bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Analgesic Efficiency Between IPACK Block and Surgical Infiltration After Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Observational

Summary: 
      The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block
      (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical
      infiltration after total knee arthroplasty. The main objective is to compare cumulative
      morphine consumption the first 24 hours after surgery. The secondary objectives are to
      compare pain scores, types and amounts of other analgesics needed during the first 24 hours
      after surgery.
    

Detailed description: 
      After patient agreement, data will be collected on patient records and will be compared into
      2 groups.

      Data will be :

        -  cumulative consumption of morphine during the first 24 hours after surgery

        -  pain scores during the first 24 hours after surgery

        -  amount of analgesics during the first 24 hours after surgery

        -  maximal pain score during the first 24 hours after surgery
    

Intervention name(s): Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block; Injection of local anesthetics during total knee arthroplasty by surgical infiltration
Intervention type(s): Other; Other
Intervention description(s): Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee); Injection of local anesthetics during total knee arthroplasty by surgical infiltration.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All adults patients after a total knee arthroplasty
      
Keywords: Locoregional anesthesia; IPACK block; surgical infiltration; Total knee arthroplasty
No Routine CXR After Bronchoscopy
Condition: Pneumothorax
MeSH terms: Pneumothorax
Study type: Observational

Summary: 
      Most pulmonologist request a routine chest-x-ray after bronchoscopy with transbronchial
      biopasie to exclude pneumothorax. We published a study in CHEST showing that routine
      chest-ray might not be necessary. We would like to conduct a propsective study to validate
      the results of the CHEST-study. Before and after the procedure follwing information will be
      collected: Age, Sex, Indication for procedure, number of biopsies and segment of biopsie,
      Saturation, Physical examination, Symptoms suggestive of pneumothorax. If there is no
      aggravation of the symptoms and/or physical examination after the procedure, as compared to
      before, routine chest-x-ray will NOT be done. A phone will be made 24 to 48 hours following
      the procedure to the patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients with bronchoscopy and transbronchial biopsies will be enrolled in
        this study.
Effect of Blood Donation on Blood Pressure, Iron Metabolism, Oxidative Stress
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The investigators want to investigate the effects of blood donation to blood pressure, to
      iron metabolism and oxidative stress.

      There are results of other studies that show, that there is a positive effect of blood
      donation to high blood pressure, iron metabolism and oxidative stress.
    

Detailed description: 
      The regular application flow of blood donation at that blood bank of Charité is not
      disturbed. There are only some more questions and measurement of blood pressure, iron
      metabolism, fat metabolism and oxidative stress.

      No extra puncture of the vein is necessary.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        female and male from 18 years to 65 years, who are able and want to donate blood for the
        first time or after one year break to the last blood donation
      
Biospecimen description: 
      regular blood donation is done and from blood, that is taken for blood tests by the blood
      donation center any there are made blood tests of lipid metabolism, iron metabolism and
      antioxidative stress
    
Keywords: Hypertension; Ferritin; Phlebotomy; Blood donation
Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle
Condition: Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Ischemic compression is considered the fastest and most common method for providing relief in
      trigger point therapy, whereas cupping therapy is not a method often used for this purpose.
      The muscle that has a great impact on tension-type headaches and neck pain is the trapezius,
      whose upper fibres are where the most common trigger point in the back is located.

      The aim of this study was to evaluate and compare the effectiveness of single ischemic
      compression and single dry cupping therapy on the most common trigger point, on the
      descending part of the trapezius muscle.
    


Intervention name(s): 1) cupping therapy; 2) control test (no intervention); 3) ischemic compression
Intervention type(s): Other; Other; Other
Intervention description(s): The participant lay on his front on a couch. The examiner applied a plastic cup on a pre-marked trigger point, suctioned it with a mechanical pump and left it for 2 minutes. This was a stationary application with medium suction force. Therapy was performed on both sides. Measurements were taken before and 2 minutes after the therapy.; The participant lay on his front on a couch for 4 minutes without any activity and without anyy intervention. Measurements were taken before and after the session.; The participant lay on his front on a couch. The researcher applied pressure to a pre-marked trigger point using the thumb for 2 minutes until tissue resistance was felt. This included 60-second compression and after a break of a few seconds, another 60 seconds of compression. Therapies were performed on each side. Measurements were taken before and 2 minutes after the therapy.
Intervention model: Single Group Assignment
Intervention model description: Each person participated in three tests with an interval of approximately one week between them. The following study protocol was followed; (short version)
cupping therapy;
- a minimum interval of 7 days;
control test;
- a minimum interval 7 days;
ischemic compression.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ischemic compression; cupping; algometer; trapezius muscle
How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction
Condition: Excessive Diet Restriction
Study type: Observational

Summary: 
      The purpose of this study is to gain knowledge about how participants behave and respond on
      their own after completing a 2-year intervention of calorie restriction.
    

Detailed description: 
      You will not be assigned to any particular group during the Follow-Up Study. In the Follow-Up
      study there is no diet intervention. You will not be asked to follow a calorie-restricted
      diet or any other diet.

      Month 3 and Month 6 (Outpatient Visits)following procedures performed:

        -  Blood pressure, heart rate, temperature, Weight & Waist Measurement

        -  Medication and medical history

        -  Blood draw (approximately ½ cup)

        -  DEXA and QuickScan

        -  Psychological assessment questionnaires reviewed for completeness

        -  Body Acceptability Morph Test (BAM)

        -  Review of 7-day food diary

      Month 12 and Month 24 (Outpatient Visits) procedures performed:

        -  Collection of 4 urine samples

        -  Dosing with doubly labeled water (DLW)

        -  DEXA and QuickScan

        -  Eat breakfast and lunch

        -  Receive 7-day food diary

        -  Psychological assessment questionnaires

        -  Body Acceptability Morph Test (BAM)

      Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures
      performed:

        -  Collection of 2 urine samples

        -  Blood pressure, heart rate, temperature, Weight & Waist Measurement

        -  Blood draw (approximately ½ cup)

        -  Medication and medical history

        -  Review of 7-day food diary

        -  Metabolic Chamber

        -  Resting Metabolic Rate (RMR)
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Participants that completeded the CALERIE II study at Pennington Biomedical Research
        Center.
      
Keywords: CALERIE II Follow-up
Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding
Condition: Obesity
Study type: Interventional

Summary: 
      This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on
      energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition
      Research Institute (UNC NRI).
    

Detailed description: 
      Subjects will complete a baseline eucaloric study day. Following this, subjects will be
      randomized to complete 3 days of overfeeding (150% of baseline eucaloric energy requirements)
      or 3 days of underfeeding (50% of baseline eucaloric energy requirements). After completing
      one of these study arms, subjects will cross-over and complete the second arm. All study arms
      will be separated by two weeks. 24-hour energy expenditure will be measured 3 times during
      each of 3 day periods. We hypothesize that the impact of over or underfeeding on EE will be
      evident after 24-hours and will be comparable to 72 hour EE.
    

Intervention name(s): 24-hour energy expenditure
Intervention type(s): Other
Intervention description(s): To assess 24-hour energy expenditure and substrate utilization subjects will spend 23 hours and 15 minutes each day in the metabolic chamber at the UNC NRI. Subjects will be requested to arrive at the study center each morning following a 10hour overnight fast. During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements and the study protocol (i.e. 50% or 150% of calorie requirements).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety of the PET-511BTM Transesophageal Transducer
Condition: Patient Requiring TEE Procedure by Their Physician
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate the safety of the redesigned transesophageal
      echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through
      the mouth.
    

Detailed description: 
      The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba
      Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a
      real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize
      a plane of the heart through the esophageal wall.

      The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE
      transducer for ease of passage and during transitioning into and down the esophagus to
      complete a normal TEE study.
    

Intervention name(s): PET-511BTM
Intervention type(s): Device
Intervention description(s): Transesophageal Transducer
Other intervention name(s): TEE Transducer; TEE Probe
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have been scheduled for a TEE procedure by their physician.
      
Keywords: transesophageal; transducer; TEE
Peripheral Nociceptive Effects of Levcromakalim
Condition: Pain; Levcromakalim
Study type: Interventional

Summary: 
      Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the
      forehead and forearm of healthy subjects and the following will be investigated:

        1. Prevalence and intensity of pain

        2. Prevalence and intensity of itching

        3. Occurrence and intensity of local redness and swelling

        4. Occurrence and intensity of local changes in skin temperature and blood flow
    


Intervention name(s): Levcromakalim; Saline
Intervention type(s): Drug; Drug
Intervention description(s): To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.; To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Parallel, randomized placebo controlled and crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Condition: Migraine; Photophobia; Phonophobia
MeSH terms: Hyperacusis; Migraine Disorders; Photophobia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating
      subjects suffering moderate pain form a migraine attack, with or without aura. The study is
      also intended to show the effectiveness of PRO-513 for associated symptoms of nausea,
      photophobia, and phonophobia due to a migraine attack.
    


Intervention name(s): PRO-513
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Photophobia; Phonophobia; Aura
Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Primary objective of the study is the assessment of the patients' discomfort following
      cataract extraction surgery by means of phacoemulsification and intraocular lens
      implantation.
    

Detailed description: 
      Participants will be recruited from the Cataract Service of the University Hospital of
      Alexandroupolis (UHA), the Naval Hospital in Athens, the Papanikolaou General Hospital in
      Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By
      means of a custom computer randomization program all participants will randomly populate
      either study group [who will receive fixed combination of tobramycin and dexamethasone
      (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel,
      Pharmex, Greece) quid for 6 weeks], and control group [who will receive Tobradex quid for 3
      weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks].
    

Intervention name(s): Sodium Hyaluronate 0.1% drops; Sodium Hyaluronate 0.2% drops
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be administered Drops of Sodium Hyaluronate 0.1% quid; Patients will be administered Drops of Sodium Hyaluronate 0.2% quid
Other intervention name(s): Sodium Hyaluronate 0.1% drops (artificial tear medication); Sodium Hyaluronate 0.2% drops (artificial tear medication)
Intervention MeSH terms: Lubricant Eye Drops; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effects of Pilates in Risk Fall in Older Population
Condition: Falling Injury
Study type: Interventional

Summary: 
      The intervention will consist in a 6 week of pilates practice in older population to check
      the prevention of fall effectiveness.
    

Detailed description: 
      A study population of elder people will be randomly allocated to intervention or control
      group, consisted in Pilates and a booklet of balance tips respectively.

      The protocol will be performed for 6 weeks.
    

Intervention name(s): Pilates and fall prevention
Intervention type(s): Other
Intervention description(s): A 2 days per week during 6 week Pilates practice will be performed in experimental group in order to check the effectiveness in fall prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical and Instrumental Evaluation of Swallowing in Children With Cerebral Palsy
Condition: Cerebral Palsy; Deglutition Disorders
MeSH terms: Deglutition Disorders; Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The purpose of this study is to correlate the alimentary consistencies and deglutition
      disorders in children with cerebral palsy.
    

Detailed description: 
      Cross-sectional and quantitative study with sample consisted of 50 children with cerebral
      palsy. The data collection consisted in detection of the main dysphagic manifestations in
      different consistency of food and types of cerebral palsy.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with Cerebral Palsy diagnoses
      
Keywords: Cerebral Palsy; Deglutition; Deglutition disorders; Endoscopy
Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism
Condition: Hypogonadism
MeSH terms: Metabolic Syndrome; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to answer the following questions:

        1. Is hypogonadism a cause for the metabolic syndrome ?

        2. What is the effect of testosterone replacement on the metabolic parameters ?
    

Detailed description: 
      This is a retrospective design, which is performed by investigating the registrations of
      patients with hypogonadotrophic hypogonadism between the years 2002-2009.
    

Intervention name(s): Testosteron
Intervention type(s): Drug
Intervention description(s): Testosteron 250mg injection per 3-4 weeks for 6 months
Other intervention name(s): Sustanon 250mg
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Metabolic syndrome; Hypogonadism; Testosterone
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
Condition: Repeated IVF Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple
      doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a
      history of repeated IVF failures.
    

Detailed description: 
      NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple
      doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures.
      Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100
      low dose, NT100 high dose, or placebo, qd for up to 4 weeks.

      Screening will include a standard IVF stimulation protocol, followed by fertilization and
      culture of embryos. If the subject remains eligible, she will be randomized to receive study
      drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10
      of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to
      assess subsequent pregnancy, delivery, and neonatal outcomes.
    

Intervention name(s): NT100; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF failure; Repeated IVF failure; Implantation failure; Repeated implantation failure; IVF; NT100
Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in
      participants with schizophrenia. The first six weeks of the study will be double-blind and
      the remainder of the study will be open label. Participants in this study consist of
      participants who have completed the preceding short-term study (P06124 [NCT01098110]), who
      meet the inclusion criteria and wish to continue receiving study drug, and whom the
      investigators have deemed eligible for study participation. Participants who were on placebo
      twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg
      asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after
      week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg
      BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or
      asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will
      be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After
      re-randomization, drug will be administered open-label for 46 weeks. During this period dose
      is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and
      tolerability.
    


Intervention name(s): Asenapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Asenapine 5 mg sublingual tablet BID, Asenapine 10 mg sublingual tablet BID; Placebo sublingual tablet BID (first 2 weeks, participants who were in placebo arm of P06124 study only)
Other intervention name(s): SCH 900274
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction
Condition: Non-ST Segment Elevation Myocardial Infarction; ST Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than
      clopidogrel and is associated with less interindividual variability. In the PLATO trial, it
      was found to be superior to clopidogrel with respect to cardiovascular outcomes and total
      mortality without increasing the risk of bleedings.

      More potent and reversible receptor bindings are possible explanation for the superior
      outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has
      previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake
      in tissue level and can induce adenosine triphosphate (ATP) release from human red cells,
      which both stimulate vasodilation of in red blood cells.
    


Intervention name(s): Clopidogrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel 600mg loading; Ticagrelor 180mg loading
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment