louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01336725: Learning and Coping With Chronic Illness
Official title: Learning and Coping With Chronic Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Morbid obesity
Patient education
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Learning and mastery centre

Brief summary: The purpose of this study is to determine whether the participants have improved their scores on health related quality of life (HRQL) 1 year after completing a learning and mastery course and whether sociodemographic variables are associated with HRQL.

Detailed description: Persons with chronic illnesses have to adjust to changes in their life-style. In the last 10 years Learning and Mastery Centres have been established in Norwegian hospitals to offer patient education for the chronically ill. It is not known whether these courses impact any changes in HRQL 1 year after course completion.

Eligibility criteria: Inclusion Criteria:

* diagnosis of morbid obesity
* attending learning and mastery course for the obese

Primary outcomes:
measure: Health related quality of life
timeFrame: 1 year after course completion
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo universiy hospital, Aker
Study officials:
References:
citation: Lerdal A, Gay CL, Bonsaksen T, Fagermoen MS. Predictors of physical and mental health in persons with morbid obesity attending a patient education course - a two-year follow-up study. Health Qual Life Outcomes. 2017 May 15;15(1):103. doi: 10.1186/s12955-017-0675-z.
citation: Andenaes R, Fagermoen MS, Eide H, Lerdal A. Changes in health-related quality of life in people with morbid obesity attending a learning and mastery course. A longitudinal study with 12-months follow-up. Health Qual Life Outcomes. 2012 Aug 18;10:95. doi: 10.1186/1477-7525-10-95.
Clinical trial NCT05898425: Coronary Collaterals and Post-reperfusion Intramyocardial Hemorrhage
Official title: Impact of Coronary Collaterals on Intramyocardial Hemorrhage in AMI Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Coronary Angiography
Intramyocardial Hemorrhage
Cardiac Magnetic Resonance
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 262
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: The study population comprises individuals aged 18 years or older who are diagnosed with Index STEMI, based on ACC/AHA criteria, and have completed coronary angiogram with PCI and CMR.

Brief summary: This study examines the relationship between angiographic coronary collaterals (Rentrop grades) and post-reperfusion microvascular injury. This study aims to assess the impact of coronary collateral circulation on intramyocardial hemorrhage incidence and extent.


Eligibility criteria: 1. Age 18-85 years
2. Index STEMI
3. Coronary angiogram with Primary coronary intervention
4. No contraindications for Cardiac MRI

Primary outcomes:
measure: Incidence of Intramyocardial hemorrhage (IMH)
timeFrame: Day 3
measure: Volume of Intramyocardial hemorrhage (IMH)
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rohan Dharmakumar, PhD
role: STUDY_DIRECTOR
affiliation: Indiana University School of Medicine
name: Keyur P Vora, MD FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06072625: Enteral Feeding of Premature Babies and Olive Oil Supplementation
Official title: The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature
Olive Oil
Enteral Feeding
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding.

Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values.

Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Premature babies born at 32 weeks or less
* Babies who tolerate full enteral feeding at the before end of the second week
* Babies given consent by their parents -

Exclusion Criteria:

* Having a congenital or genetic anomaly

Primary outcomes:
measure: Number of patients who completed the study
timeFrame: 15 months
measure: Postnatal growth retardation rates
timeFrame: 18 months
Secondary outcomes:
measure: Frequency and severity of retinopathy of prematurity
timeFrame: 18 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
Study officials:
References:
Clinical trial NCT06696625: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
Official title: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Keywords: taVNS
Dry eye
RCT
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease.

Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 and Age \<=65.
2. complaint of DED symptoms for 6 months or longer at screening.
3. ocular surface disease index (OSDI) score of 25 or higher.
4. tear film breakup time (TFBUT) of 5 seconds or less.
5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
6. tCFS score of 4 or higher.

Exclusion Criteria:

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.

Primary outcomes:
measure: OSDI
timeFrame: Baseline, month 1, 3, and 6
Secondary outcomes:
measure: TBUT
timeFrame: Baseline, month 1, 3, and 6
measure: Schirmer
timeFrame: Baseline, month 1, 3, and 6
measure: CFS
timeFrame: Baseline, month 1, 3, and 6
measure: DEQ-5
timeFrame: Baseline, month 1, 3, and 6
measure: PHQ-9
timeFrame: Baseline, month 1, 3, and 6
measure: SF-36
timeFrame: Baseline, month 3, 6 and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Beijing TongRen Hospital, Capital Medical University Beijing, China
state: Beijing
Study officials:
References:
Clinical trial NCT06838325: The Effect of the Prostate Cancer Foundation Screening Guidelines for Black Men on Intention to Screen in Faith-based Communities
Official title: The Effect of the Prostate Cancer Foundation Screening Guidelines for Black Men on Intention to Screen in Faith-based Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer Screening
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 24
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To learn about barriers to prostate cancer screening in Black, faith-based communities. Investigators will use the information collected in this study to create a prostate cancer education program that is relevant to Black men within the church and improve prostate cancer screening.

Detailed description: Primary Objective To determine barriers to prostate cancer screening in Black faith-based communities through focus group assessments which will inform a culturally relevant prostate cancer education and early detection program.

Eligibility criteria: Inclusion Criteria:

* Self-reported identification of Black/ African American
* Willingness to participate in the study with signed and dated informed consent

Exclusion Criteria:

* Non-english proficiency
* Unwillingness to participate in the study or inability to sign and date an informed consent

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Matthew T Smith
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860625: A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Icure Pharmaceutical Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* BMI : more than 20 ㎏/㎡, less than 26 ㎏/㎡
* Systolic blood pressure : more than 90, less than 140 (mmHg)
* Diastolic blood pressure : more than 60, less than 100 (mmHg)

Exclusion Criteria:

* Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
* A history of skin disease or skin graft
* Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
* A known or suspected history of drug or alcohol dependency or abuse
* Patients who have participated in another clinical study within 60 days.
* Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
* Heavy caffeine intake(more than 5 units/day)
* Heavy alcohol intake(more than 21 units/week)
* Heavy smoker(more than 10 cigarette/day)
* Abnormal clinical laboratory values which are judged clinically significant by the investigator.
* Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.

Primary outcomes:
measure: safety and tolerability evaluation
timeFrame: -1d~20d
Secondary outcomes:
measure: pharmacokinetics characteristic evaluation
timeFrame: 1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
Study officials:
References:
citation: Choi HY, Kim YH, Hong D, Kim SS, Bae KS, Lim HS. Therapeutic dosage assessment based on population pharmacokinetics of a novel single-dose transdermal donepezil patch in healthy volunteers. Eur J Clin Pharmacol. 2015 Aug;71(8):967-77. doi: 10.1007/s00228-015-1875-2. Epub 2015 May 28.
Clinical trial NCT03665025: Immediate Implant Placement With Immediate Professionalization in Aesthetic Area
Official title: Immediate Implant Placement With Immediate Professionalization in the Maxillary Esthetic Zone Using Mixture of Allograft and Xenograft vs Xenografts to Augment the Jumping Gap
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Site Reaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: jumping gap area in aesthetic area
Primary purpose: TREATMENT

Brief summary: Immediate implant placement with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap

Detailed description: Implant placement in fresh extraction sockets in conjunction with appropriate guided bone regeneration has many benefits, which ultimately affect the total treatment plan. The immediate placement of implants provides significant advantages, including fewer surgical procedures, shorter treatment time, and improved esthetics. The goals of osseous replacement are maintenance of contour, elimination of dead space, and reduce postoperative infection, provide good support for dental implant and enhance bony and soft tissue healing. allograft bone has gold standard over other augment techniques including favorable bone quality and minimal bone resorption.

Eligibility criteria: Inclusion Criteria:

* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Primary outcomes:
measure: Crestal bone loss
timeFrame: 1 year
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Mohammed
state: Q8
Study officials:
References:
Clinical trial NCT01016925: Bacterial Colonization After Tunneling in Femoral Perineural Catheters
Official title: Bacterial Colonization After Tunneling in Femoral Perineural Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Colonization
Keywords: femoral perineural catheter
tunnelization
complication
colonization
infection
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis.

Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters.

Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome).

Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter

Exclusion Criteria:

* Age under 18 years
* Local nerve pathology
* Refusal to regional anaesthesia
* Major psychological disorder
* Major cardiac conduction disease
* Infection at the puncture site

Primary outcomes:
measure: incidence of femoral perineural catheter colonization
timeFrame: between 24 hours and 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT06669325: Role of Apfel's Score in Predicting Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official title: Role of Apfel's Score in Predicting Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: APFEL RİSK SCORE
Post Operative Nausea and Vomiting (PONV)
Lead sponsor: National Medical College Birgunj
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients who are undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. These patients are treated at the Department of General Surgery at National Medical College Teaching Hospital, Birgunj, Nepal.

Brief summary: The goal of this observational study is to assess the role of Apfel's score in predicting postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in patients with symptomatic cholelithiasis. The main questions it aims to answer are:

1. Does Apfel's score accurately predict the occurrence of PONV after laparoscopic cholecystectomy?
2. Which components of Apfel's score are most strongly associated with PONV?

Participants will undergo laparoscopic cholecystectomy under general anesthesia. Researchers will calculate each participant's Apfel score preoperatively, and postoperative outcomes, such as nausea and vomiting, will be monitored for 24 to 48 hours. Researchers will compare PONV incidence among patients with varying Apfel scores to determine if higher scores correlate with a higher risk of PONV.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 90 years.
* Patient scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis.
* Patients who provided written informed consent to participate in the study.

Exclusion Criteria:

* Patients receiving prophylactic antiemetic medications prior to surgery.
* Patients on opioid analgesics for reasons other than the surgical procedure.
* Pregnant women.
* Patients whose laparoscopic cholecystectomy was converted to open cholecystectomy during the operation.

Primary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: Assessed for 24 hours post-surgery.
Secondary outcomes:
measure: Relationship Between Apfel's Score and PONV Incidence
timeFrame: Assessed for 24 hours post-surgery.
Other outcomes:
Locations:
city: Birgunj
country: Nepal
facility: National Medical College and Teaching Hospital, Birgunj
state: Madesh
Study officials:
References:
Clinical trial NCT00643825: Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients
Official title: Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or "Stop and Go" in Glioblastoma Patients: The PATSGO Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Temozolomide
Phase II
Chemotherapy
Glioblastoma
Progression-free Survival
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically confirmed diagnosis of GBM
2. Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended
3. Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy.
4. A brain MRI with or without a PET-Scan-methionine must be performed before enrolment.
5. Age ≥ 18 years
6. Karnofsky Performance status ≥ 60
7. Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l
8. Normal liver function: total bilirubin \< 1.5 x ULN, alkaline phosphatase and transaminases (ASAT/ALAT) \< 2.5 times the upper limit of the normal range
9. Serum creatinine \< 1.5 x ULN
10. Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia
11. No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast).
12. All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study.
13. Signed informed consent from the patient or legal representative must be obtained.

Exclusion Criteria:

All non inclusion criteria

Primary outcomes:
measure: to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months
timeFrame: 36 months
Secondary outcomes:
measure: safety and adverse event profile of prolonged adjuvant Temozolomide
timeFrame: 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Europe
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Francois Baurain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: