bioihbjkbjnl/mcl2 huggingface dataset:
TMS-evoked Potentials During Heat Pain
Condition: Heat; Pain; Electroencephalography; Transcranial Magnetic Stimulation
Study type: Interventional

Summary: 
      This study investigates the modification of the local-to-global connectivity pattern in
      response to experimental heat pain. Transcranial magnetic stimulation (TMS) will be applied
      to elicit electroencephalography (EEG) responses in healthy volunteers. The TMS-evoked
      potentials (TEPs) will be recorded and serve as a reflection of cortical reactivity to TMS. A
      thermal cutaneous heat stimulus will induce painful sensations.
    

Detailed description: 
      Abnormal connectivity patterns interfere with the normal function of a given neuronal
      network, thus leading to circuit dysfunction and, subsequently, chronic pain. In the last few
      years, neuroscience has been heavily influenced by network science. This synergistic
      association provided a new framework for understanding brain function in health and how
      dysfunction in specific neuronal brain circuits can lead to symptoms. A network comprises
      nodes (e.g., areas of the brain) and edges (functional connections between nodes). An
      effective network can process and share large amounts of information while maintaining
      specificity and not allowing noise to contaminate the flow of information across the
      circuits. The network approach to brain functioning has been able to integrate what has been
      known for several decades as spatial structural anatomy with the time-varying streaming of
      information (connectivity) in a dynamic perspective. In this context, symptoms of diseases
      are seen as being correlated with specific network abnormalities, and therapeutic
      interventions as being associated with the normalisation of these abnormal patterns of
      connection. This study will investigate the responses of specific neuronal brain circuits to
      experimental heat pain in healthy volunteers. It has been hypothesised that the
      local-to-global connectivity pattern obtained by the stimulation of different cortical hubs
      (e.g., the primary motor and dorsolateral prefrontal cortices) will be described by TMS-EEG
      responses in healthy individuals, and the modification in cortical connectivity in
      experimental models will be described and compared it with a non-painful sensory stimulation
      of the same salience.
    

Intervention name(s): Heat stimulus
Intervention type(s): Device
Intervention description(s): Contact heat pain stimulus with a termode set at 46 degrees and contact warm stimulus with a termode set at 40 degrees
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects
Condition: Pharmacodynamic Interaction; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate whether naproxen and darexaban which have
      different effects on blood coagulation influence each other in their effects. Also it will be
      investigated whether the blood levels of either drug are influenced by the presence of the
      other drug. In addition, the safety and tolerability of each drug and the combination of the
      drugs will be investigated.
    


Intervention name(s): darexaban; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM150; Naprosyne
Intervention MeSH terms: Naproxen; Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacodynamics; darexaban; naproxen; YM150; Phase 1
The Outcomes of Subject After Total Knee Arthroplasty
Condition: Satisfaction, Patient
Study type: Observational

Summary: 
      Total Knee Arthroplasty (TKA) is a standard of intervention for severe knee osteoarthritis,
      also been proven with benefits in improving pain, mobility, and quality of life. However, the
      outcomes after TKA is controversial.
    

Detailed description: 
      Total Knee Arthroplasty (TKA) clinical pathway provides preoperative education, postoperative
      rehabilitation, and routine outpatient follow-up. The overall functional performance of the
      patient was assessed. The aim of this study was to analyze (1) clinical pain relief, anxiety
      reduction and functional recovery after TKA; (2) factors affecting individual functional
      recovery, such as age, gender, BMI, etc.

      The results can be used as a reference for improving the quality in TKA patients.
    

Intervention name(s): Total knee arthroplasty
Intervention type(s): Procedure
Intervention description(s): patient who received a TKA in our hospital
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The data were collected from CCH2000 / TKA clinical pathway databank retrospectively.
      
Keywords: Total Knee Arthroplasty (TKA); Western Ontario and McMaster Universities Arthritis Index
Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer
Condition: Advanced Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether AZD0156 is safe, what is the best dose to
      give, and how it is processed by the body when given alone or in combination with other
      agents. The study will also collect some initial information about how effective it is.
    

Detailed description: 
      The study will consist of a number of study modules, each evaluating the safety and
      tolerability of AZD0156 with a specific combination agent. The combination option may require
      an initial monotherapy dose escalation to gain an understanding of pharmacokinetics, safety
      and tolerability before initiating dose escalation in combination. An oral formulation of
      AZD0156 will be used.

      Module 1 explores AZD0156 in combination with olaparib Module 2 explores AZD0156 in
      combination with irinotecan/FOLFIRI Additional modules may be added to explore AZD0156 as a
      monotherapy or in combination with other agents and may be in different tumour types.

      Expansion cohorts may enroll additional patients to explore further the safety, tolerability,
      pharmacokinetics and biological activity at selected dose(s) or alternate dosing schedules,
      and to get a preliminary assessment of efficacy .

      Module 1 includes an expansion cohort in locally advanced/metastatic tumours including but
      not limited to gastric adenocarcinoma Module 2 includes an expansion cohort in colorectal
      cancer
    

Intervention name(s): AZD0156; Olaparib; irinotecan; Fluorouracil; Folinic Acid
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): All patients will receive AZD0156 as a monotherapy or in combination to assess safety and tolerability.; Module 1 combination with olaparib; Module 2 combination with irinotecan/FOLFIRI; Module 2 combination with irinotecan/FOLFIRI; Module 2 combination with irinotecan/FOLFIRI
Other intervention name(s): AZD2281, Lynparza; Camptosar; 5-FU, Adrucil; leucovorin
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Irinotecan; Olaparib; AZD0156; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I, open label study; safety and efficacy of AZD0156; ATM inhibitor
Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to explore the efficacy, dose-response and safety of PG201
      tablet in Korean patients with osteoarthritis.
    

Detailed description: 
      In this study, the PG201 extract, the study drug, was administered twice daily after a meal
      to two investigational groups, the lower-dose group and the higher-dose group. The efficacy
      of each of dose group was compared to that of the control group to determine if there was a
      statistically significant difference between the investigational groups and the placebo
      group. In addition, the efficacy between the lower dose group and the high dose group was
      also compared to determine if there was a statistically significant difference.
    

Intervention name(s): PG201; Placebo
Intervention type(s): Other; Other
Intervention description(s): two tablets; two tablets
Other intervention name(s): Botanical drug; control drug(placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with
      pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head
      comparison in the same patient. The investigators hypothesize that pharmacologic stress
      myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion
      SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery
      disease (CAD) who present with symptoms consistent with possible worsening of their CAD.
    


Intervention name(s): Myocardial perfusion imaging
Intervention type(s): Procedure
Intervention description(s): Randomization assignment to one of SPECT or PET myocardial perfusion imaging
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Myocardial perfusion imaging; Single photon emission computed tomography; Positron emission tomography
Independent Walking Speed and Crossing a City Street
Condition: Balance Problems; Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine if selected sequence training using the Balance
      Master, added to established physical therapy treatment programs, will increase gait velocity
      of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their
      ability to cross an intersection within the confines of community traffic signal (>120
      cm/sec).
    

Detailed description: 
      The ability to adequately perform functional tasks at a level that allows independent
      community living is key to measuring the success of any physical therapy program. The
      essential tasks needed to allow independent community living have been well documented in the
      elderly population. However, these tasks have not been delineated in the pediatric
      population. The investigators aim to determine if selected sequence training using the
      Balance Master, added to established physical therapy treatment programs, will increase gait
      velocity of ambulatory children receiving in-or outpatient rehabilitation in relation to
      their ability to cross an intersection within the confines of community traffic signal (>120
      cm/sec). One essential task that is necessary in the urban environment is to have the ability
      to cross a street within the time constraint of a traffic signal. Walking speed becomes
      increasingly important for those living in urban settings, as the ability to cross the street
      safely is fundamental for achieving independence. One of the major criticisms of
      clinic/lab-based measures of gait speed is that relative performance may not be
      representative of independence within the community. Participants aged 5 to 21 years, will be
      recruited from the patient population at Blythedale Children's Hospital for a six week trial.
      Children will be assigned to one of two random groups: one weekly Balance Master sequence
      training group (in addition to their regularly scheduled therapy sessions) and a group that
      continue regularly scheduled therapy sessions alone. Gait velocity will be measured by "Walk
      Across" Functional Assessment using Balance Master long force plate.
    

Intervention name(s): Balance Master; Customary Care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gait; balance; street-crossing
Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this study is to determine the clinical performance of comfilcon A in comparison
      to senofilcon C.
    

Detailed description: 
      This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily
      wear, two month dispensing study comparing the clinical performance of comfilcon A and
      senofilcon C lenses after one month of wear.
    

Intervention name(s): comfilcon A; senofilcon C
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position
Condition: Cardiac Index
Study type: Interventional

Summary: 
      The purpose of this study is to find out the effect of low abdominal pressure vs. standard
      abdominal pressure on the cardiac and respiratory function of the patients undergoing
      laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the
      effect of the degree of neuromuscular blockade on the surgical condition of the patients
      undergoing laparoscopic colon surgery in Trendelenberg position.
    


Intervention name(s): Standard abdominal pressure; Low abdominal pressure; Conventional neuromuscular blockade; Deep neuromuscular blockade
Intervention type(s): Device; Device; Drug; Drug
Intervention description(s): Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery; Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery; Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch; Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch
Other intervention name(s): Abdominal pressure
Intervention MeSH terms: Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Early Rest on Recovery From Pediatric Concussion
Condition: Mild Traumatic Brain Injury; Concussion; Post-concussive Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to find out if strict rest for 5 days helps children get better
      after concussion.
    

Detailed description: 
      The purpose of this study is to find out if strict rest for 5 days helps children get better
      after concussion. This research is being done because, currently, there is no effective
      treatment for concussion. Physical activity (for example; running, playing sports) and brain
      activity (for example; homework and tests) may make concussion symptoms worse. We are
      studying whether strict rest after concussion may help improve symptoms. About 110 children,
      ages 11-22 years old will take part in this study at the Children's Hospital of Wisconsin.
      This study is being funded by the Injury Research Center. The research grant pays for study
      procedures, follow-up testing, and patient reimbursement. Research staff is not being
      provided incentives to enroll subjects.
    

Intervention name(s): Mandated Rest, Intervention
Intervention type(s): Behavioral
Intervention description(s): In addition to CDC based discharge instructions, the intervention group will receive instructions with strict activity restriction explicitly stating "No return to school" and "No Physical Activity" for the next five days. Patients and parents in the intervention group will be provided school and work excuses for the five days post-injury.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: mild traumatic brain injury; Concussion; postconcussive syndrome
Insulin Glulisine in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To compare the pharmacodynamics of insulin glulisine and insulin lispro injected
      subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects
      with type 2 diabetes.

      Secondary objectives:

        -  To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese
           subjects with type 2 diabetes, injected subcutaneously before three standard meals
           during a 12-hour day.

        -  The safety of insulin glulisine, the relationship of the pharmacodynamics and
           pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid,
           triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.
    


Intervention name(s): Insulin Glulisine
Intervention type(s): Drug
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Condition: Vitamin D Deficiency
MeSH terms: Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the
      Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3
      (Rocaltrol) in the patients with CKD stage 3-5.
    

Detailed description: 
      This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney
      disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global
      Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin
      D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2
      group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of
      patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25
      hydroxyvitamin D. Other outcomes will also be assessed, which include secondary
      hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.
    

Intervention name(s): Vitamin D2; 1,25(OH)2 Vit D3
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with Vit D2.; Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Other intervention name(s): Vitamin D2 soft capsules; Rocaltrol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic kidney disease mineral and bone disorder; vitamin D2; parathyroid hormone
A Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Participants With Negative Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether add-on TAK-831 is superior to placebo on
      the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).
    

Detailed description: 
      The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat
      negative symptoms in participants who have schizophrenia.

      The study will enroll approximately 234 participants. Participants will then be randomly
      assigned (by chance, like flipping a coin) to one of the four treatment groups in the
      double-blind period-which will remain undisclosed to the participant and study doctor during
      the study (unless there is an urgent medical need):

        -  TAK-831 50 mg once daily

        -  TAK-831 125 mg once daily

        -  TAK-831 500 mg once daily

        -  Placebo once daily

      This multi-center trial will be conducted in the United States, Spain, Italy, Czech Republic,
      Poland, Bulgaria and Ukraine. The overall time to participate in this study is approximately
      20 weeks. Participants will make 11 visits to the clinic, and will be followed up for safety
      assessment 10 to 14 days after the last dose of study drug (Day 98).
    

Intervention name(s): Luvadaxistat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-831 tablets.; Luvadaxistat placebo-matching tablets.
Other intervention name(s): TAK-831
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug therapy
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort
      study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses
      of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will
      participate in this study, with the first 9 volunteers in each cohort to qualify being
      randomized to receive study medication and the remaining 3 to be used as backups/ alternates.
      In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will
      receive placebo.
    

Detailed description: 
      Doses from 1 to 30 mg were tested
    

Intervention name(s): NW-3509a
Intervention type(s): Drug
Intervention description(s): single dose
Other intervention name(s): NW-3509
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment