louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01185678: Data on Oral Contraceptives Compliance in Non Stop Regimen
Official title: Observation of Compliance With Dosage in Women Using Oral Contraceptives Designed for the Non Stop Use, (it Means 28 Pills for 28-days Cycle).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Contraception
Compliance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 8416
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gynecological practices ptients - starters or current users.

Brief summary: Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.


Eligibility criteria: Inclusion Criteria:

* Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria:

* Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.

Primary outcomes:
measure: The percentage of users showing noncompliant behaviors
timeFrame: 3 consecutive cycles (28-days per cycle)
Secondary outcomes:
measure: The characteristics of noncompliant behavior.
timeFrame: 3 consecutive cycles (28-days per cycle)
measure: The relation between noncompliant behavior and selected factors.
timeFrame: 3 consecutive cycles (28-days per cycle)
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03442478: Comparison of Digital Breast Tomosynthesis to Conventional Mammography
Official title: The Performance of Digital Breast Tomosynthesis Compared to Conventional Mammography in Visualization and Characterization of Suspicious Breast Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In March 2009, Health Canada approved Tomosynthesis for use in screening and diagnosis of breast cancer. The Tomosynthesis technology is designed as a complementary imaging model that is incorporated into the 2D Mammography system. This new imaging system has the capability to provide 2D, 3D and combination mode models. It consists of generating thin slice images that can be viewed individually as multiple images from the same breast. Tomosynthesis provides improved visibility of possible lesions within the breast. The study aims to compare the performance of Tomosynthesis to the conventional Digital Mammography in detecting and characterizing suspicious findings in subjects who will be having breast biopsies.


Eligibility criteria: Inclusion Criteria:

* Subject is female of any race and ethnicity
* Following routine mammography imaging, subject is categorized as Breast Imaging Reporting and Data System (BI-RADS®) 4 or 5 because of calcifications / masses and architectural distortion will undergo study imaging within 30 days of routine imaging
* Subject will undergo 2D/3D digital breast tomosynthesis prior to biopsy

Exclusion Criteria:

* Subject unable or unwilling to undergo informed consent
* Subjects who are unable or unwilling to tolerate compression
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are breast-feeding
* The subject is too large to be imaged on the large 24 x 30 cm detector

Primary outcomes:
measure: Comparison of Tomosynthesis to Standard Digital Mammography
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anabel Scaranelo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431378: Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
Official title: Pilot Study of Model Based Iterative Reconstruction Using 64-Slice Multidetector-Row CT Datasets Obtained From the Central Nervous System, Thorax, and Abdomen
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Posterior Fossa Hemorrhage
Lung Cancer
Flank Pain
Urolithiasis
Focal Hepatic Necrosis
Keywords: CT scan
CNS
Thorax
Abdomen
staging of a known or suspected lung cancer
suspected urolithiasis
known or suspected focal liver lesion
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: American College of Radiology - Image Metrix
First posted: 2011-09-09
Enrollment: 92
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population to include women or men 30 years of age or older referred for a CT scan

Brief summary: This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve general image quality characteristics at equivalent radiation dose levels.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* Men or Women 30 years of age or older voluntarily willing to sign an informed consent.
* Patients indicated for one of the following:

CNS: Known or suspected pathology in the posterior fossa Thorax: Patients referred for staging of a known or suspected lung cancer Abdomen: Patients with acute flank pain and suspected urolithiasis or Abdomen: Patients with a known or suspected focal liver lesion

Exclusion Criteria:

* Subjects less than 30 years of age
* Pregnant women as confirmed by urine test or current accepted institution standard
* If IV contrast is required:
* Severe or uncontrolled allergy to iodinated contrast media
* Serum creatinine \> 1.7 mg/dl or estimated glomerular filtration rate \[eGFR\] of \<60 mg/min as recorded in medical file or by current accepted institution standard
* Unable or unwilling to provide written informed consent by self or legal guardian at the time of study enrollment
* Unstable physical condition as identified by physician

Primary outcomes:
measure: Evidence for reduced x-ray radiation exposure for applicable patient indications
timeFrame: Side by side comparison once both scans have been performed
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Miwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT06477978: The Prevalence of Sarcopenia in a Cohort of Haemodialysis Patients and Its Correlation With Mortality
Official title: The Prevalence of Sarcopenia in a Cohort of Patients With End Stage Kidney Disease on Haemodialysis Patients and Its Correlation With Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Kidney Disease
End-stage Renal Disease
Dialysis Dependent Chronic Kidney Disease
Sarcopenia
Keywords: sarcopenia
end stage renal disease
end stage kidney disease
dialysis dependent end stage renal disease
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 274
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is cohort prospective study of end stage kidney disease patients on hemodialysis
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis

Detailed description: In our study , we aim to explore the correlation between the prevalence of sarcopenia and one year mortality among patients on maintenance hemodialysis The lean muscle mass was measured using bio-impedance analysis (BIA ). The hand-grip test was used to measure the function .

Sarcopenia was defined using European Working Group on Sarcopenia in Older people (EWGSOP) definition which involves reduced muscle function and reduced muscle mass

Eligibility criteria: Inclusion Criteria:

* Patients with End stage kidney disease on maintenance dialysis

Exclusion Criteria:

* unable to consent or terminal malignancy

Primary outcomes:
measure: One year mortality
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy University Hospitals
Study officials:
affiliation: Kasr El Aini Hospital
name: Tarek Abdelaziz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04937478: Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes
Official title: Correlation of Ultrafiltered Volume (UFV) During Hemodialysis With a New Battery Powered, Body Worn Electronic Patch Measuring Bioimpedance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis, Ultrafiltration, Bioimpedance
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: St. Olavs Hospital
name: Helse Nord-Trøndelag HF
First posted: 2021-06-24
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with hemodialysis for survival.

Brief summary: Patient submitted to hemodialysis are followed through a dialysis - interim - dialysis cycle.

No intervention is done. Additional blood tests and clinical tests are used as pseudo-endpoints. Correlation is made to ultrafiltrated volume (UFV).


Eligibility criteria: Inclusion Criteria:

* patients scheduled for hemodialysis
* signed Informed Consent Form

Exclusion Criteria:

* acute intercurrent disease,
* subjects with known hypersensitivity to plasters (adhesive or gel).

Primary outcomes:
measure: Correlation between ultrafiltered volume (UFV) and measured bioimpedance change
timeFrame: During hemodialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital
city: Trondheim
country: Norway
facility: St Olavs university hospital
Study officials:
References:
Clinical trial NCT04752878: Turkish Version of Ottawa Sitting Scale in Patients With Stroke
Official title: The Turkish Version Of The Ottawa Sitting Scale: Its Cultural Adaptation, Validation And Reliability In Patients Wıth Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall Due to Loss of Equilibrium
Acute Stroke
Balance; Distorted
Fear
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age diagnosed with acute ischemic or hemorrhagic stroke

Brief summary: The aim of the study is to describe the cultural adaptation of the Ottawa Sitting Scale and to examine the factor structure, reliability and validity of the scale in patients with stroke.

The scale will be translated into Turkish language by following the procedure. 80 patients will be recruited in the study. Berg Balance Scale and Trunk Impairment Scale will be included with Turkish Ottawa Sitting Scale to test the validity. Outcome measures will be repeated by a second physiotherapist the day after the first assessment for interrater reliability and conducted twice within 2 weeks (test-retest) for reliability.

The interrater and intrarater reliability of the Ottawa sitting scale will be determined using intraclass correlation coefficients and internal consistency will be assessed using Cronbach's alpha.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with acute stroke
* aged above 18 years

Exclusion Criteria:

* Patients who do not cooperate enough to read or approve the consent

Primary outcomes:
measure: Ottawa sitting scale
timeFrame: Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
Secondary outcomes:
measure: Berg balance scale
timeFrame: Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
measure: Trunk Impairment scale
timeFrame: Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sağlık Bilimleri Üniversitesi
Study officials:
References:
Clinical trial NCT05439278: Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
Official title: Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glioblastoma
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 178
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed glioblastoma according to the 2021 World Health Organization classification
* interval of ≤4 weeks between pathological diagnosis and randomization
* aged 70 years or older
* gadolinium-enhanced MRI within 72 hours of surgery
* known o6-methylguanine-DNA-methyltransferase promoter methylation status
* Karnofsky performance score ≥60
* stable or decreasing dose of steroid (if necessary)
* no history of brain radiotherapy
* no history of any systemic chemotherapy
* adequate hematological, renal and hepatic functions for temozolomide
* able to start radiotherapy within 3 weeks from randomization

Exclusion Criteria:

* patients with spinal leptomeningeal carcinomatosis
* history of cancer other than the followings:
* carcinoma in situ of the cervix
* completely excised non-melanoma skin cancer
* cancers without any evidence of residual disease for 5 years or longer
* patients with serious active infection or other serious underlying medical conditions
* patients with psychological issues that cannot comply to the protocol
* patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
* patients who are currently participating in other clinical trials

Primary outcomes:
measure: Overall survival
timeFrame: follow-up until 2 years
Secondary outcomes:
measure: progression-free survival
timeFrame: follow-up until 2 years
measure: treatment-related toxicity
timeFrame: follow-up until 2 years
measure: patient-reported quality of life
timeFrame: follow-up until 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Severance Hospital
name: Chan Woo Wee, MD, PhD
role: STUDY_CHAIR
affiliation: Seoul National University Bundang Hospital
name: In Ah Kim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06614478: Frailty, Hip Fractures and Inflammatory Biomarkers
Official title: Frailty in Hip Fracture Patients Treated With Surgery; the Role of Simple Inflammatory Biomarkers. An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Hip Fracture
Inflammatory Biomarkers
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hip fracture patients treated with surgery

Brief summary: We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

Detailed description: Frailty (F) is a prevalent syndrome among elderly patient with hip fractures (HF) and has been linked to poor prognosis. Inflammatory biomarkers have been used as prognostic indexes in patients with HF. We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

Eligibility criteria: Inclusion Criteria:

* age \&amp;gt;65 years, ASA PS I-III, non- institutionalized, able to communicate patients

Exclusion Criteria:

* Patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate

Primary outcomes:
measure: Frailty status
timeFrame: preoperatively
measure: Inflammatory biomarkers
timeFrame: preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessaly
city: Larissa
country: Greece
facility: UHL
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01219478: Research of the Correlation Between Metabolic Syndrome, Retinal Thickness and Visual Acuity
Official title: Research of the Correlation Between Metabolic Syndrome, Retinal Thickness and Visual Acuity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Keywords: To investigate the relationship between retinal thickness (RT) and metabolic risks (MRs) in patients without retinal lesion
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were over 60 y/o were divided into four groups according to their MRs of hypertension, hyperlipidemia or hyperglyceremia.

Brief summary: Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks (MRs) in patients without retinal lesion.

Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination, optical coherence tomography was performed to measure RT.


Eligibility criteria: Inclusion Criteria:

* We enrolled the patients included age more than 60 years old, no positive finding during dilated fundus examination.

Exclusion Criteria:

* The exclusion criteria were as followed:

  * systemic disease that will affect visual acuity evaluation (for example: CVA), \*opaque cornea and vitreous
  * glaucoma
  * uvietis and other clinically established ocular disease.
* According to the LOCS III11, those who had nuclear opalescence, nuclear color more than grade 3 or any grade of cortical cataract and posterior subcapsular cataract were also eliminated.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hui-Chun Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06194578: A Study of Sterile Saline Infusion in Healthy Volunteers
Official title: A Phase 0, Single-Center Study to Evaluate the Safety and Tolerability of Injecting Sterile Saline Subcutaneously Into the Abdomen and Thigh of Healthy Volunteers Using Varying Volumes and Rates of Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index greater than (\>)18 and less than (\<) 36
* Able to understand the English language
* Has a negative coronavirus-2019 (COVID-19) test result at the time of admission, prior to administration of study intervention

Exclusion Criteria:

* Age \< 18 years and \> 60 years
* BMI \< 18 or \> 36
* Unable to understand the English language
* Currently pregnant or lactating
* History of skin sensitivity or allergy to steel needle or adhesive tape
* History of abnormal blood coagulation or bleeding
* History of abnormal immune function or frequent skin infections
* Active cardiovascular, pulmonary, dermatologic, endocrine, rheumatologic, hematologic, ophthalmologic, psychiatric, metabolic, hepatic, renal, immune, gastrointestinal, neurological, or musculoskeletal disease
* Has tattoo(s) or scarring at the site of injection or any other condition which may interfere with the injection site examination, in the opinion of the investigator

Primary outcomes:
measure: Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score
timeFrame: Up to 10 minutes after completion of the saline infusion
measure: Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)
timeFrame: Up to 10 minutes after completion of the saline solution
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: