bioihbjkbjnl/mcl2 huggingface dataset:
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
Condition: Distal Femur Fracture; Tibial Plateau Fracture; Distal Tibia Fracture; Pilon Fracture
MeSH terms: Fractures, Bone; Femoral Fractures; Tibial Fractures; Tibial Plateau Fractures; Femoral Fractures, Distal
Study type: Interventional

Summary: 
      The overall objective of this study is to compare outcomes following early advanced weight
      bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical
      therapy for adult patients with lower extremity periarticular injuries.
    


Intervention name(s): AlterG anti-gravity treadmill
Intervention type(s): Other
Intervention description(s): The AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anti-gravity
Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
Condition: Basic Science: Safety, Tolerability, Efficacy of CLP
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
    


Intervention name(s): Cross-Linked Polyelectrolyte (CLP)
Intervention type(s): Drug
Intervention description(s): CLP was administered orally, in capsules, for 9 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CLP
Smartphone Addiction and Physical Activity
Condition: Sports Physical Therapy
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Interventional

Summary: 
      This study aimed to determine the effect of smartphone addiction on physical activity level
      in healthy individuals. A total of 300 (134 female) healthy university students were included
      in this study. The mean age of the subjects was 21.36 ± 2.33 year.
    

Detailed description: 
      This study aimed to determine the effect of smartphone addiction on physical activity level
      in healthy individuals. A total of 300 (134 female) healthy university students were included
      in this study. The mean age of the subjects was 21.36 ± 2.33 year. The universe of the study
      consisted of volunteer students (Coaching Education, Physical Education and Sports Teaching,
      Sports Management, Recreation Departments) at the Faculty of Sport Sciences. Participants'
      demographic information was obtained and their physical activity levels were questioned with
      International Physical Activity Questionnaires (IPAQ) and smartphone addictions with the
      Smartphone Addiction Scale- Short Verison (SAS-SV).
    

Intervention name(s): addiction
Intervention type(s): Other
Intervention description(s): questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Addiction; Healthy individuals; Physical activity; Smartphone; Sport science
Swiss National Iodine Survey 2015
Condition: Healthy Subjects
Study type: Observational

Summary: 
      The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the
      authorities regarding iodine content in iodized salt. As a proxy for the entire population
      the investigators will study school aged children, pregnant women and women of reproduction
      age.
    

Detailed description: 
      In a national sample of school aged children (n=990), pregnant women (n=700) and women of
      reproductive age (n=700) urinary iodine will be determined in order to assess iodine
      nutrition in Switzerland. In addition, in both groups of women a blood sample will be taken
      for the determination of thyroid hormones, iron- and folate status. Questionnaires will be
      used for the determination of dietary iodine and salt intake as well as sociodemographic
      parameters.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        school aged children, 6-12 years pregnant women, 18-44 years women of reproductive age,
        18-44 years
Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position
Condition: Anesthesia, Conduction
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle
      placement. The primary aim is to compare "Sitting Cross-legged Fetal Position -SCF" with
      "Lateral Decubitus Fetal Position-LDF" anatomically via sonography.

      Secondary aim is to compare their comfort.
    

Detailed description: 
      Fifty participants were included to this prospective, randomized, consecutive controlled
      clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST),
      skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left
      paraspinal muscle [LPM] and right paraspinal muscle [RPM]), interspinous gap opening (ISGO),
      mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via
      ultrasonography (USG) according to the positioning techniques were also calculated. The
      calculations are explained briefly in primary outcomes (including the change of SCF-LDF in
      ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort
      (LC), and abdominal comfort (AC) were evaluated by the participants with the 7-point
      Numerical Rating Scale (NRS).
    

Intervention name(s): Anatomical intervention with USG and comfort evaluation with NRS
Intervention type(s): Procedure
Intervention description(s): The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Systematic randomization was made from 150 volunteers, and 50 participants were chosen. All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are SCF and LDF. The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 7-point numerical rating scale from minimum
1 meaning "very bad" to maximum 7 meaning "excellent."
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: neuraxial anesthesia positioning technique; sitting cross-legged fetal position; lateral decubitus fetal position; ultrasonography
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Condition: Degenerative Arthritis
MeSH terms: Arthritis; Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      degenerative arthritis.
    

Detailed description: 
      degenerative arthritis is the most common type of arthritis. It is estimated that 26.9
      million Americans 25 years old or older have clinical degenerative arthritis of some joints,
      with a higher percentage of affliction in the older population. Its clinical manifestations
      include joint pain and impairment to movement, and surrounding tissues are often affected
      with local inflammation. The etiology of degenerative arthritis is not completely understood;
      however, injury, age, and genetics have been considered among the risk factors.

      Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage,
      with associated changes in bone. Cartilage has limited intrinsic healing and regenerative
      capacities.

      Due to the increasing incidence of degenerative arthritis and the aging population coupled
      with inefficient therapeutic choices, novel cartilage repair strategies are in need.

      The availability of large quantities of MSCs and their potential for ready chondrogenic
      differentiation after prolonged in vitro expansion have made MSCs the most hopeful candidate
      progenitor cell source for cartilage tissue engineering.

      In the clinical study, mesenchymal stem cells will be isolated from adipose tissue and
      cultured, and administered into the cartilage tissue lesion by orthopedic surgery.

      It will be stimulate the regeneration of defective cartilage tissue and to improve their
      functions.
    

Intervention name(s): Autologous Adipose Tissue derived MSCs Transplantation
Intervention type(s): Procedure
Intervention description(s): Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
Other intervention name(s): RNL-JointStem®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and
      bortezomib improves the progression free survival and the response rate compared to
      historical controls of fludarabine and melphalan alone.
    

Detailed description: 
      Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's
      lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although
      the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both
      increasing incidence and earlier age of onset.

      The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The
      proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by
      20%.
    

Intervention name(s): Fludarabine monophosphate, melphalan, Bortezomib
Intervention type(s): Drug
Intervention description(s): Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.
Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2
Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.
Other intervention name(s): Fludara; Phenylalanine Mustard; Velcade
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Bortezomib; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Transplant
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety,
      tolerability and effect on body weight of a range of doses of metreleptin and pramlintide,
      each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.
    


Intervention name(s): pramlintide acetate; metreleptin; placebo-P; placebo-M
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous injection, twice a day; subcutaneous injection, twice a day; subcutaneous injection, twice a day; subcutaneous injection, twice a day
Other intervention name(s): Smylin; Placebo matched to pramlintide; Placebo matched to Metreleptin
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: overweight; obesity; pramlintide; metreleptin; Amylin
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV)
      formulation of edaravone in the fasting state in healthy adult subjects
    


Intervention name(s): MT-1186; MCI-186
Intervention type(s): Drug; Drug
Intervention description(s): Oral suspension; Intravenous formulation
Other intervention name(s): Edaravone; Edaravone
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial
      of soft contact lenses.
    

Detailed description: 
      The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is
      a commercially available soft contact lens (model: SiHy Daily). The number of enrolled
      subjects is 148, and clinical observation is performed for 3 months.
    

Intervention name(s): Contact Lenses
Intervention type(s): Device
Intervention description(s): Contact lenses for vision correction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This post-market, interventional, prospective, single arm, the United States (US) based
      multi-center study will assess the change in treatment satisfaction of participants who
      utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.
    


Intervention name(s): ACCU-CHEK
Intervention type(s): Device
Intervention description(s): ACCU-CHEK Connect Diabetes Management System contains ACCU-CHEK Aviva Connect Blood Glucose Monitoring System, ACCU-CHEK Connect Diabetes Management App, and ACCU-CHEK Connect Online Diabetes Management System.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder
Condition: Pain, Shoulder
MeSH terms: Bursitis; Shoulder Pain
Study type: Interventional

Summary: 
      The patients will be randomly allocated into two equal groups (each 20 patients) using sealed
      opaque numbered envelopes:

      Control Group (C Group) : Patients receive continuous US suprascapular nerve block only.

      Gabapentin Group (G Group) : Patients receive continuous US suprascapular nerve block with
      oral gabapentin 300 mg once daily at bed time.

      Both groups compared as regard:

      Visual Analogue Scale Range of passive and active movements Patients satisfaction
      complication related to block The total dose of diclofenac sodium
    


Intervention name(s): Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine
Intervention type(s): Procedure
Intervention description(s): The high frequency linear ultrasound transducer (Sonosite 6-13 MHz) in a transverse orientation will be placed over the scapular Spine.
Moving the transducer cephalad the suprascapular fossa will be identified. 18 gauge touhy needle will be inserted in plane after subcutaneous local anesthesia infiltration with 1 ml lidocaine 2% Real-time imaging will be used to direct injection of 2 ml lidocaine 2% to test perineural spread of injectate after confirmation of the position of tip of needle injection of 40mg methyl prednisolone diluted in 5 ml bupivacaine 0.5% will be done through the needle to anesthetize the nerve and create space for catheter insertion. After catheter insertion another 2 ml lidocaine 2% will be injected through the catheter to confirm position perineural in the scapular notch. Lastly Catheter will be fixed via skin tunnel and secured with skin sutures and adhesive tap.
Other intervention name(s): Oral gabapentin 300 mg at bed time in GG
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Gabapentin; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg
Condition: Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label pilot study to evaluate the efficacy and the safety of the Flowaid
      device in increasing local circulation in the legs.

      15 patients with a diagnosis of Peripheral Vascular Disease will be enrolled in this study.
      They will recieve tratment with the Flowaid device and monitored continuously by means of
      Laser Doppler Flowmetry as well as by tcPO2 and Digital Thermography. Subjective data will
      also be collected.
    

Detailed description: 
      This is a 15 patient pilot study to evaluate efficacy and safety of use of the Flowaid device
      in increasing local circulation in the legs of patients with Peripheral Vascular Disease.
      Patients will be evaluated and scored prior to treatment and then treated with the Flowaid
      device for a period of two hours. During the treatment period patients will be continuously
      monitored by digital thermograph as well as by tcPO2 and Laser Doppler Flowmetry. Patients
      will also be monitored for a brief period immediately after cessation of treatment to
      evaluate continued effect of the device on local circulation in the leg.

      The study will be individually controlled with each patients treated leg evaluated against
      the contralateral non- treated leg.

      Subjective data including distance able to walk, pain and vibratory sensation threshold will
      also be collected and evaluated appropriately.
    

Intervention name(s): External Electric Muscle Stimulation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
Condition: Gangrenous Appendicitis
MeSH terms: Appendicitis; Gangrene
Study type: Interventional

Summary: 
      A prospective, randomized controlled clinical trial was conducted at the Hospital
      Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of
      antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous
      appendicitis.
    

Detailed description: 
      Introduction: For patients with acute gangrenous appendicitis, it is common to provide
      antibiotics during 5-7 days in order to reduce the incidence of infection of the surgical
      wound; however the benefit of such treatment has not been tested. A prospective, randomized
      controlled clinical trial was conducted at the Hospital Universitario de Santander to test
      the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a
      5-day antibiotic therapy in patients with acute gangrenous appendicitis.

      Materials and Methods: From December 2007 to November 2009, 799 patients went through surgery
      after being diagnosed with acute appendicitis. Out of this set, 150 patients diagnosed with
      acute gangrenous appendicitis, were randomly assigned to one of two groups: control group
      (group A: 72 patients received a 5-day antibiotic therapy), and treatment group (group B: 78
      patients received a single 1-dose of antibiotic prophylaxis). The experimental outcomes
      included: the incidence of infection of the surgical wound, the length of the hospital stay,
      and the adverse effects derived from a prolonged use of antibiotics.
    

Intervention name(s): prophylaxis; therapy
Intervention type(s): Other; Other
Intervention description(s): single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV; antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute appendicitis; Antibiotic prophylaxis; Wound infection; Nosocomial infection
INVSENSOR00027 Clinical Performance Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study assesses the investigational sensor's (INVSENSOR00027) performance for detection
      of subjects' position and posture in bed, along with heart rate and respiratory rate.
    


Intervention name(s): INVSENSOR00027
Intervention type(s): Device
Intervention description(s): Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Condition: Diabetic Macular Edema; Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Macular Edema; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one
      of the two treatment groups to determine the effects of topical ocular administration of low
      dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and
      Age-Related Macular Degeneration.
    


Intervention name(s): MTP-131
Intervention type(s): Drug
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular edema; Macular degeneration; MTP-131; Ocuvia™