bioihbjkbjnl/mcl2 huggingface dataset:
Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the clinical utility and the feasibility, in an
      outpatient setting, of sputum induction using hypertonic saline. This study will also study
      pilot techniques on a sub using a sub-sample to assess the lower airway inflammatory cells
      and markers in relation to new emerging organisms in cystic fibrosis (CF) and antibiotic
      therapy in CF.
    

Detailed description: 
      Chronic airway infection, mainly by Staphylococcus aureus (SA) and Pseudomonas aeruginosa
      (PA), is a major cause of morbidity and mortality in patients with cystic fibrosis (CF).
      Isolation of organisms from the respiratory tract is important to optimize treatment. The
      current recommended methods for bacterial evaluation are bronchoalveolar lavage (BAL) and
      expectorated sputum (ES) analysis. However, a significant proportion of young CF patients
      cannot produce sputum spontaneously. The method used most frequently therefore is to isolate
      respiratory organisms is to perform throat swabs (TS) which have poor sensitivity and
      specificity in the evaluation of respiratory pathogens in CF patients.

      Induced sputum (IS) using hypertonic saline has been used in a limited number of studies to
      evaluate respiratory organisms in CF patients. These studies have reported that IS may be a
      useful non-invasive diagnostic test to increase the yield of detection of respiratory
      pathogens.

      Beside its use as a diagnostic test to identify bacterial pathogens induced sputum has been
      used to assess lower airway inflammation in CF. While numerous studies have clarified the
      role of S. aureus and P. aeruginosa in CF lung disease, the role of other emerging bacteria
      such as Stenotrophomonas maltophilia (SM) and Achromobacter xylosoxidans (AX) species remains
      largely unclear. IS offers the potential to possibly differentiate between colonisation and
      infection for the emerging pathogens and to help clarify their role in CF lung disease.
    

Intervention name(s): Hypertonic Saline
Intervention type(s): Drug
Intervention description(s): After each subject has performed post-bronchodilator spirometry, he/she will inhale increasing concentrations of 3, 4, and 5% of hypertonic saline for 7 minutes each for 3 cycles until expectorating a sufficient sputum sample.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pediatrics; Cystic Fibrosis; Hypertonic Saline; Induced Sputum; Expectorated Sputum
Glycemic Holter Study (Continuous Glucose Monitoring) -
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess glycemic variability and optimized glycemic control in T2DM patients
      treated with a DPP-4 inhibitor as add-on therapy to metformin.
    


Intervention name(s): Vildagliptin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, vildagliptin, continuous glucose monitoring
Robot Coach of Chronic Low Back Pain Patient
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The objective of KERAAL technological project is to create a new intelligent robot which
      allows a humanoid robot to record then to show and to follow the progress of rehabilitation
      sessions proposed by a physiotherapist to a patient, the latter being able to practice
      without the physiotherapist. The final objective is to stimulate and increase the overseen
      time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements
      notably movements of the spine with 5 degrees of freedom associated to the several levels of
      the spine. It will allow to address the population included in the protocol. RCOOL study
      tries to validate this prototype device as tool of rehabilitation.

      The main objective is the feasibility of the supervision by a humanoid robot of a succession
      of rehabilitation exercises.

      RCOOL study is a randomized clinical trial checked under single-blind condition to compare
      two rehabilitation strategies, one with exercises executed by the patients and supervised by
      Poppy and the other one with usual rehabilitation protocol.
    


Intervention name(s): Rehabilitation program with Poppy robot; Usual rehabilitation program
Intervention type(s): Device; Other
Intervention description(s): Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. Among those 3 hours, patients receive 30 minutes of physical exercises dedicated to mobility of the spine supervised by robot Poppy.; Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Chronic Low Back Pain; Rehabilitation; Robot Poppy
Comparing the "snifﬁng Position" , "Simple Head Extension" and "Neutral Position"
Condition: Therapeutic Procedural Complication
Study type: Interventional

Summary: 
      The simple head extension is recommended for optimization of glottic visualization during
      awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date
      has conﬁrmed its superiority over "snifﬁng position" . In a prospective, randomized study,
      the authors compared the snifﬁng position , simple head extension and "Neutral Position" in
      awake orotracheal Intubation.
    

Detailed description: 
      The study included seventy-five patients with anticipated difficult airways. The snifﬁng
      position was obtained by placement of a 7-cm cushion under the head of the patient. The
      extension head position was obtained by by placement of a 7-cm cushion under the shoulder.

      The head position was randomized as follows: neutral position group (NP group), sniffing
      position group (SP group) or extension position group (EP group) Randomization was performed
      by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were
      then placed in random order. At the time of a patient's enrollment, the next available
      envelope was placed with the patient's chart. At the time of intubation, the envelope was
      opened and the sequence was thus determined.
    

Intervention name(s): snifﬁng Position(place a 7-cm cushion under head ); Simple Head Extension(without cushion)
Intervention type(s): Device; Device
Intervention description(s): Awake fiberoptic bronchoscope(FOB) orotracheal under snifﬁng position.The snifﬁng position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB; Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Snifﬁng Position; Simple Head Extension; neutral position
Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
Condition: Uterine Prolapse; Urinary Incontinence; Fecal Incontinence
MeSH terms: Fecal Incontinence; Urinary Incontinence; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary
      incontinence is high. Previous studies have shown that pregnancy and childbirth are risk
      factors for developing prolapse. There is a lack of studies that follow women several years
      after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie
      vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this
      study is to get more knowledge about pathology of prolapse and incontinence, to enable
      development of preventive strategies for these conditions.

      Aim of the study is to determine whether the prevalence of symptoms and performed surgery for
      urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery
      and cesarean section 15-20 years after their first delivery.

      The investigators identify women that delivered their first child at St. Olavs Hospital,
      Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7,
      PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor
      musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of
      prolapse performed.
    


Intervention name(s): vaginal delivery; forceps extraction; vacuum extraction; cesarean section
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): vaginal delivery by forceps extraction; vaginal delivery by vacuum extraction
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between
        1990-1997
      
Keywords: Delivery, obstetric; Obstetric Surgical Procedures; Vacuum Extraction, Obstetrical; Cesarean Section; Obstetrical Forceps; Epidemiology; Norway
Effect of Fluvastatin on Brown Fat Activity
Condition: Adipose Tissue, Brown; Insulin Resistance; Clinical Trial
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue
      activity in humans.
    

Detailed description: 
      Statins, inhibitors of cholesterol biosynthesis, act by inhibiting the enzyme of the
      mevalonate pathway. Although the clinical benefits of statins are undisputable, they have
      been shown to increase insulin resistance and incidence of type 2 diabetes mellitus, the
      mechanism of which is currently not clear.

      The main function of brown adipose tissue (BAT) is non-shivering thermogenesis (i.e. heat
      production through energy dissipation) in brown adipocytes. There has been a growing interest
      in BAT as a novel therapeutic approach to increase energy expenditure in order to facilitate
      weight-loss and increase insulin sensitivity.

      BAT activity will be assessed using calorimetric test and [18F]-Fluorodeoxyglucose (FDG)
      positron emission tomography (PET).

      We speculate that statins inhibit BAT function and that this mechanism may contribute to the
      above mentioned increase in insulin resistance.
    

Intervention name(s): Fluvastatin
Intervention type(s): Drug
Intervention description(s): Fluvastatin 40 mg twice daily per mouth for 14 days.
Other intervention name(s): Lescol
Intervention model: Sequential Assignment
Intervention model description: Open-label non-randomized historic control (before-after) trial
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Brown Adipose Tissue; Brown Fat; Fluvastatin; Prospective Clinical Trial
A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of LOXO-305 on single oral dose of
      caffeine cytochrome P450 1A2 (CYP1A2) substrate, S-warfarin (CYP2C9 substrate), and
      omeprazole (CYP2C19 substrate) when administered as multiple doses by collecting the blood
      samples and conducting the blood tests to measure how much LOXO-305 is in the bloodstream and
      how the body handles and eliminates LOXO-305 in adult healthy participants. The study will
      also evaluate the safety and tolerability of LOXO-305. The study will be conducted in two
      periods. Participants will stay in this study for up to 67 days, including screening.
    


Intervention name(s): Caffeine Tablet; Omeprazole capsule; Warfarin tablet; LOXO-305
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.
Other intervention name(s): Pirtobrutinib
Intervention MeSH terms: Caffeine; Omeprazole; Warfarin; Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Accuracy & Usability Study for Soberlink Cellular Device
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study scope is to validate the accuracy and usability of the Soberlink Cellular Device
      in comparison to a predicate device, BACtrack S80 Pro.
    

Detailed description: 
      The purpose of this accuracy and usability study is to validate the performance of Soberlink
      Cellular Device in the hands of the intended (lay) users - untrained study participants who
      have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol
      content (BAC) in comparison to a predicate device.

      The purpose of this document is to define how the human factors environment impacts the
      actual user interface design as well as how usability engineering evaluates user interface
      via usability objectives and usability tests. This accuracy and usability study will be
      performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for
      Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability
      Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for
      usability engineering of medical electrical equipment), and IEC 62366 (application of
      usability engineering to medical devices).
    

Intervention name(s): Soberlink Cellular Device; BACtrack S80 Pro
Intervention type(s): Device; Device
Intervention description(s): BAC breath analyzer; BAC breath analyzer
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether or not consistent drug levels can be
      achieved in infants with presumed Gastroesophageal Reflux Disease.
    


Intervention name(s): pantoprazole
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily
      (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled
      blood glucose.
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on
      to pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment
      with pioglitazone as well as diet and exercise therapies.
    

Intervention name(s): Alogliptin and pioglitazone; Alogliptin and pioglitazone; Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.; Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other intervention name(s): Alogliptin (SYR-322); Pioglitazone: Actos®; Alogliptin (SYR-322); Pioglitazone: Actos®; Pioglitazone: Actos®
Intervention MeSH terms: Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type2; Diabetes Mellitus; Drug Therapy
Computer Guided Versus Conventional TMJ Injection
Condition: TMD
Study type: Interventional

Summary: 
      This study is designed to evaluate the clinical outcomes of computer-guided sodium
      hyaluronate injection in superior joint space in comparison to conventional injection for
      treatment of intra-articular TMJ disorder.
    

Detailed description: 
      This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above
      the conventional method from the clinician and patient point of view.
    

Intervention name(s): TMJ injection
Intervention type(s): Procedure
Intervention description(s): four sodium hyaluronate injections in superior TMJ space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMD
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
Condition: Chronic Disease; Nasal Polyposis; Rhinitis
MeSH terms: Rhinitis; Ganglion Cysts; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic
      rhinosinusitis in several ways. Patients have significantly more severe symptom burden and
      worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many
      patients return to the health care providers with persistent symptoms after repeated medical
      and surgical treatment. Patients have usually tried several different types of treatments,
      ranging from less invasive procedures to extensive surgical treatment. The surgical treatment
      is often repeated several times. The most common surgical treatment is functional endoscopic
      sinus surgery, another established procedure is Vidian neurectomy.

      The main object of this pilot study is to investigate the safety of onabotulinumtoxin A
      towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data
      will also be collected to provide indication on whether future placebo-controlled studies
      should be performed.

      Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic
      reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling,
      secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9
      months and will not lead to damage of the nerve.

      This study opens up for improved treatment with less complications.
    


Intervention name(s): botox injection Multiguide
Intervention type(s): Drug
Intervention description(s): botox injection under CT/MR navigation and with the navigation tool MultiGuide
Other intervention name(s): Botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum Toxin Type A; Block; Sphenopalatine Ganglion
Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Condition: Epithelial Ovarian Cancer
MeSH terms: Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk
      of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a
      large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae
      (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular
      method of contraception, but it is not known if its use will reduce a woman's risk of IEOC.
      Mirena® use does not block ovulation in most women but it may release sufficient progestin to
      also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the
      Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against
      IEOC.
    


Intervention name(s): Mirena® intra-uterine device (IUD)
Intervention type(s): Device
Intervention description(s): In this study, a Mirena® IUD will be inserted into volunteers scheduled for a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan Kettering Cancer Center (MSK). Alternatively, women with a Mirena® IUD already in place and who will be scheduled for an RRSO or RRS at MSK can also participate. We are seeking 14 evaluable participants. FTF tissue (and ovarian inclusion cyst tissue, when available) collected at the time of risk-reducing salpingectomy (RRS) will be tested by immunochemistry staining for Ki67 (a protein that is significantly increased when cells are preparing for division).
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mirena® IUD's; Women; risk-reducing salpingo-oophorectomy; risk-reducing salpingectomy