bioihbjkbjnl/mcl2 huggingface dataset:
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
Condition: Idiopathic Rhinitis Patients; Healthy Controls
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The term idiopathic rhinitis (IR) is used in this study to describe a patient group with
      following characteristics: patients with complaints of nasal obstruction, sneezing and/or
      rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or
      paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders.
      These patients are non-smokers and do not use medication affecting nasal function. They have
      no beneficial effect of intranasal steroid spray (INS) treatment.

      The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR
      is largely unknown. Several hypotheses have been put forward. In general it is assumed that
      neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF
      are released from afferent neurons in the nasal mucosa after activation by unspecific stimuli
      and can be responsible for the symptoms of IR.

      For this group of IR-patients, there is until now only one treatment option: intranasal
      capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its'
      therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.

      The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces
      in that way nasal symptoms.
    


Intervention name(s): Capsaicin
Intervention type(s): Drug
Intervention description(s): 5x nasal application in one day, 1 hour between each application
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

      PURPOSE: This phase II clinical trial is studying how well cetuximab given together with
      combination chemotherapy works in treating patients with stage III or stage IV oropharynx
      cancer that can be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the complete clinical response rate at 3 months in patients with stage III
           or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab,
           docetaxel, cisplatin, and fluorouracil.

      Secondary

        -  To determine the rate of tumor response.

        -  To determine progression-free and overall survival.

        -  To determine the rate of complete pathological response.

        -  To assess the tolerability of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour
      and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5.
      Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study therapy, patients are followed every 2 months for 1 year and every
      3 months for 2 years.
    

Intervention name(s): cisplatin; docetaxel; fluorouracil; Cetuximab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 75 mg/m², day 1. 3 cycles; 75 mg/m² Day 1. 3 cycles; 750 mg/m² day 1 to day 5. 3 cycles; 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; tongue cancer
Gut Microbiota Changes of HIV Patients Before and After One Year of ART
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue
      (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the
      subsequent translocation of microbial products from the gastrointestinal tract to systemic
      circulation. The gut mucosal immune system is not completely restored by cART, and the
      resultant microbial translocation may contribute to chronic inflammation, inadequate CD4
      T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed
      strong and characteristic compositional differences in gut microbiota between individuals
      with HIV infection and seronegative controls. So far, several probiotic organisms have shown
      the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and
      support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid
      bacterial overgrowth and their translocation, and produce a self-limited inflammatory
      response through development of regulatory T (Treg) cells by anti-inflammatory cytokine
      production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled
      study to determine whether the use of a probiotic can expand beneficial microbiota that aid
      in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby
      improving immune functions in HIV-infected subjects. Participants in the intervention group
      will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus
      once daily, while those in the placebo group will take placebo which contains no probiotic
      but has the same flavor and characteristics as the probiotic product.. Gut bacterial
      community diversity and composition, immune recovery and activation in peripheral plasma,
      plasma levels of gut damage, microbial translocation and inflammation at baseline and after
      12 months of receiving intervention will be analyzed.
    


Intervention name(s): Antiretroviral Therapy
Intervention type(s): Drug
Intervention description(s): All participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count.
Intervention MeSH terms: Anti-Retroviral Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients were recruited from the Department of Infectious Diseases, Peking Union Medical
        College Hospital, Beijing, China. All participants are Chinese and meet eligibility
        criteria.
      
Biospecimen description: 
      Facal samples were collected and then DNA was retracted, all samples were stored in -80oC.
The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live
      attenuated Poliomyelitis vaccine (human diploid cell)
    

Detailed description: 
      Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention
      in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese
      Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in
      Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney
      Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase
      2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial
      is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .
    

Intervention name(s): Live attenuated Poliomyelitis vaccine (Human Diploid Cell); Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
Intervention type(s): Biological; Biological
Intervention description(s): 6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).; 6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
Other intervention name(s): Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral; Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Poliomyelitis; Vaccine; Safety; efficacy
Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to explore the clinical Efficacy of robotic assisted
      spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third
      gastric adenocarcinoma（cT2-4a, N-/+, M0）.
    

Detailed description: 
      The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer,
      reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is
      closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially
      curable locally advanced upper third gastric cancer including No. 10 lymph node is the
      standard surgical treatment.

      Robotic surgery has been developed with the aim of improving surgical quality and overcoming
      the limitations of conventional laparoscopy in the performance of complex mini-invasive
      procedures. However, it remains a controversial international issue if it is safe and
      feasible to conduct robotic assisted spleen-preserving No. 10 lymph node dissection for
      advanced upper third gastric cancer. There is no prospective study to identify the results.

      The study is through a prospective, open, single-arm study,to explore the clinical outcomes
      of the robotic assisted spleen-preserving No. 10 lymph node dissection in the treatment of
      locally advanced gastric adenocarcinoma （cT2-4a, N-/+, M0）.
    

Intervention name(s): Robotic Assisted No.10 Lymph Node Dissections
Intervention type(s): Procedure
Intervention description(s): After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Robotic assisted spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach Neoplasms; Robotic Surgery; Spleen-Preserving; No.10 Lymph Node Dissection
An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects
Condition: Chronic Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label study. The study will consist of 1 treatment group: coated Nifedipine
      suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal
      fissure.
    

Detailed description: 
      This is an open label study. The study will consist of 1 treatment group: coated Nifedipine
      suppository containing 12 mg of Nifedipine. Approximately 20 subjects will participate into
      this 8-week study. A screening visit will be used to determine subject suitability for
      inclusion in the trial. Within one week of the screening visit, subjects who meet all
      inclusion criteria and none of the exclusion criteria will receive Coated Nifedipine 12 mg
      Suppository X2 a day (BID) (24 mg/day total) for a period of 8 weeks. During this period, 4
      study visits (at 0, 2, 5, and 8 weeks) will take place. Study medication will be administered
      BID (in the morning and in the evening). In addition to receiving study medication, subjects
      will be maintained on a standard treatment for Anal Fissure: sitz baths, high fiber diet.
    

Intervention name(s): Nifedipine coated suppositories
Intervention type(s): Drug
Intervention description(s): 12 mg Nifedipine coated suppositories BID
Intervention MeSH terms: Nifedipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anal fissure; pain; nifedipine
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation
Condition: Atrial Fibrillation; Inflammation
MeSH terms: Atrial Fibrillation; Inflammation
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental
      studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at
      voltages substantially below that which slowed the sinus rate, significantly suppressed AF
      inducibility and decreased AF duration. The investigators subsequently developed a
      non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of
      the VN located at the tragus, the anterior protuberance of the outer canine ear (low level
      tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS
      delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the
      investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS
      for just one hour significantly shortened the AF duration and decreased inflammatory
      cytokines.

      The overall objective of this proposal is to translate in ambulatory patients with paroxysmal
      AF the results of previous studies showing acute suppression of AF and inflammation in
      anesthetized canines as well as humans, in order to examine the long-term therapeutic effects
      of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6
      months may result in long-term decrease of AF burden and suppression inflammatory cytokines
      in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS.
      LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device
      for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time
      spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at
      baseline and at 6 months. In addition, blood samples will be collected from patients at
      baseline, and at 3 and 6 months, for cytokine measurement. These investigations will
      establish the first evidence of the long-term effects of LLTS on AF suppression in patients
      with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic
      targets of this treatment modality beyond AF.
    


Intervention name(s): Parasym device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial fibrillation; neuromodulation; inflammation
The Incidence and Progression of Myopia: Cohort Study
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      A cohort study on incidence and progression of myopia in a group of medical students
    

Detailed description: 
      A prospective cohort study to investigate the refractive error development, progression and
      their risk factors in young adult population comprises a group of medical students in China
      for two years
    

Intervention name(s): Observation study only, no specific intervention
Intervention type(s): Other
Intervention description(s): Observation study only, no specific intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        First-year medical college student from Zhongshan University
      
Keywords: Myopia
Accelerated Corneal Cross-linking With Different Riboflavin Solutions
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional
Phase: Phase 3

Summary: 
      Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation
      intensities and shorter irradiation times have been introduced. In addition, new riboflavin
      solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into
      CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated
      corneal collagen cross-linking protocol with different riboflavin solutions.
    


Intervention name(s): Riboflavin
Intervention type(s): Drug
Intervention description(s): Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively
Intervention MeSH terms: Riboflavin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis
Condition: Perforated Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      The objective of this study is to evaluate two standard post-operative pain regimens
      routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators
      hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with
      narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia
      (PCA) to oral pain medications.
    

Detailed description: 
      To assess pain control, patient and family perception of pain control, time to return of
      bowel function defined as passage of first flatus (in days), doses of anti-emetic
      medications, doses of narcotic pain medications, time to toleration of regular diet (in
      days), narcotic associated adverse effects (nausea, emesis, respiratory depression,
      constipation), length of stay, and overall hospital cost in admission.

      Post-hospitalization the investigators will assess complications including number and reasons
      for emergency visits and abscess formation, length of post-hospitalization analgesic use,
      length of post-hospitalization narcotic use, and time to return to school.
    

Intervention name(s): IV tylenol; No IV tylenol; Ketorolac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV tylenol given scheduled in addition to standard PCA; No additional IV Tylenol given; both groups receive as part of our standard postop pain protocol after all operations
Other intervention name(s): acetaminophen,; toradol
Intervention MeSH terms: Acetaminophen; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: appendicitis; pain; perforation
Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain
Condition: a Single-Dose of Etoricoxib; Post-Operative Morphine Consumption; Total Pain Relief Over 8 Hr(TOPAR8); Post Transabdominal Hysterectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      Taken together, studies of the value of pre-emptive analgesia are inconclusive. This
      randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to
      test that a reduction in post-operative morphine consumption can be achieved by a single-dose
      of etoricoxib before induction of anesthesia.
    

Detailed description: 
      Patients undergoing transabdominal hysterectomy were randomized to a group taking a single
      dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2
      hours before surgery under the same standardized general anesthesia. At the post-anesthetic
      care unit, intravenous morphine titration was given before starting self-controlled analgesia
      (PCA) device. Morphine consumption, pain relief score, sedative score, global evaluation
      score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. The primary
      end points were morphine consumption within 24-hr post-operatively and total pain relief over
      8 h (TOPAR8). Patient global satisfaction was also assessed.
    

Intervention name(s): a single-dose of Etoricoxib before induction of anesthesia
Intervention type(s): Drug
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Abdominal hysterectomy,; Etoricoxib,; morphine consumption,; pre-emptive analgesia
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.
    

Detailed description: 
      A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing
      TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM,
      0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne
      Vulgaris
    

Intervention name(s): Tretinoin cream, 0.05%; RETIN-A® (tretinoin) cream, 0.05%; Vehicle of the test product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tretinoin cream, 0.05%; RETIN-A® (tretinoin) cream, 0.05%; Vehicle of the test product
Other intervention name(s): Tretinoin; Tretinoin; placebo
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Bioequivalence
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessment of Prepulse Inhibition for Shock Pain Reduction
Condition: Pain Awareness From ICD Shocks
MeSH terms: Shock
Study type: Interventional

Summary: 
      Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's)
      is highly variable. It can be influenced by psychological factors, physical condition and the
      number of shocks delivered.

      It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low
      voltage pulse (prepulse)prior to the delivery of a stronger shock.

      A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a
      shock of equal energy without a prepulse.
    


Intervention name(s): Arbitrary Waveform Defibrillator
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Prepulse; Defibrillator