bioihbjkbjnl/mcl2 huggingface dataset:
High-Dose Steroid for Knee Arthroplasty Patients Expected to Have Postoperative Pain
Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Knee Osteoarthritis; Perioperative/Postoperative Complications; Surgery; Opioid Use; Catastrophizing Pain; Chronic Pain
MeSH terms: Chronic Pain; Pain, Postoperative; Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior
      to surgery in the setting of Fast-Track Knee surgery with Arthroplasty in a group of expected
      High Pain Responders and the effect on postoperative pain and postoperative inflammation.
    

Detailed description: 
      This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain
      after Knee Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.

      The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid
      given as an intravenous bolus after the spinal anaesthesia has been given, but before the
      surgery starts.

      The hypothesis is that by attenuating the inflammatory response to the surgery itself by the
      steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon
      ambulation 24 hours after unilateral Knee Arthroplasty.

      Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis at
      Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are
      screened and offered inclusion in the study.

      The two groups will be randomized and double blinded. One group will be treated, as the
      current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the
      medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

      The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg
      bodyweight).

      The patients will be monitored the first 7 days after surgery, during the admission to the
      hospital, and by a Pain-diary in the patients own home.

      Blood tests will be taken preoperatively and postoperatively to determine the effect of the
      highdose steroid on the inflammatory response.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): An intravenous bolus dose of dexamethasone given prior to surgery.
Other intervention name(s): Dexa-ratiopharm
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized double blinded controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Arthroplasty; Knee Replacement; Perioperative Medicine
Can Habitus Adapted Length Based Body Weight Estimation be Improved by Adding Further Parameters?
Condition: Weight-Estimation
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The purpose of this prospective single center study is to investigate if the accuracy of
      length based body weight estimation by the already investigated algorithm (CLAWAR) can be
      improved by adding another parameter. For this study 500 patients are required to collect
      anonymized data (length, weight, age, mid upperarm circumference and patient habitus by
      visual estimation) for achieving a power of 80% during statistical analysis. The main
      hypothesis ist that CLAWAR's accuracy can be improved.
    

Detailed description: 
      This prospective single center study is performed at the university children's Hospital
      zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16
      years and with a body length suitable for CLAWAR. Patient and parental information is
      performed during the pre-anaesthetic visit.

      After written consent the patient will be included. Patient ́s length and weight will be
      measures earliest one day before data collection. Data collection during anaesthesia has no
      influence on the daily anaesthesia routine and has no impact on patient safety and
      anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in
      Microsoft Excel and statistical analysis calculated with SPSS.

      500 patients are needed for a power of 80%. Primary outcome parameter is the accuracy of
      length based weight estimation using either patient habitus by visual estimation or an
      improved version of the algorithm CLAWAR using the mid upperarm circumference.
    

Intervention name(s): Accuracy of weight estimation
Intervention type(s): Other
Intervention description(s): Computer based comparison
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients planned for elecitve surgery in general anaesthesia
      
Keywords: Anaesthesia; Anthropometry; Body weight and measures; Development; Emergency treatment; Patient safety
Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetic characteristics and
      demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for
      subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference
      liquid formulation of caplacizumab.

      The secondary objective of the study is to compare the safety and tolerability, and the
      pharmacodynamic parameters of the new formulation with those of the reference formulation.
    


Intervention name(s): Caplacizumab
Intervention type(s): Biological
Intervention description(s): Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold.
Condition: Healthy
Study type: Interventional

Summary: 
      Comparison of the effects of physical activity (treadmill running) plus thoracic
      mobilization, physical activity only or a placebo intervention (only manual contact thoracic
      mobilization), on heart rate variability and pressure pain threshold.
    


Intervention name(s): Physical activity plus thoracic mobilization; Physical activity; Placebo
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Information already included in arm/group descriptions.; Information already included in arm/group descriptions.; Information already included in arm/group descriptions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asymptomatic individuals
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and probable benefit of the Low-profile
      Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when
      used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with
      bare platinum embolization coils.
    

Detailed description: 
      With the stent-assisted technique to treat wide neck intracranial aneurysms, the
      neurovascular stent is placed across the aneurysm neck, to act as a bridge to prevent coils
      from protruding into the parent artery. Stenting may allow to more safely achieve a higher
      packing density of coils. These effects may improve the rates of complete aneurysm occlusion
      and enhance the durability of the coiling treatment.The LVIS™ device manufactured by
      MicroVention, Inc. has a braided design which may provide superior conformability and parent
      artery apposition, as well as a more reliable continuous and uniform neck bridging than other
      neurovascular stents.
    

Intervention name(s): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Intervention type(s): Device
Intervention description(s): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Other intervention name(s): Low-profile Vizualized Intraluminal Support Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracranial aneurysm; wide-neck; saccular; endovascular treatment; coil embolization; stent; bare platinum
Diphenhydramine and Sweating
Condition: Diphenhydramine Causing Adverse Effects in Therapeutic Use; Hyperthermia; Allergic Rhinitis; Sweating
MeSH terms: Rhinitis; Rhinitis, Allergic; Hyperthermia
Study type: Interventional
Phase: Phase 4

Summary: 
      In 2012, it was estimated that nearly 1 in 4 Canadians suffer from allergic rhinitis. To add,
      78% of individuals working in predisposing environments are predicted to develop occupational
      rhinitis. Currently, the most popular treatment for rhinitis is antihistamine medication such
      as diphenhydramine, a first-generation antihistamine sold commercially as Benadryl®. Due it
      its anticholinergic effects, diphenhydramine has been suggested to impair the whole body
      sweating response during heat stress, potentially leaving consumers at an increased risk of
      heat-related illness. This randomized control trial approved by Health Canada will
      investigate whether ingesting extra strength diphenhydramine (50mg) will alter whole-body
      sweat losses during 60 minutes of exercise.
    


Intervention name(s): Placebo; Diphenhydramine
Intervention type(s): Drug; Drug
Intervention description(s): A placebo pill (i.e., sugar) will be consumed 2 h before intervention.; Extra strength Benadryl (DIN 02470144) will be consumed 2 h before intervention
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: thermoregulation; diphenhydramine; anticholinergic; sweating
PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      This registry is for men who have prostate cancer and have had multigene panel hereditary
      testing. The registry will gather data on genetic testing results and how that information
      may change physician treatment or follow up recommendations. It will also gather data on the
      patient's experience with genetic testing, through a post-test survey to be completed
      60-90days after results have been received and discussed with their provider.
    

Detailed description: 
      This registry will enroll men with prostate cancer who have done multi-gene testing for their
      cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN
      testing guidelines, and one for individuals who do not meet current NCCN guidelines.

      The main goal of this Registry is to assess whether nationally developed guidelines used to
      select patients for hereditary testing are adequate to identify all patients with prostate
      cancer who may benefit from testing. Patients will completed a post-test survey regarding
      their testing experience and clinicians will be asked to provide additional medical records
      review information via the Clinician Report Form.
    

Intervention name(s): Invitae multi-cancer gene panel
Intervention type(s): Diagnostic Test
Intervention description(s): Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men who have a diagnosis of prostate cancer who have not previously undergone testing for
        multi-gene hereditary cancer risk.
      
Biospecimen description: 
      Blood samples provided for clinical genetic testing that include DNA.
MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
Condition: Malignant Neoplasm of Breast
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute
      pain after tumorectomy plus sentinel lymph node dissection on one day surgery.
    

Detailed description: 
      Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the
      solution of Ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal
      volume or saline (not exceeding 30 ml of maximal volume) will be injected into the
      interpectoral space underneath the pectoralis major muscle for the Pecs 1 block. The other
      half of the solution will be injected above the serratus anterior muscle at the third rib.

      Evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three
      postoperative hours.
    

Intervention name(s): Saline; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Injection of the solution of Saline not exceeding 30 mL of maximal volume.; Dilution of Ropivacaine 7.5 mg/ml to 5 mg/ml not to exceed 3 mg/kg of maximal dose and 30 ml of maximal volume
Other intervention name(s): NA Cl 0.9%; Naropeine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Surgery conservative; Nerve block
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose
      levels by delivery of insulin operable in clinical trial settings. The safety of the system
      was proved in previous inpatient and outpatient trials in large number of patients. In the
      current study we aim to optimize post-prandial closed-loop glycemic control by developing an
      automated MD-bolus calculator and to evaluate its safety and efficacy in controlling
      postprandial blood glucose when used together with the MD-Logic artificial pancreas system in
      type 1 diabetes patients.

      The study will consist of a pilot study with two segments and a main study segment. The aim
      of each segment is detailed below:

        1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate
           the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop
           operation with no meal announcement.

        2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to
           test the optimal distribution of insulin delivery during the meal.

        3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we
           will use the results and conclusions from the previous two pilot segments to develop the
           MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this
           automated insulin bolus calculator will be tested in a randomized cross-over study that
           will compare postprandial glycemic control under MDLAP with and without the use of the
           MD-Bolus Calculator.
    


Intervention name(s): MD-bolus calculator for pre-meal bolus; No MD-bolus calculator for pre-meal bolus
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Artificial pancreas; Closed loop
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for
      inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
    

Detailed description: 
      The study will employ a multi-center, randomized, double-blind, placebo-controlled,
      parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered
      intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13
      (maxillary right second premolar to maxillary left second premolar) or maxillary primary
      teeth numbers A to J (maxillary right second primary molar to maxillary left second primary
      molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will
      be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary
      teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary
      teeth numbers A, B, I, J).

      The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study
      sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated
      with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or
      placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200
      µL or 400 µL) based on subject weight at entry: subjects weighing 10 to <20 kg, 20 to <40 kg
      and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively.
      Recruitment will be from diverse pediatric dental patient populations. To ensure adequate
      representation in the 3 dose/weight groups, each stratum will contain at least 25% of
      subjects.
    

Intervention name(s): Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasally administered regional anesthetic; Inactive ingredients supplied in identical nasal sprayer
Other intervention name(s): Kovacaine Mist; Intranasal administration of inactive ingredients
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: operative; dental procedure
Muscle-in-vein Conduits for Digital Nerve Reconstruction
Condition: Sensory Recovery
Study type: Observational

Summary: 
      The actual study should provide a first direct comparison between results after
      reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard
      methods of nerve transplantation and direct nerve suture.
    


Intervention name(s): Nerve reconstruction
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
Creatine Metabolism in Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Observational

Summary: 
      Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good
      appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The
      pathological mechanism is barely understood. Although feeding difficulties may play a role in
      this, other constitutional factors as altered metabolic processes are suspected. Preliminary
      research showed elevated plasma creatine concentrations and increased urinary
      creatine/creatinine ratios in half of the RTT girls.

      The aim of this study is to confirm previous findings and examine the functionality of the
      creatine transporter in RTT girls.

      The investigators assume that previous findings will be confirmed, and are due to an altered
      functionality of the creatine transporter.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population (identical to the population in the preliminary research project)
        consists of a well-defined group of thirteen Dutch RTT girls with complete clinical,
        molecular, neurophysiological and metabolic work-up.
      
Biospecimen description: 
      Whole blood, serum, leucocytes, erythrocytes, fibroblasts.
    
Keywords: Rett syndrome; Nutritional status; Creatine metabolism
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the ability of injections Ji Gami(TM) to induce hair
      growth in male and female subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): Two pieces of occipital scalp are taken from the subject, three weeks apart. The dermal and epidermal cells from these tissues are expanded in culture. The cells are then harvested and, for certain types of product, combined. On the day the cells are harvested after manufacture, they are then injected into the balding area of the scalp of the original subject within a certain time period.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove the safety of the gynaecological formulation in normal conditions of use.
    


Intervention name(s): Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care