bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Three Meshes in Lichtenstein Hernia Repair
Condition: Chronic Pain; Recurrences
MeSH terms: Chronic Pain; Hernia; Recurrence
Study type: Interventional

Summary: 
      Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of
      this study was to compare long-term results of hernioplasty using three different meshes
      (partly absorbable, lightweight polypropylene and thick polypropylene mesh).
    

Detailed description: 
      Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case
      surgery by the same surgeon and exactly by the same surgical technique. The patients were
      randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias),
      a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven
      polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of
      hernias were carefully followed 5 years after surgery.
    

Intervention name(s): Vypro II mesh; Premilene LP; Premilene mesh
Intervention type(s): Device; Device; Device
Intervention description(s): partly absorbable mesh; lightweight mesh; A conventional polypropylene mesh (82 g/m2)
Other intervention name(s): polypropylene-polyglactin mesh; lightweight polypropylene; polypropylene mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inguinal hernia, Lichtenstein hernioplasty, chronic pain
Intraocular Pressure and Tolerability Study of Preservative-free Prostaglandins (Bimatoprost and Latanoprost) on Glaucoma and Ocular Hypertension: European, Multicentric, Investigator-led, Single Masked Study
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product
      composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This
      new product is used as a once-daily topical ocular therapy for the reduction of elevated
      intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and
      that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is
      an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as
      bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The
      comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was
      recently launched in a number of countries in Europe and contains latanoprost in a new
      preservative free formulation.

      It is clinically important to compare these newly entered preservative free products with
      respect to tolerability and efficacy. A better tolerability combined with maximum efficacy
      will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to
      the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.

      The hypothesis of the study is that monodose bimatoprost is more effective than monodose
      latanoprost by at least 1 mmHg.

      (AIBILI applied for an unrestricted grant from Allergan to perform this study)
    


Intervention name(s): Preservative-free latanoprost; Preservative-free bimatoprost
Intervention type(s): Drug; Drug
Other intervention name(s): Monoprost
Intervention MeSH terms: Bimatoprost; Latanoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Glaucoma; Ocular hypertension; Preservative-free prostaglandins
Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh
Condition: Injection Techniques
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip
      products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the
      injection technique.
    

Detailed description: 
      Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is
      intended to restore hydrobalance and improve skin structure of the lips (referred to as lip
      rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the
      subject's pain during treatment. The objectives of this open, multicenter study are to
      evaluate efficacy and safety of the products for the studied indications and to collect
      information on injection techniques used.
    

Intervention name(s): Restylane Lip Volume; Restylane Lip Refresh
Intervention type(s): Device; Device
Intervention description(s): Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.; Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efficacy; safety; Restylane; Lip products; injection techniques
Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Condition: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Ear Diseases; Hearing Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether ancrod is effective and safe in the
      treatment of sudden sensorineural hearing loss (SSHL).
    


Intervention name(s): Ancrod; Saline solution
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections; Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Other intervention name(s): Viprinex; NM-V; Placebo
Intervention MeSH terms: Ancrod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional
      phacoemulsification using the bevel-down technique.
    

Detailed description: 
      In this prospective, comparative, masked study, patients will be randomly assigned to have
      torsional coaxial microincision cataract surgery using either the mini-flared 45-degree
      Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include
      preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial
      cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT).
      Intraoperative measurements will include phaco time, torsional time, aspiration time, case
      time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).

      The study was performed according to established ethical standards for clinical research
      Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between
      November 2010 and February of 2011. All surgeries will be performed at the University of Sao
      Paulo. Physicians conducting postoperative evaluation will not have access to patients'
      medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell
      count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg,
      amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective
      tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior
      capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will
      be subsequently excluded.
    

Intervention name(s): Mini-flared; Reversed tip
Intervention type(s): Device; Device
Intervention description(s): Mini-flared Kelman tip; Reversed Kelman tip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kelman tip; Mini-flared; phacoemulsification; cataract
Study to Evaluate Safety and Activity of Crizotinib With Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma
Condition: Glioblastoma Multiforme (Grade IV) of Cerebellum
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This multicenter, open-label, phase Ib trial aims to assess the safety and activity and
      safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients
      with newly diagnosed glioblastoma.
    


Intervention name(s): Crizotinib
Intervention type(s): Drug
Intervention description(s): Crizotinib is added to Stupp method
Intervention MeSH terms: Crizotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Determine safety and effectiveness of the technique using autologous stem cells in the
      treatment of urinary incontinence in one male subject.
    

Detailed description: 
      Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for
      multiplication and after about 6 weeks time will be injected into the subjects urethra.
    

Intervention name(s): Muscle Biopsy; Injection of autologous stem cells
Intervention type(s): Procedure; Biological
Intervention description(s): Biopsy of thigh muscle to obtain stem cell core.; After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Evaluation of γ-globin Reactivated Autologous Hematopoietic Stem Cells
Condition: β Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      This is a non-randomized, open label, single-dose, phase 1/2 study in up to 12 participants
      with β-thalassemia major.This study aims to evaluate the safety and efficacy of the treatment
      with γ-globin reactivated autologous hematopoietic stem cells in subjects with β-thalassemia
      major.
    

Detailed description: 
      γ-globin reactivated autologous hematopoietic stem cells will be manufactured using
      Crispr/Cas9 gene editing system. Subject participation for this study will be 1 year.
      Subjects who enroll in this study will be asked to participate in a subsequent long-term
      follow up study that will monitor the safety and efficacy of the treatment they receive for
      up to 15 years post-transplant.
    

Intervention name(s): γ-globin reactivated autologous hematopoietic stem cells
Intervention type(s): Biological
Intervention description(s): gene edited autologous hematopoietic stem cells with γ-globin expression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating HKI-272 Administered to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the
      same.
    


Intervention name(s): neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Health; Pharmacokinetics; healthy subjects
Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have
      insufficient glycaemic control despite treatment with a sulfonylurea drug.
    


Intervention name(s): BI 1356; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg orally (po) tablet qd; Placebo matching BI 1356 5mg one tablet daily
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Laryngeal Mask Airway Versus Air Q Laryngeal Airway
Condition: Airway Devices
Study type: Interventional

Summary: 
      Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal
      intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices
      that can be used to maintain and protect airways from aspiration of secretions and blood
      during DCR surgery. The present study was designed to compare standard LMA versus air Q as
      regards the sealing effect and aspiration of blood in DCR surgery.
    

Detailed description: 
      72 patients were divided into two groups, 36 patients each, named LMA group, and air Q group
      according to supraglottic devices used. The following parameters were recorded in both
      studied groups, continuous Electrocardiography (ECG), heart rate (HR), means arterial
      pressure (MAP), arterial oxygen saturation (SpO2), end tidal carbon di-oxide (PCO2)..Oro
      pharyngeal leak pressure in (cmH2O), exhaled tidal volume in (ml), leak volume in (ml), leak
      fraction in (%) number of shifting from LMA to air Q or ETT and shifting from air Q to LMA or
      ETT was recorded with absence or presence of surgical blood on The undersurface of the device
      used.
    

Intervention name(s): LMA group; AirQ group
Intervention type(s): Device; Device
Intervention description(s): patients were ventilated with LMA; patients were ventilated with AirQ airway
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: AirQ; LMA; dacrocystorhinostomy surgery
Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
Condition: Walking Impairment; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the efficacy and safety of ADS-5102 (at daily doses of 137 mg or 274 mg)
      compared with placebo in MS patients with walking impairment.
    

Detailed description: 
      This was a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group
      study of ADS-5102 (amantadine) extended release capsules in MS subjects with walking
      impairment. The study consisted of a screening period (up to 3 weeks), a single-blind placebo
      run-in period (4 weeks; during which subjects were blinded to treatment), and a double-blind
      treatment period (12 weeks).

      For at least 30 days prior to screening, all subjects were to have received a stable regimen
      of MS medications, both disease-modifying and symptomatic; these medications were to continue
      at the same doses and regimens for the duration of the subjects' participation in the study,
      to the extent compatible with good neurological care. Subjects were not to have used
      amantadine, dalfampridine, or any 4 aminopyridine or 2,4 diaminopyridine preparation within
      30 days prior to screening.

      Consented subjects who completed the screening period were to undergo a 4-week single-blind
      placebo run-in period during which they received placebo as 2 capsules once daily at bedtime.

      Subjects who completed the single-blind placebo run-in period and continued to meet study
      eligibility criteria were randomized with equal probability to 1 of 3 treatment groups:
      placebo or ADS-5102 at a final dose of 137 mg/day or 274 mg/day. Study drugs were
      administered as 2 capsules once daily at bedtime.

      Subjects were to return to the clinic for safety and efficacy assessments at Week 0 and Week
      2 prior to randomization and at Weeks 4 (randomization and baseline visit), 6 (only safety),
      8, 12, and 16 after randomization. In addition, telephone visits for safety assessments were
      conducted at Weeks 5 and 7. Subjects who withdrew from the study before Week 16 were to have
      an early termination visit that included safety follow-up and efficacy assessments, as
      appropriate.
    

Intervention name(s): ADS-5102, 137 mg; ADS-5102, 274 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Oral capsules; Oral capsules; Oral capsules
Other intervention name(s): ADS-5102; amantadine extended release; ADS-5102; amantadine extended release
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner,
      beginning with low doses not expected to have significant biological effects and proceeding
      to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored
      may be limited by tolerability, and will not exceed levels previously shown to be tolerable
      in animals.
    


Intervention name(s): PF-04629991; PF-04629991; PF-04629991
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses); Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses); Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: rheumatoid arthritis First in human safety pharmacokinetics pharmacodynamics
Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis?
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Post-menopausal women aged 40-65 with symptomatic hand osteoarthritis are invited to take
      part in this feasibility study. The study's aim is to investigate whether it is acceptable to
      women with painful hand OA to take an estrogen-containing therapy, and what is the best way
      of collecting some of the information in order to facilitate planning a full size trial. The
      investigator's long-term aim is to find out whether giving estrogen-containing therapy to
      women after the menopause improves hand OA symptoms.
    


Intervention name(s): Estrogen-bazedoxifene; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Conjugated estrogens 0.45 mg-bazedoxifene acetate 20 mg.; Placebo oral tablet
Other intervention name(s): Duavive
Intervention MeSH terms: Bazedoxifene; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Osteoarthritis; Hand; Hormone; Pain; Estrogen
Effects of Graston Technique in Patients With Non Specific Low Back Pain
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific low back pain upsets individuals of all age gathering and is a most significant
      provider to illness load everywhere on the world. Overseeing rules prescribe emergency to
      locate the uncommon instances of low back pain that are brought about by actually genuine
      pathology, thus need demonstrative work-up or proficient arrangement, or both. Since
      non-specific low back pain doesn't have a known pathoanatomical cause and treatment
      accentuations on diminishing in agony and its meanings.

      To determine the impacts of Graston technique in patients with non-specific low back pain.

      This examination was Quasi Experimental study and on the basis of inclusion standards, 20
      patients were involved. PNRS and ODI used to collect the data. Graston tool was used to treat
      patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions
      bised exercises protocol following pattern of APTA. The data was analyzed using SPSS 21.
    


Intervention name(s): Graston technique
Intervention type(s): Other
Intervention description(s): Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Back Pain,Pain Numeric Rating Scale,Owestry Disability Index
Virtual Reality-based Training in Cerebellar Ataxia
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of virtual reality-base training for
      cerebellar ataxia.
    


Intervention name(s): Exergaming training; Physical therapy intervention
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment