bioihbjkbjnl/mcl2 huggingface dataset:
Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
Condition: Thyroid Disease
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      Influence of the platysma suture on postoperative pain and wound healing.
    

Detailed description: 
      Does a running platysma suture after primary thyroid resection alter direct postoperative
      pain, wound healing and long term cosmetic results.

      Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain
      (detected by the visual pain score 0-10) and reduces the pain medication (detected by the
      cumulative NSAID and opioid treatment per patient). The second Question to be answered is if
      the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month
      after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.
    

Intervention name(s): platysma suture; no platysma suture
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thyroidectomy; postoperative pain; wound healing
Markers of Carnitine Acetyltransferase (CrAT) Protein Activity and Carnitine Availability
Condition: Metabolism and Nutrition Disorder; Metabolic Disturbance
MeSH terms: Nutrition Disorders
Study type: Observational

Summary: 
      This study aims to measure skeletal muscle metabolism in vivo during exercise using the
      non-invasive Magnetic Resonance Spectroscopy (MRS) technique. Specifically, phosphocreatine
      (PCr) kinetic and Acetylcarnitine levels will be determined at resting, during exercise and
      during the recovery post exercise. The target population is adult healthy men, with a wide
      range of maximal physical capacity.
    

Detailed description: 
      Skeletal muscle mitochondrial activation during the transition from resting metabolism to
      exercise may modulated by CrAT activity. Furthermore, dynamic changes in acetylcarnitine
      during the transition from exercise to resting metabolism (acetylcarnitine off-kinetic) may
      also reflect the action of CrAT protein. To date, the only possibility to get information on
      CrAT activity is by taking a muscle biopsy and perform enzyme activity assays ex vivo. By
      dynamic MRS scanning, it might be possible to deduce information that reflects CrAT activity,
      thereby making the biopsy sampling unnecessary.
    

Intervention name(s): Exercise metabolism
Intervention type(s): Other
Intervention description(s): Participants will perform a series of exercises inside and outside the MRS/MRI scanner.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        In this study, 13 healthy young males (BMI <25 kg/m2), aged 18-40yr with different maximal
        aerobic capacity will be included. Specifically, 4 volunteers with a VO2max <40 ml/kg/min,
        5 volunteers with a VO2max between 41 and 50 ml/kg/min and 4 volunteers with a VO2max >50
        ml/kg/min will be included.
      
Biospecimen description: 
      muscle biopsies
    
Keywords: Acetylcarnitine kinetic; Phosphocreatine (PCr) kinetic
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA
      occluder indicated for percutaneous LAA closure in adult male or female patients with atrial
      fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year
      following implantation of an Occlutech® LAA Occluder.
    


Intervention name(s): Implantation of LAA closure device
Intervention type(s): Device
Other intervention name(s): Occlutech LAA occluder in different sizes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Oxycodone After Major Cardiac Surgery
Condition: Heart; Dysfunction Postoperative, Cardiac Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain and analgesic treatment still remains a challenge in daily perioperative
      medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal
      cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for
      postoperative pain. Poorly controlled pain can contribute directly or indirectly to
      postoperative complications, such as myocardial ischemia, pulmonary dysfunction like
      hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and
      decreased mobility. In addition, prolonged acute pain also results in chronic pain.

      Opioids are internationally recognized as the golden standard in the treatment of acute
      postoperative pain. On one side, the high potency of opioids in pain relief is clearly
      undisputed, but on the other hand, the administration of opioids is associated with nausea,
      vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms
      including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is
      a frequently reported adverse effect and sometimes requires discontinuation of therapy, which
      results in analgesic under-treatment, severely impairing quality of life. However, there are
      many different regimes for the treatment of postoperative pain using opioids.
      Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff
      and expensive equipment. Once patients are able to tolerate oral medications, the oral route
      is preferred postoperatively because it is more convenient, noninvasive and less expensive.
    


Intervention name(s): Targin; Oxynorm; Morphine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Oxycodonhydrochlorid and naloxone hydrochloride dihydrate; oral medication consisting of Oxycodonhydrochlorid
Intervention MeSH terms: Morphine; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Condition: Cervical Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study is intended to treat patients with symptomatic degenerative disc disease at one
      level of the cervical spine. The patients will be randomized to the DISCOVER Artificial
      Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety
      and efficacy at 2 years post operative. Follow-up on patients treated with total disc
      replacement will be continued to 5 years post operative.
    

Detailed description: 
      This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects
      will be stratified by the number of levels to be treated then assigned treatment in a
      randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc
      replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group
      will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical
      Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will
      occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects
      that received the control treatment will complete their required study participation at 2
      years post operative and subjects assigned the Discover treatment will complete their
      participation at 5 years post operative. Follow-up for the Discover treatment group will be
      via a telephone administered questionnaire at 3, 4 and 5 years post operative.
    

Intervention name(s): Cervical TDR; ACDF with plate
Intervention type(s): Device; Device
Intervention description(s): Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.; Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Other intervention name(s): cervical arthroplasty; cervical disc; c-TDR; DISCOVER disc; ACDF; Slim-Loc; Anterior cervical discectomy and fusion with plate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cervical; spinal; arthroplasty; disc; surgical; ACDF; DDD
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Condition: Syncope
MeSH terms: Syncope
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a
      primary implantation of a loop recorder versus the conventional diagnostic cascade for
      syncope most likely due to cardiac arrhythmia.
    


Intervention name(s): Use of an Implantable Loop Recorder
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Syncope of uncertain etiology; Repeated presyncopes
Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars
Condition: CO2 Laser in Scars
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional
      Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.

      Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology
      Department, CMH-Abbottabad, November 2022/April 2023.

      Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using
      Openepi app and the non-probability consecutive sampling technique was used. Patient in group
      A received FCL treatment's four sessions with four weeks apart, whereas Group B received four
      PRP and FCL sessions. The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2
      is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical
      improvement at 4 weeks after each session. To determine statistical significance χ2-square
      test, taking p-value <0.05 as significant, was used.
    


Intervention name(s): Fractional CO2 laser; Fractional CO2 with Platelet Rich Plasma
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient in group A received FCL treatments four sessions with four weeks apart; Group B received four PRP and FCL sessions 4 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the safety of LY2409021 in healthy
      participants and participants with diabetes. The study drug is given as single oral doses.
      Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing
      periods. Side effects will be documented. This study is approximately 9 weeks long, not
      including screening. Screening is required within 6 weeks prior to the start of the study.
    


Intervention name(s): Placebo; LY2409021
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Bilateral Prefrontal Modulation in Crack-cocaine Addiction
Condition: Drug Addiction; Executive Dysfunction
MeSH terms: Substance-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, eligible crack-cocaine addicted inpatients recruited from specialized clinics
      for substance abuse disorder treatment, filling inclusion criteria and not showing any
      exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day)
      bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2
      milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of
      crack-cocaine was examined before (baseline), during and after the end of the tDCS treatment.

      Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC
      would favorably change clinical, cognitive and brain function in crack-cocaine addiction and
      these would be long-lasting effects.
    

Detailed description: 
      Before (baseline) and after tDCS or sham-tDCS treatment, subjects were examined:

      (1) clinically, regarding craving (obsessive compulsive scale) and relapses to the drug use.

      They were followed-up for clinical examination at least 60 days after treatment.
    

Intervention name(s): transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sham-controlled double-blind randomized clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: crack-cocaine addiction; tDCS; dlPFC; craving; cognition
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and
      persistent CIN 2 represents conisation. Surgical treatment can cause perioperative
      (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor)
      complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%.
      Imiquimod is an immunomodulating drug, that has been reported to be effective in human
      papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal
      intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present
      randomised, placebo controlled, double blind study evaluates the efficacy of a topical
      treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.
    


Intervention name(s): Topical imiquimod therapy
Intervention type(s): Drug
Intervention description(s): therapy consists of treatment with topical vaginal suppositories for 16 weeks, each vaginal suppository contains 6.25mg of imiquimod, frequency (one time a week in treatment week 1+2, two times a week in treatment week 3+4, three times a week in treatment week 5-16)
Other intervention name(s): Aldara
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 60 week study including a double-blind phase followed by an open-label extension
      phase.
    


Intervention name(s): Botulinum Toxin Type A; Placebo (saline)
Intervention type(s): Biological; Other
Intervention description(s): Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.; Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
EUS-RFA for Unresectable Pancreatic Cancer
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The clinical application of intraoperative or percutaneous radiofrequency ablation (RFA) for
      pancreatic ductal adenocarcinoma (PDAC) is limited due to higher mortality and incidence of
      adverse events. The aim of this study was to evaluate the efficacy and safety of endoscopic
      ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC. Patients with
      unresectable PDAC who underwent EUS-RFA were included from September 2013 to June 2016. Pre-
      and post-procedural clinical data was retrospective collected.
    

Detailed description: 
      evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for
      locally advanced, unresectable PDAC.
    

Intervention name(s): EUS-RFA
Intervention type(s): Procedure
Intervention description(s): Use EUS-RFA to treat unresectable pancreatic cancer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic ductal adenocarcinoma; Unresectable pancreatic cancer; Radiofrequency ablation; Endoscopic ultrasound
Non Interventional Study of Levofloxacin in Chronic Prostatitis
Condition: Chronic Prostatitis
MeSH terms: Prostatitis; Chronic Disease
Study type: Observational

Summary: 
      Chronic prostatitis is a common disease in men with the following typical symptoms decreasing
      the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.

      Following study is conducted to study Levofloxacin in chronic prostatitis.
    

Detailed description: 
      Chronic prostatitis is a common disease in men with the following typical symptoms decreasing
      the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.
      Professional societies recommend diagnosing and treating patients with chronic prostatitis on
      the basis of determination of belonging to classification categories proposed by the National
      Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health
      in the USA .

      According to the recommendations of European Association of Urologists, in chronic bacterial
      inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis
      pain), the performance of antibacterial therapy during four - six weeks is efficient. The
      first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good
      tolerance they easily penetrate into the zones of the prostate inflammation and are highly
      efficient in respect of prostatitis pathogens . Although the treatment with levofloxacin
      promotes more evident decrease in clinical symptoms and demonstrates better parameters of
      eradication of pathogen in comparison with ciprofloxacin administration, it is used less
      common, possibly due to insufficient awareness of physicians of its high efficacy in chronic
      prostatitis .
    

Intervention name(s): Levofloxacin 500
Intervention type(s): Drug
Intervention description(s): Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days
Other intervention name(s): Levolet R
Intervention MeSH terms: Levofloxacin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic prostatitis, age 18-60 years
Clinical Study on Oral Nemonoxacin Malate Capsules
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in
      healthy Chinese volunteers.
    

Detailed description: 
      Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg,
      750mg, and 1000mg.

      Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after
      consecutive 10 days.
    

Intervention name(s): Nemonoxacin
Intervention type(s): Drug
Intervention description(s): oral once daily
Other intervention name(s): TG-873870
Intervention MeSH terms: Nemonoxacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants
Condition: Weight Gain
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The primary objective is to compare weight gain (g/day) of infants receiving new protein
      fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to
      weight gain (g/day) of infants receiving PF according to a weight-driven fortification
      regimen (standard of care) over a 21 day period.
    


Intervention name(s): Protein fortifier
Intervention type(s): Combination Product
Intervention description(s): Protein Fortifier to be added to Fortified human milk according to feeding regimen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
Condition: Anemia in End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining
      and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on
      maintenance hemodialysis and receiving epoetin alfa.
    

Detailed description: 
      Dose ranging study with three consecutive dose escalation cohorts. The study objectives are
      to demonstrate that FG-4592 is effective in maintaining hemoglobin (Hb) levels when
      converting from epoetin alfa and to establish optimum starting doses and dose adjustment
      regimens for Hb maintenance.
    

Intervention name(s): FG-4592; Epoetin Alfa
Intervention type(s): Drug; Drug
Intervention description(s): TIW dosing, capsule; TIW
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia; Renal