bioihbjkbjnl/mcl2 huggingface dataset:
VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
Condition: Haemothorax; Empyema
MeSH terms: Empyema; Hemothorax
Study type: Interventional

Summary: 
      This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to
      reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is
      that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less
      complications and shorter hospital stay.
    


Intervention name(s): VATS ( Video-Assisted Thoracoscopy ); Thoracostomy Tube reinsertion
Intervention type(s): Procedure; Procedure
Intervention description(s): the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax; the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VATS( Video-Assisted Thoracoscopy ); Thoracostomy Tube; Empyema; Thoracotomy
The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects.
Condition: Diopathic Pulmonary Fibrosis; Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to learn about the safety, tolerability and
      pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer
      are:

      Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy
      subjects.Food effect in healthy subjects.Participants will complete the study including
      screening period, dosing period, and observation period. Researchers will compare the
      inhibitory activity of SC1011 tablets with pirfenidone capsules against the same
      biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.
    

Detailed description: 
      This is a double-blind, placebo-controlled, single, and multiple oral dose study conducted in
      2 parts.Part A will comprise a single-dose, sequential-group study incorporating a food
      effect evaluation. Part B will comprise a multiple-dose, sequential-group study.
    

Intervention name(s): SC1011
Intervention type(s): Drug
Intervention description(s): Each subject in the SAD groups participated in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours post dose).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Ultrasound Assessment During Exercise
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluates the ability of the transverse abdominis (TrA) to contract during and
      after two different types of exercise - either sling based exercise or traditional core
      stability exercise. The TrA is measured by real time ultrasound imaging. The investigators
      hypothesized that the sling based exercise would activate the TrA to a greater degree and
      that there would be a greater activation after the exercise.
    


Intervention name(s): Exercise; Core stability exercise
Intervention type(s): Other; Other
Intervention description(s): Redcord (sling exercise) and traditional exercise; Traditional core stability exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Core; Redcord; RUSI; low back
Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Condition: Anti-Inflammatory Agents, Non-Steroidal; Pain, Postoperative; Laparoscopy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, double blind, placebo-controlled, parallel group study will be conducted in
      the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged
      18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia
      will be involved in this study. According to previous studies and our pilot trial, the sample
      size was estimated to be 120 subjects. All eligible patients will be randomly assigned to one
      of three groups: Group A (single parecoxib) receiving parecoxib 40mg at 30min before the end
      of surgery; Group B (multiple parecoxib) receiving parecoxib 40mg at 30min before the end of
      surgery, at 8h and 20h after the surgery, respectively, and Group C (Control group) receiving
      normal saline. All patients will be managed by a standard propofol-remifentanil based total
      intravenous anesthesia protocol. The incidence and intensity of shoulder pain at rest and
      with motion will be evaluated by an independent doctor blinding to medication and grouping
      using visual analog scale (VAS) at 6h, 24h and 48h postoperatively. Other types of pain (e.g.
      trocar wound and visceral pain), side effects (such as postoperative nausea and vomiting,
      itching, dizziness, and oversedation) will be assessed as well. At the end of the
      observation, the intensity of the maximum pain will be recorded, and the effect of shoulder
      pain on the four variables regarding to quality of life (activity, mood, walking and sleep)
      will be assessed using modified Brief Pain Inventory(BPI) questionnaire.
    


Intervention name(s): parecoxib
Intervention type(s): Drug
Intervention description(s): parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a
      pregabalin controlled release tablet as compared to multiple doses of the pregabalin
      immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin
      controlled release tablet as compared to multiple doses of pregabalin immediate release
      capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin
      controlled release tablet as compared to multiple doses of the pregabalin immediate release
      capsule.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a
      pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate
      release capsule
    

Intervention name(s): Pregabalin immediate release, 300 mg; Pregabalin controlled release, 330 mg
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg immediate release capsule administered twice daily for four days; Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
Condition: Anesthesia
Study type: Interventional

Summary: 
      To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of
      anesthetic concentration and hypnotic states, and to provide evidence to support BIS™
      performance in use with Isoflurane, Sevoflurane and Desflurane in combination with opioids.
    


Intervention name(s): BIS Complete Monitoring System
Intervention type(s): Device
Intervention description(s): The BIS™ EEG complete monitoring system is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The system and its associated parameters are intended for use on adult patients within a hospital or medical facility, providing patient care to monitor the state of the brain by data acquisition of EEG signals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized study to collect data to evaluate the relationship between BIS and inhaled anesthetics
Masking: None (Open Label)
Primary purpose: Other
Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
Condition: Peritoneal Carcinosis (PC)
MeSH terms: Carcinoma; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of
      optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC)
      with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating
      doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis
      (PC).
    


Intervention name(s): cytoreductive surgery and HIPEC
Intervention type(s): Procedure
Intervention description(s): The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C).
The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC.
Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperthermic intraoperative peritoneal chemotherapy (HIPEC); Irinotecan; Pharmacokinetics; peritoneal carcinomatosis (PC)
Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the tolerability of Quetiapine Fumarate immediate release formulation
      and Quetiapine Fumarate extended release formulation during initial dose escalation in
      healthy volunteers.
    


Intervention name(s): Quetiapine Fumarate; Quetiapine Fumarate
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, Oral, once daily; Tablet, Oral, once daily
Other intervention name(s): Seroquel IR; Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare a single intravitreal injection of 4.0 mg of
      triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular
      edema.
    

Detailed description: 
      Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg
      of bevacizumab regarding the ability of central macular thickness reduction. Secondary
      objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The
      patients data were statistically analyzed if there was a 24 week follow up completed.
    

Intervention name(s): Bevacizumab; Triamcinolone acetonide
Intervention type(s): Drug; Drug
Intervention description(s): 1.25mg bevacizumab (0.05ml); 4.0 mg Triamcinolone acetonide injection
Other intervention name(s): 1.Bevacizumab; 2.Avastin; 1. Theracort; 2. Kenalog
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bevacizumab; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic macular edema; intravitreal injection; Pharmacological treatment
Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Iron deficiency anemia is the most common nutritional problem in the world.

      The objectives of this study are:

        -  to evaluate the prevalence of anemia in children from 6 to 24 months of age and the
           therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin
           levels.

        -  to compare the effect of folic acid supplementation with ferrous sulfate on the linear
           and weight growth of anemic and non-anemic

      Study hypothesis:

        -  The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.

        -  The folic acid supplementation with ferrous sulfate have effect on the linear and weight
           growth of anemic and non-anemic.
    

Detailed description: 
      Purpose

      The objective of this study were:

        -  to assess the prevalence of anemia and the therapeutic and prophylactic response to
           ferrous sulfate and folic acid.

        -  to compare the effect of folic acid supplementation with ferrous sulfate on the linear
           and weight growth of anemic and non-anemic.

      A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24
      months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The
      children were assigned to two treatment groups that received a daily dose (5 times a week) of
      either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate
      + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate +
      folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo.
      Supplementation lasted approximately three months.
    

Intervention name(s): ferrous sulfate; folic acid; placebo (folic acid)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Keywords: Anemia; Iron deficiency anemia; Infants; Children; Clinical trials; Ferrous sulfate; Folic acid; Daycare centers; Anaemia in children; born at term; non-twins; with parental approval for participation in the study; growth
The Effect of Oxygen Administration on Regional Cerebral Oxygen Saturation (rSO2) in the Non-block Side After Stellate Ganglion Block
Condition: SSNHL(Sudden Sensory Neural Hearing Loss)
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the
      stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows
      continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation
      (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the
      baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with
      cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow
      in the non-block side. The investigators researched the effect of oxygen administration on
      rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was
      supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were
      measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.

      The present study suggests that oxygen administration can increase the rSO2 of non-block
      side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with
      cerebral vascular disease during SGB.
    


Intervention name(s): oxygen administration
Intervention type(s): Procedure
Intervention description(s): nasal O2 5L/min via nasal cannula
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
Condition: Nutritional Deficiency
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Bioavailability of iron and zinc from habitual plant-based diets consumed by young children
      in Mexico is low due to the high phytate content. Whey protein has been found to increase
      zinc absorption, thus, providing a whey based supplement with micronutrients may be an
      effective strategy to increase iron and zinc bioavailability from plant-based foods and
      alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron
      in children receiving diets with and without whey protein supplements (WPS).
    

Detailed description: 
      Study 1: Zinc absorption studies The zinc study employed a 2-day cross-over design, labeling
      the WPS diet with a different zinc stable isotope (67Zn) than the control diet (70Zn). All
      meals during the 2-day period were labeled with tracer. The dual isotope ratio technique was
      used with a 3rd Zn stable isotope (68Zn) given intravenously and urine enrichment of all
      isotopes measured on Study Days 6-9 to measure fractional absorption of Zn (FAZ). The amount
      of Zn absorbed for the day was determined by multiplying the Zn intake for the day
      (determined from lab analyses of duplicate test meals) by the FAZ. Children (n=16) were
      randomized as to the order in which they consume the test and control meals on Study Day 1
      and 2.

      Study 2: Iron absorption studies The iron study was a cross sectional study with one group
      receiving control meals and the second group receiving the same control meal plus WPS. Iron
      absorption was measured using the erythrocyte iron incorporation technique with labeling of
      all meals over 2 days (58Fe). This was preceded by a reference dose of Fe57 and ascorbate on
      the previous day. Children (n=32) were randomized to receive the control diet or intervention
      diet (control diet + WPS).
    

Intervention name(s): Study 1: Whey Supplement Day 1; Study 1: Whey Supplement Day 2; Study 2: Whey Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Whey supplement was given on day 1, control diet on day 2; Control diet was given day 1, whey supplement was given day 2; Whey supplement was given as part of diet for both day 1 and 2 of study
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Zinc absorption; Iron Absorption; Whey Protein; Mexico; Stable isotopes
Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression
Condition: Cardiovascular Function; Gene Expression
Study type: Interventional

Summary: 
      It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce
      blood pressure. However, the mechanisms implicated in these effects have not been elucidated
      yet. The purpose of this study is to evaluate changes in gene expression induced by the
      administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells
      (PBMC) in humans.
    

Detailed description: 
      This is a prospective, randomized, controlled, double-blind and cross-over study. The
      intervention will consist in the administration of 250g of chocolate cream with or without
      the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours
      after the administration. At each time point, blood pressure and endothelial function (with a
      non-invasive method) will be measured.
    

Intervention name(s): Polyphenol-rich cocoa extract; Chocolate cream
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared
      to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus,
      respiratory depression, urinary retention, allergies, hallucination) by 50% in adult patients
      operated on for prosthetic hip surgery.
    


Intervention name(s): Standard Care morphine hydrochloride; Oxycodone
Intervention type(s): Drug; Drug
Intervention description(s): Post-operative analgesia including morphine (patient controlled analgesia).; Post-operative analgesia including oxycodone (patient controlled analgesia).
Other intervention name(s): morphine hydrochloride; oxycodone hydrochloride
Intervention MeSH terms: Morphine; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxycodone; morphine; hip replacement; analgesia; post operative analgesia
Evaluating Wearable Robotic Assistance on Gait
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overarching goal of this study is to improve mobility in individuals with movement
      disorders through advances in wearable assistance (i.e. powered orthoses).
    

Detailed description: 
      Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week
      for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the
      same participants will complete low frequency over-ground gait training (2x/week for 2
      weeks).
    

Intervention name(s): powered orthosis
Intervention type(s): Device
Intervention description(s): Novel powered leg brace to provide assistance during walking.
Other intervention name(s): exoskeleton
Intervention model: Single Group Assignment
Intervention model description: Feasibility assessment of powered orthosis assistance and resistance during walking. All participants received high frequency gait training followed by a washout period then low frequency gait training.
Masking: None (Open Label)
Primary purpose: Device Feasibility