bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer
Condition: Erectile Dysfunction; Sigmoid Colon Cancer; Rectal Cancer
MeSH terms: Rectal Neoplasms; Sigmoid Neoplasms; Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A
      Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical
      resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will
      be evaluated in treatment for patient with chronic erectile dysfunction, which developed
      after radical resection for sigmoid and rectal cancer and continues 12 months after the
      surgery.
    

Detailed description: 
      Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid
      colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized
      to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable
      during anterior rectal dissection. There may be also a contribution of psychological factors
      from the presence of stoma and fear of recurrent cancer. Recently, several studies reported
      that erectile dysfunction after rectal excision for rectal cancer was completely reversed or
      satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new
      phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also
      demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and
      tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the
      PDE11 isozyme and not produce significant myalgia. back pain, or leg pain.

      This prospective, randomized study was designed to evaluate the efficacy of Udenafil
      treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and
      rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed
      to Udenafil group or placebo group.
    

Intervention name(s): Udenafil
Intervention type(s): Drug
Intervention description(s): oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)
Other intervention name(s): Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected
      predominantly at a young age who in the most severe cases remain with permanent
      physical,psychological and cognitive deficits.This study will investigate the therapeutic
      effects of intranasal Nerve Growth Factor(NGF) in TBI.
    

Detailed description: 
      Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the
      severity of head injury, and NGF upregulation correlates with better neurologic outcomes and
      could be useful to obtain clinical and prognostic information in patients with serve TBI.

      However, the clinical use of NGF is difficulty associated with delivering them to the CNS
      because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a
      noninvasive and convenient novel method bypassing BBB, which results in targeting
      therapeutics to the CNS rapidly.

      The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting
      between 24 to 72 hours post TBI, continuing for 2 weeks.
    

Intervention name(s): nerve growth factor; nomral saline
Intervention type(s): Drug; Drug
Intervention description(s): The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.; The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nerve growth factor; traumatic brain injury; intranasal; prognosis; neurological function
Identifying the Role of Oxytocin and Vasopressin in the Functioning of Neurocognitive Systems Involved in Mood Disorders
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Observational

Summary: 
      The goal of this protocol, broadly stated, is to use targeted manipulations with intranasally
      administered oxytocin (OT) and arginine vasopressin (AVP) in conjunction with neurocognitive
      and neuroimaging paradigms to evaluate claims that OT and AVP inhibit and facilitate,
      respectively, the effective processing of aversive signals. Moreover, we wish to examine
      whether increased vasopressin levels will increase, and increased oxytocin levels decrease,
      the neural response in the amygdala and other limbic structures to aversive stimuli. In
      addition, we wish to assess whether OT and AVP administration will lead to the facilitation
      of conspecific recognition as appears to be the case for other mammalian species....
    

Detailed description: 
      Objective:

      The goal of this protocol, broadly stated, is to use targeted manipulations with intranasally
      administered oxytocin (OT) and arginine vasopressin (AVP) in conjunction with neurocognitive
      and neuroimaging paradigms to evaluate claims that OT and AVP inhibit and facilitate,
      respectively, the effective processing of aversive signals.

      Study Population:

      A total of 216 healthy male and female adults between 20-40 years of age.

      Design:

      This protocol will involve a series of independent studies. Each study will require one visit
      in addition to a screening visit, involves a physical and psychiatric assessment. The study
      visit itself will involve pharmacological challenge followed by neurocognitive or
      neuroimaging testing.

      Outcome Measures:

      Moreover, we wish to examine whether increased vasopressin levels will increase, and
      increased oxytocin levels decrease, the neural response in the amygdala and other limbic
      structures to aversive stimuli. In addition, we wish to assess whether OT and AVP
      administration will lead to the facilitation of conspecific recognition as appears to be the
      case for other mammalian species.
    

Keywords: Amygdala; Emotion; Memory; Threat; Peptides; Neuropeptides; Oxytocin; Vasopressin; Mood Disorder
Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass
Condition: Genetic Predisposition; Genetic Hypertension
MeSH terms: Hypertension; Genetic Predisposition to Disease
Study type: Observational

Summary: 
      This is a retrospective analysis of data collected within two previous studies. The data has
      been combined and used to investigate the impact of having a family history of hypertension
      on left ventricular muscle mass with and without controlling for moderate and vigorous
      intensity physical activity frequency per week. The hypothesis was that in a sample of mostly
      active participants, no differences in left ventricular mass between family history of
      hypertension groups would be observed, but the positive family history of hypertension group
      would have elevated left ventricular mass compared to the negative family history of
      hypertension group following statistical control of activity frequency.
    

Detailed description: 
      A positive family history of hypertension (FHH) (+FHH) is associated with elevated left
      ventricular mass (LVM). Regular physical activity (PA) may eliminate differences in LVM
      between +FHH and negative family history of hypertension (-FHH) adults. PURPOSE: To determine
      if a +FHH is associated with a greater LVM compared to a -FHH group within a sample of young,
      mostly active healthy adults with and without statistically controlling for PA. METHODS:
      Healthy young (18-32yrs) participants self-reported FHH status and habitual moderate and
      vigorous PA frequency. Participants then underwent an echocardiogram.
    

Intervention name(s): Family history of hypertension
Intervention type(s): Other
Intervention description(s): Presence or absence of a family history of hypertension in a cross sectional study design.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Young healthy normotensive adults who are capable of self reporting family history of
        hypertension.
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
Condition: Methicillin-Resistant Staphylococcus Aureus; Bacterial Infections; Staphylococcal Skin Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Cellulitis; Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute
      bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive),
      known or suspected to be caused by susceptible Gram-positive organisms, including
      methicillin-resistant strains of Staphylococcus aureus.
    


Intervention name(s): Dalbavancin single dose; Dalbavancin two dose; Comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dalbavancin, weight-adjusted dose, up to 1500mg. Intravenous (IV) administration. Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used. Patients age birth to <3 months will only receive the single-dose regimen of dalbavancin; any concomitant antibacterial therapy may be administered in this age group based on local standard of care.; Dalbavancin, weight-adjusted dose, up to 1000mg. Intravenous (IV) administration, with second dalbavancin weight-adjusted dose, up to 500mg. Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used.; Course of either vancomycin not to exceed a total daily dose of 4000 mg;or oxacillin; or flucloxacillin not to exceed a total daily dose of 2000 mg. Intravenous (IV) administration. Possible oral switch after at least 72 hours from oxacillin or flucloxacillin to oral cefadroxil, or from IV vancomycin to oral clindamycin (for MRSA). Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used. Additional comparator drugs may be used, if an alternate comparator regimen is indicated by local susceptibility patterns. No patient age birth to < 3 months will be randomized to the comparator arm.
Intervention MeSH terms: Dalbavancin; Teicoplanin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Cryopreserved Human Meniscus Transplantation
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The purpose of this study is to determine the long-term survivorship and clinical outcomes of
      all cryopreserved meniscus transplants performed by Dr. Frank Noyes.
    

Detailed description: 
      All patients receiving cryopreserved meniscus transplants will be followed at 1, 2, 5, 10,
      and 15 years postoperatively. Study examination will include comprehensive knee examination
      by Dr. Noyes, x-rays, and potentially MRI. Patients will complete the following forms of the
      Cincinnati Knee Rating System: Symptom Rating Form, Sports Activity and Function Form, and
      Occupational Rating Form. All patient identification will be kept confidential. Patient data
      will be entered into the Knee Registry database according to their unique study number by the
      clinical research assistant.
    

Intervention name(s): Cryopreserved meniscus transplants
Intervention type(s): Procedure
Intervention description(s): Lateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Minimum age: 14 Years Maximum age: 49 Years Gender: Both Accepts Healthy Volunteers: No
        Patients post-meniscectomy, symptomatic with activities, early cartilage degeneration in
        affected tibiofemoral compartment.
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its
      instillation on the ocular surface of healthy volunteers through the following variables:
      unexpected adverse events incidence and photophobia (primary outcome variables); as well as
      pupillary diameter, expected adverse events incidence, best near corrected visual acuity
      (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and
      conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
    

Detailed description: 
      A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop
      of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of
      14 days on both eyes. A final safety call will be performed one week after the last day of
      product application.
    

Intervention name(s): Atropine Sulfate
Intervention type(s): Drug
Intervention description(s): Administration of one drop QD on both eyes for 14 days.
Intervention MeSH terms: Atropine
Intervention model: Single Group Assignment
Intervention model description: Phase I, controlled, non-comparative, open, unicentric study.
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Lutein Supplementation on Subclinical Atherosclerosis
Condition: Carotid Atherosclerosis; Carotid Intimal Medial Thickness 1
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is to investigate the possible positive effects of lutein and lycopene
      supplementation on early atherosclerosis in Beijing.
    

Detailed description: 
      Atherosclerosis is the primary cause of cardiovascular and cerebrovascular diseases, both of
      which are the top two causes of death in industrialized countries including China. Lutein was
      found to be protective against atherosclerosis in some case control studies. However, the
      intervention on atherosclerosis have not been reported. In the present study, 192 subjects
      were randomly assigned to four groups treated with different amounts of lutein. The
      investigators observe the changes of serum lutein concentration by hyper-pressure liquid
      chromatography (HPLC), and compare the differences of common carotid IMT and arterial
      stiffness by carotid ultrasonography before and after the intervention. Serum biochemistry
      indexes including cholesterol (CHO), triglyceride (TG), high density lipoprotein-cholesterol
      (HDL-C), low density lipoprotein-cholesterol (LDL-C) and glucose (Glu) were measured at 0, 7
      and 12 months of treatment by auto-analyzer.
    

Intervention name(s): Placebo; Lutein group; Combination group; Normal lutein control group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): one gelatine capsule containing starch per day, for 12 months; one gelatine capsule containing 20mg lutein per day, for 12 months; one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months; subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: early atherosclerosis; serum lutein; serum lycopene; intima-media thickness; arterial stiffness; combined effect
Dental Implants in Patients Under Oral Anticoagulant Therapy
Condition: Oral Anticoagulant Therapy
Study type: Interventional

Summary: 
      This study evaluated the outcomes in the post-operative recovery following dental implant
      surgery in patients who continued on oral anticoagulated therapy (OAT) with warfarin. The
      primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery
      and presence of intraoral/extraoral hematomas in skin and mucosa oral.
    

Detailed description: 
      The aim of this study was compare: 1) the frequency of immediate and short term postoperative
      bleeding using tranexamic acid (TXAg), bismuth subgallate (BSg) or dry gauze (DGg) as local
      hemostatic 2) explore the relation between bleeding and the occurrence of hematomas, with
      length of incision, duration of surgery, and alveolar ridge recontouring. 80 surgical
      procedures performed in a total of 71 patients (20 surgical procedures in 18 patients not on
      OAT and 60 surgical procedures performed in 53 patients on OAT) that were assigned to one of
      four groups, so that each group included 20 procedures. The control group (Cg) comprised 20
      procedures performed in patients not on OAT. The 60 procedures to be performed in patients on
      OAT were randomly to one of the three following experimental groups: 1) TXAg group, OAT plus
      TXA as local hemostatic agent; 2) BSg group, OAT plus BS as local hemostatic agent; 3) DGg
      group, OAT plus compression with dry gauze as local hemostatic agent. Outcomes variables
      were:

      Intraoperative variables: length of incision expressed (Li) alveolar ridge recontouring
      (Arr), total duration of surgery (Ds), surgical quadrant and implant location.

      Postoperative variables: immediate postoperative bleeding (within the first 30 minutes after
      surgery), short-term bleeding: within the first 5 days post-surgery, determined according to
      the index described by Bacci, presence of intraoral/extraoral hematomas in skin or mucosa.
      Descriptive statistical, analysis of variance and regression logistic analysis was performed.
      Statistical significance was set at a value of p<0.05.
    

Intervention name(s): Dental implant surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 80 surgical procedures (pr) in 71 patients (18 not OAT/53 on OAT) were assigned to one of four groups: control group (Cg n=20 pr not OAT) and 3 experimental groups of patients on OAT with local hemostatic management were randomized: tranexamic acid group (TXAg n=20 pr), bismuth subgallate group (BSg n=20 pr) and dry gauze group (DGg n=20 pr).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dental Implants; Anticoagulant Therapy; Warfarin; Tranexamic Acid; Bismuth subgallate
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral
      administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly
      diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard
      TB treatment.
    


Intervention name(s): PA-824
Intervention type(s): Drug
Intervention description(s): 200 mg, 600 mg, 100 mg, 1200 mg qd
Other intervention name(s): Rifafour e-275
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Bactericidal Activity; EBA; pulmonary tuberculosis; PA-824; Pretomanid; CL-007
Symmetric on Total Knee Arthroplasty (TKA)
Condition: Wound Closure
Study type: Interventional

Summary: 
      A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound
      closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
      (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty
      (TKA)
    

Detailed description: 
      The primary objective of this prospective, randomized controlled study is to evaluate the
      wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in
      patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined
      as the total time required to close the surgical incisions in patients undergoing TKA
      procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures.
      Secondary objectives will include the evaluation of differences in overall surgical procedure
      time, operating room (OR) time, length of stay, procedure costs, quality of life measures
      including pain, and range of motion (ROM). In addition, the difference in the safety profiles
      for both wound closure procedures will be evaluated through the analysis of the incidence of
      wound complications including dehiscence, wound infections, and other adverse events.
    

Intervention name(s): "STRATAFIX™ Symmetric" Knotless Tissue; VICRYL® PLUS; "STRATAFIX Spiral" sutures; DERMABOND™ Advance™ Skin Closure System
Intervention type(s): Device; Device; Device; Device
Intervention description(s): This devices will be used in deep and intermediate layers of barbed suture group.; This devices will be used in deep and intermediate layers of conventional suture group.; This devices will be used in intradermal layer of both barbed suture and conventional suture group.; This devices will be used in skin layer of both barbed suture and conventional suture group.
Other intervention name(s): STRATAFIX Symmetric; Polyglactin 910; Spiral; DERMABOND
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TKA; Barbed suture; Surgical time