bioihbjkbjnl/mcl2 huggingface dataset:
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
Condition: Cholesteatoma
MeSH terms: Cholesteatoma
Study type: Interventional

Summary: 
      the main objective of the study is to compare endoscopic transcanal tympanoplasty with
      attico-antrostomy with endoscopic assisted canal wall up mastoidectomy in treatment of
      limited attic cholesteatoma.
    


Intervention name(s): endoscopic transcanal tympanoplasty with attico-antrostomy; endoscopic assisted canal wall up mastoidectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac; traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects
Condition: Flexible Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat
      foot. Little is known about the effectiveness of their interaction on managing flatfoot.

      The study aims to evaluate the effect of insoles and short foot exercise on the height and
      area of the medial longitudinal arch of flexible flatfoot participants as well as the force
      and pressure.
    

Detailed description: 
      Study design: A parallel, active-control study design was used to conduct a single-blinded
      randomized controlled trial.

      Method: The toe rising test, the "too many toes" sign, and the navicular drop test was used
      to select 30 participants with flexible flatfoot. Participants was randomly assigned either
      to an experimental group (n = 15) or a control group (n = 15). The experimental group
      received short foot exercises (SFE) and insoles, and the control group received only insoles.
      SFE was implemented 30 times for a duration of three minutes each day over the course of six
      weeks. The exercise progressed from sitting to standing and finally to one leg stance
      position within every two weeks. The participants wore shoes containing orthotic insoles for
      eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure
      distribution (force, area, and pressure) at baseline and at two-week intervals throughout the
      six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate
      restriction in participants' functional abilities, and the navicular drop test (NDT) was used
      to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline
      and at the sixth week.

      Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two
      groups across time and within-subject observations of the outcomes.
    

Intervention name(s): foot insole; short foot exercise
Intervention type(s): Device; Other
Intervention description(s): the subject was instructed to wear foot insole for 8 hours.; the subject was instructed to perform exercise once a day 30 repetitions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Flatfoot; Insole; Short-foot exercise; Orthotic
Assessment of Spinal Stability
Condition: Spine Stability; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in
      humans, and develop non-invasive techniques to measure intervertebral kinematics of the
      lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a
      foundation for clinical trials on low back pain patients using this methodology.
    


Intervention name(s): method (non-surgical) to measure neuromuscular neutral zones
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healty men and women between 21 and 45 years old with no history of low back pain of low
        back injury.
      
Keywords: lumbar spine; low back pain
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      This study is a multicenter, randomized, controlled, open-label trial designed to evaluate
      the safety and efficacy of DermACELL in subjects with a single target chronic venous leg
      ulcer (VLU).
    

Detailed description: 
      This study is a multicenter, randomized, controlled, open-label trial designed to evaluate
      the safety and efficacy of DermACELL in subjects with a single target chronic venous leg
      ulcer (VLU). After eligibility is determined at a screening visit, VLU subjects will be
      entered into a 2 week run-in period of conventional wound care with moist wound therapy and
      multilayer compression bandage.

      At baseline, those continuing to meet eligibility criteria will be randomized to either
      DermACELL or conventional care wound management at a ratio of 1:1. The appropriate size of
      DermACELL will be applied to the wound of subjects in the DermACELL arm. The ADM will be
      attached with sutures, sterile adhesive strips, or bioadhesive, and covered with a dressing.
      For subjects in the conventional care wound management arm, the debrided wound will undergo a
      moist-wound therapy consisting of alginates, foams, or hydrogels, and will be covered with a
      gauze that is appropriate for the type of wound (moist or dry).

      Subsequent study visits will occur every week until 100% re-epithelialization or up to 16
      weeks after treatment (whichever comes first).
    

Intervention name(s): DermACELL AWM
Intervention type(s): Other
Intervention description(s): DermACELL AWM is a sterile, ready to use acellular dermal matrix
Other intervention name(s): Acellular dermal matrix
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomized, controlled, open-label trial comparing DermACELL AWM to conventional care
Masking: None (Open Label)
Primary purpose: Treatment
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of ecopipam tablets in children and adolescents in the
      treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam
      tablets, while the other half will receive matching placebo tablets
    

Detailed description: 
      Multicenter, placebo-controlled, double-blind, randomized, parallel-group, Phase 2b study in
      pediatric subjects (aged greater than equal to 6 to less than 18 years of age) with TS.
      Following a 28-day Screening period and Baseline visit, eligible subjects will be randomized
      1:1 to receive either ecopipam hydrochloride (HCl) or matching placebo for a 12 week
      treatment period. Doses will be titrated up and down from target dose of 2 mg/kg/day. Follow
      Up visit will be conducted after the last dose of study medication.
    

Intervention name(s): Ecopipam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ecopipam HCI tablets administered PO to establish 2 mg/kg/day; Matching Placebo
Intervention MeSH terms: Ecopipam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Vinegar Co-ingestion in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main objective of this study is to assess the acute effect of co-ingested vinegar on
      postprandial plasma glucose levels in type 2 diabetes patients.
    

Detailed description: 
      Plasma glucose and insulin concentrations are assessed over the 2 hr period following
      ingestion of carbohydrate-rich beverage with or without added vinegar.
    

Intervention name(s): placebo co-ingestion; vinegar co-ingestion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 25 ml water co-ingested with a glucose-containing beverage; 25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
Other intervention name(s): vinegar; acetic acid
Intervention MeSH terms: Acetic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in
      patients with Nonalcoholic Steatohepatitis (NASH).
    

Detailed description: 
      This is an exploratory phase II, multi-center, two-part study (Part 1: randomized,
      placebo-controlled, two-arm with 60 patients; Part 2: non-randomized, single-arm, open-label
      with 30 patients) designed to evaluate the safety and efficacy of leronlimab after
      subcutaneous (SC) administration in patients with NASH for 13 weeks.

      A Follow Up visit was conducted 28 (± 3) days after receiving the last study treatment (i.e.,
      after last dose of Leronlimab (PRO 140) or placebo.
    

Intervention name(s): Placebo; leronlimab 700 mg; leronlimab 350 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will be administered subcutaneously every week for 13 weeks.; 700 mg leronlimab will be administered subcutaneously every week for 13 weeks.; 350 mg leronlimab will be administered subcutaneously every week for 13 weeks.
Other intervention name(s): PRO 140; PRO 140
Intervention MeSH terms: Leronlimab; HIV Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NASH; PRO 140; Leronlimab
Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive People With Obesity
Condition: Obesity; Blood Pressure; Whole Body Vibration; Exercise
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase
      peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate
      effect on hemodynamic response and fatigue parameters in patients with obesity.
    


Intervention name(s): Whole Body Vibration Training
Intervention type(s): Other
Intervention description(s): Whole Body Vibration Training (WBVT) method has been used as an alternative to conventional strengthening exercises. In this method, the patient stands on the platform of the WBVT device in a static position or performs dynamic exercises, the mechanical vibration produced by the device is transferred to the body
Other intervention name(s): Standard Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active Whole Body Vibration (aWBVT) group, performed ten dynamic standard exercises on a vibration platform. The vibration protocol lasted for 15 minutes, in a frequency of 30 Hz and amplitude of 2 mm. Control group performed only ten dynamic standard exercises with no vibration application. Blood Pressure, heart rate, saturated oxygen were measured for the hemodynamic response. Modified Borg Dyspnoea Scale (MBDS) and The Borg Rating of Perceived Exertion (BRPE) Scale were used in order to evaluate fatigue level. All evaluations were performed at the beginning of the study, at the end of the session and at the recovery period
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Behavior Therapy Prior to Bariatric Surgery
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Obesity is an ever increasing public health problem in this country. Bariatric surgery is
      currently the most effective treatment for morbid obesity and two hundred thousand surgeries
      are performed in the United States each year. Unfortunately, despite anatomically successful
      surgery, it is estimated that at most surgical centers about 30 percent of patients will not
      achieve significant weight loss following surgery. It has been proposed that participation in
      preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence
      for this premise is lacking. The current study is a pilot project designed to conduct a
      prospective randomized trial to examine the impact of participation in a 12-week standardized
      preoperative behavioral weight management program on percentage of excess weight loss and
      psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The
      cost of bariatric surgery is not covered by this study and only patients local to the
      Rochester, Minnesota area are eligible to participate.

      It is hypothesized that patients who complete the 12-week behavioral program will experience
      greater weight loss and improved psychosocial and medical outcomes compared to controls.
    


Intervention name(s): LEARN group
Intervention type(s): Behavioral
Intervention description(s): Participants will complete a 12-week behavioral weight management intervention (the LEARN program) prior to bariatric surgery, which is the current standard clinical practice at Mayo Clinic Rochester. This involves weekly group meetings, weigh-ins, and goal setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bariatric surgery; behavioral weight management; psychosocial outcomes following bariatric surgery
Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older
Condition: Quadrivalent Influenza Virus Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People
      Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old
      and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus
      Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after
      7 days.
    


Intervention name(s): One dose of Quadrivalent Influenza Virus Vaccine; One dose of Quadrivalent Influenza Virus Vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; safety
Obesity and Intracytoplasmic Sperm Injection Cycle Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Obesity has been associated with menstrual irregularities, chronic an-ovulation, infertility,
      and poor outcomes in women undergoing in vitro fertilization.

      There is strong evidence that obesity is associated with a higher n vitro fertilization cycle
      cancellation rate (despite administration of higher doses of exogenous gonadotrophins), a
      lower mature oocyte yield and lower number of cryopreservation cycles.

      Furthermore, obese women have been shown to have impaired response to ovarian stimulation and
      significantly lower live births after in vitro fertilization. Indeed, obesity affects many
      ovarian intra-follicular steroidogenic, metabolic and inflammatory pathways.This is
      particularly evident in women with abdominal (central obesity). Waist circumference
      measurement is used to identify individuals with abdominal obesity but it cannot
      differentiate between intra-abdominal fat and subcutaneous abdominal fat accumulation.

      The reliable measurement of visceral fat and subcutaneous fat is not only important as a tool
      to predict cardiovascular and metabolic disease risk, but it is also essential to evaluate
      the effect of these fat compartments on female reproductive function. Intra-abdominal fat
      accumulation is related to insulin resistance in women with polycystic ovary syndrome and in
      these women the resulting hyperinsulinemia contributes to an-ovulation.

      Obese anovulatory women with polycystic ovary syndrome who resume ovulation during a 6-month
      lifestyle program lose more visceral fat with no difference in the change of subcutaneous fat
      compared to the women who did not resume ovulation.

      Another recent study that enrolled 140 non-polycystic ovary syndrome in vitro fertilization
      women demonstrated that women with increased waist circumference and higher follicular fluid
      leptin have less oocytes fertilized and failed in vitro fertilization outcomes. Increased
      intra-abdominal fat during early pregnancy is associated with insulin resistance and
      increased diastolic blood pressure and it can predict glucose intolerance in later pregnancy.
    


Intervention name(s): Visceral fat thickness; Body mass index
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.; Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Physical Status and Upper Airway Function in Neuromuscular Patients
Condition: Neuromuscular Diseases; Physical Disability; Airway Disease
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      Inside of studies that report an upper airway function impaired, the upper limb strength has
      been demonstrated to be determinant in breath, speech and swallow performance. Nevertheless,
      no previous studies in neuromuscular disease have explored the relation between general
      disability and upper airway function.

      There is a suspicion of upper airway which is associated with physical deterioration, however
      the extent to which if feeds back has not been explored.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed of neuromuscular disease aged 6-65 years with an impairment of the upper
        airway, whether in ventilatory, deglutory or communication capacity.
TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)
Condition: Chronic Kidney Disease; End Stage Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this study are to assess safety and to evaluate the biologic activity of
      TARGTEPO treatment.
    

Detailed description: 
      This is a Phase I-II, open-label study. Each patient will receive targeted dose of EPO
      delivered via TARGTEPO. The targeted doses will be determined according to 3 cohorts as
      follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day), Group C (55-65 IU/Kg/day). The
      objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining
      Hb levels within the target range of 9-12 g/dl. Biological activity assessments will include
      duration of TARGTEPO secretion as measured by serum EPO levels above baseline
    

Intervention name(s): MDGN201 TARGTEPO
Intervention type(s): Biological
Intervention description(s): Erythropoietin secreted by TARGTEPO transduced with MDGN201
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Polarization Sensitive Optical Coherence Tomography
Condition: Myopia
MeSH terms: Myopia; Hypersensitivity
Study type: Observational

Summary: 
      The purpose of the study is to use the polarization sensitive optical coherence tomography
      (PS-OCT) developed by Singapore Eye Research Institute, to evaluate the potential OCT scleral
      biomarkers capable of predicting risk of myopia progression.
    


Intervention name(s): Polarization sensitive optical coherence tomography (PS-OCT)
Intervention type(s): Device
Intervention description(s): The PS-OCT is a prototype, also known as an early version of a medical device, specially developed by the Ocular Imaging Research Group, Singapore Eye Research Institute, for prediction of myopia progression. It has not been approved for use in any other country. There is currently no method to identify who is at risk of myopia progression. The PS-OCT device will provide the capabilities of OCT scleral biomarkers, which may have the potential to identify individuals at high risk for myopia.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult and children cohorts
Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic
      Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
    

Detailed description: 
      Currently,there is no standard second-line therapy for esophageal squamous cell
      carcinoma.More effective therapy for patients with this disease who developed disease
      progression after first line therapy is needed.Although Erlotinib is recommended in NCCN
      Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line
      therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this
      phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for
      patients with recurrent or metastasis esophageal squamous carcinoma after failure of
      conventional chemotherapy,and analyse the value of biomarkers of these patient to identify
      who benefit.
    

Intervention name(s): Icotinib Hydrochloride
Intervention type(s): Drug
Intervention description(s): Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Other intervention name(s): Conmana
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment