bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude
Condition: Ketogenic Dieting; Altitude Hypoxia; Physical Activity
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional

Summary: 
      A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories
      with fat. KD is of increasing interest among athletes because it may increase their maximal
      oxygen uptake (VO2max), the principal performance limitation at high altitudes. The
      investigators examined the tolerance of a 4-week isocaloric KD (ICKD) under simulated hypoxia
      and the possibility of evaluating ICKD performance benefits with a maximal graded exercise
      bike test under hypoxia and collected data on the effect of the diet on performance markers
      and arterial blood gases.
    

Detailed description: 
      In a randomised single-blind cross-over model, 6 recreational mountaineers (age 24 to 44
      years) will complete a 4-week ICKD followed or preceded by a 4-week habitual mixed western
      diet (HD). Performance parameters (VO2max, lactate threshold [LT], peak power [Ppeak]) and
      arterial blood gases (PaO2, PaCO2, pH, HCO3-) will be measured at baseline under two
      conditions (normoxia and hypoxia) as well as after a 4-week HD and 4-week ICKD under the
      hypoxic condition.
    

Intervention name(s): Isocaloric ketogenic diet
Intervention type(s): Dietary Supplement
Intervention description(s): The ICKD definition was based on the works of Sansone (2018) and Trimboli (2020). We defined ICKD as a daily CHOs ingestion < 30 to 50 g.d-1, without any limitation in fat consumption. Participants self-selected their own diet based on a list of advised and forbidden foods developed to fit the definition of ICKD. There were no instructions to limit calories.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety of a Ready to Drink Supplement
Condition: Dietary Supplements
Study type: Interventional

Summary: 
      This study will examine a Ready to Drink (RTD) supplement.
    

Detailed description: 
      This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink
      (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and
      self-reported side effects.
    

Intervention name(s): RTD; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ready to Drink Supplement; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal
      glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in
      participants with type 1 diabetes mellitus (T1DM).
    


Intervention name(s): Nasal Glucagon; Intramuscular Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): Administered nasally; Administered IM
Other intervention name(s): LY900018; GlucaGen®
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      There is an impressive and growing body of data suggesting that massage therapy is effective
      in decreasing some symptoms of pathological conditions as well as facilitating growth,
      reducing pain, increasing alertness, diminishing symptoms of depression and anxiety, and
      enhancing immune function. Preliminary studies suggest that massage therapy decreases
      symptoms of anxiety and depression, and lowers salivary cortisol levels in a wide array of
      childhood and adult neuropsychiatric disorders including post-traumatic stress disorder,
      attention-deficit-disorder hyperactivity, depression, bulimia and anorexia-nervosa.
      Generalized Anxiety Disorder (GAD) is characterized by the presence of a constellation of
      signs and symptoms for at least 6 months in duration, with some type of functional disability
      or decrease in quality of life. The signs and symptoms of GAD include a myriad of somatic
      symptoms including muscle tension, headaches, backaches, fatigue, restlessness, insomnia, as
      well as psychological feelings of worry, anxiety, and feeling overwhelmed. Both
      pharmacotherapy and psychotherapy are effective in decreasing the signs and symptoms of GAD.
      Unfortunately, the vast majority of patients with GAD never receive adequate pharmacotherapy
      or psychotherapy. Therefore, the development of a complementary and alternative therapy that
      has demonstrated efficacy for GAD might be well received by patients.

      This study's goals are to investigate the efficacy of Swedish massage therapy vs. light touch
      therapy and better understand the biological effects of massage in patients with anxiety.
      Qualified participants will be randomly assigned to one of two groups in which they will
      receive Swedish massage therapy twice per week for 12 weeks or Light Touch therapy twice per
      week for 6 weeks followed by Swedish massage therapy twice per week for the next 6 weeks. The
      total length of the study is 13 weeks, which includes a screening visit that takes about 3
      hours and two therapy visits per week for 12 weeks that last about 1 hour each. Blood and
      urine will be collected at three of the visits. Compensation is up to $400 for completing the
      entire study.
    


Intervention name(s): Swedish Massage; Light Touch
Intervention type(s): Other; Other
Intervention description(s): Swedish massage, 45 minutes, 2 x per week for 6 weeks; Light touch, 45 minutes, 2 x week for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety, GAD, Massage
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to investigate a medicine for the treatment of symptoms and
      complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
    

Detailed description: 
      The NDO often occurs in patients with spina bifida or other spinal cord damage where the
      bladder muscle contracts more than normal during filling. These patients often have an
      inability to void, so that catheterization is required to empty the bladder.

      The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets
      are given to adults for the treatment of overactive bladder. A new liquid suspension has been
      developed to treat children and adolescents in this and other studies.

      The efficacy and safety of the solifenacin suspension was investigated. The take-up and
      length of time that the solifenacin suspension stays in the body was also investigated during
      this study. Effectiveness was measured by urodynamics (the filling and emptying of the
      bladder) and the urine volumes during catheterization together with the diary responses
      relating to the number of incontinence episodes or incontinence free days.

      Safety assessments included analysis of the blood and urine, review of the electrocardiogram
      (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function)
      and the ability to see near and far objects (visual accommodation).
    

Intervention name(s): Solifenacin succinate
Intervention type(s): Drug
Intervention description(s): Oral suspension administered once a day via syringe.
Other intervention name(s): YM905
Intervention MeSH terms: Solifenacin Succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Function; Phase 3; Neurogenic Detrusor Overactivity; Pharmacokinetics; Ocular Accommodation; Urodynamics
Effect of Ketamine on Opioid-Induced Hyperalgesia
Condition: Pain; Chronic Pain; Hyperalgesia
MeSH terms: Hyperalgesia; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare pain threshold, pain tolerance, and wind up, as
      measured by QST, before and after a single dose of ketamine infusion under two clinical
      conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid
      therapy.
    

Detailed description: 
      We hypothesize that:

        1. Chronic pain patients on chronic opioids would have a lower pain threshold and lower
           pain tolerance when compared to opioid naïve patients (patients with chronic pain with
           non-opioids treatment)., as measured by QST in a non-affected neutral limb;

        2. Chronic pain patients on chronic opioids would have an increased response to painful
           stimulation, so called "windup" as demonstrated by QST;

        3. Both "wind-up" and altered pain threshold and tolerance would be indicative of the
           presence of opioid-induced hyperalgesia;

        4. Intravenous ketamine, an NMDA receptor antagonist, could be used to differentiate
           between opioid-induced hyperalgesia and opioid tolerance.
    

Intervention name(s): Ketamine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.; To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
Other intervention name(s): Ketalar; Saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Pain; Chronic pain; Opioid induced hyperalgesia; Opioid therapy
The Effect of Central Sensitization on Assessment Capacity of Patients
Condition: Symptomatic Irreversible Pulpitis; Acute Apical Periodontitis of Pulpal Origin
MeSH terms: Periodontitis; Pulpitis; Periapical Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      the aim of this study is to evaluate the effect of dental hyperalgesia and mechanical
      allodynia on the assessment capacity of individuals in a local Turkish population. The
      hypothesis of this study is that excessive amounts of pain and a major functional shift in
      the somatosensory system due to central sensitization might cause unwitting intent.
    

Detailed description: 
      It included patients between the ages of 18 and 70 who had a symptomatic tooth in need of
      non-surgical root canal treatment. All enrolled subjects volunteered and signed a written
      informed consent. Patients diagnosed with systemic diseases and those who had used an
      analgesic within 12 hours prior to the appointment were excluded from the study. A total of
      30 patients were included in the study. A data sheet including patients' demographic data,
      diagnostic data, and data of explicit declaration of intent was completed. All pain scores
      were recorded according to the Visual Analog Scale (VAS). After the demographic data,
      diagnostic data. Patients were explicitly informed that the answers they were going to
      provide to the questions related to their explicit declaration of intent would not affect
      their diagnosis or the treatment they would undergo.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        non
      
Keywords: capacity; clinical ethics; autonomy; competence
Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Condition: Remote Ischemic Conditioning
MeSH terms: Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of remote ischemic conditioning on
      dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous
      thrombolysis.
    

Detailed description: 
      In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours
      from onset are included. The experimental group receive basic treatment and remote ischemic
      conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control
      group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times
      within 6 hours to 24 hours from thrombolysis . Both groups underwent dynamic cerebral
      autoregulation measurements at days 1 to 2 and 7 to 10 of onset and recorded the relevant
      indexes, and blood samples were collected before and 24 hours after intravenous thrombolysis,
      we aimed to determine the impact of remote ischemic conditioning combined with intravenous
      thrombolysis on dynamic cerebral autoregulation in acute ischemic stroke patients. We
      hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation
      in patients with acute ischemic stroke receiving intravenous thrombolysis.
    

Intervention name(s): remote ischemic conditioning; sham remote ischemic conditioning
Intervention type(s): Procedure; Procedure
Intervention description(s): Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. All patients underwent dynamic cerebral autoregulation on days 1-2 and 7-10 after onset, and intravenous blood was collected by a nurse and stored in the laboratory 0-6 hours after thrombolysis and 24 hours after thrombolysis.; Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. All patients underwent dynamic cerebral autoregulation on days 1-2 and 7-10 after onset, and intravenous blood was collected by a nurse and stored in the laboratory 0-6 hours after thrombolysis and 24 hours after thrombolysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Remote Ischemic Conditioning; Dynamic Cerebral Autoregulation
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
Condition: Major Depression; Temporal Lobe Epilepsy
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of
      major depression in subjects with temporal lobe epilepsy. The purpose of the study is to
      measure the severity and change in depressive and anxiety symptoms after 10 weeks of study
      treatment with escitalopram or placebo as measured by certain rating scales and
      questionnaires. In addition, the study will measure the frequency of seizures using a patient
      diary during the study. Finally, the study will assess the change in the quality of life
      using rating scales.
    


Intervention name(s): escitalopram; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study; Placebo
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of
      a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with
      elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily
      soluble allantoin that is then excreted.
    

Detailed description: 
      This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of
      a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with
      elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily
      soluble allantoin that is then excreted. Cohorts of Subjects will be given a single,
      ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid
      levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.
    

Intervention name(s): SEL-037 (pegsiticase)
Intervention type(s): Biological
Intervention description(s): Intravenous infusion of SEL-037
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction
Condition: Cardiovascular Disease; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      This study is a randomized 3-period crossover, controlled feeding study designed to evaluate
      the effects of the most commonly consumed spices in the U.S. on CVD risk factors,
      inflammation & immune function, and diet satisfaction in participants at risk for CVD.
    

Detailed description: 
      A 3-period randomized crossover controlled-feeding study will be conducted. Participants will
      be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet
      period will be separated by a standard 4-week compliance break. Data collection will be
      conducted across at baseline (start of study) and the end of each diet period to assess the
      effects of chronic spice consumption on selected cardiovascular endpoints.
    

Intervention name(s): Controlled feeding diet
Intervention type(s): Other
Intervention description(s): Average American diet with different levels of spices
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Effects of 3D-printed on Lower Extremity Biomechanics in Individuals With Knee Osteoarthritis
Condition: Medial Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle
      co-activation ratio of level walking and stair negotiation under three different conditions
      (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges),
      (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model,
      then, evaluate the compressive forces acting on the medial aspect of the knee during level
      walking and stair negotiation.
    

Detailed description: 
      This study is a cross-sectional study with patients serving as their own control. The
      investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system,
      force plates, wireless EMG to capture the motion data of patients during walking and stair
      negotiation in each condition.
    

Intervention name(s): 3D-printed foot orthoses; 5 degrees lateral wedge insoles
Intervention type(s): Device; Device
Intervention description(s): 3D printed foot orthoses with arch support; Insoles with a lateral inclination set at 5 degrees
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and
      Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster
      at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers
    


Intervention name(s): 1a - rMenB+OMV NZ and routine vaccines; 1b - rMenB+OMV NZ and routine vaccines; 2a - Routine and rMenB+OMV NZ vaccines; 2b - rMenB+OMV NZ and routine vaccines; 3a - rMenB+OMV NZ and routine vaccines; 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations; 4a- rMenB+OMV NZ and routine vaccines; 4b - rMenB+OMV NZ and routine vaccines
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose of rMenB vaccine and routine vaccine at study month 12.; One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.; One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.; Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.; One dose of rMenB vaccine and one dose of routine vaccine at study month 12.; One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.; One dose of rMenB vaccine and one dose of routine vaccine at study month 12.; One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: toddler; Meningococcal disease; prevention; vaccination