louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06100458: Use of Continence Care Protocol in UK Nursing Homes.
Official title: Use of Skin and Leakage Protocol and Its Impact on Continence Care at Nursing Homes in the UK.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence Due to Cognitive Impairment
Urinary Incontinence
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
Collaborators: name: Lincolnshire Community Health Services NHS Trust
First posted: 2023-10-25
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects to be evaluated will be subjects of the selected Care homes who meet all the required Inclusion and Exclusion criteria and who's data is available on the appropriate databases. Subjects will be considered eligible to participate in the study if:

All eligible subjects, that data is available for, cared for at the selected care homes and subjected to the protocol are to be assessed. Typically, all residents that use containment products are assessed at the care home.

Brief summary: This is a retrospective cohort study. In the investigation the clinical use of the Skin and leakage protocol (SLEP) is to be investigated. The SLEP is a generic digital diary form filled out to give information about the current status of continence care among care home residents. The SLEP tracks the number of leakage occurrences and daily skin health over a period of time with the purpose of assisting care staff in making decisions regarding continence care. The SLEP has been introduced at several United kingdom National Health Service care homes and with this investigation the investigators want to retrospectively analyse the data to determine the clinical usefulness of the form.

The primary objective of the study is to describe any changes in product leakage rate at the baseline and follow up time period.


Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with urinary incontinence managed with an absorbing incontinence product.
* The skin and leakage protocol have been used in the care of the subject and there is data from at least two measurements.
* Subject is cared for in a Residential care home using the skin and leakage protocol.
* Subject is over 18 years of age.

Exclusion Criteria:

* Subject is not using an absorbing incontinence product to manage incontinence.

Primary outcomes:
measure: Change in leakage rate
timeFrame: 28 days
Secondary outcomes:
measure: Subject care profile
timeFrame: 28 days
measure: Change in skin health score
timeFrame: 28 days
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: Lincolnshire Community Health Services NHS Trust
Study officials:
affiliation: Lincolnshire Community Health Services National Health Services Trust
name: Debbie Jeffrey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156858: Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study
Official title: Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancy
Keywords: pharmacokinetics
transplantation
busulfan
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of pharmacokinetics of daily intravenous busulfan

Detailed description: A study of pharmacokinetics of daily intravenous busulfan

Eligibility criteria: Inclusion Criteria:

* patients undergoing transplantation

Exclusion Criteria:

-

Primary outcomes:
measure: pharmacokinetic data
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Cancerboard
name: James Russell, FRCp
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02170558: Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis
Official title: Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Degenerative Disc Disease
Keywords: Trabecular Metal
Metal reduction CT
TM- Ardis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who are having a spinal fusion procedure with TM-Ardis and meet the requirements below are eligible for this study.

Brief summary: To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant

Detailed description: To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.

Eligibility criteria: Inclusion Criteria:

* A signed informed consent.
* Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar.
* Participant must be at least 18 years of age.

Exclusion Criteria:

* Patient is pregnant Patient is unable to comprehend the requirements of the study.
* Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).

Primary outcomes:
measure: CT scan to determine if the study software can reduce metal scatter on the scan.
timeFrame: 6 month post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: St Alphonsus Regional Medical Center
state: Idaho
Study officials:
affiliation: Zimmer Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References:
Clinical trial NCT04296058: The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma
Official title: SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Translational Research of SOX4 in Hepatocellular Carcinoma
Keywords: SOX4
angiogenesis
microvessel density
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with pathologic diagnosis of hepatocellular carcinoma

Brief summary: Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational study. The inclusion criterion was intended curative hepatectomy for HCC patients by image analysis, and the exclusion criteria were unresectable disease, synchronous cancers, recurrent cancers, or distant metastasis. The study endpoint was 30 March 2019, and tumor staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system for HCC

Detailed description: To determine the role of SOX4 in tumor progression in patients with HCC, we examined SOX4 expression through immunohistochemistry (IHC) staining of 200 formalin-fixed and paraffin-embedded (FFPE) HCC specimens . The SOX4 high group of patients was associated with positive etiology of hepatitis B virus (P = 0.044), tumor size \>5 cm (P = 0.014), thrombus formation (P = 0.012), higher microvessel density (MVD) (P = 0.012) in tumor lesions, and distant metastasis (P \<0.001).

Cox regression analysis showed that patients with elderly age (P \<0.001), higher ⍺-fetal protein (AFP) (P = 0.045), presence of cirrhosis (P = 0.008), and SOX4 high in tumor specimen (P = 0.042) were independent risk factors . The SOX4 high group performed significantly worse regarding overall survival (OS) (P = 0.043) and disease-free survival (DFS) (P = 0.019) based on the Kaplan-Meier analysis.

Eligibility criteria: Inclusion Criteria:

subjects with pathologic diagnosis of hepatocellular carcinoma and curative partial hepatectomies -

Exclusion Criteria:

history of different malignant disease, subject cannot be treated with curative surgery -

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: a month
Secondary outcomes:
measure: Overall survival
timeFrame: a month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00861458: Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Official title: A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Virus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will test two different formulations. The results will be used to select formulation for phase 3.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers.

Exclusion Criteria:

* Standard for healthy volunteers.

Primary outcomes:
measure: AUC inf, Cmax
timeFrame: 2 days
Secondary outcomes:
measure: Adverse events
timeFrame: 2 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06327958: THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES
Official title: THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES IN THE LARYNGOSCOPY TRAINING OF MEDICAL STUDENTS: A SIMULATION STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Being a 5th Year Student at the Faculty of Medicine
No Previous Laryngoscopy Experience
Keywords: Cormack-Lehane
percentage of glottic opening (POGO) score
medical students.
manikin study
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population was determined as students who participated in anesthesiology internships in the 2021-2022 academic year.

Brief summary: Direct laryngoscopy (DL) is a conventional and highly difficult method that is used in endotracheal intubation (ETI) training. Today, the usage of video-laryngoscopes (VLs) to teach airway management to inexperienced healthcare personnel is a prevalent practice. In ETI training, it is recommended to train students on simulators before allowing them direct access to patients.


Eligibility criteria: Inclusion Criteria:

* Students who were informed,
* whose informed consent was received were invited to participate in the study

Exclusion Criteria:

* Students who were experienced in laryngoscopy,
* those who had received relevant training,
* those who had watched videos on the subject,
* those who refused to participate were excluded.

Primary outcomes:
measure: The percentage of glottic opening (POGO) scores in the airway management training of medical students.
timeFrame: September 2021-June 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT00453258: Pilot Study of Human Tear Proteins
Official title: Analysis of Human Tear Proteins: A Pilot Study to Describe the Tear Film Proteome of Patients Undergoing Ophthalmic Examination.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Eye Disease
Keywords: ocular proteomics
eye disease
proteomics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2007-03-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receiving eye examination

Brief summary: The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film from diseased and non-diseased patients. This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* able to cooperate with tear sample collection
* provide written informed consent

Exclusion Criteria:

* special populations (children, pregnant or lactating females, prisoners, etc)
* refusal to sign sudy consent

Primary outcomes:
measure: Plan Prospective Research
timeFrame: Throughout study participation
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
Study officials:
affiliation: Rocky Mountain Lions Eye Institute
name: Malik Y. Kahook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583258: A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones
Official title: A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Stones
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.


Eligibility criteria: Inclusion Criteria:

* first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
* stone radiopaque on KUB, distal to the sacro-iliac joint
* patient suitable for discharge from ER
* patient willing to return for follow-up on a weekly basis for maximum 4 visits

Exclusion Criteria:

* more than one ureteral calculi
* radiolucent stones or cystine stones
* prior ipsilateral calculus or ureteral surgery
* congenital anomalies of the ureter
* patients presents with an absolute indication for intervention
* allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP \<90 mmHg)
* patient currently taking an alpha-blocker
* hepatic insufficiency
* pregnancy

Primary outcomes:
measure: The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Kenneth A Pace, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03480958: Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Official title: Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Breast Cancer
Keywords: erector spinae plane block
thoracic paravertebral block
breast surgery
postoperative pain
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 75
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.


Eligibility criteria: Inclusion Criteria:

* 25-70 years of agge
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Numering Rating Scale scores for pain
timeFrame: 24 hour
measure: Postoperative nausea and vomiting
timeFrame: 24h
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
References:
citation: Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
Clinical trial NCT04268758: A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon
Official title: A Single-center Study Designed to Evaluate the Safety and Efficacy of a New Hygienic Device, Tulipon, in Adult Females With Normal Monthly Menstruation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Safety Issues
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Gals Bio Ltd.
First posted: 2020-02-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females with normal monthly menstruation.

Brief summary: Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Detailed description: Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Eligibility criteria: Inclusion Criteria:

1. Women aged 18-45 years
2. Regular menstrual cycles (21-35 days)
3. Uses tampons every month for the last 2 months to handle their monthly bleeding.
4. Active Bleeding lasts at least 3 days
5. Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
6. Non-pregnant, with no intentions to get pregnant during the clinical trial
7. Willing to use pads provided thought the study only for the duration of this study
8. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
9. Signed written informed consent form (ICF) to participate in the study

Exclusion Criteria:

1. Pregnant or lactating women
2. Gave birth less than a 12 month prior to the study.
3. Virgin
4. Using medications to manage pain during active bleeding
5. Using intrauterine device or intrauterine device with hormones (Mirena)
6. Had experienced Toxic shock syndrome (TSS)
7. Previous diagnosis of primary or secondary dysmenorrhea
8. Previous diagnosis of endometriosis
9. Experiences urinary incontinence
10. Suffers from uterus or urine prolapse
11. Abnormal findings following the gynecological exam
12. Subjects with a known or suspected sensitivity to any of the device materials (Polyethylene, Polyurethane, Nylon, Cotton)
13. Been through a vaginal operation in the last 6 months prior to the study.
14. Participation in current or recent clinical trial within 30 days prior to baseline visit

Primary outcomes:
measure: safety and efficacy of the Tulipon.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: