bioihbjkbjnl/mcl2 huggingface dataset:
ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
Condition: Obesity, Morbid; Spinal Anesthesia; Cesarean Delivery
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the
      super obese population undergoing cesarean section under a combined spinal epidural
      technique.
    


Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) <0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bupivacaine ED90; Cesarean Delivery; Obesity; Spinal Anesthesia
The Circadian Rhythm of Copeptin
Condition: Circadian Rhythm; Copeptin Blood Levels
MeSH terms: Diabetes Insipidus
Study type: Observational

Summary: 
      The circadian rhythm of copeptin will be examined in healthy subjects.
    

Detailed description: 
      In 18 healthy volunteers the circadian rhythm of copeptin will be examined by withdrawing
      blood samples for copeptin levels every 30 minutes for 24 hours.
    

Intervention name(s): observation
Intervention type(s): Other
Intervention description(s): blood sampling during 24 hours
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
Guided Bone Regeneration Versus Bone Block Grafting
Condition: Atrophy; Bone
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the volumetric gain and stability of the newly formed
      bone tissue comparing guided bone regeneration with block graft.
    


Intervention name(s): Khoury technique; Guided bone regeneration
Intervention type(s): Procedure; Procedure
Intervention description(s): the bone block will be used following the principles of the Khoury technique to augment the bone volume.; the membrane and the bone granules will be used to perform the guided bone regeneration technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone Regeneration
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the dose-response relationship and safety of VX-150 in treating
      acute pain following bunionectomy.
    


Intervention name(s): VX-150; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules for oral administration.; Capsules for oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin
Condition: Type 2 Diabetic Patients; Insufficient Metabolic Control; OAD Treatment
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to show that treatment with Glargine will lead to an improvement in
      beta cell function especially within times of maximal beta cell stress occurring after a
      meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will
      be performed and the postprandial secretion of intact proinsulin levels will be measured.
      These measurements will be performed with patients treated in combination with metformin and
      insulin glargine versus metformin plus NPH insulin (within the core study) and if significant
      difference is observed, with a third treatment arm with metformin plus insulin detemir.

      Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours
      after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin
      levels of metformin plus NPH insulin.
    


Intervention name(s): Insulin Glargin; NPH insulin; Insulin detemir; metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): metformin (2000 mg/day)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Detemir; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor
      itraconazole on the single-dose PK of TAK-954.
    

Detailed description: 
      The drug being tested in this study is called TAK-954. TAK-954 is being tested in healthy
      participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on
      the single-dose PK of TAK-954.

      The study will enroll approximately 10 participants. Participants will receive the following
      treatment sequences:

      • TAK-954 0.2 mg; Itraconazole 200 mg + TAK-954 0.2 mg

      Participants will be given an intravenous infusion of TAK-954 on Day 1 of First Intervention
      Period (6 days) followed by minimum 7-day washout period, after which participants will be
      given Itraconazole capsule on Days 1 to 8 along with TAK-945 infusion on Day 4 of Second
      Intervention Period (9 days).

      This single center trial will be conducted in the United States. The overall duration to
      participate in this study is 7 to 8 weeks. Participants will visit the clinic on Day -1 and
      remained confined until Day 6 (First Intervention Period) and Day 9 (Second Intervention
      Period). Participants will return for a Follow-up Visit 10 to 14 days after last dose of
      study drug (approximately up to Day 34).
    

Intervention name(s): TAK-954; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): TAK-954 Infusion; Itraconazole Capsule
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Brown Adipose Tissue Activation: Effect of Exercise Training and Irisin
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study investigates the brown adipose tissue (BAT) activation and metabolism using
      positron emission tomography (PET) imaging before and after exercise training intervention at
      fasting state under normal room temperature and during cold stimulation.The investigators
      hypothesize that BAT glucose uptake is increased after exercise and BAT becomes metabolically
      more active.

      Understanding the mechanisms of BAT activation and the role of exercise in humans is crucial
      to combat epidemic of obesity and diabetes.
    

Detailed description: 
      Exercise training has been suggested to activate and recruit human BAT through the activation
      of sympathetic nervous system and contracting skeletal muscles by the release of myokines
      such as lactate and irisin that signal WAT to induce expression of beige adipocytes. It has
      been also suggested that exercise training could enhance the metabolism of already existed
      functional BAT by increasing uncoupling protein-1 (UCP-1) gene transcription, mitochondrial
      biogenesis and hyperplasia. This is of clinical relevance because brown fat activation has
      been found to improve metabolic factors linked to obesity and diabetes.

      In this study the investigators use a PET radiotracer 2-[18F] flouro-2-deoxy-D-glucose (FDG)
      to quantify the glucose uptake in BAT, whie adipose tissue and the muscle.The participants
      are scanned thrice at fast in this study once at room temperature, second at cold exposure
      and third after six weeks of exercise at cold exposure. This study will provide an insight
      about the role of exercise in activation of BAT metabolism.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise, brown adipose tissue
PECS II Versus ICBN Block Plus SCNB for AV Fistula Creation in CRF Patients
Condition: Intraoperative Analgesia; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Brachial plexus block (BPB) is often utilized for proximal arm arteriovenous access creation.
      However, the medial upper arm and axilla are often inadequately anesthetized, as the
      Intercostobrachial nerve (which provides sensory supply to the axilla, upper medial arm, and
      a small area at the upper lateral chest) is not a component of the brachial plexus. This
      requires repeated, an intraoperative local anesthetic (LA) supplementation up to conversion
      into GA. The intercostobrachial nerve (ICBN) is a purely sensory nerve that arises primarily
      from the second intercostal nerve (T2) with occasional contribution from T3. Therefore, It is
      not a component of the brachial plexus and is not anesthetized by brachial plexus blockade.
      The ICBN can be blocked together with other nerves, such as the pectoral, intercostal, and
      long thoracic nerves in a recently described technique named pectoral nerves block type II
      (PECS II ).In this thesis, investigators compared the use of the PECS II block and ICBN block
      as a supplement to supraclavicular brachial plexus block for providing complete anesthesia of
      the upper arm for fistula creation surgery.
    


Intervention name(s): ultrasUltrasound-guided Intercostobrachial nerve block supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 m; ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block
Intervention type(s): Other; Other
Intervention description(s): patients recieved ultrasound-guided Intercostobrachial nerve block with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl ) .; Patients received ultrasound-guided pectoral nerves block type II with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl )
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen
Condition: Urologic Neoplasms; Carcinoma, Transitional Cell
MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Urologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for
      patients with transitional cell carcinoma of urothelium
    


Intervention name(s): Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transitional cell carcinoma of urothelium
Patient Education for Patients With Back Pain Referred to Physical Therapy
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate patients with low back pain who are scheduled to
      begin physical therapy but have not yet had their first appointment to better understand
      their beliefs and attitudes and to evaluate the effects of an educational session about low
      back pain.
    

Detailed description: 
      The investigators will conduct a randomized trial to examine the effectiveness of a patient
      education session provided prior to beginning physical therapy on outcomes of usual physical
      therapy for acute/sub-acute low back pain patients. The study compares two groups, one group
      will be treated with usual physical therapy with no pre-treatment education and the other
      group will also receive the pre-treatment. Patients will be followed after 6 weeks and 3
      months. Physical therapy care is left to the discretion of the physical therapist in
      conjunction with the patient. Outcomes will include pain and disability, and patients
      attitude and believes (pain catastrophizing, fear avoidance behavior). The overall hypothesis
      is that the additional educational treatment may address and improve pain, disability and
      fear.
    

Intervention name(s): Patient Education; Control
Intervention type(s): Behavioral; Other
Intervention description(s): An educational video was watched based on Consumer Reports Choosing Wisely patient education supporting the recommendation that imaging is not helpful early for low back pain and the best strategy is to remain as active as possible. Key themes were discussed with a physical therapist and the patient's questions were answered.; Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Efficacy of the Prototype RPC (Rapid Pulse Confirmation) Device in Detecting Return of Pulsatile Flow in Patients Preparing to Separate From CPB (Cardiopulmonary Bypass)
Condition: Circulatory Failure; Cardiac Arrest
MeSH terms: Shock
Study type: Observational

Summary: 
      Effective chest compressions are essential to survival in an arrest patient receiving CPR
      (cardiopulmonary resuscitation). A challenge in providing effective chest compressions is
      frequent interruption of compressions. A major cause of a recurrent interruption of chest
      compressions is pulse checks. Pulse checks are difficult to quickly and accurately perform in
      the AHA recommended time interval of under 10 seconds for reasons ranging from inexperience
      to body habitus. Unnecessarily long pulse checks often delay reinitiating chest compressions
      leading to a fall in perfusion pressure to the coronary arteries lowering the chances of
      return of spontaneous circulation (ROSC). To potentially solve the issues of evaluating the
      chest compression effectiveness and minimize the time interval of pulse checks, the authors
      have constructed a novel device that can be rapidly applied to an arresting patient and
      evaluate the current state of the circulatory system. The device is called the Rapid Pulse
      Confirmation (RPC) device. It is designed to applied over a major artery (radial, ulnar,
      brachial, carotid, and femoral) and detect Doppler shift of red blood cells to gauge red
      blood cell velocity and rate of pulsation. Feasibility testing on the device was carried out
      using patients requiring cardiopulmonary bypass. Arrest and return of spontaneous circulation
      during cardiopulmonary bypass is predictable and provided an ideal environment to test the
      initial performance of a device meant to detect return of spontaneous circulation. The
      primary working hypothesis was that there would be no significant difference in time of
      detection of ROSC between the arterial line catheter and the RPC device at the end of
      cardiopulmonary bypass. The secondary hypothesis was that there would be no difference in
      pulse rate reading between the arterial line catheter and the RPC device.
    


Intervention name(s): rapid pulse confirmation device
Intervention type(s): Device
Intervention description(s): device used to detect pulsatile blood blood during and after cardiac arrest
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled isolated open-heart valve or isolated coronary artery bypass graft
        surgery.
      
Keywords: cardio pulmonary resuscitation; pulse detection; chest compressions
School-based Treatment for Anxious Children
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of a school-based cognitive behavior therapy in
      urban, predominantly low-income, African-American children diagnosed with an anxiety
      disorder.
    

Detailed description: 
      Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal
      part of life and growing up, for some children this anxiety becomes chronic, relentless, and
      progressively worse if left untreated. Physical symptoms typically accompany the intense
      anxiety caused by the disorder and may include blushing, profuse sweating, trembling, nausea,
      and difficulty talking. Anxiety disorders among children have become increasingly prevalent,
      indicating that excessive fear, worry, and anxiety in children are emerging public health
      issues. Recent studies have shown that CBT is an effective form of treatment for childhood
      anxiety disorders; however, it often requires the use of expert CBT clinicians. The purpose
      of this study is to deliver a school-based version of CBT to predominantly low-income,
      inner-city, African-American children with anxiety disorders. Clinicians within the school
      will undergo CBT training and adapt the treatment program to fit the needs of the
      participating children.

      All participants in this study will undergo an initial evaluation to assess anxiety symptoms,
      disorders, and associated impairments. The children will then be randomly assigned to receive
      12 weekly sessions of school-based CBT or treatment as usual, which will involve 12 weekly
      sessions of psychosocial treatment. Three parent sessions will be offered for families in
      both groups at Weeks 2, 6, and 10. All treatment sessions will occur at school during the day
      and will be led by school-based clinicians. A follow-up session will be conducted at
      post-treatment and 1 month after the last session to assess anxiety symptoms and disorders.
      Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of
      each child.
    

Intervention name(s): Cognitive behavioral therapy (CBT); Treatment as usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.; TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Other intervention name(s): CBT; TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive behavioral therapy; Youth; School; African American
Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Observational cross-sectional multicenter study about clinical effect of intermitent
      continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public
      health system.
    

Detailed description: 
      Observational cross-sectional multicenter study about clinical effect of intermitent
      continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public
      health system.

      All clinical variables are gathered from chart review. Data analysis is conducted using SPSS
      statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or
      Wilconxon signed test were used fr the analysis differences. Comparison between proportions
      were analyzed using a chi-square test. A P value <0.05 was considered statistically
      significant.

      The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic
      Commitee. All participants provided written consent.
    

Intervention name(s): Flash
Intervention type(s): Device
Intervention description(s): Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.
Other intervention name(s): FreeStyle Libre; iCGM
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients >18 years with type 1 diabetes and previously followed in the DIACAM study
        (see reference).
      
Keywords: type 1 diabetes; intermitent continous glucose monitoring; Flash
Pharmacokinetics of Metronidazole Dermal Products
Condition: Bioequivalence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Generate human PK data by collecting data following the application of metronidazole
      formulations.
    

Detailed description: 
      This research study is intended to develop models for in vitro/in vivo correlation (IVIVC) of
      drug absorption from dermal products. This study will use metronidazole products that have
      already been approved by the Food and Drug Administration (FDA) and are already sold to
      customers in the United States; will not include any placebos.
    

Intervention name(s): Metronidazole gel 1; Metronidazole gel 2; Metronidazole cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RLD gel; generic gel; generic cream
Other intervention name(s): metronidazole; metronidazole; metronidazole
Intervention MeSH terms: Metronidazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science