bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Interactions of Metamizole (Dipyrone) in Healthy Subjects
Condition: Inhibition; Induction; Drug-Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigators conducted a single center, two-phased, open, controlled pharmacokinetic study
      to investigate the drug-drug interaction potential of metamizole. For this reason, healthy
      male volunteers were screened.

      Enrolled participants were phenotyped on day 1 using the Basel Cocktail (phenotyping cocktail
      containing specific substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4). After,
      they received metamizole treatment for 8 days (3 grams per day). On the 8th day (day 9), they
      were phenotyped again with the Basel Cocktail and the respective phenotypes (d1 vs. d9) were
      compared.
    

Detailed description: 
      12 healthy male subjects meeting the inclusion and exclusion criteria were enrolled. On day
      1, they ingested a capsule containing the Basel Cocktail (1A2: caffeine, 2B6: efavirenz, 2C9:
      flurbiprofen, 2C19: omeprazole, 2D6: metoprolol, 3A4: midazolam) in fastened state. Blood
      samples were withdrawn over 24 hours and the AUC ratios between metabolite and parent were
      calculated to determine the phenotype.

      Probands began metamizole treatment (3000 mg/day) at the day of the 24h measurement. After
      3-4 day, probands were returning to the facility to ensure safety during the metamizole
      treatment, blood cell count and metamizole metabolites were measured. After the 7 days of
      treatment, probands were exposed again to the Basel Cocktail in a fastened state. Probands
      were still exposed to metamizole to ensure potential inhibition. 24 hours plasma samples were
      withdrawn, area under the curve (AUC) ratios were calculated and compared to the basal state.
      After an end of study visit on the day of the 24h blood sample (following the second study
      day), probands were discharged.
    

Intervention name(s): Metamizole
Intervention type(s): Drug
Intervention description(s): One week treatment with metamizole (500 mg tablets, 2-2-2)
Intervention MeSH terms: Dipyrone
Intervention model: Single Group Assignment
Intervention model description: Two phase study, before-after comparison
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metamizole; Dipyrone; Basel Cocktail; Drug-Drug Interaction; Phenotyping
Potato Fiber and Gastrointestinal Function: Phase 3
Condition: Gastrointestinal Symptoms; Gastrointestinal Transit Time; Stool Frequency
Study type: Interventional

Summary: 
      The primary physiological impacts of fiber intake include the gastrointestinal effects of
      stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT).
      Fermentation of resistant starches by microbiota increases bacterial numbers, which increases
      fecal bulk and may impact frequency and transit time. The purpose of this study is to
      determine the effects of resistant potato starches (potato fiber) on stool frequency, transit
      time and microbiota in healthy individuals.
    

Detailed description: 
      Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals
      (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant
      changes in gastrointestinal function and microbiota profile.

      Objectives:

        1. To determine the effect of potato fibers on stool frequency, gastrointestinal transit
           time and gastrointestinal symptoms.

        2. To determine the effect of potato fibers on microbial diversity in healthy individuals.
    

Intervention name(s): PF-RS; PF-RO1; PF-RO2; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): n=20 will consume PF-RS containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.; n=20 will consume PF-RO1 containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.; n=20 will consume PF-RO2 containing 30 g potato fiber for 14 days and then will consume a control containing no fiber for 14 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Fiber; Gastrointestinal
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
Condition: Vomiting; Nausea Post Chemotherapy; Head Neck Cancer
MeSH terms: Head and Neck Neoplasms; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone
      to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT)
      cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck
    

Detailed description: 
      To evaluate the complete response rate, nause-free rate, vomiting-free rate, and the quality
      of life of aprepitant combined with ondansetron and dexamethasone for the nausea and vomiting
      induced by chemoradiotherapy in HNSCC.
    

Intervention name(s): Aprepitant
Intervention type(s): Drug
Intervention description(s): Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. Patients receive concurrent aprepitant 125mg, dexamethasone 12mg, and ondansetron 8mg p.o. on day1. AND then patients received aprepitant 80mg, dexamethasone 8mg on day 2-5 at every chemotherapy cycle.
Other intervention name(s): Dexamethasone; Ondansetron
Intervention MeSH terms: Dexamethasone; Ondansetron; Aprepitant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Condition: Vulvar Intraepithelial Neoplasia (VIN)
MeSH terms: Neoplasms; Carcinoma in Situ
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the incidence of vulva dysplasia
      recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or
      ultrasonic aspiration.
    

Detailed description: 
      Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still
      lacks a standard of care for optimal treatment. Current treatment options aim to treat the
      symptoms associated with VIN and result in a high recurrence rate. Due to the high
      reoccurrence rate and the nature of the current treatments, a more effective treatment option
      is warranted. An effective treatment that targets only the diseased areas could potentially
      decrease recurrence rates. Additionally, a more conservative treatment modality could
      contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught.
      The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60%
      reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.

      This study will employ a randomized controlled trial (RCT) design. This is a phase III study
      to determine the effectiveness of a more targeted treatment therapy for VIN (comparing
      ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified
      through the gynecological clinical practices following diagnosis of high grade VIN and will
      be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for
      multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic
      Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of
      vulvar dysplasia.
    

Intervention name(s): Sonopet Ultrasonic Aspirator; CO2 Laser Ablation
Intervention type(s): Device; Device
Intervention description(s): To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation; To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 1

Summary: 
      Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant
      problems. First-line of management for patient with osteoarthritis consists of weight
      reduction, education, and analgesic medication. If necessary, invasive treatment like total
      hip replacement are performed for the patient. The objective of this study was to assess the
      safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip
      osteoarthritis
    

Detailed description: 
      This is a phase one clinical study designed to investigate the safety of intra-articular
      injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate
      for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs
      will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection
      of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be
      done before and 6 months after treatment. Pain relief and functional improvement of the joint
      will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2
      and 6 months after treatment.
    

Intervention name(s): stem cell injection
Intervention type(s): Biological
Intervention description(s): intra articular inection of mesenchymal stem cell
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; hip joint; mesenchymal stem cell
Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta
      cell.
    


Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): 8 weeks treatment of dapagliflozin added to the type 2 diabetes patients with unsufficiently controlled with metformin or sulfonylurea
Intervention MeSH terms: Dapagliflozin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers
Condition: A-PRF
Study type: Interventional

Summary: 
      the investigators aim from this study to evaluate platelet rich fibrin potential to heal the
      periodontal tissue and to form new native bone in smokers that require socket augmentation
      following dental extraction and before implant placement.

      Materials and Methods: 18 adult smoker patients with 40 extracted sockets were recruited for
      this study, and the extracted sockets were distributed into four different groups as follows;
      Group 1- A-PRF alone, Group 2- Factors-enriched bone graft matrix (commonly known as sticky
      bone) using autologous fibrin glue combined with an FDBA with CGF-Enriched Fibrin Membrane to
      covered it, Group 3- an FDBA with a crosslinked collagen membrane and Group 4-Resorbable
      collagen plug (RCP) alone serving as a negative control group.

      The patients were randomly grouped into a previously mentioned group, and the socket
      dimensions were measured four times, immediately after the extraction (0 days), after 10, 21,
      and 28 days to assess epithelial layer healing.

      After six months and before placing the implant fixture, both soft and hard tissue samples
      will be harvested to be evaluated and compared histologically, also standardized CBCT will be
      taken before and after extraction to evaluate the amount of mineral content and vital bone
      formation radiographically.
    


Intervention name(s): platelet rich fibrin
Intervention type(s): Biological
Intervention description(s): we would like to measure the effect of PRF on soft and hard tissue healing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg
      for extensive and poor metabolizers will be administered with the objective to evaluate urine
      and blood concentrations in healthy volunteers.
    


Intervention name(s): Tramadol.
Intervention type(s): Drug
Intervention description(s): Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers.
Intervention MeSH terms: Tramadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate and compare the pharmacokinetics of a single 25-mg dose of
      MK-3102 in participants with moderate hepatic impairment and matched healthy participants.
      The primary hypothesis is that in participants with moderately impaired hepatic function, the
      area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to
      that observed in healthy matched control participants following a single 25 mg oral dose of
      MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy
      matched control subjects) of geometric means for AUC0-∞ is no greater than 2.
    


Intervention name(s): MK-3102
Intervention type(s): Drug
Intervention description(s): Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases
The Role of Atrial Natriuretic Peptide in the Lipolytic Process: Effect of Obesity and Exercise
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      In the developing countries, obesity prevalence is on a dramatic rise. Obesity is related to
      co-morbidities and as a result, obesity significantly shortens life expectancy and lowers
      quality of life. To prevent this, participation in exercise or training programs is
      absolutely necessary, in order to generate adipose tissue mass loss. The amount of adipose
      tissue mass loss is, amongst others, dependent on lipolysis which is under endocrine
      regulation by, mainly, catecholamines, insulin and atrial natriuretic peptide. However, large
      variations in adipose tissue mass loss and gain are likely in obese subjects, possibly due to
      a decreased lipolytic effect of these hormones (as was shown for catecholamines in the
      subcutaneous adipose tissue of obese subjects). However, the relative contribution of atrial
      natriuretic peptide in the lipolytic process remains elusive, particularly in subjects with
      obesity, which show an increased plasma expression of atrial natriuretic peptide.

      The aim of the present study is to observe the contribution of atrial natriuretic peptide in
      the subcutaneous adipose tissue of obese subjects. This will be tested by measurements of
      extracellular glycerol levels (by microdialysis) in the subcutaneous adipose tissue in situ
      at rest and during endurance exercise under local beta- and alpha-blockade.

      Eventually, the knowledge gained from this research will contribute to the optimization of
      exercise programs for people with obesity.
    


Intervention name(s): subcutaneous adipose tissue microdialysis under local beta/alpha blockade
Intervention type(s): Other
Intervention description(s): adipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        subjects with obesity
      
Keywords: obesity; adipose tissue lipolysis; lipolysis; microdialysis; atrial natriuretic peptide
Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

Summary: 
      A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and
      the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age,
      high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of
      urodynamic stress incontinence were also independent predictors for OAB-wet, and the above
      might indicate that OAB-wet and OAB-dry have at least partly different underlying
      pathophysiologies.
    

Detailed description: 
      Aims: To identify factors predicting the presence of OAB-wet and to further derive the
      underlying pathophysiology in OAB-wet vs. OAB-dry.

      Methods: Between September 2007 and September 2013, the medical records of women with OAB who
      completed a 3-day bladder diary and underwent urodynamic studies in a tertiary referral
      center will be reviewed. OAB-wet will be diagnosed in patients who complained of at least one
      episode of urgency incontinence in the previous month; otherwise, OAB-dry is diagnosed.
      Multivariate logistic regression analysis will be used to predict the presence of OAB-wet.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with OAB who completed a 3-day bladder diary and underwent urodynamic studies at the
        urogynecologic outpatient clinics of the Department of Obstetrics and Gynecology of a
        medical center
      
Keywords: Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urodynamics
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared
      with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM
      within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival
      will be collected for 5 years after surgery. To evaluate the safety, data on adverse events
      will be collected during treatment. Patients'quality of life will be assessed by means of a
      questionnaire.
    


Intervention name(s): UFT (uracil, tegafur) and tamoxifen; CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
Intervention type(s): Drug; Drug
Intervention description(s): UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.; CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.
Intervention MeSH terms: Tamoxifen; Cyclophosphamide; Fluorouracil; Methotrexate; Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer
Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The current trial will examine the efficacy and safety of Exubera administered as a mealtime
      insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or
      = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion
      of subjects to reach target glycosylated hemoglobin (A1C) levels.
    


Intervention name(s): Insulin Lispro; Exubera
Intervention type(s): Drug; Drug
Intervention description(s): Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.; Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type two diabetes, insulin, HbA1c
Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
Condition: Osteoarticular Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a biomedical research, prospective, mono centric, tolerance study Of the
      administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.
    


Intervention name(s): teicoplanin
Intervention type(s): Drug
Intervention MeSH terms: Teicoplanin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: subcutaneous teicoplanin; osteoarticular; infections; tolerance; teicoplanin
Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth
Condition: Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      Regenerative endodontic procedures have been used to successfully treat human mature
      permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to
      apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical
      case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature
      teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration.
      The aim of this study is to assess the regenerative potential of mature permanent teethwith
      necrotic pulps after disinfecting the root canal using diode laser andcompare it with dynamic
      agitation of xp-endo finisher and conventionaltriple antibiotic paste
    


Intervention name(s): Method
Intervention type(s): Other
Intervention description(s): treatment of mature teeth with apical periodontitis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment