bioihbjkbjnl/mcl2 huggingface dataset:
Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
Condition: Blood Volume Analysis
Study type: Interventional

Summary: 
      Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital.
      This type of anesthesia reduces the average arterial pressure. Benefits include reduced
      bleeding and lower risk of blood clots.

      The purpose of this study is to determine the effect of intravenous fluids administered with
      hypotensive anesthesia on your blood volume. With this parameter we will be able to
      understand how much of your blood is lost because of bleeding and how much of the drop is
      related to dilution.

      Study hypothesis: Hemodilution associated with intravenous fluid substitution during
      hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels
    

Detailed description: 
      Recent technology allows the measurement of patients' total blood volume with 98% accuracy
      within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia
      on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the
      dilutional effect of intravenous fluid given during the procedure. Increases in TBV could
      result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive
      anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of
      postoperative blood management and transfusion triggers.
    

Intervention name(s): 1mL of I-131 Human Serum Albumin is injected prior to the measurements
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes
      for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes
      evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation
      index) and heart rate variability (HRV) indexes.
    

Detailed description: 
      This is a cross-sectional study collecting data from patients from the Sleep Institute of
      Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in
      accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline
      polysomnography is performed using a computerised system. The following extracted signals are
      measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram
      channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial
      oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation
      DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: obstructive sleep apnea; polysomnography; heart rate variability; mathematical biomarker
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      No randomized trials have compared long-term outcomes following endoscopic and open carpal
      tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a
      single-center randomized controlled trial between January 1998 and December 2002, including
      128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed
      idiopathic CTS. The outcome measures included the validated CTS symptom severity and
      functional status scales completed at baseline and 1 year postoperatively. The trial showed
      that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and
      function were equivalent. This extended follow-up of the randomized trial will primarily
      measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by
      mail to the patients. The questionnaire will consist of the CTS symptom severity and
      functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of
      the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog
      scale about treatment satisfaction. The patients will also be asked about whether they had
      undergone further surgery for CTS in the same or contralateral hand after their operation in
      the randomized trial. The completed questionnaires will be scanned into a database. The
      scores for the different scales will be calculated. Analysis will include comparison between
      the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15
      years.
    


Intervention name(s): Endoscopic surgery; Open surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgery dwas done under local anesthesia injected at the portal sites only. Tourniquet was used. Each of the two skin incisions in the endoscopic procedure was 1 cm long. With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge. Incisions were closed with non-absorbables sutures and a soft dressing was applied. Sutures were removed 10 days postoperatively.; Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet. The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease. The transverse carpal ligament was divided; no additional procedures were performed. a soft dressing was applied. Dressing and sutures were removed 10 days postoperatively.
Other intervention name(s): Endoscopic carpal tunnel release surgery; Open carpal tunnel release surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carpal tunnel syndrome; Surgery; Outcomes
Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
Condition: Multiple Sclerosis; Healthy Controls
MeSH terms: Multiple Sclerosis; Insulin Resistance; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a combined training programme and
      a high intensity interval training programme on insulin resistance, muscle strength/ muscle
      contractile properties, aerobic capacity and body composition in MS patients.

      It is assumed that the the above mentioned clinical parameters will improve due to physical
      exercise.
    


Intervention name(s): Training
Intervention type(s): Behavioral
Other intervention name(s): 12 weeks of high intensity interval training or combined exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high intensity interval training; combined training; insulin resistance; muscle contractile properties
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the effect of linerixibat on plasma concentrations of
      obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the
      potential for drug interaction with coadministration of linerixibat and OCA.
    


Intervention name(s): Obeticholic acid; Linerixibat
Intervention type(s): Drug; Drug
Intervention description(s): OCA will be administered; Linerixibat will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms will be evaluated in parallel in Part A. After Part A, if Part B is conducted, one of the two remaining arms will be evaluated.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction; Healthy Volunteers; Linerixibat; Obeticholic acid; Pharmacokinetics
Change in Taste Sensation After Orthognathic Surgery
Condition: Orthognathic Surgery; Altered Taste
MeSH terms: Dysgeusia
Study type: Interventional

Summary: 
      Orthognathic surgery refers to jaw operations that can be performed on the upper jaws (Le
      Fort I osteotomy) and lower jaws (Sagittal Split Ramus osteotomy). In orthognathic surgery
      practice, taste perception could be affected by potential damage to peripheral nerves that
      conduct chemosensory information regarding gustation from the palate and tongue. This study
      aimed to evaluate the changes in the sense of taste after Le Fort I osteotomy, Sagittal Split
      Ramus osteotomy, and bimaxillary surgery.
    

Detailed description: 
      The subjects were orthognathic surgery patients with facial skeletal deformities who applied
      to the Department of Oral and Maxillofacial Surgery. Thirty-five patients, aged 17-42 years,
      gustatory functions were evaluated by administering localized taste tests and whole mouth
      taste tests preoperatively and at postoperative 1st, 3rd, and 6th months. In the tests,
      solutions containing sucrose for a sweet taste, sodium chloride for a salty taste, citric
      acid for a sour taste, and quinine hydrochloride for a bitter taste were used. Patients were
      compared between the operation group they were in and between operation groups.
    

Intervention name(s): Whole mouth taste tests; Localized taste tests
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Patients who underwent Le Fort I osteotomy, Sagittal Split Ramus Osteotomy, and Bimaxillary Surgeries were asked to identify the quality of 4 basic taste modalities preoperatively and at postoperative 1st, 3rd, and 6th months by administering whole mouth taste tests. In the whole mouth taste test, one ml of the specific solution was drawn into the syringe and sprayed into the mouth of the patient circularly. After each administration, patients spat out the solutions and reported whether they perceived any taste and, if so, which taste it was.; Patients who underwent Le Fort I osteotomy, Sagittal Split Ramus Osteotomy, and Bimaxillary Surgeries were asked to identify the quality of 4 basic taste modalities preoperatively and at postoperative 1st, 3rd, and 6th months by administering localized taste tests. In the localized mouth taste test, the highest concentration solution of one of the four flavors was administered. In each application, 0.25 ml of solution was absorbed on a sterile cotton swab and applied on 6 test areas on the palate and tongue.
Other intervention name(s): Spatial taste test
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Gustation; Taste sense
Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
Condition: Malnutrition; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Malnutrition
Study type: Interventional

Summary: 
      RATIONALE: An individualized, computer-designed health program may promote changes in diet
      and physical activity and may improve quality of life in patients who have early-stage
      prostate cancer.

      PURPOSE: Randomized clinical trial to compare the effectiveness of an individualized,
      computer-designed diet and exercise-based counseling program with that of a standard
      counseling program in promoting health in patients who have early-stage prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effectiveness of a computer-tailored, correspondence course vs standardized
           materials in promoting changes in diet and physical activity (PA) behaviors in patients
           with early stage prostate or breast (closed to accrual as of 8/1/03) cancer who
           currently do not practice goal behavior in at least 2 of the following 3 areas:
           performance of moderate PA for at least 150 minutes per week; consumption of at least 5
           servings of vegetables or fruit daily; or consumption of a diet with less than 30% fat
           (with less than 10% of kilocalories from either saturates or polyunsaturates).

        -  Compare the health and quality of life of patients treated with these interventions.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients participate in a computer-tailored, correspondence course comprising
           personalized diet and exercise intervention and other health information over a 10-month
           period.

        -  Arm II: Patients receive usual care comprising standardized print materials related to
           diet, exercise, cancer, and other pertinent health issues over a 10-month period.

      In both arms, diet and exercise behavior, quality of life, co-morbidity status, depression,
      social support, worry, self efficacy, and coping style are assessed during phone interviews
      conducted at baseline, after completion of 10 months of study intervention, and then at 1
      year. Intervention usefulness is assessed after completion of 10 months of study
      intervention.

      Patients in both arms who live within a 1-hour drive from Duke University Medical Center may
      undergo blood draw to test for substances related to fruit and vegetable intake and
      measurement of height and weight. Patients may also be asked to wear a pedometer for a 1-week
      period.

      PROJECTED ACCRUAL: A total of 530 patients will be accrued for this study.
    

Intervention name(s): nutritional support; quality-of-life assessment
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Primary purpose: Other
Keywords: malnutrition; stage I prostate cancer; stage II B prostate cancer; stage II A prostate cancer
A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety, tolerability, and
      pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and
      elderly participants.
    


Intervention name(s): E2511; E2511 Matched Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2511 tablets.; Placebo tablets matching E2511 tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: E2511; Healthy Participants
Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis
Condition: Tinea
MeSH terms: Infections; Mycoses; Tinea
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64
      mg/g association (Candicort®) cream versus clotrimazole 10mg and dexamethasone acetate 0.443
      mg/g association (Baycuten N®) cream, general relief of signs and symptoms (erythema,
      maceration, peeling, blistering / papules / pustules, itching and burning / stinging) 06 (±
      1) days after onset treatment.
    

Detailed description: 
      Candicort® presents formulation with agents that act both etiological agent of superficial
      mycosis, with coverage for dermatophytes and more frequent yeast; as inflammation generated
      by the infectious process or prior to it, in cases of secondary fungal infection in wet or
      potentially infected eczema fungal dermatitis (atopic dermatitis, seborrhoeic dermatitis,
      intertrigo, dyshidrosis, contact dermatitis).

      The active ingredients ketoconazole and betamethasone act, respectively, on the etiologic
      agent of the infection and the inflammation generated by the process, and the association of
      both showed a positive therapeutic response in dermatitis with confirmed secondary infections
      or potential yeast (analysis carried out in association with sulfate neomycin, aimed to cover
      bacterial infections together).

      160 participants that meet all the inclusion criteria and are not classified in any of the
      exclusion criteria will be randomly allocated to one of two treatment groups(Candicort® or
      Baycuten N®) of the study.
    

Intervention name(s): Candicort®; Nizoral®; Baycuten N®; Canesten®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Apply on the affected area and around it twice a day; Apply on the affected area and around it twice a day; Apply on the affected area and around it twice a day; Apply on the affected area and around it twice a day
Other intervention name(s): ketoconazole and betamethasone dipropionate; ketoconazole; clotrimazole and dexamethasone acetate; clotrimazole
Intervention MeSH terms: Ketoconazole; Clotrimazole; Miconazole; Dexamethasone; Dexamethasone acetate; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fungal infection; Skin infection; Dermatophytoses
Bleb Vascularity and the Outcomes After Trabeculectomy
Condition: Glaucoma; Filtering Bleb
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      1. Study objective: To evaluate the relationship between filtering bleb vascularity and the
           surgical outcomes after trabeculectomy

        2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented
           trabeculectomy. The follow-up was 12 months.
    

Detailed description: 
      Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs
      of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs
      were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP
      without antiglaucoma medications or additional surgical interventions) or failed. Linear
      regression analysis was performed to determine the correlation of the bleb vascularity with
      IOP.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with medically uncontrolled glaucoma who underwent primary trabeculectomy with
        mitomycin C (MMC) in the Department of Diagnostics and Microsurgery of Glaucoma of Medical
        University of Lublin, Poland
      
Keywords: filtering bleb; trabeculectomy; glaucoma
Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Observational

Summary: 
      Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of
      disability after injury accidents in young adults. Among the many symptoms, fatigue is very
      common with a significant impact on quality of life. Also, the disability caused by multiple
      sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as
      proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often
      deficient in this population with consequences in physical performance such as endurance and
      muscle strength. We propose to study the link between fatigue and shortcomings encountered in
      a defined population of MS patients.
    


Intervention name(s): Blood sampling; Gustatory sensitivity test using Taste strips; Questionnaires
Intervention type(s): Procedure; Other; Other
Intervention description(s): A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.; 16 Taste Strips impregnated with 4 flavors (sweet, sour, salty, bitter, each flavor present at 4 different concentrations), are offered to the patient one after the other in a so-called pseudorandomized sequence. The task of the patient is to choose one of the following answers: sweet / sour / salty / bitter / no taste.
Each correct answer is granted one point. In addition to the impregnated strips, two tasteless strips can be integrated in the examination at any point of time (no point); Evaluation of the following parameters by validated questionnaires (name of the questionnaire in bracket):
Fatigue (EMIF-SEP)
Dysphagia (DYMUS)
Food intake (semi-structured questionnaire)
Depression (BDI-II)
Daily energy expenditure (NAP)
Visual analog scale to study quality of sleep
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with MS defined according to the revised diagnostic criteria of Mac Donald, with
        ages between 18 to 65 years with an Expended disability status scale (EDSS) between 0 and 7
        and followed in the services of neurology or physical medicine and rehabilitation.
      
Biospecimen description: 
      Biological analysis in serum: magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.
    
Keywords: Multiple Sclerosis, Fatigue, Nutritional Status, Disability.
Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate whether the addition of two pain
      neurophysiology education sessions to motor control training may result in an improvement of
      the outcome measures of pain and disability, compared to motor control training alone.
    

Detailed description: 
      Sixty-two subjects with unspecific low-back pain were randomly recruited for the present
      study. The subjects were randomly allocated to a control group (which received only motor
      control training) and an intervention group (which underwent two pain neurophysiology
      education sessions prior to motor control training). Primary outcome measures were pain
      (measured with the Visual Analogical Scale) and disability (measured with the Oswestry
      Disability Index). Secondary outcome measures are kinesiophobia (Tampa Scale for
      Kinesiophobia), the global perceived effect (Global Perceived Effect Scale) and quality of
      life (SF-12). These will be measured before the intervention, at the end of the intervention,
      and 3 and 6 months after ending the intervention.
    

Intervention name(s): motor control training; pain neurophysiology education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercises to strengthen the lumbar musculature and control the posture.; Educational sessions to improve patient's neurophysiology of pain knowledge.
Other intervention name(s): pain neuroscience education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; pain neurophysiology education; motor control