bioihbjkbjnl/mcl2 huggingface dataset:
A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of
      intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with
      community-acquired pneumonia (CAP).
    

Detailed description: 
      Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and
      developed countries. In the choice of antibacterial agents used to treat CAP,
      fluoroquinolones have received considerable attention because of their wide spectrum of
      bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a
      selective bacterial topoisomerase inhibitor.

      This study will evaluate the clinical efficacy, microbiological efficacy and safety of
      Intravenous nemonoxacin compared with Intravenous levofloxacin in adult patients with
      community-acquired pneumonia.

      Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after
      continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
    

Intervention name(s): Nemonoxacin; Levofloxacin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levofloxacin; Nemonoxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intravenous nemonoxacin; community-acquired pneumonia
A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of
      Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with
      hydrofluoroolefin (HFO) [Test] and hydrofluoroalkane (HFA) [Reference] in healthy
      participants (male or female).
    

Detailed description: 
      This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3
      way cross-over study to assess pharmacokinetic and safety of BGF MDI when administered with
      different propellants, HFO (HFO-1234ze) - test and HFA (HFA-134a) - reference.

      The study will comprise of:

        -  A screening period up to 28 days prior to first dosing;

        -  Three Treatment Periods: Participants will be resident at the Clinical Unit from the
           morning on the day before dosing with BGF MDI on Day -1 of Treatment Period 1, until 24
           hours following the final dose on Day 2 of Treatment Period 3, with a washout period of
           3 to 7 days between each dose; and

        -  Follow-up: final safety Follow-up Phone Call within 3 to 7 days after the last
           administration of BGF MDI in Treatment Period 3.

      Each participant will receive 3 single dose treatments of BGF MDI (Treatment A: BGF MDI HFO
      [Test]; Treatment B: BGF MDI HFA [Reference]) following an overnight fast of at least 8 hours
      on Day 1 of each treatment period.

      The reference formulation will be administered during 2 of the 3 treatment periods.

      There will be a minimum of a 3 to 7 day washout between administration of each treatment.

      Each participant will be involved in the study for approximately 55 days.
    

Intervention name(s): Treatment A: BGF MDI HFO; Treatment B: BGF MDI HFA
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 4 oral inhalations as a single dose - test formulation; administered during 1 treatment period.; Participants will receive 4 oral inhalations as a single dose - reference formulation; administered during 2 treatment periods.
Other intervention name(s): Budesonide/Glycopyronium/Formoterol fumarate pressurized inhalation suspension, HFO; Budesonide/Glycopyronium/Formoterol fumarate pressurized inhalation suspension, HFA
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bioequivalence; Propellant; Corticosteroid; Long acting muscarine agonist (LAMA); Long acting beta agonist; Lung exposure; Healthy subjects; Inhaled corticosteroid (ICS); Long-acting β2 agonist (LABA); Next generation propellant (NGP)
Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This is a prospective, comparative, randomized, controlled, single-blind, single-surgeon,
      single-center PMCF clinical study whereby participants undergoing refractive surgery for
      correction of ametropia will receive a transepithelial PRK (tPRK) and conventional PRK
      treatment in the contralateral eye. To avoid bias in the clinical outcomes, the two PRK
      treatment options are randomized to the eyes of the patients based on ocular dominance. In
      addition, a 1:1 randomization is applied within the tPRK group to eyes with and without
      end-treatment laser polishing.

      Both procedures, standard PRK and tPRK, are performed in a one-step procedure. The main
      difference between the procedures is, that in conventional PRK, the epithelium will be
      removed using alcohol, whereas in tPRK procedures, the epithelium will be removed by laser
      ablation.
    


Intervention name(s): Transepithelial Photorefractive keratectomy (tPRK) without laser polishing; Transepithelial Photorefractive keratectomy (tPRK) with laser polishing; Standard Photorefractive keratectomy (PRK)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Transepithelial Photorefractive keratectomy (tPRK) with laser ablation of the corneal epithelium and stroma in a single-step procedure using the B+L Teneo 317 Model 2 Excimer Laser.; Transepithelial Photorefractive keratectomy (tPRK) using the B+L Teneo 317 Model 2 Excimer Laser with end-treatment laser polishing using a fixed thickness of the additional layer of 5 μm.; Conventional Photorefractive keratectomy (PRK) with alcohol-assisted epithelium ablation. Then the aspheric ablation profile will be performed using the B+L Teneo 317 Model 2 Excimer Laser.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
Condition: Type 2 Diabetes; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Lowering LDL cholesterol by statins has been proven to be associated with reduction of
      proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the
      effects of newer cholesterol lowering agents such as ezetemibe with respect to their
      anti-inflammatory potential are less intensively studied. Therefore the investigators
      analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination
      with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear
      cells (PBMCs) of patients with type 2 diabetes.
    


Intervention name(s): Simvastatin 80 mg; Sim10/Eze10; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): treatment with 80 mg of simvastatin over a period of 8 weeks; treatment with combination of simvastatin 10 mg and ezetimibe 10 mg; treatment with placebo over 8 weeks
Other intervention name(s): zocor; simvastatin; inegy
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Condition: Drug-induced Ototoxicity in Peritoneal Dialysis Patients
MeSH terms: Ototoxicity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether N-acetylcysteine is effective in the
      prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced
      ototoxicity in peritoneal dialysis patients.
    


Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ototoxicity; aminoglycoside; vancomycine; peritoneal dialysis; peritonitis
Comparative Study Efficacy and Safety of of Activated Versus Non-Activated PRP
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This was comparative prospective study conducted on 40 subjects, diagnosed with alopecia
      areata of 40 the scalp, carried in a period from February 2020 and March 2021
    

Detailed description: 
      Alopecia areata is a common recurrent T cell-mediated autoimmune-induced non-scarring hair
      loss with not fully understood pathogenesis which affects nearly 2% of the general population
      during lifetime. The course of the disease is unpredictable and currently, no treatment is
      available for complete cure or prevention. Platelet-rich plasma is an autologous
      blood-derived product which widely spread in the last decades for the treatment of different
      dermatological conditions including different hair disorders.

      The aim of this work was to evaluate the efficacy and safety of activated platelet-rich
      plasma in comparison to non-activated platelet-rich plasma in the treatment of alopecia
      areata.
    

Intervention name(s): Intradermal injection
Intervention type(s): Drug
Intervention description(s): Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.
Other intervention name(s): Plasma rich in platelets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 40 patients with alopecia areata will be divided into 2 groups:
Group A: 20 patients will be treated by activated PRP with Calcium chloride (CaCl2). Those patients will be treated with an intradermal injection.
Group B: 20 patients will be treated by non-activated PRP through intradermal injection
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, open-label, two part, parallel group study. This study is being
      conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in
      subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects
      with mild and moderate hepatic impairment and healthy control subjects matched to the
      subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be
      based on a review of the preliminary safety and pharmacokinetic data from subjects with
      moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment.
      Additionally, based on emergent data from Part 1, matched controls to the severe hepatic
      group may be enrolled (optional). Due to the potential difficulty in identifying eligible
      subjects with severe hepatic impairment, the study may be stopped prior to full enrollment in
      Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic impairment have
      been enrolled. The study will consist of a Screening visit, a single dose Treatment Period
      and a Follow-up visit. Subjects will be screened for eligibility criteria within 30 days of
      enrolment. Subjects will be admitted to the clinical unit on Day -1; each subject will
      receive a single dose of GSK2336805 on Day 1 and will remain in the clinical unit for 5 days
      (check-out on Day 4). The follow-up visit will be conducted within 7-10 days after Day 1
      dosing.
    


Intervention name(s): GSK2336805
Intervention type(s): Drug
Intervention description(s): Two 30 mg GSK2336805 tablets for a 60 mg single dose will be administered in this study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plasma; tolerability; safety; matched control; GSK2336805; hepatic impairment; pharmacokinetics
The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
Condition: Parotid Tumor
MeSH terms: Parotid Neoplasms; Sweating, Gustatory
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation
      could prevent infraauricular depressed deformities and Frey's syndrome following total
      parotidectomy.
    

Detailed description: 
      Seventy patients who underwent total parotidectomy were selected for inclusion in the study.
      We analyzed 41 cases of total parotidectomy (control group) and 29 cases of simultaneous ADM
      implantation following total parotidectomy (ADM group) for infraauricular depressed
      deformities and the presence of gustatory flushing or sweating. The follow-up periods ranged
      from 6 months to 7 years.

      The Results showed facial contours and bilateral symmetry improved after surgery in the ADM
      group. In the control group, an infraauricular depressed deformity was evident in all 41
      cases. Frey's syndrome was recorded in one patient (3.4%) from the ADM group and 14 patients
      (34.1%) from the control group. No cases of immune rejection, infection, hematoma, or
      salivary fistula were observed in either group.
    

Intervention name(s): ADM
Intervention type(s): Procedure
Intervention description(s): 29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
Other intervention name(s): Acellular dermal matrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: human acellular dermal matrix; parotid tumor; total parotidectomy
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women
Condition: Ovarian Follicle
Study type: Interventional

Summary: 
      We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives
      (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles
      in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate
      that this will provide us with information to facilitate the development of a new method for
      ovarian synchronization; a safer, more effective ovulation induction therapy; a new method
      for emergency contraception; and a greater understanding of human folliculogenesis.
    


Intervention name(s): Marvelon; Nuvaring; Letrozole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral contraceptive; contraceptive vaginal ring; Aromatase Inhibitors
Intervention MeSH terms: Letrozole; NuvaRing; Desogestrel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: ovarian synchronization; folliculogenesis
Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Single Centre, open label assignment phase II clinical study.

      To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to
      endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma
      H2AX analysis, compared to control biopsies.
    

Detailed description: 
      Primary Objective: To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets,
      (administered as 8 x 25 mg), prior to endoscopy, on double-stranded DNA breaks in colonic
      biopsy samples assessed by histone γH2AX analysis, compared to control biopsies collected
      during standard white light colonoscopy without the prior use of Methylene Blue MMX®.

      Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX®
      tablets.. To evaluate the staining score for colonoscopy obtained with oral Methylene Blue
      MMX® tablets . Time to reach the caecum during colonoscopy and withdrawal time from caecum to
      exit.
    

Intervention name(s): standard white light colonoscopy-equivalent to placebo; Methylene Blue MMX tablets
Intervention type(s): Procedure; Drug
Intervention description(s): standard white light colonoscopy; 8x25mg methylene blue MMX tablets administered before a colonoscopy
Intervention MeSH terms: Methylene Blue
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Rural Engagement in Primary Care for Optimizing Weight Reduction
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare three methods for managing obesity in rural patients,
      to see which method will result in patients being able to attain their weight loss goal and
      maintain that weight loss.
    

Detailed description: 
      Nearly 20% of the U.S. population lives in rural communities. Rural residents suffer at a
      higher rate from obesity and obesity-related illnesses, including diabetes, heart disease,
      and arthritis. Local primary care physicians are an important resource for treating obesity
      in rural areas because of a lack of other community resources.

      This study is looking at how effective current, real-world primary care treatment models are
      in helping rural residents lose weight and maintain that weight loss. Physician clinics will
      be randomized (like picking numbers from a hat) to conduct one of the three methods. The
      method a participant is part of will depend on the method their physician's clinic is
      randomized to. The three methods involved in this study are:

        1. Individual weight-management counseling in person (in clinic individual visits)

        2. Group weight-management counseling, both in person and by telephone; the latter if
           preferred by the group (in clinic group visits)

        3. Group weight-management counseling by telephone (phone group visits)

      Participants will be in the study about 24 months. The number of in-person clinic visits and
      phone calls each participant will be asked to complete depends on the method.
    

Intervention name(s): Fee-for-Service Model (FFS, In clinic individual visits); Patient Centered Medical Home (PCMH, In clinic group visits); Disease Management (DM, Phone group visits)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): To be performed by participant's doctor or other healthcare professional in their doctor's office.; To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.; To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
Other intervention name(s): Individual weight management counseling; Group weight management counseling (in-person and telephone); Group weight management counseling (telephone)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Weight management; Diabetes; Heart disease
Switching From Consta® to Sustenna® in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The aim of this study is observation of effectiveness and side effect of patients with
      schizophrenia who will switch the antipsychotics from risperidone long acting injection to
      paliperidone palmitate.
    

Detailed description: 
      In this study, investigators are going to enroll the patients who will switch the risperidone
      long acting injection to paliperidone palmitate. And investigators will examine the
      effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side
      effect related variables will be studied.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with schizophrenia who would be switched to Paliperidone Palmitate from
        Risperidone Long Acting Injection
      
Keywords: Paliperidone; Palmitate; switching; schizophrenia; subjective well-being
Safety and Tolerability Study of Ragweed SLIT Tablets
Condition: Rhinitis, Allergic, Seasonal; Ragweed Pollen Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of several doses of
      ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic
      rhinitis to ragweed.
    


Intervention name(s): Sublingual tablet of ragweed pollen allergen extract
Intervention type(s): Drug
Intervention description(s): administered once a day over 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ragweed, allergy, sublingual immunotherapy
Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1
      flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years
      of age.
    


Intervention name(s): GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations); GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations); Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, one or two doses; Intramuscular injection, two doses; Intramuscular injection, one dose
Other intervention name(s): Arepanrix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; H1N1; Pandemic