louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06656013: Motivational Interview and Nomophobia
Official title: The Effect of Motivational Interviewing on the Level of Nomophobia and Smartphone Addiction of Nursing Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nomophobia
Smartphone Addiction
Keywords: nursing student
smartphone addiction
nomophobia
motivational interview
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A preparation session and a motivational interview consisting of 4 sessions will be applied to nursing students. Data collection tools will be applied before, after and at 3 months.


Eligibility criteria: Inclusion Criteria:

* being over 18 years of age
* being a first-year nursing student
* agreeing to participate in the research

Exclusion Criteria:

* having problems understanding and speaking Turkish
* having visual or hearing impairment
* having a neuropsychiatric disease

Primary outcomes:
measure: Nomophobia Scale
timeFrame: Pre-test
measure: Smartphone Addiction Scale-Short Form
timeFrame: Pre-test
measure: Nomophobia Scale
timeFrame: 6 weeks after pre-test
measure: Smartphone Addiction Scale-Short Form
timeFrame: 6 weeks after pre-test
measure: Nomophobia Scale
timeFrame: Follow-up (18 weeks after pre-test)
measure: Smartphone Addiction Scale-Short Form
timeFrame: Follow-up (18 weeks after pre-test)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00605813: Special Investigation Of Long Term Use Of Sertraline.
Official title: Special Investigation Of Long Term Use Of J ZOLOFT.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Panic Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 542
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.

Brief summary: Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug regarding long time use.

Detailed description: All the patients for whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

Exclusion Criteria:

Patients not taking sertraline hydrochloride.

Primary outcomes:
measure: Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
timeFrame: Baseline up to 52 weeks
measure: Number of Participants of Treatment Related Adverse Events (TRAEs)
timeFrame: Baseline up to 52 weeks
Secondary outcomes:
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
timeFrame: Baseline up to 52 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies
timeFrame: Baseline up to 52 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)
timeFrame: Baseline up to 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01454713: Retrospective Analysis of Veritas in Breast Reconstruction
Official title: Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seroma
Necrosis
Infection
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2011-10-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas

Brief summary: Retrospective data collection of the use of Veritas in breast reconstruction surgery

Detailed description: This is a multi-center study to retrospectively collect data on the use of Veritas Collagen Matrix in breast reconstruction. Data will be collected on post-operative complications in immediate breast reconstruction and then be compared to literature reported post-operative complication rates associated with the use of acellular dermal matrix in immediate breast reconstruction.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Patients who underwent mastectomy with immediate breast reconstruction using Veritas collagen matrix
* Patients who underwent mastectomy with single stage procedures or two-stage procedures using Veritas collagen matrix

Exclusion Criteria:

* Patients who underwent delayed breast reconstruction
* Reconstruction with something other than Veritas collagen matrix
* Breasts that were created with DIEP or TRAM procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Mark M. Mofid, MD
state: California
city: Troy
country: United States
facility: Michael Meininger, MD
state: Michigan
city: St. Paul
country: United States
facility: Martin Lacey, MD
state: Minnesota
Study officials:
affiliation: UCSD
name: Mark M Mofid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06957613: The Prospective Segeberg Registry for Coronary Chronic Total Occlusions (CTO)
Official title: A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing Recanalization of Coronary Lesions With Chronic Total Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Chronic Total Occlusions
Keywords: Chronic Total Occlusion
Lead sponsor: Segeberger Kliniken GmbH
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary chronic total occlusions undergoing recanalization vie percutaneous coronary interventions

Brief summary: A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing Recanalization for Coronary Chronic Total Occlusion Lesion/s

Detailed description: A prospective single center registry including all patients treated for Chronic Total Occlusion Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary chronic total occlusions undergoing recanalization via percutaneous coronary interventions

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of in-hospital and long-term cardiovascular adverse events in percent
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Herzzentrum Segeberger Kliniken GmbH
state: Schleswig Holstein
Study officials:
affiliation: Herzzentrum Segeberger Kliniken GmbH
name: Holger Nef, Prof., MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03634813: Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health
Official title: Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 cohort parallel
Primary purpose: DIAGNOSTIC

Brief summary: To explore in a pilot randomized clinical trial, the impact of Home Blood Pressure Monitoring with patient directed information as compared to usual care on the postoperative management of blood pressure.

Detailed description: The intervention and control groups will be defined by, 1) preoperative home blood pressure monitoring with a detailed report sent to the patient, and 2) usual standard of care including a suggestion during the pre-operative clinic appointment to follow up with Primary Care. Both groups will receive a brief questionnaire about their blood pressure treatment and medication adherence. We will examine the rate of primary care follow-up and changes in hypertension treatment at 60 days post-operative, through a telephone call. This information, along with information regarding patient acceptance of the intervention will be used to inform the design of a future clinical trial powered to outcomes, including follow-up visits and blood pressure management.

Eligibility criteria: Inclusion Criteria:

* We propose to recruit patients who present for ambulatory surgery, aged \>18 years, with a preoperative blood pressure \> 140/90 mmHg taken as the mean of two readings during the pre-admission testing visit.

Exclusion Criteria:

* Patients who are unable or unwilling to be contacted by telephone, are non-English speaking, or are unable to operate an automated home blood pressure monitor will also be excluded.
* Healthy patients with blood pressure readings that fall within the American Heart Association (AHA) guidelines.

Primary outcomes:
measure: Patients Reporting Primary Care Follow-up
timeFrame: 60 days
measure: Patients Reporting New/Adjusted Hypertension Treatment.
timeFrame: 60 days
Secondary outcomes:
measure: Patient Acceptance/Satisfaction With Blood Pressure Care
timeFrame: 60 days
Other outcomes:
measure: Patients Demonstrating HBPM Elevation.
timeFrame: 1 year
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital PreAdmission Testing Clinic
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert Schonberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz SI, Yan L, Dai F, Zhou B, Burg MM, Schonberger RB. Feasibility of a randomized hypertension screening initiative in the perioperative setting. Perioper Med (Lond). 2021 Nov 22;10(1):39. doi: 10.1186/s13741-021-00210-7.
Clinical trial NCT00564213: Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
Official title: Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Myopia
Keywords: Myopia
Mitomycin
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (\> -7.0 D).

Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months


Eligibility criteria: Inclusion Criteria:

* Myopia or compound myopic astigmatism
* Stable refractive error
* No associated eye disease

Exclusion Criteria:

* Diabetes,
* Autoimmune diseases
* Topographic abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Olhos de GOiânia
name: Belquiz A Nassaralla
role: STUDY_CHAIR
References:
Clinical trial NCT00000313: Predictive Values of Serotonergic Alterations for Outcome - 2
Official title: Predictive Values of Serotonergic Alterations for Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: VA Office of Research and Development
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the predictive value of serotonergic alterations for outcome.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Neuroendocrine changes
measure: Psychological changes
measure: Craving
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: VA Medical Center
state: New York
Study officials:
affiliation: VA Medical Center
name: Laure Buydens-Branchey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711813: TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
Official title: Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Theramab LLC
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
* Active SLE (SLE Disease Activity Index ≥ 6)
* Skin or joint SLE manifestations

Exclusion Criteria:

* Lupus-nephritis and/or central nervous system affection (neuro-lupus)
* Prohibited treatment
* Pregnant or nursing women
* Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization

Primary outcomes:
measure: Number and proportion of treatment responders per SLE Responder Index (SRI)
timeFrame: 24 weeks
measure: Adverse Events
timeFrame: 24 weeks
Secondary outcomes:
measure: Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)
timeFrame: 24 weeks
measure: Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences
Study officials:
affiliation: Theramab LLC
name: Daniil Nemenov, M.D.
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Clinical trial NCT05959213: Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.
Official title: Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas: a Further Plea for Biological Resectability Criteria.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Keywords: Ca 19.9
Pancreatic adenocarcinoma
Pancreatoduodenectomy
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 2034
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: A total of 2,034 patients were included in the study.

Brief summary: In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .

Detailed description: A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.

Eligibility criteria: Inclusion Criteria:

* All patients undergone pancreatoduodenectomy
* No preoperative radiological suspicion of lymph node metastases.

Exclusion Criteria:

- Age \< 18

Primary outcomes:
measure: Quantitative data - Preoperatory levels of CA 19.9 (U/ml)
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06086613: A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGA2115 in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteogenesis Imperfecta
Lead sponsor: Angitia Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women ≥18 to ≤65 years old.
* Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.

Exclusion Criteria:

* History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1.
* Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
* Hyper- or hypocalcemia.
* Known sensitivity to mammalian-derived drug preparations and/or any biologics.
* Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Secondary outcomes:
measure: Maximum observed concentration (Cmax) of AGA2115
timeFrame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
measure: Time to maximum observed concentration (Tmax) of AGA2115
timeFrame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
measure: Area under the concentration time curve (AUC) of AGA2115
timeFrame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Angitia Incorporated Limited
name: Angitia Medical Director
role: STUDY_DIRECTOR
References: