bioihbjkbjnl/mcl2 huggingface dataset:
Open to Laparoscopic Reverse Conversion of Perforated Appendicitis
Condition: Laparoscopic Surgery; Acute Appendicitis With Rupture; Sepsis; Abdominal Abscess
MeSH terms: Appendicitis; Abscess; Abdominal Abscess; Rupture
Study type: Interventional

Summary: 
      A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in
      management of Acute Perforated Appendicitis
    

Detailed description: 
      Introduction: Acute appendicitis (AA), a frequent intra-abdominal surgical pathology,
      necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical
      management. The surgical approach to AA is appendectomy; nevertheless, the medical literature
      continues to argue the merits of open vs laparoscopic surgery. As with other laparoscopic
      surgical techniques, the literature reports lower discomfort, earlier resumption of oral
      feeding and shorter hospital stay following laparoscopic appendectomy (LA) as compared to
      open appendectomy (OA). Additionally, laparoscopy has some drawbacks such as greater cost and
      lengthier operating durations as compared to open surgery. The goal of this clinical study:
      was to compare open appendectomy versus laparoscopic conversion from open (reverse
      conversion) for the treatment of acute perforated appendicitis in our setting. Patients and
      procedures: 426 patients had perforated appendectomy and divided between two groups: group A
      (interventional) 213 patients who were subjected to the reverse conversion technique and
      group B (control)213 patients who were operated by the open technique. The key end goals for
      comparing both groups were the rates of intraabdominal abscess, rates of wound infection,
      rates of ileus and rates of reoperation. The hospital length of stay and the operative time
      were used as secondary end goals for comparison.
    

Intervention name(s): reverse conversion technique
Intervention type(s): Procedure
Intervention description(s): converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis
Other intervention name(s): laparoscopic lavage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laparoscopic; appendectomy; reverse conversion; reoperation; intraabdominal abscesses
Verifying the Effectiveness of the NUsurface® System
Condition: Meniscectomy; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized,
      interventional clinical trial to test the hypothesis that the NUsurface implant is superior
      to the non-surgical standard of care in treating the target population.The rationale for
      performing this clinical study is to gather clinical data to evaluate the safety and
      effectiveness of the NUsurface device compared to the Standard of Care.
    

Detailed description: 
      The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain
      that have had a previous partial medial meniscectomy.

      Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization
      into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS
      (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation
      Committee) forms will be used to provide a comprehensive evaluation of the patients'
      pre-intervention and post-intervention condition including activity levels, pain, swelling,
      locking, stability, support, sports activity, and quality of life assessment.
    

Intervention name(s): NUsurface® Meniscus Implant; NSAID's and Non-surgical Treatment Options; Intra-Articular Injections with Corticosteroids; Intra-Articular Injections with Hyaluronic Acid (HA)
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.; Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise; Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).; Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: meniscectomy; meniscus; implant; koos; nusurface
Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers and Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of
      itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts
      1 and 2) and a 2-period crossover study of single doses of itraconazole administered as a dry
      powder for inhalation (PUR1900) and an oral solution (Sporanox) in adults with mild to
      moderate, stable asthma (part 3)
    

Detailed description: 
      Phase 1, multi-center, 3-part, open-label study in healthy adults (Parts 1 and 2) and adults
      with mild to moderate, stable asthma (Part 3).

      Safety, tolerability and PK will be assessed following either single ascending (SAD) or
      multiple ascending (MAD) dosing of itraconazole administered as a dry powder for inhalation
      (PUR1900; Part 1 and Part 2, respectively). Part 1 will comprise 3 separate cohorts planned
      to receive single doses of 5, 10 and 25 mg itraconzaole, respectively. The study will have an
      interleaved design; Part 2 will comprise 2 separate cohorts planned to receive daily doses of
      itraconazole 10 and 20 mg per day for 14 days, respectively. Part 2, Cohort 1 will commence
      after a review of safety data from Part 1 Cohort 2 suggests it is safe to do so.

      Part 3 is a 2-period, randomised, crossover study in adult subjects with mild to moderate
      stable asthma to assess the safety, tolerability and PK of single doses of itraconazole
      administered as a dry powder for inhalation (PUR1900) and administered as an oral solution
      (Sporanox® Oral Solution).
    

Intervention name(s): Itraconazole Powder; Itraconazole 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): Itraconazole administered as a dry powder for inhalation (PUR1900); Sporanox® Oral Solution
Other intervention name(s): PUR1900; Sporanox®
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study has 3 parts: 1) Single Ascending Dose Escalation and 2) Multiple Ascending Dose Escalation to be conducted in Normal Healthy Volunteers and 3) A two-period crossover study of single doses of PUR1900 and Sporanox in Adults with Asthma
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Study type: Interventional

Summary: 
      Background

      Present treatment strategies for trigger finger when conservative management including
      steroid injection was failed include percutaneous or open A1 pulley release, but some people
      showed prolonged swelling and delay of complete healing.

      We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid
      injection simultaneously with percutaneous release compared with conventional percutaneous
      release alone

      Methods

      We designed a double-blind, randomized controlled trial.

      Inclusion criteria is the patient who has symptom of trigger finger warranted surgical
      release after sufficient time of conservative treatment.

      Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid
      arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5)
      Previous surgery history of finger 6); the patients who got steroid injection more than 4
      time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.

      After power analysis by a statistician, total 40 patients would be required for each group
      (percutaneous alone group versus percutaneous alone + steroid injection group).

      The surgery will be performed by outpatients clinic basis with local injection. Additional
      steroid injection will be given to half of patients after allocation with randomized
      selection by permutaed block randomization.

      Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary
      outcome will be proportion of patients with good response (defined as "Perfect" or "much
      better" as reported by patients).

      Follow-up will be conducted 3 weeks and 3 month after index procedure
    


Intervention name(s): Steroid injection
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I prospective, open-labeled, single-center study to evaluate the safety and
      immunogenicity of MVC-COV1901.
    

Detailed description: 
      This is a phase I prospective, open-labeled, single-center study to evaluate the safety and
      immunogenicity of MVC-COV1901. This study is a dose escalation study with three separate arms
      for subjects at the age of ≥20 and <50 years. The vaccination schedule for primary regimen
      consists of two doses of MVC-COV1901 for each study subject, administered by intramuscular
      (IM) injection 0.5mL in the deltoid region of non-dominant arm preferably 28 days apart, on
      Day 1 and Day 29. Subjects will receive a single booster vaccination of MVC-COV1901 on Day
      209, 180 days after completion of the primary regimen.
    

Intervention name(s): MVC-COV1901
Intervention type(s): Biological
Intervention description(s): MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19 vaccine
Hematotoxic Effects of Particulate Exposure
Condition: Cancer
Study type: Observational

Summary: 
      Hematotoxicity is caused by a number of agents such as a benzene by-product called
      hydroquinone and the antitumor agent doxorubicin. This is a basic research study, conducted
      using normal human donors, of mechanisms involved in hematotoxicity and of the protective
      response of human hematopoietic progenitor cells to hematotoxic agents. Tumor necrosis factor
      exposure protects these cells from a subsequent exposure to hematotoxic agents. The
      alteration of gene expression in these cells caused by tumor necrosis factor is being
      studied. Additionally, the tumor necrosis factor-induced biochemical pathways involved in
      protection of human hematopoietic progenitor cells will be studied.
    


Keywords: Hematotoxicity; Benzene; Bone Marrow
Peripheral Optics in Myopia and Orthokeratology
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The primary objective of the current study is to investigate changes in peripheral refraction
      and aberration in children wearing orthokeratology lenses and single-vision spectacles.
    

Detailed description: 
      Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown
      to have potential in retarding myopic progression. The central cornea is flattened and
      peripheral optics altered in orthokeratology and it has been suggested that orthokeratology
      slows myopic progression through the alteration of peripheral optics. The aim of the current
      study is to investigate the changes in peripheral refraction and aberration in children
      wearing orthokeratology (study group) and single-vision spectacles (control group).
    

Intervention name(s): Orthokeratology lenses; Spectacles
Intervention type(s): Device; Device
Intervention description(s): Nightly use of orthokeratology lenses to correct the refractive errors; Daily use of single vision lenses to correct refractive errors
Other intervention name(s): Menicon Z Night Lens 2; Menicon Z Night Lens 2 Toric; Glasses; Eyeglasses
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Peripheral refraction; Aberration; Eyeball length; Myopic control; Myopia; Corneal reshaping; Orthokeratology
A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200
Condition: X-linked Hypohidrotic Ectodermal Dysplasia
MeSH terms: Ectodermal Dysplasia; Ectodermal Dysplasia 1, Anhidrotic
Study type: Interventional
Phase: Phase 1

Summary: 
      Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked
      Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure data
      for EDI200 in anticipation of dosing XLHED-affected neonates. Selecting XLHED-affected adults
      for this study provides a genetic match and biologic relevance to XLHED-affected neonates.
      Both males and females will be enrolled, providing safety experience with EDI200 that will
      inform the planned neonate study as well as supportive data for potential future trials of
      antenatal EDI200 administration.
    

Detailed description: 
      The Phase 1 study will enroll two cohorts of 3 XLHED-affected adults each, for a total of 6
      subjects. The size and scope of the study design are consistent with a drug development
      program in an ultra-rare disease and supported by the absence of safety concerns in a GLP
      non-human primate toxicology study. All subjects must meet entry criteria including
      documentation of an EDA mutation. Mirroring the conditions of use anticipated for the
      XLHED-affected newborn study, the adult cohort study incorporates a multiple-dose regimen
      associated with maximal efficacy in the newborn canine model. Primary outcome measures will
      be safety, tolerability, immunogenicity and pharmacokinetics (PK). While current data does
      not support a likelihood of clinical benefit for the XLHED-affected adult subjects, assays of
      pharmacodynamic/biologic activity are incorporated into the study design as exploratory
      objectives.
    

Intervention name(s): EDI200
Intervention type(s): Drug
Intervention description(s): Cohort 1 will be dosed at 3 mg/kg/dose. Cohort 2 will be dosed at 10 mg/kg/dose. Both cohorts will receive 2 doses/week for a total of 5 doses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: XLHED
Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool
      transplant" from a healthy individual to a C. difficile-infected recipient, and has long been
      a successful approach to recurrent/refractory C. difficile. The purpose of this project is to
      generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used
      repeatedly, particularly in those who do not have a healthy intimate partner or other related
      donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by
      the nasogastric route. This study will evaluate the safety and secondarily the efficacy of an
      inoculum administered by frozen orally-administered capsules.

      Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules

      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,
      systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.
      difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a
      normal bowel status for the individual. Secondary efficacy endpoints include weight,
      subjective well-being and relative clinical improvement per standardized questionnaire, and
      subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects
      will be monitored for clinical safety by history and standard exams and the follow-up
      questionnaire as well as followed closely by phone and in person.
    


Intervention name(s): Fecal Microbiota Transplant
Intervention type(s): Drug
Intervention description(s): Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via frozen capsule
Other intervention name(s): Poop transplant; Fecal bacteriotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal Microbiota Transplant; Clostridium difficile; Diarrhea
Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing RIRS
Condition: Urolithiasis
MeSH terms: Urolithiasis; Pain, Postoperative
Study type: Interventional

Summary: 
      This study will include patients aged between 18 and 70 who will undergo retrograde
      intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will
      be recruited, and will be randomized into 2 groups consisting of 40 patients in each group.
      The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned
      prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases
      the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or
      not affects the level of pain felt by patients in the postoperative period.
    

Detailed description: 
      The level of pain of the patients in both groups will be evaluated by using visual analog
      score (VAS) and verbal rating score (VRS) in the postoperative 0 min (the moment patients
      gets consciousness after he/she wakes up from general anesthesia), 10th min, 30th min, 60th
      min and 120th min.
    

Intervention name(s): RIRS with ureteral access sheath; RIRS without ureteral access sheath
Intervention type(s): Device; Device
Intervention description(s): Ureteral access sheath will be used during RIRS.; Ureteral access sheath will not be used during RIRS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal stone; retrograde intrarenal surgery; ureteral access sheath; pain
Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous
      NSCLC
    

Detailed description: 
      Sintilimab is expected to increase the PFS from 6 months to 9.2 months. Anti-PD-1 therapy in
      Chinese non-squamous NSCLC naïve patients will be investigated in this clinical trial.

      Additionally the correlation between PD-L1 expression and the response to Sintilimab
      treatment in Chinese non-squamous NSCLC as well as the role of iRECIST in immune checkpoint
      inhibitor treatment evaluation will also be assessed.
    

Intervention name(s): Sintilimab; Pemetrexed; Platinum; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.; 500mg/m^2; Q3W (qualer 3 weeks), day1, I.V.; Q3W (qualer 3 weeks), day1, I.V.; first 4 cycles.; 10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.
Other intervention name(s): IBI308
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study on the Safety of the Approved Product Empedic L Cream During Its Routine Use (Active Ingredient is Clotrimazole 1%)
Condition: Vaginal Candida
Study type: Observational

Summary: 
      Researchers already did trials that showed Empecid L Cream worked for patients with Vaginal
      yeast infection who were in those trials. In this trial, they want to learn if consumers that
      use the cream under the guidance of a pharmacist have any medical problems during the trial
    


Intervention name(s): Clotrimazole 1% (Empecid L Cream, BAYB5097)
Intervention type(s): Drug
Intervention description(s): Consumers who self-select and are then deemed appropriate users of the product by the pharmacist for treatment of Vulvar itching with rash due to recurrent vaginal candida (only in patients previously diagnosed and treated by a doctor).
Intervention MeSH terms: Clotrimazole; Miconazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The primary population of interest is composed of subjects 15 years or older and under 60
        years who purchase Empecid L Cream.
Investigating the Role of the Polyol Pathway in the Central Nervous System
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure
      intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of
      hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess
      cerebrospinal fluid levels of metabolites.
    


Intervention name(s): Brain MRS during hyperglycemic clamp; Analysis of Metabolites in cerebrospinal fluid
Intervention type(s): Other; Other
Intervention description(s): All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique; All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science