louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02348892: Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.
Official title: Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly Patients in Complex Situations
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eligible patients for the study will be the patients of 70 and more years old hospitalized in the Nantes UH in the acute care medical department internal medical departement medical urgency, rehabilitation unit, neurology, gastro-enterology of the CHU of Nantes and which are in complex medical and social situation, whoever is their motive for hospitalization.

Brief summary: The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.

Since July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.


Eligibility criteria: Inclusion Criteria:

* Patient of 70 and more years old
* Patient living on Nantes
* Hospitalized in Nantes UH
* Patient whose the hospitalization is not relevant at the time of the request of trajectory case manager
* Patient whose the situation is complex (without solution at the time of the request)
* Patient (or legal representative) having given his assent of participation

Exclusion Criteria:

* Patient (or legal representative) refusing to participate in the protocol
* Patient whose follow-up is impossible (ex: programmed move, life expectation)

Primary outcomes:
measure: Cost-utility analysis (CUA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes UH
Study officials:
References:
Clinical trial NCT04504292: Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients
Official title: Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inpatient Colonoscopy
Oral Sulfate Solution
Polyethelene Glycol
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will test the efficacy, tolerability, and feasibility of an oral sulfate solution (SUPREP) for inpatient colonoscopy preparation, compared to the standard of care (GoLytely). The hypothesis is that SUPREP will be well tolerated and non-inferior to standard polyethylene glycol bowel preparation for colonoscopies in an inpatient setting. To test this, at least 124 subjects who are undergoing an inpatient colonoscopy will be randomized to receive either SUPREP or standard of care. The Boston Bowel Preparation Score will be collected as standard of care for both groups. Safety will be monitored from standard of care blood tests and ECG (when indicated). Subjects will be given a survey to assess how tolerable they found the procedure.

A non-inferiority design will be used to compare SUPREP to the standard of care polyethylene glycol preparation. Data analysis will be performed on Boston Bowel Preparation Score and rate of failure of preparation (measured as number of successful subsequent colonoscopies).


Eligibility criteria: Inclusion Criteria:

* Patients will be approached with consent for the study only if there is a clinical indication for pursuing an inpatient colonoscopy

Exclusion Criteria:

* Inability to consent (patient or POA)

Primary outcomes:
measure: Non-inferiority design to compare SUPREP to GoLytely (standard of care)
timeFrame: 6 months
Secondary outcomes:
measure: Failure of performing colonoscopy
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.
Clinical trial NCT01080092: Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study
Official title: Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: smokers
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This project aims to evaluate the effect of stress-management and a short breathing technique, reinforced by means of visualisation , on the experience of craving in smokers who are prepared to stay abstinent for at least 3 hours before the start of the intervention. It is expected that this strategy can provide supplementary gains in craving control.


Eligibility criteria: Inclusion Criteria:

* smokers (at least 10 cigarettes/day);
* 18 years of age or older;
* prepared to stay abstinent for 3 hours before the start of the session;
* not prepared to stop smoking;
* Dutch speaking.

Exclusion Criteria:

* acute health related problems;
* psychiatric co-morbidities;
* quit attempts in the past 3 months;
* participation in other clinical trials.

Primary outcomes:
measure: Craving at the end of each of two (learning) sessions;
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hedwig Boudrez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05702892: Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases
Official title: Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: periodontitis
saliva
sclerostin
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.

Detailed description: Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined.

Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).

Eligibility criteria: Inclusion Criteria:

* 18-65 years old.
* not having any systemic disease that may affect periodontal status
* not smoking and alcohol use
* volunteer to participate in the study

Exclusion Criteria:

* periapical pathologies;
* resulting from orthodontics and occlusion extreme forces, including mechanical forces;
* chronic high-dose steroid therapy;
* radiation or immunosuppressive therapy;
* pregnancy;
* breastfeeding;
* allergy or sensitivity to any medication.
* Periodontal therapy or drug therapy for at least 6 months of study participants

Primary outcomes:
measure: Evaluation of bone metabolism biomarkers in different periodontal conditions
timeFrame: baseline
Secondary outcomes:
measure: Probing pocket depth
timeFrame: baseline
measure: Gingival index
timeFrame: baseline
measure: Plaque index
timeFrame: baseline
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References:
Clinical trial NCT03634592: AF Ablation With the Ablation Index
Official title: A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 450
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (both males and females aged 18-79 years) with indications to atrial fibrillation ablation undergoing radiofrequency catheter pulmonary vein isolation

Brief summary: This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.

Detailed description: This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.

Eligibility criteria: Inclusion Criteria:

* indications for catheter ablation of atrial fibrillation;
* signed informed consent

Exclusion Criteria:

* Presence of contraindications to AF ablation

Primary outcomes:
measure: Freedom from atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: Acute complications
timeFrame: 30 days
measure: Procedure time
timeFrame: 180 minutes
measure: Fluoroscopy time
timeFrame: 24 hours
measure: Electrical reconduction
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation
Study officials:
References:
Clinical trial NCT00166192: Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid
Official title: Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Melasma
Keywords: Melasma
Jessner's solution
Trichloroacetic acid (TCA)
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years old
* Clinical diagnosis of melasma
* Mental capacity to give informed consent

Exclusion Criteria:

* Pregnancy
* H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone
* Active dermatitis
* Presence of cutaneous infection

Primary outcomes:
measure: Clinical efficacy by clinician's evaluation
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy by subject's evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Dermatology Clinic
state: Georgia
Study officials:
affiliation: Emory University Department of Dermatology
name: Carl Washington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02173392: A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Official title: A Bioequivalence Study Comparing a Single Subcutaneous Injection With a 1.5 mL Prefilled Syringe Versus 2 Subcutaneous Injections of 1 mL and 0.5 mL Prefilled Syringes of Brodalumab 140 mg/mL to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab

Detailed description: A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)

Eligibility criteria: Inclusion Criteria:

* healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential

Exclusion Criteria:

* no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.

Primary outcomes:
measure: Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.
timeFrame: 60 days
measure: Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab
timeFrame: 60 days
Secondary outcomes:
measure: Immunogenicity
timeFrame: 60 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Aventura
country: United States
facility: Research Site
state: Florida
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06117592: The CASCADE Project
Official title: Co-design of Acute Oncology Standardised Assessment Documents and Their Evaluation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 1400
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: Cancer patients with suspected neutropenic sepsis or MSCC

Brief summary: People with cancer, treated for cancer, or have been recently treated for cancer are at a higher risk of becoming rapidly unwell. This is referred to as an oncological emergency and can be life-threatening.

The investigators want to see if a new, standardised assessment of acute oncology knowledge and skills of all health care staff (The Acute Oncology Passport) following education and training, has an effect on the diagnosis and treatment of two relatively-common oncological emergencies: sepsis and MSCC? Sepsis is blood poisoning, which causes serious injuries if it is not diagnosed and treated as an emergency and may result in death if not treated quickly enough. MSCC is metastatic spinal cord compression, where the cancer presses on the spinal cord and can cause permanent paralysis. The investigators have chosen these two conditions, not only because of how serious and relatively common they are for people living with cancer, but also because all NHS Trusts in the UK routinely collect and report standardised data about patients who are admitted with suspected sepsis or MSCC.

The investigators plan to compare data that is routinely collected about the diagnosis and treatment of patients with suspected sepsis and MSCC before and after education, training and assessment of staff about acute oncology. The investigators will conduct 'secondary analysis' on the data, as it was originally collected for another purpose. The routinely data collected at five hospital Trusts across the UK from 1st April 2023 to 30th June 2023 and 1st October to 31st December 2023 will be included in this study.

This research is part of a larger UK-wide project, funded until March 2024 by NHS England Workforce, Training and Education Directorate. If acute oncology education, training and assessment of staff is shown to make a difference to patient diagnosis and treatment, the Acute Oncology Passports will be rolled-out nationally.


Eligibility criteria: Inclusion Criteria:

* All patient KPI's of interest that occur in the study time frame will be collected.

Exclusion Criteria:

* KPI data collected from people under the age of 18 KPI data other than items stated in this application, i.e. data that is not reporting neutropenic sepsis nor MSCC outcomes

Primary outcomes:
measure: Acute Oncology Key Performance Indicators (KPIs)
timeFrame: 1st April 2023- 31st December 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Clare Griffin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02580292: Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
Official title: Diagnostic Accuracy of Renal, Carotid, and Aortic Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 100
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: Adult patients undergoing cardiac surgery

Brief summary: To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.

Detailed description: To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.

Eligibility criteria: Inclusion Criteria:

* adult patients \>= 18 years
* undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement

Exclusion Criteria:

* chronic kidney diseases (estimated GFR \< 60 ml/min/1.73m2)
* prior carotid endarterectomy
* known carotid artery stenosis of 50% or greater
* dissection or aneurysm involving renal or carotid arteries
* scheduled aortic or aortic valve surgery
* heart transplant
* intraaortic balloon pump, ventricular assist device, or exctracorporeal membrane oxygenation support.

Primary outcomes:
measure: Acute kidney injury - Lassnigg grade-minimal
timeFrame: 2nd postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Cardiovascular Center - University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Milo Engoren
role: PRINCIPAL_INVESTIGATOR
References: