bioihbjkbjnl/mcl2 huggingface dataset:
Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG
Condition: Sentinel Lymph Node; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This clinical trial is a prospective, multicenter, self-controlled clinical study. In order
      to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph
      node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital
      precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine
      green (ICG) on imaging detection and the control group, routine medical using methylene blue
      test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of
      breast cancer were compared.
    

Detailed description: 
      This trial was a prospective, multicenter, and self controlled clinical trial. The subjects
      who were in line with this scheme were detected by fluorimetry and staining, and the primary
      effectiveness evaluation index, secondary effectiveness evaluation index and safety
      evaluation index were established during the operation. Record evaluation. At present, in the
      clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue
      staining method. A large number of clinical data show that the number of blue staining
      methods was 1-2.4, and the number of fluorescence detection is 2-3.7. Therefore, choosing a
      self controlled clinical trial can increase the number of sentinel lymph node detection.
    

Intervention name(s): Methylene Blue; Indocyanine Green
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection of injection point at the periphery of the areola or tumor, injecting 1% methylene blue 0.5ml at each point, a total of 2-3 points.; Within 5 minutes after MB injection, 2.5mg/ml ICG 0.5ml was injected at each point, a total of 2-3 points. Methylene blue and ICG injection points do not coincide
Other intervention name(s): MB; ICG
Intervention MeSH terms: Methylene Blue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Near-infrared fluorescence; Image guided surgery; Sentinel lymph node biopsy; Indocyanine green; Methylene blue
Patient Satisfaction After Ingrown Toenail Surgery
Condition: Ingrowing Nail With Infection
MeSH terms: Nails, Ingrown
Study type: Observational

Summary: 
      In this study, demographic characteristics (age, gender, which toe is involved, family
      history) of the patients who were operated because of ingrown nails were examined, and the
      post-operative satisfaction score of the patients was noted, and the recurrence rate and
      complications were recorded.
    

Detailed description: 
      The study was designed as single-center, single-surgeon observational study. Approximately
      4000 patients who were operated on by the same surgeon between 2015-2020 due to ingrown nails
      were reached by phone, and patients' satisfaction was assessed by using the Surgical
      Satisfaction Questionnaire (SSQ-8). Outcomes such as retrospective treatment processes and
      complications were asked using a questionnaire, and patients' demographic characteristics
      were also recorded.
    

Intervention name(s): Toenail surgery
Intervention type(s): Procedure
Intervention description(s): modified Winograd procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who had ingrown toenail surgery between 8 and 80 years old.
      
Keywords: patient satisfaction; operative treatment; ingrown toenail; onychocryptosis
Effect of Different Concentrations of Lidocaine in Relieving Pain in Wide Awake Hand Surgery Using Tumescence
Condition: Lidocaine
Study type: Interventional
Phase: Phase 1

Summary: 
      Lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of
      procedures. This has been quite popular especially in wide awake surgery of the hand with no
      tourniquet. However, the appropriate lidocaine concentration is yet to be established. This
      randomized control trial will study the minimum effective lidocaine concentration in hand
      surgery using the tumescent technique.
    


Intervention name(s): lidocaine
Intervention type(s): Drug
Intervention description(s): different concentrations of lidocaine with same concentration of adrenaline
Other intervention name(s): adrenaline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
Condition: Adult Spinal Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an
      anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex,
      reconstructive spinal fusion surgeries.
    

Detailed description: 
      After consent is obtained and the patient is enrolled in the trial, patients will be assigned
      de-identified, unique identification (ID) numbers. Randomization of these IDs to either low
      or high dose TXA will occur via a computer generated random assignment. Given the variations
      that may exist in surgical technique (e.g. performance of osteotomies), stratified
      randomization will be performed by attending surgeon. Based upon the randomization, the
      pharmacy will prepare TXA for one of two intravenous dosing protocols:

        1. Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes,
           followed by 1mg/kg/hr via continuous infusion

        2. High Dose (Study Group): Loading Dose 50mg/kg given over 15 minutes, followed by
           5mg/kg/hr via continuous infusion.

      The surgeon, anesthesia team, and operating room staff will be blind to the concentration of
      TXA in the medications received. Treatments may be "unblinded" at the discretion of the
      surgeon and anesthesiologist, in cases of extreme blood loss. If additional
      anti-fibrinolytics are given, the change in dose will be recorded.

      Post-operative care will be the same as any other patient and data collection will be
      information contained in the patient's medical record that is part of routine, standard of
      care.
    

Intervention name(s): Tranexamic Acid (Cyklokapron)
Intervention type(s): Drug
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tranexamic acid, reconstructive spine surgery
Evaluation of the Reliability, Validity, and Acceptability of the London Measure of Unplanned Pregnancy in a U.S. Population of Women
Condition: Unplanned Pregnancy
Study type: Observational

Summary: 
      The aim of the study is to evaluate the reliability, validity, and acceptability of the
      London Measure of Unplanned Pregnancy (LMUP) in a U.S. population of women. The researchers
      hypothesize that the LMUP will be acceptable to a U.S. population and will be reliable and
      valid.
    

Detailed description: 
      The concept of "unplanned pregnancy" is used frequently in health research and policy. The
      majority of tools used to assess unplanned pregnancy planning have not been validated.
      Recently the London Measure of Unplanned Pregnancy (LMUP) has been developed and validated.
      The LMUP had been found to be valid and reproducible, but has not been studied outside of the
      United Kingdom. If we are able to validate this measure in a U.S. population, its use in
      studies will improve the quality of data about family planning in U.S. women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        target population for this study is pregnant women who present to san Francisco General
        Hospital (SFGH) Women's Options Center (WOC) for abortion and to the Women's Health Center
        for prenatal care. The population is racially and ethnically diverse, and the majority are
        financially challenged and have no insurance or Medicaid.
      
Keywords: Pregnancy; Unplanned pregnancy; Psychosocial; Measure
Immunological Consequences of CARD15/NOD2 Mutations in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The project is based on adult and paediatric cohorts among the largest ones in Paris and
      located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM
      Unit U843 in collaboration with the department of immunology and statistics, Robert Debré
      Hospital.
    

Detailed description: 
      Crohn's Disease (CD) affects about 60.000 to 80.000 people in France. It is characterised by
      a chronic or relapsing inflammation of the gut. Its aetiology is largely unknown, limiting
      the development of preventive and curative therapeutic options. In 2001, we have identified
      the first CD susceptibility gene: CARD15/NOD2. This gene is involved in the innate immune
      response but we do not know today how gene mutations may induce the disease lesions. However,
      many data suggest that the intestinal inflammation may be related with an abnormal function
      of the lymphoid tissue present in the gut.

      The aim of the present proposal is to better understand the role of CARD15/NOD2 mutations
      (R702W, G908R and 1007fs) in the development and the function of the intestinal lymphoid
      tissue. 250 patients and controls will be enrolled at Robert Debré and Saint Louis Hospital
      (Paris, France) within a 2 years period.

      For participant, 4 to 5 ileal biopsies will be taken during a routine colonoscopy. Patients
      will be classed in three groups according to their number of CARD15/NOD2 mutations (1)
      wild-type, 2) mutated heterozygotes and 3) mutated homozygotes or compound heterozygotes). A
      comparison between groups and with non inflammatory (colonoscopy performed for other reasons)
      or inflammatory (ulcerative colitis patients) controls will be done. For each group, cell
      phenotype, cytokine profile, permeability and bacterial translocation will be analysed on
      Peyer's patches.

      The project is based on adult and paediatric cohorts among the largest ones in Paris and
      located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM
      Unit U843 in collaboration with the department of immunology and statistics, Robert Debré
      Hospital.
    

Intervention name(s): intestinal biopsies
Intervention type(s): Other
Intervention description(s): intestinal biopsies during routine endoscopy
Other intervention name(s): intestinal biopsies during routine endoscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Crohn's Disease, inflammatory bowel disease, Peyer's patches
Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with
      placebo.
    

Detailed description: 
      The efficacy and safety will be compared between Chiglitazar and placebo after treatment of
      24 weeks. The long term efficacy and safety of Chiglitazar will be evaluated after 52 weeks
      treatment.
    

Intervention name(s): Chiglitazar; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Take orally; Take orally
Other intervention name(s): CS038; Plb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chiglitazar,diabetes,type 2 diabetes
OLGA and OLGIM Stage System for Gastric Cancer
Condition: Stomach Neoplasms; Atrophic Gastritis; Intestinal Metaplasia
MeSH terms: Stomach Neoplasms; Gastritis; Gastritis, Atrophic; Metaplasia
Study type: Observational

Summary: 
      To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk
      according to Lauren's histologic classification in South Korea. Also attempted to estimate
      synergistic interaction among the several risk factors to help establish surveillance
      strategy.
    

Detailed description: 
      To validated the OLGA and OLGIM staging system with serum pepsinogen to estimate gastric
      cancer risk according to Lauren's histologic classification in South Korea, where the
      incidence rate of GC is high. In addition, the investigators attempted to investigate the
      interaction among the several risk factors including OLGA or OLGIM staging system for the
      risk of GC to help establish surveillance strategy.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who visited gastroenterology department complaining of gastrointestinal symptoms
        and underwent esophagogastroduodenoscopy (EGD)
      
Keywords: OLGA; OLGIM; Helicobacter pylori; Gastric cancer; pepsinogen
Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main
      objectives of this study is to calculate mortality probability by two different risk score
      system and to inquire effects of informing anesthesiologist and surgical team; of score of
      the patient; on length of hospitalization and intensive care and also on actualized
      mortality.
    


Sampling method: Probability Sample
Study population: 
        Cardiac surgery patients
      
Keywords: Mortality; Length; hospitalization; cardiac surgery; patients
Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?
Condition: Supervision of Pregnancy Resulting From In-vitro Fertilization
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to determine whether spontaneous LH peak is superior to human
      chorionic gonadotropin before a transfer of a day 3 frozen embryo.
    

Detailed description: 
      For surplus embryos after fresh IVF-cycles, cryopreservation has become common medical
      practice. These frozen embryos are mostly replaced in an artificial cycle with exogenous
      estrogen and progesterone or in a natural cycle. Often, hCG is administered as an ovulation
      induction agent for scheduling purposes.

      Successful implantation requires a co-ordinated series of events allowing a timely dialogue
      between a receptive endometrium and the intrusive blastocyst . The period of receptivity is
      thought to be 3 days in human. It is suggested that blastocyst apposition begins about day
      LH+6 and is completed by day LH+10

      In general, the aim is to transfer the embryo during the 'window of implantation', what is
      defined as the period during which the uterus is receptive for implantation of the free-lying
      blastocyst. This has been a subject of debate since many years.

      A prospective study by Fatemi et al. (2010) revealed a significantly higher ongoing pregnancy
      rate after transferring frozen-thawed embryos in natural cycles with a spontaneous LH peak
      compared with natural cycles controlled by hCG for final oocyte maturation and ovulation
      (31.1% vs. 14.3%, respectively). In this trial, FrET (frozen embryo transfer) was planned 5
      days after the LH surge or 5 days after the administration of 5000IU of hCG.

      In order to optimize the synchronization in the hCG group, and therefore enhance the
      pregnancy rates, the aim is to plan a FrET 6 days after hCG administration instead of 5 days.
      The rationale behind is that day 3 frozen embryos are thawed the day before embryo transfer,
      which means they are already at day 4 of the embryonic development.
    

Intervention name(s): hCG; LH peak
Intervention type(s): Drug; Other
Other intervention name(s): spontaneous LH peak
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET in Healthy Subjects Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg
      MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé & PEPCID® (Famotidine)
      20mg Tablets, USP.
    

Detailed description: 
      An open-label, randomized, single dose, two-treatment, two-period, two-sequence, crossover
      bioequivalence with a washout period of at least 7 days between doses Healthy mixed skin Arab
      & Mediterranean Subjects ages between 18 and 45 years, body-mass index 18.5 to 30.0 kg/m2
      inclusive, non-smokers or light smokers (smokers of not more than 10 cigarettes per day).
    

Intervention name(s): FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET; ANTADYS® 100 mg, PEPCID® 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): MULTI-LAYER TABLET; ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
Other intervention name(s): MULTI-LAYER TABLET; ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
Intervention MeSH terms: Flurbiprofen; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: fasting condition
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, 5-period study in healthy male and non-pregnant and
      non-lactating healthy female subjects.
    

Detailed description: 
      It is planned to enroll 14 subjects who will receive single oral doses of active IMP in a
      sequential manner over 5 periods, with a minimum of 7days between dosing in each period.
    

Intervention name(s): acoramidis
Intervention type(s): Drug
Intervention description(s): acoramidis
Other intervention name(s): AG10
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules
      (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
    


Intervention name(s): UHAC 62 XX tablet; UHAC 62 XX capsule
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preemptive Analgesia for Primary Dysmenorrhoea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Preemptive analgesia before the release of pain mediators
    

Detailed description: 
      spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a
      usual absence from school . prostaglandin release is one of the most accepted theory
      responsible for spasmodic dysmenorrhea.

      Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications
      for spasmodic dysmenorrhea.

      Getting the idea of what is called preemptive anesthesia by blocking the receptors before
      catching pain mediators the study participants will be divided randomly into 2 group group 1
      receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only
      during menstruation as analgesia
    

Intervention name(s): preemptive mefenamic acid; mefenamic acid
Intervention type(s): Drug; Drug
Intervention description(s): preemptive analgesia before menstrual pain; mefenamic acid given only during menstruation
Other intervention name(s): ponstan forte; ponstan forte
Intervention MeSH terms: Mefenamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: primary dysmenorrhea; preemptive analgesia
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Condition: Mesenchymal Stromal Cells
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical
      cord blood derived mesenchymal stem cells) in the premature infants with intraventricular
      hemorrhage (IVH, grade 3-4)
    


Intervention name(s): pneumostem
Intervention type(s): Drug
Intervention description(s): human umbilical cord blood derived mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intraventricular hemorrhage
caBozantinib in cOllectiNg ductS Renal Cell cArcInoma
Condition: Collecting Duct Carcinoma (Kidney)
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Carcinoma, Ductal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate
      activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic
      Collecting Duct Renal Cell Carcinoma
    

Detailed description: 
      This is a single-arm, phase II trial (monocentric)
    

Intervention name(s): cabozantinib
Intervention type(s): Drug
Intervention description(s): cabozantinib 60 mg orally once daily
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor
      SHR0302 in subjects with active ankylosing spondylitis.
    


Intervention name(s): SHR0302; SHR0302 placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR0302, oral, once daily; SHR0302 placebo, oral, once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment