bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Focused Shockwave Therapy in Patients With CTS
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common entrapment of upper extremity. Patients with
      CTS will experience symptoms of pain, numbness of tingling sensation along the median nerve
      distribution. In more severe case, patients may have difficult manipulating objects that
      disturb function and patient's quality of life. Extracorporeal Shockwave Therapy (ESWT) is
      one of physical modalities that uses to treat many musculoskeletal disorders. For CTS,
      previous evidence showed that ESWT can improve symptoms, function as well as
      electrophysiologic parameters. However, standardized guidelines as well as the study in
      patients with moderate to severe CTS has not been established. Thus, the objective of the
      present study was to evaluate efficacy of ESWT in term of symptoms, function,
      electrophysiologic parameters, as well as sonography of median nerve in patients with
      moderate to severe CTS.
    

Detailed description: 
      -  The present study was a single-blinded randomized controlled trial comparing the
           efficacy of focused ESWT (F-ESWT) to conservative treatment in patients with CTS.

        -  24 patients who was diagnosed as CTS based on symptoms of CTS and physical examination.
           They were randomly allocated into two groups (21 patients per group), mainly F-ESWT plus
           conservative treatment and conservative treatment only.

        -  Outcome measures were BCTQ including symptom and function subscales, electrophysiologic
           parameters, and sonography to evaluate cross-sectional area (CSA) of the median nerve.
           All measures were recorded at baseline, 3 weeks and 6 weeks of treatment.

        -  Statistical analysis was performed to determine changes within the same group and
           compare difference between the two groups.
    

Intervention name(s): Focused ESWT; Control
Intervention type(s): Device; Behavioral
Intervention description(s): F-ESWT (dose 0.01-0.15 mJ/mm2, frequency 4-5 Hz, 1500 shocks) was applied perpendicular to the palmar side of the wrist which was done once a week for a total of three sessions plus conservative treatment.; Participants in the control group received only conservative treatment including disease education, advice about proper posture and activity, night wrist splint and nerve gliding exercise.
Other intervention name(s): F-ESWT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal Tunnel Syndrome, ESWT, shockwave therapy
The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease.
      Vitamin D has potent immunomodulatory properties that have promoted its potential use in the
      treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE
      patients and determined alterations in inflammatory, hemostatic markers as well as disease
      activity before and after vitamin D supplementation.

      248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were
      randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months.
      Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18,
      TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12
      months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were
      measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were
      classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The mean
      25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.
    


Intervention name(s): vitamin D 25(OH)D; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2000IU/day for 12 months; 2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SLE; disease activity markers; vitamin D
Breast Reconstruction in Previously Irradiated Breast
Condition: Mammaplasty; Radiotherapy; Complications; Breast Implant; Complications; Transplant Failure
Study type: Observational

Summary: 
      For patients with breast cancer subject to a mastectomy, preserving the morphology of the
      breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

      There are several types of breast reconstruction: prosthetic in one or two stages and
      autologous reconstruction.

      Adjuvant radiotherapy has shown an improvement of the overall survival and of the local
      control for patients with positive lymph nodes. As a consequence, plastic surgeons come into
      contact with more patients with a history of irradiation of their breasts than ever before.

      However, there are few studies with a significant number that evaluate the effect of
      pre-reconstruction radiotherapy on the three types of reconstruction.

      The aim of this study is to compare retrospectively these three types of reconstruction
      techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic
      reconstruction.
    


Intervention name(s): Pre reconstruction Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Previous PMRT
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients of some Breast Units in Italy
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the efficacy and safety of DU-176b compared with
      enoxaparin sodium for the prevention of venous thromboembolism in patients after elective
      total knee arthroplasty.
    


Intervention name(s): edoxaban; enoxaparin sodium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: anticoagulant; venus thromboembolism; thrombosis; thromboembolism; embolism and thrombosis; deep vein thrombosis; DU-176b; Edoxaban; factor Xa; total knee arthroplasty; Enoxaparin sodium
Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared
      to placebo when administered to healthy adult subjects.
    

Detailed description: 
      This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to
      evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to
      healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across
      4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV).
      A total of 4 different dose levels of investigational product will be evaluated across the
      cohorts. Subjects will be followed for approximately 100 days.
    

Intervention name(s): MEDI8852; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: MEDI8852
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza, Flu, Flu A, Influenza A
East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia
Condition: Chronic Non-specific, Uncomplicated Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of east-west collaborative
      treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and
      quality of life of patients with chronic cervicalgia
    


Intervention name(s): Bee Venom Acupuncture; Loxoprofen
Intervention type(s): Procedure; Drug
Intervention description(s): Bee Venom 1:20,000 under BVA Increment Protocol
- Increment Protocol as
1st week - SC 0.2cc/day, 2 days/week
2nd week - SC 0.4cc/day, 2 days/week
3nd week - SC 0.8cc/day, 2 days/week; 60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other intervention name(s): pharmacopuncture; Loxonin
Intervention MeSH terms: Loxoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic neck pain; combined treatment between conventional and complementary alternative medical treatment; bee venom acupuncture; NSAIDs
Kinesiotaping Versus Pilate Exercises
Condition: Dysmenorrhea; Exercise
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Sixty girls participated in this study and their main complaints were pain and cramping
      during menstruation. They were divided randomly into two equal groups.
    

Detailed description: 
      Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive
      menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3
      months except the days of menstruation. Visual analogue scale to assess pain intensity,
      Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire,
      WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma
      prostaglandin level were applied for each girl in both groups before and after the treatment
      course.
    

Intervention name(s): kinesiotaping application; Pilate exercises program
Intervention type(s): Other; Other
Intervention description(s): kinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations.; Each girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was designed as a randomized controlled trial.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: kinesiotaping; pilate exercises; primary dysmenorrhea
Effects of Exercise and Insole on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Pes Planus
Condition: Pes Planus
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The aim is to compare the effects of intrinsic foot muscles and tibialis posterior
      strengthening exercise, and customized arch support insoles on foot posture, plantar force
      distribution, and balance in individuals with flexible pes planus.
    

Detailed description: 
      The aim is to compare the effects of intrinsic foot muscles and tibialis posterior
      strengthening exercise, and customized arch support insoles on foot posture, plantar force
      distribution, and balance in individuals with flexible pes planus. Forty-two individuals with
      flexible pes planus will be recruited into the study according to the inclusion criteria.
      Participants will be randomly divided into three groups: (1) Exercise, (2) Insole, (3)
      Exercise plus Insole. Exercises will be performed three times per week for six weeks, also
      custom-made insoles will be worn for six weeks. Foot posture will be assessed using the
      Navicular drop, Valgus index and Foot posture index-6. Plantar force variables will be
      recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the
      6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds:
      self-selected slow, normal and fast speeds, (3) Walking just after the heel-rise test for
      endurance. Balance performance will be assessed by the Balance Master System (NeuroCom®
      International Inc., USA). The assessments will be made pre/post intervention and at 6-weeks
      follow-up.
    

Intervention name(s): Exercise; Orthesis
Intervention type(s): Other; Other
Intervention description(s): Intrinsic foot muscles and tibialis posterior strengthening exercises; Customized arch support insoles
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pes planus; Foot posture; Plantar pressure variables; Balance; Short foot exercises; Tibials posterior strengthening; Intrinsic foot muscles; Custom-made insole; Arch support insole
Validation and Predictive Equation for Sit-to-stand Test in Children
Condition: Healthy
Study type: Interventional

Summary: 
      Validation and development of predictive values for the one minute sit-to-stand test in
      children between 6 and 18 years.
    


Intervention name(s): sit-to-stand test; six minute walking test
Intervention type(s): Other; Other
Intervention description(s): to sit and stand from a chair; to walk for six minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks
Condition: Pain, Post Operative; Regional Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. Recent
      studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial
      surgery but have been poorly investigated in orthognathic surgery. This study is designed to
      evaluate analgesic effectiveness, through opioids consumption, of a bilateral double
      ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular
      osteotomy.
    

Detailed description: 
      Maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery.
      It mostly requires opioids use which lead to well known side effects. Regional anesthesia has
      strongly modified post-surgical rehabilitation of many procedures. Maxillary nerve block has
      proved its efficiency on opioid consumption reduction in pediatric cleft palet surgery but
      has been rarely evaluated in orthognathic surgery. Mandibular nerve block has never been
      investigated in maxillo-mandibular osteotomy as well as benefit of bilateral ultra-sound
      guided technique to perform these nerve blocks. Consequently, this trial is designed to
      evaluate analgesic effectiveness of a double ultra-sound guided nerve blocks (maxillar and
      mandibular nerve) in maxillo-mandibular osteotomy.

      This monocentric, single-blinded, randomized controled trial is designed with 2 groups of 25
      patients receiving either bilateral double ultra-sound guided nerve block (maxillary and
      mandibular) with ROPIVACAINE 4.75mg/mL either local infiltration of LIDOCAINE 1% at incision
      sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy. Per
      et post-surgery anesthesic protocol and analgesia are standardized for both group. The main
      outcome corresponds to opioid consumption in MME of the first 24h after surgery. Follow-up
      occurs at 24h and 48h after end of surgery to assess analgesia, pain and opioid consumption.
    

Intervention name(s): bilateral ultra-sound guided maxillary and mandibular nerve blocks; Infiltration of Lidocaine 1%
Intervention type(s): Procedure; Procedure
Intervention description(s): Interventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml.; Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Orthognathic surgery; Maxillary-mandibular osteotomy; Double jaw osteotomy; Bimaxillary surgery; Maxillary nerve block; Mandibular nerve block; Regional anesthesia; Nerve blocks
Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess safety and efficacy of various doses of BTX 1503
      liquid formulation in subjects with moderate to severe acne vulgaris of the face.
    

Detailed description: 
      This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group,
      dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). The objective
      of this study is to assess the safety and efficacy of various doses of BTX 1503 in subjects
      with moderate to severe acne vulgaris of the face.
    

Intervention name(s): BTX 1503; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation; Placebo
Other intervention name(s): BTX1503
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Synthetic CBD; Cannabidiol
Community Engaged Colon Cancer Screening Patient Navigator Program
Condition: ColoRectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The goal of the project is to increase colorectal cancer screening within the priority
      population of female and male adults age 50 to 85 in Northern Nevada. A successful
      community-based cancer patient navigator program will be modified in partnership with the
      community into a multi-level screening intervention.
    

Detailed description: 
      The goal of the project is to increase colorectal cancer screening within the priority
      population of female and male adults age 50 to 85 in Northern Nevada. A successful
      community-based cancer patient navigator program will be modified in partnership with the
      community into a multi-level screening intervention. A well-tested behavioral change theory
      (the health belief model; HBM) will guide the intervention and the relative efficacy of a)
      the theory's constructs and b) evidence-based intervention practices on increasing screening
      rates will be examined. Although increased screening rates are associated with program
      navigators, it is unclear which program components are related to the outcome. In addition,
      there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b)
      the relationships among the model's constructs. A quasi-experimental time-series design will
      be used to evaluate the outcome objective of increased screening rates by comparing screening
      rates one year pre- and post-intervention and whether navigated patients are better prepared
      for screening than non-navigated patients. A minimum of 315 participants (to correspond with
      a power level of .80) in the navigator program will be surveyed on knowledge about colorectal
      cancer, and satisfaction with and usefulness of the program. The anticipated contribution of
      the project will be to increase community efficacy, colorectal cancer screening in the
      project area, and to reduce cancer morbidity and mortality.
    

Intervention name(s): Screening patient navigation; Non-Navigated
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.; Randomly matched sample of non-navigated clinic patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: community engagement, navigation, cancer screening
A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
Condition: Recurrent or Metastatic Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with
      recurrent or metastatic solid tumors.
    

Detailed description: 
      This is a Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to
      evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and
      antitumor activity of MEDI6383 alone and in combination with MEDI4736 in adult subjects with
      recurrent or metastatic solid tumors.
    

Intervention name(s): MEDI6383; MEDI6383 and MEDI4736
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive MEDI6383 until disease progression or adverse event.; Subjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent or metastatic solid tumors, MEDI6383, OX40
The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube
Condition: Recruiting; Completed
Study type: Interventional
Phase: Phase 3

Summary: 
      Single-center prospective randomized trial to evaluate the effect of thermal damage of
      Ligasure® to destroy cornual portion of fallopian tube tisse.

      Right of Left side of fallpian tube is randomized and coagulated one more time than other
      side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at
      both cornual portion of cut off specimen.
    

Detailed description: 
      When investigators perform salpingectomy, both side of cornual portion of the uterus are
      coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is
      coagulated one more time at the cornual portion than unselected other side of fallopian tube.
      Hypothesis is that the side selected and coagulated twice would have less fallopian tube
      tisse left at fianl pathology than the side only once coagulated by Ligasure®.
    

Intervention name(s): The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment