading
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Ageing populations have made osteoporosis and fragility fractures a major public health
      concern worldwide. Half of all women and 30% of all men will suffer a fracture related to
      osteoporosis during their lifetime. While medical prevention of this immense problem is
      impossible at population level, it is necessary to find efficient preventive strategies.
      Exercise is one of the major prevention approaches because one reason behind the increasing
      burden of osteoporosis is the modern sedentary lifestyle. However, the optimal type,
      intensity, frequency, and duration of exercise that best enhances skeletal integrity are
      still largely unknown.

      We conducted a 12-month population-based randomized controlled exercise intervention in 120
      premenopausal women. The aim was to investigate the effect of impact exercise on bone mineral
      density, geometry and metabolism in healthy women with the intention of assessing the
      intensity and amount of impact loading with a novel accelerometer-based measurement device.
      Training effects on risk factors of osteoporotic fractures, physical performance and risk
      factors of cardiovascular diseases were also evaluated.

      This study demonstrated that 12 months of regular impact exercise favoured bone formation,
      increased bone mineral density in weight-bearing bones, especially at the hip, and led to
      geometric adaptations by increasing periosteal circumference. Bone adaptations had a dose-
      and intensity-dependent relationship with measured impact loading. Changes in proximal femur
      were threshold-dependent, indicating the importance of high impacts exceeding acceleration of
      4 g as an osteogenic stimulus. The number of impacts needed to achieve this stimulation was
      60 per day. Impact exercise also had a favourable effect on physical performance and
      cardiorespiratory risk factors by increasing maximal oxygen uptake, dynamic leg strength and
      decreasing low-density lipoproteins and waist circumference. Changes were dose-dependent with
      impact loading at wide intensity range.

      Bone adapts to impact loading through various mechanisms to ensure optimal bone strength. The
      number of impacts needed to achieve bone stimulation appeared to be 60 per day, comparable to
      the same number of daily jumps. If done on a regular basis, impact exercise may be an
      efficient and safe way of preventing osteoporosis.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Progressive impact exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: acceleration; bone density; cardiovascular diseases; exercise; female; fragility fractures; impact intensity; intervention studies; osteoporosis; premenopause
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),
      and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
    


Intervention name(s): SBI-087
Intervention type(s): Drug
Intervention description(s): Single IV or SC dose of SBI-087
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; pharmacokinetics
Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing
Condition: Catheter-Related Infections
MeSH terms: Infections; Catheter-Related Infections
Study type: Interventional

Summary: 
      Investigators have designed a single-center randomized controlled trial to compare
      chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to
      their effects on the infection outcomes. The study was condcuted in the pediatric intensive
      care unit in the 18 months period.
    

Detailed description: 
      The single-center randomized controlled trial study aimed to compare chlorhexidine gluconate
      (CHG)-impregnated dressing and standard dressing with respect to their effects on the
      frequency of central-line associated bloodstream infection (CLABSI), catheter related
      bloodstream infection (CRBSI), primary bloodstream infection (BSI) and catheter colonization
      in critically ill pediatric patients with short-term non-tunneled central venous catheter
      (CVC) in a pediatric intensive care unit (PICU) of a tertiary referral hospital in Turkey..
      Pediatric patients aged 1 month to 18 years admitted to our PICU between May 2018 and
      December 2019, who had received placement of a short-term non-tunneled CVC which had stayed
      in place for at least 48 hours were included into the study. The patients were grouped with
      respect to the type of catheter fixation they had received, either with CHG-impregnated
      dressing or standard dressing, which were assigned in a randomized fashion. The groups were
      compared with regard to the frequencies of CLABSI, CRBSI, primary BSI and catheter
      colonization, as well as microorganism etiology. Any adverse event related to catheter
      dressing were recorded. Independent risk factors of CLABSI frequency were analyzed.
    

Intervention name(s): Standard dressing; Chlorhexidine gluconate -impregnated dressing group
Intervention type(s): Other; Other
Intervention description(s): a standard breathable, hypoallergenic, transparent dressing (TegadermTM 1635 [8.5 x 10.5cm] or 1633 [7 × 8.5 cm] depending on patient size; 3M, Neuss, Germany); A chlorhexidine gluconate -gel impregnated transparent dressing (TegadermTM CHG 1660R [7 x 8.5 cm] or [11.5 x 8.5 cm] depending on patient size; 3M, Neuss, Germany).
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chlorhexidine dressing; Central venous catheter; Central line associated bloodstream infection; Colonization; Pediatric critical care
Mindfulness-Based Physical Activity Intervention
Condition: Mindfulness; Physical Activity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aims of this parallel two-arm pilot randomized controlled trial is to assess the
      feasibility and acceptability of an audio-recorded mindfulness-based intervention and to
      assess whether the intervention results in a clinically meaningful difference in physical
      activity compared to the control condition
    


Intervention name(s): Mindfulness; Heart-Rate
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Received instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention; Given a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA MRA
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Observational

Summary: 
      The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate
      meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show:

        1. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image
           quality and diagnostic confidence to MRA using gadobutrol.

        2. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy
           for vascular lesion and stenosis detection compared to MRA using gadobutrol.
    

Detailed description: 
      In this study, we will assess the image quality and accuracy of MRA studies acquired using
      these two contrast agents. In the cases where Digital Subtraction Angiography (DSA) or CT
      angiography images are available, the results of the study using both contrast agents will be
      compared to the DSA or CTA findings. All MRA images will be assessed independently by two
      readers. The readers will be blinded to the clinical symptoms, contrast agent and DSA/CTA
      results. A five-level system rating for image quality of each arterial segment will be used
      (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis
      suspected but not established, 3 = fair quality with established diagnosis, 4=good quality
      with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent
      quality image information). Vascular lesions will also be graded on a 1-5 scale. Vessel
      segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2)
      mild (<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total
      occlusion.

      Grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as
      significant for diagnostic accuracy testing.
    

Intervention name(s): Dotarem
Intervention type(s): Diagnostic Test
Intervention description(s): (Dotarem) (0.4 ml/kg (0.2 mmol/kg))
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        qualifying MRA
Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether glucagon administered by microneedle patch
      is comparable to glucagon administered by injection pen in the treatment of insulin-induced
      hypoglycemia.
    

Detailed description: 
      The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0.5
      mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way
      crossover open label design. Eligible subjects giving informed consent will be randomised to
      a treatment sequence of each of the four treatments in one week intervals. At each treatment
      visit, subjects will undergo an insulin induction procedure designed to safely induce
      hypoglycemia, and then have a treatment applied, either by injection or by patch, and then
      monitored for return to normoglycemia.
    

Intervention name(s): Glucagon (ZP-Glucagon); Glucagon (GlucaGen)
Intervention type(s): Drug; Drug
Intervention description(s): chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes; recombinant glucagon administered via subcutaneous injection
Other intervention name(s): glucagon; glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness
Condition: Acute Mountain Sickness; Environmental Illness
MeSH terms: Altitude Sickness; Environmental Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance
      physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat
      fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are
      widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by
      human study. The investigators conducted a randomized, double blind, placebo controlled,
      crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
    

Detailed description: 
      The number of people traveling to altitude for work or for recreation is rising, and
      increased media attention towards these activities has also raised the profile of altitude
      related illness. The most effective preventive measure for acute mountain sickness
      (AMS)-gradual ascent-is frequently difficult or impractical for modern international travel
      to locations such as Lhasa in Tibet (3650 m) and La Paz in Bolivia (3740 m). In order to
      solve this problem, prophylactic acetazolamide was most commonly used. But prescription
      needed and side effects such as paresthesia and nausea are the disadvantage of using
      acetazolamide. Some over-the-counter herbal supplements with essentially no adverse effect
      were widely used, such as Rhodiola species. Rhodiola crenulata are widely used to prevent AMS
      in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators
      conducted a randomized, double blind, placebo controlled, crossover study to investigate the
      efficacy of Rhodiola crenulata in preventing AMS.
    

Intervention name(s): Rhodiola crenulata; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering; Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other intervention name(s): Rhodiola; Golden root; Hong Jing Tian; Starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: acute mountain sickness; AMS; Rhodiola Crenulata; mountaineering; pulse oximetry; oxygen saturation
A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA
Condition: Iron Deficiency Anemia (IDA)
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, open-label, non-randomized, multi-center, single arm study to
      characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric
      Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15
      mg/kg dose of Ferric Carboxymaltose.
    

Detailed description: 
      This is a Phase II, open-label, non-randomized, multi-center, single arm study to
      characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric
      Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15
      mg/kg dose of Ferric Carboxymaltose.
    

Intervention name(s): Ferric Carboxymaltose (FCM)
Intervention type(s): Drug
Other intervention name(s): Injectafer
Intervention model: Sequential Assignment
Intervention model description: Eligible subjects were enrolled sequentially in Cohort 1 (FCM at 7.5 mg/kg with a maximum single dose of 750 mg) and Cohort 2 (FCM at 15 mg/kg with a maximum single dose of 750 mg). Enrollment in Cohort 2 was initiated only after all subjects in Cohort 1 completed 4 weeks of therapy and a Data and Safety Monitoring Board (DSMB) approved continuation.
Masking: None (Open Label)
Primary purpose: Treatment
Liver Glycogen Dynamics
Condition: Hepatic Glycogen
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of prolonged overnight fasting in the
      hepatic glycogen stores
    


Intervention name(s): Overnight fasting duration
Intervention type(s): Behavioral
Intervention description(s): Subjects will adhere to overnight fasting protocol for 1 day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Condition: Post Bariatric Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous
      exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous
      formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare
      disease with unmet clinical need.
    

Detailed description: 
      Post-Bariatric Hypoglycemia (PBH) is a rare, but increasingly reported disease occurring
      after bariatric surgery, characterized by severe hypoglycemic episodes accompanied by
      symptoms of hypoglycemia. At the moment, no medical therapies have been developed for this
      disorder, but the clinical need is great. The major contributory factor is thought to be an
      exaggerated secretion of glucagon-like peptide-1 (GLP-1) due to altered nutrient transit
      after bariatric surgery. GLP-1 is an incretin hormone secreted primarily by the distal ileum
      that contributes to postprandial glucose regulation. Exendin (9-39) is a specific GLP-1
      receptor antagonist, that when given via continuous IV infusion, has been shown to
      effectively prevent postprandial hypoglycemia and reduce symptoms of hypoglycemia in patients
      with PBH. This study is designed to assess the efficacy, safety and pharmacokinetic profile
      of a novel subcutaneous formulation of exendin (9-39).
    

Intervention name(s): Lyo avexitide; Liq avexitide
Intervention type(s): Drug; Drug
Intervention description(s): Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc); Liquid avexitide (Liq avexitide) administered subcutaneously (sc)
Other intervention name(s): Exendin (9-39); Exendin (9-39)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Bariatric surgery complications; Glucose Metabolism Disorders; Exendin (9-39); GLP-1
A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery
Condition: Anesthesia for Elective Surgery Patients
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate
      compared to propofol for general anesthesia during elective surgery.
    


Intervention name(s): Remimazolam Tosilate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): For induction and maintenance of general anesthesia; For induction and maintenance of general anesthesia
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, single-dose phase I study to investigate the absorption,
      metabolism and excretion of [14C] SH-1028 in healthy Chinese male subjects. The study will be
      conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot
      study to grope for the collection time of plasma, urine and feces sampling post-dose. Then,
      the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4
      subjects will be adjusted according to the pilot study.
    

Detailed description: 
      Subjects who had signed informed consent and meet inclusion criteria and no exclusion
      criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning
      of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an
      overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (88 μCi)
      of [14C]SH-1028 as an oral suspension. Then, after two days of the dosing, subjects will be
      transferred back to Phase I Clinical Unit ward and confined to this unit until blood or
      excreta sampling and safety monitoring at the designated time points or intervals are
      complete.
    

Intervention name(s): [14C] SH-1028
Intervention type(s): Drug
Intervention description(s): Volunteer will receive a single oral dose of 200 mg/88 uCi [14C]SH-1028 as a solution on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness
Condition: Serious Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention
      designed to increase activity participation and improve meaning in the lives of people with
      serious mental illness living in the community.
    

Detailed description: 
      5 Assertive Community Treatment (ACT) Teams from Kingston (n=2), Belleville (n=1), and Ottawa
      (n=2) will be involved in a 12 week randomized controlled trial of our Time Use Intervention.
      20 subjects (4 subjects from each team) will participate in this pilot study and will be
      treated individually by their ACT team Occupational Therapist (1 OT per ACT Team). This pilot
      test will help to determine the clinical utility and efficacy of our treatment protocol.

      Comparison: Standard ACT treatment with the Occupational Time Use Intervention vs. Standard
      ACT treatment
    

Intervention name(s): Occupational Time Use Intervention
Intervention type(s): Behavioral
Intervention description(s): 12 week behavioral intervention administered by Occupational Therapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Psychosis; Occupational Disengagement; Occupational Imbalance