bioihbjkbjnl/mcl2 huggingface dataset:
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare drug concentrations in aqueous humor following ocular
      instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.
    

Detailed description: 
      The objective of this study is to compare drug concentrations in aqueous humor following
      ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The
      hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour
      period is greater than VIGAMOX because of unique properties of Besivance which promote
      increased contact time of this antibiotic with the ocular surface.

      Subjects with scheduled cataract surgery will be screened during their pre-operative visit.
      Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will
      self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to
      surgery.Subjects will have one final drop of study medication on the day of
      surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will
      be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will
      be determined by an independent laboratory using standardized high pressure liquid
      chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the
      aqueous humor concentration-time data will minimally include the area under the curve and the
      maximum concentration.
    

Intervention name(s): Moxifloxacin; besifloxacin
Intervention type(s): Drug; Drug
Intervention description(s): One drop 4 times daily for 3 days and one drop the day of sample collection; One drop 4 times daily for 3 days and one drop on day of sample collection
Other intervention name(s): Vigamox; Besivance
Intervention MeSH terms: Moxifloxacin; Besifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study all patients will be treated with the same medicine, the QUTENZA patch.
      Subjects will receive up to 6 QUTENZA patch applications over 12 months.
    

Detailed description: 
      The rationale for the current study is to evaluate the safety of repeated QUTENZA
      applications, including the effect of QUTENZA on sensory function in subjects diagnosed with
      different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the
      long-term safety QUTENZA in well defined patient populations the current study will enroll a
      minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic
      Neuralgia (PHN).
    

Intervention name(s): QUTENZA
Intervention type(s): Drug
Intervention description(s): Cutaneous patch
Intervention MeSH terms: Capsaicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuralgia, Postherpetic; QUTENZA
Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy
Condition: Gestational Diabetes Mellitus; Medical Nutrition Therapy; Overweight/Obese; Gut Microbiota; Adverse Pregnancy Outcomes
MeSH terms: Diabetes, Gestational; Overweight
Study type: Interventional

Summary: 
      Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the
      rise globally, how to improve the intrauterine environment of the offspring and prevent
      obesity and metabolic diseases from the early life has become a medical research. Since 2012,
      journals such as Nature and Science have reported that intestinal micro-ecological
      environments composed of intestinal microbes and their interactions are involved in human
      body and energy metabolism, and a variety of metabolic diseases including obesity and type 2
      diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have
      an important impact on human health, the research on intestinal microecology during pregnancy
      is still in its infancy. The current research is still unclear about the relationship between
      intestinal microecology and pregnancy outcomes and whether it can be a potential target for
      regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims
      to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to
      explore the effects of interventions targeting intestinal microbes on glucose and lipid
      metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order
      to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great
      significance and value to improve the quality of the birth population in China and to
      alleviate the medical economic burden caused by obesity and metabolic diseases.
    


Intervention name(s): Prebiotic-containing dairy; Dietary intervention
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day).; The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia
Condition: Dysphagia; Stroke
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of
      swallowing in patients having dysphagia problems.
    

Detailed description: 
      This trial will be a double blind, randomized, crossover, controlled, and interventional
      trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first
      then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study
      visit).

      The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be
      females and males aged between 18 and 85 years with mild proven dysphagia.
    

Intervention name(s): Cereal extract concentration 1; Cereal extract concentration 2; Cereal extract concentration 3; Thicken up clear concentration 1; Thicken up clear concentration 2; Thicken up clear concentration 3
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab
      (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78
      than placebo in adults with coronary artery disease taking lipid lowering therapy.
    


Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha®
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cholesterol; High Cholesterol; Elevated Cholesterol; Raised Cholesterol
A Study on the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics (MK-0000-175)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relationship between upper and lower airway
      allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the
      following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2)
      cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation
      between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.
    


Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period; Matching placebo tablets as a single oral dose on Day 1 of each study period
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nasal Allergen Challenge, Inhaled Allergen Challenge, Asthma
Psychological Assessment of Patients With Chest Wall Deformities
Condition: Pectus Excavatum; Pectus Carinatum
MeSH terms: Funnel Chest; Pectus Carinatum
Study type: Observational

Summary: 
      The study aims to investigate the most frequent psychological outcomes associated to chest
      wall deformities and patients' quality of life.
    

Detailed description: 
      The study aims at providing psychological assessment (body image, self-esteem, overall mental
      health) and quality of life investigation of adolescents affected by chest wall deformities,
      in relation to the severity and type of deformity, and patients' age; identifying risk
      factors for psychological disorders.

      The following hypotheses were tested: differences between patients with different chest wall
      deformities regarding body image and mental health were expected; no hypothesis on the
      possible results concerning the effect of the severity of deformity on each studied variable
      was formulated, since previous findings are unclear. Concerning age, some differences
      according to different age ranges were expected. Regarding risk factors for mental health
      problems, older age and greater body image dissatisfaction were expected to be significant
      risk factors for psychological problems; regarding the severity and type of deformity,
      results of previous studies are unclear or lacking, so no hypothesis was tested; quality of
      life and self-esteem variables were also tested, as previous studies showed they are
      significantly related to general well being and mental health in adolescents.

      Adolescents coming at the outpatient clinics for the first evaluation of their chest wall and
      one of their parents/caregivers were enrolled. After the medical examination, patients
      meeting inclusion criteria are invited to participate in the study and to be assessed by a
      trained psychologist who administered them all questionnaires after they expressed their
      informed consent.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents coming for the first medical examination of their chest wall at the Pectus
        Center outpatient clinic will be invited to participate in the study. Adolescents who
        express their voluntary participation will be enrolled. One of their parents/caregivers is
        also invited to take part in the study.
      
Keywords: Pectus excavatum; Pectus carinatum; Adolescents; Psychological Assessment; Quality of life
Effect of Transversus Abdominis Plane Block With Compound Lidocaine on Pain After Gynecological Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Purpose:

      To explore effects of ultrasound-guided transversus abdominis plane block with compound
      lidocaine on postoperative pain after gynecological laparotomy.
    

Detailed description: 
      Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation,
      and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal
      analgesia strategies to minimise opioid-related side effects are highly desirable in open
      surgical procedures. The transversus abdominis plane block is a novel technique involving
      injection of local anaesthetic between the internal oblique and the transversus abdominis
      muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique,
      the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound
      lidocaine injection has a better and longer analgesic activity since it contains menthol and
      ethanol with appropriate concentrations. However, whether compound lidocaine injection is
      efficiency in the transversus abdominis plane block for abdominal open sugery lacks
      investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus
      abdominis plane (USG-TAP) block with compound lidocaine injection for postoperative analgesia
      in patients undergoing gynecological laparotomy.
    

Intervention name(s): Normal saline; Ropivacaine; Compound lidocaine at low concentration; Compound lidocaine at high concentration
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side; Before the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side; Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side; Before the induction of anesthesia, 0.6% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Other intervention name(s): 0. 9% Sodium Chloride Injection; Ropivacaine Hydrochloride Injection; Compound Hydrochloride Lidocaine Injection; Compound Hydrochloride Lidocaine Injection
Intervention MeSH terms: Lidocaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Compound lidocaine; Ropivacaine; pain intensity; Transversus abdominis plane block
A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of
      ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and
      ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus
      infection. This study will contain 2 parts.

      Part 1: Approximately 20 participants and at least 10 of the 20 participants previously
      treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or
      without RBV, and experienced treatment failure.

      Part 2: Approximately 10 participants and all participants previously treated with
      SOF/ledipasvir and experienced treatment failure.
    

Detailed description: 
      Efficacy, safety, and demographic analyses were performed separately for the 2 study parts
      using the intent-to-treat (ITT) population, which consists of all enrolled participants who
      received at least one dose of study drug.
    

Intervention name(s): ombitasvir/paritaprevir/ritonavir and dasabuvir; Sofosbuvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir; tablet; tablet
Other intervention name(s): ABT-450/r/ABT-267; Viekira Pak; paritaprevir also known as ABT-450; ombitasvir also known as ABT-267; dasabuvir also known as ABT-333; Sovaldi; RBV
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Interferon-Free; Treatment Experienced; Chronic Hepatitis C; Hepatitis C Virus
Development of Small Airway Disease Questionnaire
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The aim of this study is to develop a patient reported outcome tool specific to small airways
      disease, which assesses symptoms and signs of small airways disease and may help in addition
      to FEF50% to discriminate between asthmatic patients with and without small airways disease.
    

Detailed description: 
      Inflammation of the small airways contributes to the severity of the disease and affects the
      quality of life of patients with asthma. However, the exact role and relevance of small
      airways disease in asthma is still unclear. This is partly due to the difficulty of measuring
      small airways pathology with a sensitive and specific parameter. The most commonly used
      variable as an indicator of small airway obstruction is the FEF50%. Currently, it is not
      known which clinical symptoms are associated with small airways disease and how a patient
      will perceive small airway abnormalities. This knowledge is important to assess small airways
      disease in patients with asthma and adjust therapy to improve quality of life.The primary
      purpose of this study is to develop a questionnaire for patients with asthma with and without
      small airways disease for general and specialist practice.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will contain a total of 60 adult patients with asthma, 30 patients
        with small airways disease and 30 patients without small airways disease.
      
Keywords: Asthma; Small airways disease; Questionnaire
A Study of CDX-0159 in Patients With Prurigo Nodularis
Condition: Prurigo Nodularis
MeSH terms: Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and
      pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.
    

Detailed description: 
      The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and
      pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

      There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a
      16-week follow-up period after treatment. Patients will receive one dose of CDX-0159
      (barzolvolimab) or placebo.
    

Intervention name(s): CDX-0159; Normal saline
Intervention type(s): Biological; Drug
Intervention description(s): administered intravenously; administered intravenously
Other intervention name(s): barzolvolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CDX-0159; barzolvolimab
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT
      in treating patients with multiple brain metastases from NSCLC.
    

Detailed description: 
      Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is
      one of the primary reasons resulting in treatment failure and the death. Whole-brain
      radiation therapy (WBRT) is the standard approach to the treatment of multiple brain
      metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with
      systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal
      growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the
      blood-brain barrier and show promising antitumor activity against brain metastases from
      NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed
      with chemotherapy.
    

Intervention name(s): Icotinib
Intervention type(s): Drug
Intervention description(s): Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tumors metastatic to brain; non-small cell lung cancer; Icotinib
ET-01 in Subjects With Lateral Canthal Lines, LCL-209
Condition: Lateral Canthal Lines, LCL; Crow's Feet
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Detailed description: 
      This product is being tested for its ability to reduce lateral canthal lines (LCL), also
      known as Crow's Feet.
    

Intervention name(s): botulinum toxin, Type A; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): topical liniment; Vehicle Formulation
Other intervention name(s): ET-01 1610U
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: vehicle controlled, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment