louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00724776: Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Dose of Albinterferon Alfa 2b (Alb-IFN), Recombinant Human Albumin-interferon Alfa Fusion Protein in Japanese Chronic Hepatitis C Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period.
* Age 20 to 69 years
* Have compensated liver disease results on screening laboratory assessment

Exclusion Criteria:

* Evidence of decompensated liver disease and/or liver cirrhosis.
* Body weight \< 50 kg.
* A history of immunologically mediated disease.
* A history or other clinical evidence of interstitial lung disease

Primary outcomes:
measure: Safety and tolerability after single dose
timeFrame: 5 weeks after single dose
Secondary outcomes:
measure: Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
timeFrame: 5 weeks after single dose
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals, Japan
Study officials:
References:
Clinical trial NCT03868527: The ARCAN Database is Used for Retrospective Non-interventional Research Projects. The Database Collects Clinical and Laboratory Data From Patients With Lymphoid Malignancies. The Database Doesn't Require Biological Sample of Patients, it Records Only Information Based on the Patients' Medical File.
Official title: The ARCAN Database is Used for Retrospective Non-interventional Research Projects. The Database Collects Clinical and Laboratory Data From Patients With Lymphoid Malignancies. The Database Doesn't Require Biological Sample of Patients, it Records Only Information Based on the Patients' Medical File.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Diseases
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 13000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for lymphoid malignant hemopathy in Lyon Sud Hospital

Brief summary: To identify the diagnostic and therapeutic approach (efficacy and toxicity) of patients with lymphoid malignant hemopathy who are managed in the hematology department.


Eligibility criteria: Inclusion Criteria:

- Patients followed for hematological diseases in Lyon Sud Hospital

Exclusion Criteria:

- Patients who doesn't have hematological diseases

Primary outcomes:
measure: Progression-free survival
timeFrame: 730 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Gilles Salles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05275127: Impact of Periodontal Treatment on Local miRNA Expression
Official title: Analysis of Gingival Crevicular Fluid miRNA Changes After Periodontal Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Periodontal Diseases
Keywords: Periodontitis, GCF
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Q-SRP (no. 44 patients), FM-SRP (no. 45 patients)

Brief summary: To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with periodontitis extent.

Detailed description: The patients selected for the study were divided into 2 groups: group 1 (FM-SRP), group 2 (Q-SRP). Any selected subject underwent anamnestic and periodontal examination, blood and GCF sampling. MiRNA in the GCF was extracted through a commercially available kit and then measured carrying out real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical attachment level reduction
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
state: CT
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01234727: Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes
Official title: Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: diabetes, SMBG, glucose testing systems, accuracy
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
Collaborators: name: ikfe-CRO GmbH
First posted: 2010-11-04
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 480 subjects with type 1 or 2 diabetes mellitus

Brief summary: A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany \& Holland.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with type 1 or type 2 diabetes mellitus
* Age between 18 and 75 years.
* Patients with stable blood glucose in judgment of the investigator.
* Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
* Patients perform blood glucose self measurements on a routine basis
* Patients must have experience in self measurement blood glucose for at least 6 months.

Exclusion Criteria:

* Patients with unstable blood glucose in judgment of the investigator.
* Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
* Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
* Subject without legal capacity.
* Blood donation within the last 30 days.
* Known pregnancy.
* Subject has already participated in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Zentrum für Diabetes und Gefäßerkrankungen
city: Neuwied
country: Germany
facility: Diabetes Zentrum Neuwied
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Centre
Study officials:
affiliation: Abbott Diabetes Care
name: Joe Bugler
role: STUDY_DIRECTOR
References:
Clinical trial NCT03680027: Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects
Official title: Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects: A Randomized-Controlled Trial: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: Serum lipids
Hyperlipidemia
Walnut
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. Current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals.

Detailed description: In this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. All subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. The walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. In order to follow nutritional status of subjects, they were visited every 15 days (in total 4 times). Anthropometric measurements of the subjects were taken and were monitored at each visit during the study. Blood samples were measured at the beginning and again at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Hyperlipidemic patients who are not using any lipid lowering medications
* Non-smoker
* No alcohol consumption
* Individuals who are having ≤30kg/m2
* Individuals who do not have any allergy for nut consumption
* Female participants who are not pregnant or breastfeeding
* Individuals should not be in a weight loss programme
* Having not consumed regular nuts for the last 1 month,
* Except hypertension, they should not have other chronic diseases (such as diabetes, chronic renal failure)
* No intense exercise

Exclusion Criteria:

* Failure to meet the criteria for inclusion criteria.

Primary outcomes:
measure: Reduction in serum lipids and fasting glucose levels
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eastern Mediterranean University
name: Gözde Okburan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01731327: A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
Official title: A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
relative bioavailability
modified release
tofacitinib
CP-690
550
pharmacokinetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects who are of non-childbearing potential.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months

Primary outcomes:
measure: AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
timeFrame: 72 hours post dose
measure: Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
timeFrame: 72 hours post dose
Secondary outcomes:
measure: AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized
timeFrame: 72 hours post dose
measure: AUCinf: Area Under the Curve From Time Zero to Infinity
timeFrame: 72 hours post dose
measure: Cmax: Maximum Observed Plasma Concentration
timeFrame: 72 hours post dose
measure: AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration
timeFrame: 72 hours post dose
measure: Tmax: Amount of time drug takes to reach Cmax
timeFrame: 72 hours post dose
measure: t ½: Terminal elimination half-life
timeFrame: 72 hours post dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02507427: Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)
Official title: Safety and Efficacy of Pelvic Autonomic Nerve Monitoring and Mapping During Robot Assisted Laparoscopic Radical Prostatectomy for Preservation of Erectile Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer, robot, nerve mapping and monitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.

Detailed description: Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. In this feasibility and protocol setting phase I/II study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using NIM-Eclipse monitoring instrument.

Eligibility criteria: Inclusion Criteria:

* pathologically proven localized prostate cancer (≤cT3a)
* patients to undergo robot-assisted laparoscopic prostatectomy at our center

Exclusion Criteria:

* prior hormone therapy
* prior radiation treatment on prostate or pelvis
* refused to participate

Primary outcomes:
measure: Completion rate of nerve monitoring and mapping during RALP
timeFrame: During the operation
Secondary outcomes:
measure: Adverse event
timeFrame: 12 months
measure: Quantification of erectile nerve preservation
timeFrame: During the operation
measure: Correlation between the quantification and subjective nerve preservation grade
timeFrame: During the operation
measure: Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198027: Peritubal Infiltration of Bupivacaine in PCNL
Official title: Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: Percutaneous nephrolithotomy
postoperative analgesia
peritubal block
pain
Visual Analog Pain Scale
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years of age
* Single PCNL track

Exclusion Criteria:

* Spinal Disc Prolapse
* Any previous renal surgery
* Complication secondary to PCNL

  * Hydrothorax that requires intervention
  * Pneumothorax
  * Massive hemorrhage that requires more than 1 U transfusion
  * Conversion to open procedure.

Primary outcomes:
measure: Mean time for first demand of rescue analgesic
timeFrame: Release of the patient from the hospital or 24 hours (whichever comes first)
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sind
Study officials:
affiliation: The Indus Hospital
name: Zeeshan Arshad, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Indus Hospital
name: Zafar Zaidi, MBBS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00381927: Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development
Official title: Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer Risk
Counseling
Prevention
Anxiety
BRCA1 mutation
BRCA2 mutation
Tamoxifen
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2006-09-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To evaluate 1) the extent of patient overestimation of breast cancer development risk in subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician counseling to improve patient risk perception and reduce psychological distress; 3) to identify factors relevant in clinical practice associated with increased distress and risk perception.

Detailed description: Patients referred to the Baystate Comprehensive Breast Center High-Risk Clinic wil, after giving consent, complete an intake evaluation of breast cancer risk, the patient's perceptions of breast cancer development risk, and the Brief Symptom Inventory-18. Physician history, physical and counseling then takes place, with sharing of risk estimates based on modified Gail model and Myriad tables regarding breast cancer risk and probability of BRCA1/2 mutation. After counseling, patients complete another assessment of risk perception and BSI-18, and again 2 months and 1 year post counseling. Recommendations for hormonal management and referral for formal genetic evaluation and testing will be tracked.

Eligibility criteria: Inclusion Criteria:

* Attendance at High-risk Clinic
* Ability to complete BSI-18 and risk perception questionnaire

Exclusion Criteria:

* Diagnosis of invasive breast cancer
* Diagnosis of ductal carcinoma in situ.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Comprehensive Breast Center
state: Massachusetts
Study officials:
affiliation: Baystate Regional Cancer Program/Baystate Medical Center
name: Wilson C Mertens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537327: Incidence of Recurrent Caries Next to Tooth Restorations
Official title: Epidemiological Study on the Incidence and Characteristics of Secondary Caries Next to Tooth Restorations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Caries
Keywords: Recurrent caries
Secondary caries
Dental composite
Dental amalgam
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up

Brief summary: The aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.

Detailed description: The data will be collected from patients who are visiting the dental clinic for a check-up. These data will be retrieved in the patient records. In particular the clinical (mouth) exam and the radiographic images ('RX-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. Information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. In addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (Saliva-Check Buffer, GC, Tokyo, Japan) and dental plaque (Tri Plaque ID Gel, GC, Tokyo, Japan), which are a part of the routine care of the patients at the clinic.

Eligibility criteria: Inclusion Criteria:

* Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up

Exclusion Criteria:

* Patients for who not all necessary data could be registered (incomplete mouth exam records, missing RX-bite wings, etc)

Primary outcomes:
measure: Incidence of recurrent caries
timeFrame: Two years
Secondary outcomes:
measure: Caries risk of the patient
timeFrame: Two years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven and UZ Leuven, Department of oral health sciences
Study officials:
affiliation: BIOMAT, Department of Oral Health Sciences, University of Leuven & Dentistry University Hospitals Leuven
name: Kirsten L. Van Landuyt, DDS, PhD
role: STUDY_CHAIR
References: