bioihbjkbjnl/mcl2 huggingface dataset:
Fibrinogen Concentrate and Placenta Acreta Spectrum
Condition: Obstetric Anesthesia Problems; Placenta Accreta
MeSH terms: Placenta Accreta
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the relationship between fibrinogen use and bleeding in
      patients who underwent cesarean section with a prediagnosis of PAS.

      The key question(s) it aims to answer are:

      [Does the use of fibrinogen concentrate reduce bleeding in PAS patients?] Patients who had a
      cesarean section with a pre-diagnosis of PAS were analyzed retrospectively. The choice of
      anesthesia applied to the patients and the relationship between the use of blood products and
      bleeding were evaluated.
    

Detailed description: 
      Our study was designed as a retrospective randomized study. Patients aged 20-50 years and >34
      weeks of gestation who accepted the birth with a cesarean section with a pre-diagnosis of PAS
      were evaluated retrospectively.

      examined. were randomized into 2 groups, 53 patients in each group: group1: GNF : the group
      without fibrinogen concentrate

      Group 2: GF: the group with fibrinogen concentrate
    

Intervention name(s): the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
Intervention type(s): Procedure
Intervention description(s): the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)
Other intervention name(s): group 1: the group without fibrinogen concentrate (GNF); group 2: the group with fibrinogen concentrate (GF)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: retrospective randomized study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fibrinogen concentrate; obstetric anesthesia; plasenta acreata spectrum; postpartum hemorrhage
GalaFlex Mesh in Facelift
Condition: Superficial Musculoaponeurotic System (SMAS) Procedure
Study type: Observational

Summary: 
      In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted
      and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater
      surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinics
      
Keywords: plastic surgery
Austrian Multivessel Taxus-Stent Registry
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel
      disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and
      12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to
      economic considerations, the secondary aim is to enhance experience in multivessel stenting
      with drug-eluting stents in order to improve short- and long-term outcomes of the patients
      with severe multiple coronary artery stenoses.

      The objectives of the study are:

        1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical
           follow-up after multivessel intervention with drug-eluting stents in a prospective
           patient cohort..

        2. To determine the rate of in-stent restenosis, target lesion and target vessel
           revascularization (angiographic measures) 6 months in patients with multiple DESs in
           multiple lesions.

        3. To investigate the clinical and angiographic outcomes after implantation of multiple
           DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal
           insufficiency) with known high restenosis and late complication rate.

        4. To evaluate potential cost burden in attempting a strategy of complete revascularization
           by multiple DES in patients with multivessel disease.
    


Intervention name(s): Intracoronary stent implantation
Intervention type(s): Device
Intervention description(s): Taxus stent implantation in patients with multivessel coronary artery disease
Other intervention name(s): Taxus Express; Taxus Liberte
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary artery disease; drug-eluting stent; percutaneous coronary intervention; major adverse cardiac event; in-stent restenosis; stent thrombosis
Needless Laser Injector for Antiaging Effect of Dermal Filler
Condition: Aging Problems
Study type: Interventional

Summary: 
      The investigators aimed to evaluate the efficacy and safety of needless laser injector for
      antiaging effect of dermal filler.
    

Detailed description: 
      A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was
      conducted to compare the clinical efficacy and safety of needless laser injector versus
      needle injection for anti-aging effect of dermal filler.
    

Intervention name(s): needless laser injector (Mirajet); needle injection
Intervention type(s): Device; Device
Intervention description(s): Mirajet injection was performed 2-3 passes until a total of 2cc of diluted PLA/HA solution was completely injected to the one half of the face.; For traditional method of needle injection, intradermal injection using multi-puncture/micro-papule technique was used. A series of injections at 0.5-1 cm apart was performed on one half of the face so that a total of 2cc of diluted PLA/HA solution was injected.
Other intervention name(s): polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler; polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®.
Condition: Occlusal Splints
Study type: Interventional

Summary: 
      To compare the accuracy of the occlusal splints made by conventional impression and milled
      with the splint made by intraoral scanner and milled.
    

Detailed description: 
      Forty participants received two different occlusal devices from two different workflows
      (fully conventional and fully digital). Every splint was scanned before and after the
      occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were
      compared in a software Geomagic® Control X calculates and measures the distance from every
      surface point from the initial dataset (occlusal devices before adjustment) to the final
      dataset (occlusal device after adjustment).
    

Intervention name(s): Occlusal Splints Analogic-Analogic; Occlusal Splints Analogic-Digital; Occlusal Splints Digital-Digital
Intervention type(s): Other; Other; Other
Intervention description(s): Take a conventional impression to the patient and conventional fabrication of the splint.; Take a conventional impression to the patient and digital fabrication of the splint.; Take a digital impression to the patient and digital fabrication of the splint.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This clinical study has three arms of equal size: occlusal splints made by conventional impression and conventional fabrication (Group 1), occlusal splints made by conventional impression and digital design and fabrication (Group 2), and occlusal splints performed by intra-oral scanner and digital design and fabrication (Group 3).
Otherwise, the allocation of each subject to each group will be done at random by a list made with specialized software until the sample will be fulfilled when the patient is recruited.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Digital Dentistry; Occlusal records; Intraoral scan
Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Condition: BPH; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral
      prostatectomy) in men with symptomatic benign prostatic hyperplasia.
    

Detailed description: 
      The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled
      Tissue Resection System is safe and efficacious as a surgical treatment for men with
      symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected
      that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will
      allow a < 24 hour post-operative hospital stay in > 50% of patients undergoing this
      procedure.
    

Intervention name(s): Bipolar Transurethral Resection of the Prostate; Monopolar Transurethral Resection of the Prostate
Intervention type(s): Procedure; Procedure
Intervention description(s): Bipolar TURP; Monopolar TURP
Other intervention name(s): Vista, Bipolar TURP; Monopolar TURP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transurethral Resection of Prostate; TURP
Air Pollution Study: The Effect of Ozone on the Lung
Condition: Air Pollution
Study type: Interventional

Summary: 
      The purpose of the study is to better understand the mechanisms of lung injury from ozone
      exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone.
      Subjects will be asked to produce sputum through coughing after each exposure. The samples
      will be analyzed for macrophage activity.
    

Detailed description: 
      Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5
      study visits. A physical exam to determine eligibility will be done at the first study visit.
      If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled
      for 2 3-hour exposure visits. One exposure will be to clean air and the other exposure will
      be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise
      bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum
      collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood,
      urine, and exhaled breath samples will also be collected at each visit.
    

Intervention name(s): Clean Air; Ozone
Intervention type(s): Other; Other
Intervention description(s): Subjects will have the clean air exposure first, followed by the ozone exposure; Subjects will have the ozone exposure first, followed by the clean air exposure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Macrophage
Carpal Tunnel Release Through Mini Transverse Approach
Condition: Carpal Tunnel Syndrome; Carpal Tunnel Release; Carpal Tunnel Surgery; Carpal Tunnel Transverse Approach; CTS
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm
      length.
    

Detailed description: 
      Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5
      cm, the benefits of this technique is less surgical traumatic and more tender, it takes less
      time for rehabilitation, so the patient can work next day of operation, and it has very
      cosmetic and gentle scar in results and outcome.
    

Intervention name(s): Carpal tunnel release through Mini Transverse Approach
Intervention type(s): Procedure
Intervention description(s): Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CTS; Carpal tunnel syndrome; Carpal tunnel release; Mini incision of carpal tunnel release; Cosmetic surgery of carpal tunnel syndrome; endoscopic carpal tunnel surgery; Carpal Tunnel Release Through Mini Transverse Approach; Dr. Sayed Issa's Approach; CTRMTA; OCTR; ECTR; Open Carpal Tunnel Release; Endoscopic Carpal Tunnel Release; Syria; Cosmetic; Safety; Rehabilitation,; Complications; Surgery; Satisfaction
A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first time in human study enrolling approximately 42 healthy adult
      subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the
      safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV
      dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially.
      Subjects will be followed for safety from the time of Informed Consent through 85 days post
      dose.
    


Intervention name(s): 9MW1411 injection; 9MW1411 injection placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): 9MW1411 injection; 9MW1411 injection placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Simultaneous Endotracheal Tube Insertion With GlideScope Use
Condition: Intubation; Videolaryngoscopy
Study type: Interventional

Summary: 
      Patients presenting for elective surgery requiring orotracheal intubation will be randomized
      to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then
      having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in
      the more common fashion with the GlideScope being inserted first and having the ETT then
      advanced via the pharynx into the trachea.
    

Detailed description: 
      Patients presenting for elective surgery requiring orotracheal intubation will be randomized
      to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then
      having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in
      the more common fashion with the GlideScope being inserted first and having the ETT then
      advanced via the pharynx into the trachea. The primary outcome is time to intubation.
      Secondary outcomes include: 1) Ease of intubation as noted by operator (measured on a 10-cm
      Visual Analogue Scale) 2) Number of intubation attempts 3) Number of failures to intubate 4)
      Use of external laryngeal pressure 5) Laryngoscopic grade distribution
    

Intervention name(s): Simultaneous Intubation; Standard Intubation
Intervention type(s): Procedure; Procedure
Intervention description(s): Intubation with GlideScope and ETT inserted simultaneously; Intubation with GlideScope inserted first and ETT insertion after the GlideScope view is obtained
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: D007440
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of multiple doses of an immediate release
      (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels
      in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart
      rate (QTc).
    

Detailed description: 
      This is a randomized (study medication assigned by chance), double-blind (neither physician
      nor participant knows the treatment that the participant receives), 4-way crossover (method
      used to switch participants from one treatment arm to another), placebo- and
      positive-controlled (the experimental treatment or procedure is compared to an inactive
      substance and a standard treatment or procedure), single site, multiple dose study. The study
      has 3 phases: a Screening Phase (up to 35 days); a Double-blind Treatment Phase (4 treatment
      periods with a washout period of 7 to 15 days); and a Post-treatment Phase (Day 5 of Period 4
      or at the time of early withdrawal). All eligible participants will receive each of the 4
      treatments: tramadol HCl at therapeutic dose of 400 milligram per day (mg/day), tramadol HCl
      at supratherapeutic dose of 600 mg/day, placebo, and positive control moxifloxacin 400 mg; in
      any of the treatment period as per assigned treatment sequence. The total duration of each
      participant's participation will be up to a maximum of 100 days. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Tramadol HCl; Moxifloxacin 400 mg; Tramadol HCl Placebo; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tramadol HCl 50 mg immediate release (IR) tablet administered orally.; Moxifloxacin 400 mg tablet administered orally.; Placebo matched to tramadol HCl IR tablet administered orally.; Placebo matched to Moxifloxacin 400 mg tablet administered orally.
Other intervention name(s): RWJ-26898-002; Avelox
Intervention MeSH terms: Moxifloxacin; Tramadol; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; QT interval; QTc interval; Electrocardiogram; Tramadol hydrochloride; Moxifloxacin; Placebo
Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension
Condition: Idiopathic Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      Recent researches indicate that impairment of vascular and endothelial homeostasis plays a
      major role in the initiation and development of IPAH.We have recently reported the safety and
      feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients
      with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for
      therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such
      therapy. To help answer these questions, we designed the one year follow-up to investigate
      the safety and efficacy of autologous EPCs injection in patients with IPAH.
    


Intervention name(s): Transplantation of autologous endothelial progenitor cells
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Assess Efficacy and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients
Condition: Breast Cancer Metastatic; Breast Cancer Recurrent; Breast Cancer Female
MeSH terms: Breast Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal
      growth factor Receptor). HER2 receptor plays an important role in cell growth and
      differentiation (5). However, when HER2 overexpresses, it may lead to cancer. HER2 positive
      malignance exacerbates pathology and worsens clinical outcome, such as shortened overall
      survival (OS) compared with non-HER2 overexpression patients (6), (7). About 20-30%
      overexpression HER2/neogene breast cancer patients and patients having HER2 overexpression
      tumor have disease progression and poor prognosis in metastatic process (8), (9).

      Currently, targeted therapeutic, which attaches to the HER2 receptor, inhibiting the growth
      of cancer cells has been approved. One of these products is Trastuzumab.

      The study processed on 128 females aged between 18 and 65, recurrent or metastatic breast
      cancer patients with positive HER2.

      The subjects were randomly distributed in 2 groups as NNG-TMAB + docetaxel or Herceptin® +
      docetaxel, in blocks of 4 in a 1: 1 ratio (NNG-TMAB: Herceptin®). In each block of 4 will be
      2 patients in the experimental group and 2 patients in the control group

      Primany endpoints is Overall Response Rate (ORR) according to RECIST 1.1. ORR includes
      Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an
      Independent Tumor Evaluation Board (ITEB).

      This trial is intended to assess the biosimilarity of efficacy and safety between NNG-TMAB
      (Trastuzumab) and Herceptin® in combination with Docetaxel on recurrent or metastatic breast
      cancer patients with positive HER2.
    


Intervention name(s): Faceptor; Herceptin; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.; Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.; The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.
Other intervention name(s): NNG-TMAB; Trastazumab; Trastazumab; Taxotere
Intervention MeSH terms: Docetaxel; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group: study drug and reference
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of the safety and immunogenicity of three commercially available influenza
      vaccines in children.
    

Detailed description: 
      A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical
      Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of
      a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a
      commercially available influenza vaccine in Healthy Children
    

Intervention name(s): Influenza vaccine
Intervention type(s): Biological
Intervention description(s): Seasonal Influenza Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: influenza; children; vaccine; influenza disease