bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Condition: Infection
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely
      used antibiotic for surgery in patients with an allergy to penicillin. During cardiac
      surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used
      and can lower the level of the antibiotic. The purpose of this study is to quantify the
      change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified
      ultrafiltration.
    

Detailed description: 
      Subjects having cardiac surgery in which they will be on a heart-lung machine and will
      receive the antibiotic vancomycin, will be able to participate.

      Up to ten blood samples testing for vancomycin concentrations will be collected in subjects
      administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and
      modified ultrafiltration. Participation will be complete once the cardiac surgery has been
      finished.
    

Intervention name(s): Vancomycin concentrations
Intervention type(s): Other
Intervention description(s): Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
Other intervention name(s): pharmacodynamics; vancomycin monitoring; serum concentrations of vancomycin
Intervention MeSH terms: Vancomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: heart lung machine; blood pump; cardiac surgery; cardiopulmonary bypass; circulation
Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy
Condition: Chronic Allograft Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one
      of the major determinants of long term graft survival. There are a number of factors that can
      contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors.
      Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy.
      renal biopsy has a number of complications . This includes infection and bleeding. The non
      invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very
      good yield of detecting and scoring fibrosis.

      In this study our aim is to determine the sensitivity and specificity of ( strain
      sono-elastography) in the detection and classifying of chronic allograft nephropathy as
      compared to transcutaneous renal biops
    

Detailed description: 
      Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one
      of the major determinants of long term graft survival. There are a number of factors that can
      contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors.
      Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy.
      renal biopsy has a number of complications . This includes infection and bleeding. The non
      invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very
      good yield of detecting and scoring fibrosis.

      In this study our aim is to determine the sensitivity and specificity of ( strain
      sono-elastography) in the detection and classifying of chronic allograft nephropathy as
      compared to transcutaneous renal biopsy
    

Intervention name(s): Elastography arm
Intervention type(s): Diagnostic Test
Intervention description(s): Renal ultrasound elastography to detect and classify the degree of fibrosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Nephropathy, Chronic Tubulointerstitial; Kidney Transplantation; ultrasonography; Elasticity Imaging Techniques
A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of
      PSN821 in patients with type 2 diabetes.

      Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the
      start of treatment and at the end of a 12 week treatment period as the primary endpoint.
      HbA1c, fasting plasma glucose and body weight are secondary endpoints.
    


Intervention name(s): PSN821; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.; Placebo twice a day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Interstitial Lung Disease Associated
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD
      spectrum share the same clinical manifestations and outcome with CTD feature disease
      spectrum.
    

Detailed description: 
      We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia
      during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between
      January 2012 and December 2021.

        1. Baseline data collection:

             1. Baseline information at the time of initial diagnosis was obtained, and the
                following items were analyzed: demographic information (age, gender), clinical
                course, clinical symptoms and signs, laboratory findings [routine blood,
                erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP),
                rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests
                (PFTs), and chest HRCT scans.

             2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.

             3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists.
                The HRCT scans were analyzed for the following characteristics: ground-glass
                opacities, reticular patterns, honeycombing, traction bronchiectasis.

             4. Spirometry was performed according to standardized guidelines. PFTs results were
                expressed as percentages of the predicted values, thereby correcting for age,
                gender and bodyweight.

        2. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine,
           cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to
           the time of patient's last visit or time of death, and the outcomes were defined as
           death from all causes.

        3. Outcome
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Interstitial pneumonia based on clinical symptoms and radiologic features, with or without
        histopathologic results.
      
Keywords: Interstitial lung disease, ANCA, CTD, IPAF, IIP
Sexual Dysfunction and Dental Care
Condition: Dyspareunia; Hypoactive Sexual Desire Disorder; Erectile Dysfunction; Vaginismus
MeSH terms: Erectile Dysfunction; Dyspareunia; Vaginismus; Sexual Dysfunctions, Psychological
Study type: Observational

Summary: 
      Evaluation of sexual functioning of patients at the Sexual Medical Center, at Sheba Medical
      Center in Israel. Sexual functioning shall be compared with their dental behavior.

      Hypothesis: a positive association will be found.
    

Detailed description: 
      Patients, male and female, age over 18, who apply to the Sexual Medical Center, at Sheba
      Medical Center will fill a battery of questionnaires regarding their sexual function and
      dental treatment.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women, over 18 years old, who come for sexual therapy/ counseling to the Sexual
        Medical Center, in Sheba Medical Center, Israel Partners or spouses of the above.
      
Keywords: sexual dysfunction; male; female; dental care; need of control
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing
      dentinal hypersensitivity over a two week treatment period.
    


Intervention name(s): Stannous Fluoride; Sodium Monofluorophosphate
Intervention type(s): Drug; Drug
Intervention description(s): dentifrice containing stannous fluoride; dentifrice containing Sodium Monofluorophosphate
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess whether renal impairment could affect fevipiprant
      pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient
      population.

      The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic
      profile as the procedure might remove a significant fraction of the drug.
    

Detailed description: 
      The purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is
      different in patients with renal impariment compared to healthy matched volunteers to an
      extent that would require an adjustment of the dosage. Data from this study will be used to
      guide enrollment criteria in future clinical trials and to support regulatory submission and
      labeling information
    

Intervention name(s): QAW039; QAW39A; QAW39A2107; QAW39A2107
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 450 mg; 450 mg; 450 mg; 450 mg
Other intervention name(s): fevipiprant; fevipiprant; fevipiprant; fevipiprant
Intervention MeSH terms: Indoleacetic Acids
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end stage renal disase ESRD; dialysis effect on pharmacokinetics PK; renal impairment
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
Condition: Therapeutic Equivalency; Food
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial
      formulation in both under fasted and fed condition, and bioequivalence between formulation
      E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective
      is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set
      to get data for Japanese regulatory submission.
    


Intervention name(s): Fesoterodine; Fesoterodine; Fesoterodine; Fesoterodine; Fesoterodine; Fesoterodine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 2 x 4 mg tab in formulation F under fed condition; Single dose of 1 x 8 mg tab in formulation F under fed condition; Single dose of 1 x 8 mg tab in formulation E(1) under fed condition; Single dose of 1 x 8 mg tab in formulation F under fed condition; Single dose of 2 x 4 mg tab in formulation F under fasted condition; Single dose of 1 x 8 mg tab in formulation F under fasted condition
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence, food effect
State-wide Health Approach to Increase Reach and Effectiveness: Study 1
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      Behavioral weight loss programs can successfully reduce body weight, but these programs are
      available to limited numbers of overweight and obese individuals. This project evaluates a
      unique weight loss approach that combines a self-sustaining weight loss campaign (for
      outreach) with training in behavioral weight loss strategies and strategies to increase
      accountability (to improve weight loss success). This innovative combination has the
      potential to be a cost-effective model for disseminating weight control interventions.
    

Detailed description: 
      Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI;
      a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss
      program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group).
      Primary outcome is weight loss at 12-weeks.
    

Intervention name(s): Shape Up Rhode Island + Online Resources; Shape Up Rhode Island + Online Weight Loss Program; Shape Up Rhode Island + Online Weight Loss Program + Group sessions
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources; Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program; Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of BiCROS Fitting Benefits
Condition: Unilateral Deafness
MeSH terms: Deafness; Hearing Loss, Unilateral
Study type: Interventional

Summary: 
      23 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a
      CROS device. Following a real-world trial, each participant will be tested on a range of
      outcome measures including speech recognition in noise, ratings of listening effort, and
      ratings of preference.
    

Detailed description: 
      Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one
      ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating
      associated with audiological, psychosocial and educational challenges. Audiological
      challenges include the reduced ability to localize sounds, reduced awareness on the unaidable
      side and difficulties hearing in noise or at a distance.

      One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral
      Contralateral routing of signals (BiCROS) using a so-called CROS transmitter together with a
      hearing aid.

      The rationale for this clinical investigation is to collect clinical data with a rechargeable
      CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative
      treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening
      situations.

      Hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the
      National Centre for Audiology in London, Ontario. Those visits are available at the Sonova
      Innovation Centre Toronto in Mississauga, Ontario, upon request. Outcome measurements are
      only conducted at the National Centre for Audiology in London, Ontario.
    

Intervention name(s): BiCROS fitting; Monaural hearing aid fitting; Unaided condition
Intervention type(s): Other; Other; Other
Intervention description(s): Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear.; Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear.
Monaural hearing aid fitting acts as control intervention.; No treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid.
Unaided condition acts as control intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
Condition: Catartact
Study type: Interventional

Summary: 
      The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601
      PY for the monocular uncorrected distance visual acuity and compare it to the reference
      monofocal IOL Acrysof IQ SN60WF.
    


Intervention name(s): Implantation of CT LUCIA IOL; Implantation of Acrysof IQ SN60WF IOL
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048
      bid over three days each administered as four experimental formulations relative to drinking
      solution with and without coadministration of 40 mg Pantoprazole
    


Intervention name(s): BIBR 1048 MS Capsule E; BIBR 1048 MS Capsule F; BIBR 1048 MS Capsule G; BIBR 1048 MS Tablet H; BIBR 1048 MS Drinking solution; Pantoprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mg BIBR 1048 MS; 50 mg BIBR 1048 MS; 50 mg BIBR 1048 MS; 50 mg BIBR 1048 MS; 50 mg BIBR 1048 MS tartaric acid solution; 40 mg Pantoprazole
Intervention MeSH terms: Pantoprazole; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validity and Reliability Study of the Motor Accuracy Test
Condition: Test-Retest Reliability
Study type: Observational

Summary: 
      The Motor Accuracy-Revised Test's validity and reliability in Turkey was studied in this
      paper.
    

Detailed description: 
      The study sample group consists of 100 children who are studying in a primary school
      registered to Hatay Provincial Directorate of National Education. The children's ages range
      between 6 years and 8 years 11 months.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study sample group consists of 100 children who are studying in a primary school
        registered to Hatay Provincial Directorate of National Education. The children's ages range
        between 6 years and 8 years 11 months.
      
Keywords: SIPT; Motor Accuracy; Validity; Reliability
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple
      doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)
    


Intervention name(s): Imsidolimab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Other intervention name(s): ANB019
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PPP
Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of a 90-day
      intravaginal ring (IVR) containing tenofovir (TFV).
    

Detailed description: 
      This study will evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring
      (IVR) containing tenofovir (TFV) in healthy, HIV-uninfected individuals assigned female sex
      at birth.

      Participants will be randomly assigned to receive an IVR containing either 1.4 g TFV or
      placebo. The IVR will be inserted at the enrollment visit (Day 0) and used continuously for
      approximately 91 days.

      Additional study visits will occur at Days 1, 7, 14, 28, 42, 56, 91, and 92. Study visits may
      include behavioral assessments, physical examinations, blood and urine collection, and pelvic
      and rectal specimen collection.
    

Intervention name(s): Tenofovir (TFV) IVR; Placebo IVR
Intervention type(s): Drug; Drug
Intervention description(s): Contains 1.4 g TFV; Contains placebo
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Ramelteon in Adults With Chronic Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily
      (QD), in adult subjects with chronic insomnia.
    

Detailed description: 
      Insomnia is characterized by difficulties initiating and maintaining sleep or complaints of
      nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third
      to one-half of the US population, based on the results of 2 surveys of representative samples
      of the adult US population conducted by the Gallup Organization in which respondents were
      asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent"
      sleep difficulty, results from the same studies suggest that approximately one-tenth of the
      US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the
      latency to onset of sleep and increase total sleep time, without a negative impact on sleep
      architecture and without safety concerns or next-day effects.

      Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical
      Industries, Ltd, for the treatment of transient and chronic insomnia and for the treatment of
      Circadian Rhythm Sleep Disorders.

      This study is designed to determine the safety and efficacy of 35-day treatment of chronic
      insomnia with Ramelteon, using subjective measures of sleep. Total subject participation time
      in this study is expected to be approximately 2 months.
    

Intervention name(s): Ramelteon; Ramelteon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ramelteon, 8 mg, tablets, orally, once daily for up to 5 weeks.; Ramelteon, 16 mg, tablets, orally, once daily for up to 5 weeks.; Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
Other intervention name(s): Rozerem™; TAK-375; Rozerem™; TAK-375
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Disorder; Insomnia