bioihbjkbjnl/mcl2 huggingface dataset:
TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery
Condition: Colorectal Surgery; TAP Blocks
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized study designed to compare the pain control from a single
      shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters
      with ropivicaine bolus in patients undergoing elective colorectal surgery.
    

Detailed description: 
      At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal
      surgery patients for perioperative pain control. This practice, however, is resource
      intensive, adds the risk of catheter-related complications, and adds increased burden to
      patients by requiring them to be tethered to 2 catheters.

      An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel),
      an extended release local anesthetic that is FDA-approved for surgical plane infiltration
      including TAP blocks.

      With this prospective study, we seek to improve patient care at UC Davis and educate other
      institutions through the use of concrete data comparing these 2 treatment options.
    

Intervention name(s): Exparel; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.; Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Other intervention name(s): Bupivacaine liposome injectable suspension; Naropin
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
Condition: Atrial Fibrillation; Hypertension
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to determine the role of renal sympathetic denervation in the
      prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a
      catheter-based AF ablation procedure is planned. Patients will be randomized to either AF
      catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
    


Intervention name(s): catheter ablation; renal sympathetic denervation
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient anesthesia will be administered according to standard EP lab protocol. Arterial and venous access will be achieved through cannulation of the right and/or left femoral arteries and veins as per the usual practice of the EP lab. Full systemic anticoagulation will be instituted as per standard hospital procedures to a target ACT of approximately 300 seconds or greater. Intravascular ultrasound may be used to assist in the positioning of study catheters during the procedure. The AF ablation procedure will be performed using a cryoballoon ablation catheter. Complete pulmonary vein isolation will be the goal of the ablation procedure and PV isolation must be confirmed by a multielectrode mapping catheter within each PV. Pulmonary vein isolation is the only intervention. A cavo-tricuspid isthmus line may be placed in patients with either a history of ECG-determined typical flutter or induced typical flutter during the procedure.; Right or left femoral artery access. Real-time 3D aorta-renal artery maps constructed with the use of a navigation system and ablation catheter. Mapping and ablation performed after PVI and under identical sedation protocol used for AF ablation. RF delivery of 6 watts to be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium; RF duration of each delivery 1.5 mins; lesions delivered at multiple sites based on multipolar catheter position within renal artery. Use of specifically designed RF delivery system for renal artery denervation is mandatory (RDN). To confirm renal denervation, high-frequency stimulation (HFS) will be applied before the initial and after each RF delivery within the renal artery. Rectangular electrical stimuli will be delivered at the ostium of the targeted renal artery at a frequency of 20 Hz, with an amplitude 15 V and pulse duration of 10 ms for 10 secs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Condition: Tardive Dyskinesia (TD)
MeSH terms: Dyskinesias; Tardive Dyskinesia; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the
      potential for clinical dependence and withdrawal symptoms associated with valbenazine.
    


Intervention name(s): Valbenazine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Other intervention name(s): Ingrezza, NBI-98854
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
Condition: Pain, Acute
MeSH terms: Acute Pain; Hip Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group
      block which is performed preoperatively to assist positioning patients for performance of
      spinal anesthesia.
    


Intervention name(s): PENG Block; Conventional opioid analgesia (Fentanyl)
Intervention type(s): Procedure; Drug
Intervention description(s): Pericapsular Nerve Group Block; standardised intravenous opioid
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hip fracture, postoperative analgesia, positioning pain
Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy
Condition: Cancer
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      Cancer-related fatigue has been described as a subjective feeling of physical, emotional,
      and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome
      symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the
      trajectory of their disease. Treatment interventions for cancer-related fatigue have been
      largely unsuccessful. Homeopathy involves treatment of patients with diluted natural
      substances aimed at stimulating the body's healing system. In the efficacy trial literature,
      individualized homeopathy shows the most promise over other forms of homeopathic
      intervention. Individualized homeopathic treatment involves a unique yet established method
      of case taking. During the consultation, the homeopath asks a series of broad questions to
      elicit subjective symptoms related to the patient's disease, their medical history, as well
      as particular characteristics (physical or psychological) related to the individual. This
      study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat
      their fatigue. This study hypothesizes that homeopathic treatment will effectively treat
      fatigue.
    


Intervention name(s): Homeopathic Remedies
Intervention type(s): Other
Intervention description(s): The homeopathic remedy will be administered as either 1 globule sublingual or 0.2 mL oral (depending on chosen formulation) up to 3 times per day. The homeopath will decide which formulation will be used. Homeopathic remedies prepared according to the standards as set out by Health Canada. The caregiver or patient will be asked to administer the homeopathic remedy at least 30 minutes before or after taking other medications, food and strong smelling substances (such as camphor, mint, or coffee).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cancer; Fatigue; Chemotherapy; Pediatrics; Homeopathy
A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in
      healthy Chinese volunteers.
    

Detailed description: 
      Single dose safety and tolerability study: evaluate safety and tolerability of intravenous
      infusion nemonoxacin 25mg, 50mg, 125mg, 250mg, 500mg, 750mg, 1000mg and 1250mg.

      Single dose pharmacokinetic (PK) study:evaluate PK profile of doses of 250mg, 500mg or 750mg
      intravenous infusion nemonoxacin .

      Multiple dose study: evaluate PK profile of doses of 500mg, 650mg or 750mg intravenous
      infusion nemonoxacin after consecutive 10 days.
    

Intervention name(s): Nemonoxacin Malate Sodium Chloride
Intervention type(s): Drug
Intervention description(s): Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Intervention MeSH terms: Nemonoxacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Volunteers
Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy
Condition: Paravertebral Block; Hepatectomy; Analgesia; Postoperative Recovery
Study type: Interventional

Summary: 
      Hepatectomy induces moderate to severe postoperative pain. Patient-controlled intravenous
      analgesia has been used in many medical centers for post-hepatectomy analgesia, but the
      effects are limited and often cause undesirable adverse effects.

      Regional Block has been used for postoperative analgesia in many surgeries. Some studies
      suggest that regional analgesia has an opioid-sparing effect and can reduce the incidence of
      chronic pain. Also, the programmed intermittent bolus infusion is better than continuous
      infusion, with less analgesic consumption and fewer adverse effects.

      Studies on the early and late postoperative analgesia and recovery effects of paravertebral
      block for open hepatectomy are scarce. Therefore, the investigators aim to conduct a
      prospective, randomized, subject and assessor-blinded, parallel-group, placebo-controlled
      study to test the hypothesis that the programmed intermittent bolus infusion of right
      thoracic paravertebral block reduces postoperative intravenous analgesic use and pain scores
      and improved patients' satisfaction.
    

Detailed description: 
      This study aims to compare the early postoperative morphine consumptions, pain scores, rescue
      analgesics, adverse effects and recovery indices, and the late postoperative life quality
      between patients with and without paravertebral block.
    

Intervention name(s): Paravertebral block-ropivacaine; Paravertebral block-saline; patient controlled analgesia with morphine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h); Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% saline infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h); Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg
Other intervention name(s): PVB group; Control group; PCIA
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Impact of Ketogenic Diets in Preventing Relapse in Obesity Management
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Low-carb ketogenic diets have become extremely popular because of large weight loss in the
      short-term. Yet their potential benefits in preventing long-term weight regain have not been
      assessed in large scale studies.

      The aim of this study is to determine the effect of a low-carbohydrate (CHO) ketogenic diet,
      compared with an isocaloric balanced diet, on the maintenance of weight loss. The secondary
      aim is to investigate the impact of both diets on appetite. Adults with obesity (30<BMI<40
      kg/m2), will first undergo 4 weeks of a very-low energy diet aimed at inducing 5-10% weight
      loss and then will be randomized to two different weight maintenance diets for 1 year. One
      will be a low-CHO ketogenic diet (50 g CHO/day) plant-based (e.g. with less animal protein
      and more plant-based), and the other a diet following the Norwegian Health Directorate
      recommendations. Only conventional foods will be used in both diets.
    


Intervention name(s): Ketogenic weight loss maintenance diet; Isocaloric balanced weight loss maintenance diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.; The isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diet, Ketogenic; Weight Loss; Body Weight
Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare two treatment strategies (doubling the dose of inhaled steroids or
      adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not
      controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one
      inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.
    

Detailed description: 
      A multicentre, randomised, double-blind, double dummy, parallel group study to compare the
      salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily
      and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a
      dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not
      controlled by inhaled corticosteroids alone at medium dose
    

Intervention name(s): Fluticasone propionate; Fluticasone propionate/salmeterol
Intervention type(s): Drug; Drug
Intervention description(s): 200μg twice daily; 50/100μg twice daily
Other intervention name(s): Fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FLIXOTIDE; asthmatics children 4-11 years; SERETIDE; asthma-control
Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose
Condition: Diabetes; Hypertension; Sleep
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to test the short-term effects of intermittent standing, slow cycling and
      slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure
      among pre-hypertensive and pre-diabetic adults.
    

Detailed description: 
      This study will enroll 10 adults who will each complete four experimental conditions in
      random order. Each of the four experimental conditions are as follows: 1) sit continuously
      for 8 hours in a simulated office environment, 2) break-up sitting time with standing based
      on set hourly intervals, 3) break-up sitting time with slow-walking on a treadmill desk based
      on set hourly intervals, 4) increase energy expenditure by slow cycling based on set hourly
      intervals. Participants will completed each condition one week apart and dietary intake will
      be standardized by giving participants the same meals during each intervention condition.
      Study measures will include: anthropometrics (height and weight), blood pressure, fasting
      glucose, 24-continuous glucose monitoring, full-day ambulatory blood pressure monitoring,
      cognitive testing (cognitive performance), energy expenditure, physical activity via
      accelerometer, sleep via accelerometer, and heart rate.
    

Intervention name(s): Maintaining posture and energy expenditure; Increasing energy expenditure; Changing posture; Increasing energy expenditure and changing posture
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will sit continuously for 8-hrs during a simulated office environment; Participants will cycle slowly while seated in prescribed hourly intervals. This condition will increase energy expenditure while keeping a sitting posture; Participants will transition from sitting to standing in prescribed hourly intervals. This condition will change posture (sit to stand) while maintaining low energy expenditure; Participants will transition from sitting to a walking workstation in prescribed hourly intervals. This condition will both increase energy expenditure and change posture.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
Condition: Cicatrix; Wound-healing
MeSH terms: Cicatrix; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate early wound healing of one application of four
      different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects
      two years post-menopausal.
    

Detailed description: 
      Each subject received a total of six, 3mm punch biopsy wounds; three wounds to the upper
      inner aspect of each arm. Each punch biopsy site was randomly allocated to receive one of six
      treatments: Zesteem (0.02μg, 0.1μg, 0.2μg and 0.4μg/100μl), Placebo (vehicle), and Standard
      Care (moist wound healing dressings) only.

      Zesteem and Placebo were administered to marked, anaesthetised sites, by intradermal
      injection 10 to 30 minutes before wounding. Sites randomised to receive Standard Care only
      received no additional treatment before wounding. After wounding, all sites received moist
      wound healing dressings (Standard Care).

      Three days after wounding, all biopsy sites were anaesthetised and the wounds excised using a
      5mm punch biopsy, for histological analysis. The Investigator closed all excision sites using
      sutures and Steri-strips to achieve a cosmetically acceptable result. Subjects attended a
      post-trial follow-up visit (13-18 days after dosing) where their sutures were removed and
      final safety assessments were performed.
    

Intervention name(s): Zesteem; Zesteem; Zesteem; Zesteem; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy; Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy; Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy; Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy; Intradermal placebo, 100μl administered once before punch biopsy
Other intervention name(s): 17β-Estradiol; RN1002; 17β-Estradiol; RN1002; 17β-Estradiol; RN1002; 17β-Estradiol; RN1002
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cicatrix; Scar; Wound-healing; Zesteem; 17β-Estradiol; RN1002
Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
Condition: Digestive System Diseases; Colonoscopy Sedation
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional

Summary: 
      Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the
      administration of propofol by non-anesthesiologists, despite moderate quality evidence that
      support its' use.

      There is only one small trial of a direct comparison of propofol sedation by
      anesthesiologists versus non-anesthesiologists.

      Our aim is to compare the incidence of sedation related adverse events, the procedural
      quality indicators, times (onset, recovery, discharge) and patient satisfaction between
      non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist
      propofol sedation.

      A randomized clinical trial with the incidence of sedation related minor adverse events as
      primary endpoint will be conducted. Secondary endpoints include procedure quality indicators,
      propofol dosage and patient satisfaction.

      A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90%
      power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events
      incidence, estimated from our pilot experience. The sample size was adjusted for a 2%
      cross-over rate.

      Informed and consenting patients undergoing colonoscopy examinations will be randomly
      assigned to one of two arms. One group will be sedated by an anesthesiologist according to a
      protocol of propofol mono-sedation. The other group will be sedated with propofol boluses,
      according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a
      3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained
      in NAAP and exclusively dedicated to sedation and patient monitoring.
    


Intervention name(s): Non-anesthesiologist propofol sedation; Propofol sedation administered by an anesthesiologist; Colonoscopy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy; Propofol sedation by an anesthesiologist; Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Colonoscopy; Sedation; Propofol; Non-anesthesiologist propofol administration