louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06164535: The Effects of DPPIs on Cognitive Function of Diabetic Patients
Official title: The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cognitive Impairment
Keywords: Cognitive
DPP-4 inhibitors
Diabetes
Depression
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Clinical Pharmacy Department, Faculty of Pharmacy, 6 October University
name: Faculty of Medicine, Minia University
First posted: 2023-12-11
Enrollment: 105
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.

Detailed description: All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria.

diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups.

Group I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Eligibility criteria: Inclusion Criteria:

Type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.

Exclusion Criteria:

Those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.

Primary outcomes:
measure: Serum Inflammatory mediators; TNF-α
timeFrame: Before and post 6 month of treatment
measure: MMSE score
timeFrame: Before and post 6 month of treatment
measure: PHQ-9
timeFrame: Before and post 6 month of treatment
measure: serum amyloid-β
timeFrame: Before and post 6 month of treatment
Secondary outcomes:
measure: Serum Insulin
timeFrame: Before and post 6 month of treatment
measure: Serum fasting and 2-he post prandial glucose
timeFrame: Before and post 6 month of treatment
measure: HOMA-IR
timeFrame: Before and post 6 month of treatment
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University hospital
Study officials:
References:
Clinical trial NCT03113435: Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
Official title: Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodynamic Instability
Keywords: CO2 gap
oxygen consumption
Stroke volume optimization
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Flavia Torrini
name: Alessandra Bisanti
name: Eleonora Filipponi
name: Domenica Luca Grieco
name: Massimo Antonelli
name: Liliana Sollazzi
name: Valter Perilli
name: Andrea Russo
name: Pierpaolo Ciocchetti
First posted: 2017-04-13
Enrollment: 76
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 compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.


Eligibility criteria: Inclusion Criteria:

* patients aged \> 18 years
* acquisition of written informed consent
* Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours

Exclusion Criteria:

* Absolute contraindication to CVC placement
* pregnant women
* hepatic surgery
* laparoscopic surgery
* Major vascular surgery
* Dialysis treatment and kidney transplant surgery
* Severe heart failure (EF ≤ 35%)
* Emergency surgery

Primary outcomes:
measure: Perioperative fluid balance
timeFrame: surgery
Secondary outcomes:
measure: Survival at 28 days
timeFrame: 28 days after surgery
measure: Survival at hospital discharge
timeFrame: 1 day (Hospital discharge)
measure: Post-operative complication
timeFrame: 1 day (Hospital discharge)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli
name: Antonio M Dell'Anna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01269658: A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
Official title: A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Blepharitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.


Eligibility criteria: Inclusion Criteria:

* Have a current diagnosis of blepharitis
* Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

* If female, are non-pregnant or non-lactating

Exclusion Criteria:

* Have a concurrent acute hordeolum (stye) or chalazion
* Have inflammation of the ocular surface
* Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

* Have had ocular surgery in the past 90 days or will require it during the

study

* Unable to withhold the use of contact lenses during the study
* Have a known hypersensitivity to azithromycin, erythromycin, any other

macrolide antibiotic, or any of the other ingredients in the study

medication

* Have been diagnosed with ongoing glaucoma
* Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

* Have a serious medical condition which could confound study assessments

Primary outcomes:
measure: Resolution of clinical signs of blepharitis
timeFrame: Day 28
Secondary outcomes:
measure: Time to first clinical resolution
timeFrame: Days 7, 14, 21, 28, 42, 56, 70, and 84
measure: Mean and change from baseline for clinical signs of blepharitis
timeFrame: Days 7, 14, 21, 28, 42, 56, 70, and 84
measure: Mean and change from end of dosing for clinical signs of blepharitis
timeFrame: Days 42, 56, 70, and 84
measure: Response to the Blepharitis Symptoms Questionnaire (BSQ)
timeFrame: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
Other outcomes:
Locations:
Study officials:
affiliation: Chief Medical Officer
name: Charles Johnson, MBChB
role: STUDY_CHAIR
References:
Clinical trial NCT03967158: Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Coronary Disease
Keywords: Xience Sierra
Drug Eluting Stent
Percutaneous coronary intervention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2019-05-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Xience Sierra coronary stent

Brief summary: The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Patient with Xience Sierra Everolimus eluting coronary stent
* Written consent

Exclusion Criteria:

* Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
* Life-expectancy less than 1 year
* Cardiac shock

Primary outcomes:
measure: Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
timeFrame: 1 year
Secondary outcomes:
measure: All cause death
timeFrame: 5 year
measure: Cardiac death
timeFrame: 5 year
measure: Myocardial Infarction
timeFrame: 5 year
measure: Composite event rate of death or myocardial infarction (MI)
timeFrame: 5 year
measure: Composite event rate of cardiac death or myocardial infarction (MI)
timeFrame: 5 year
measure: Target- Vessel Revascularization
timeFrame: 5 year
measure: Target- Lesion Revascularization
timeFrame: 5 year
measure: Stent thrombosis
timeFrame: 5 year
measure: Stroke
timeFrame: 5 year
measure: Procedural Success rate
timeFrame: 5 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References:
Clinical trial NCT00467558: Double-Blind Naltrexone in Compulsive Sexual Behavior
Official title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Compulsive Sexual Behavior
Keywords: Impulse Control Disorder
Compulsive Sexual Behavior
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2007-04-30
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Detailed description: The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Eligibility criteria: Inclusion Criteria:

1. men and women age 21-75;
2. current diagnosis of compulsive sexual behavior

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 1 month) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
timeFrame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
Secondary outcomes:
measure: Clinical Global Impression Scale - Severity
timeFrame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jon E Grant, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03582358: Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation
Official title: Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements (ONS) in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation. Biomedical, Monocentric, Comparative, Clustered and Open Randomized Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Hospitalized in Follow up Care or Rehabilitation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: Protein-energy malnutrition results from an imbalance between the body's intake and needs. Among the elderly in long-term care, the prevalence of undernutrition varies from 30% to 70%. It is responsible for or aggravates a state of fragility or dependence, and promotes the occurrence of morbidities. It is also associated with worsening prognosis for underlying diseases and increases the risk of death. Nutritional management of undernutrition is an issue, especially in health facilities. Among the various existing nutritional care methods, oral nutritional supplements should be considered in the event of failure of food enrichment measures or even at the outset in undernourished elderly people. However, compliance or acceptance of these products among the elderly remains limited and variable with consumption of oral nutritional supplements ranging between 48% and 94% according to studies, and, because of their ease of prescription, oral supplements are sometimes the only nutritional intervention.


Eligibility criteria: Inclusion Criteria:

* Undernourished or at-risk individuals with blood albumin levels below 35 g/L or prealbumin levels below 200 mg/L,
* Person admitted to geriatric follow up care less than 48 hours ago,
* Person fed orally,
* Person with a prescription for an ONS,
* Person who speaks and understands French.

Exclusion Criteria:

* Person not affiliated to a national health insurance scheme
* Person requiring enteral or parenteral feeding
* Person refusing to consume ONS
* People at the very end of their lives

Primary outcomes:
measure: Quantity of oral nutritional supplements consumed daily
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04605458: Contingency Management to Promote Smoking Abstinence in Cancer Patients
Official title: Contingency Management to Promote Smoking Abstinence in Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-28
Enrollment: 282
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 is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. smoking 1 or more combustible tobacco products per day
3. diagnosed with or suspicion of any type of operable cancer

Exclusion Criteria:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia
2. non-English speaking
3. use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc)
4. pregnant women

Primary outcomes:
measure: Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing
timeFrame: Changes between the study intake appointment to day of surgery, up to five weeks apart
Secondary outcomes:
measure: Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing
timeFrame: Three and Six months after surgery date
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Benjamin Toll
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rojewski AM, Fucito LM, Baker NL, Palmer AM, Foster MG, Warren GW, Bernstein SL, Toll BA. Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial. BMJ Open. 2021 Jun 29;11(6):e051226. doi: 10.1136/bmjopen-2021-051226.
Clinical trial NCT06491758: ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroparesis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function

Detailed description: Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Gastroparetic subjects will also undergo vagal maneuver using either the regular EKG electrodes or the MEA electrodes.

Subjects will also complete health history questionnaires.

Eligibility criteria: Inclusion Criteria healthy volunteers

* Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
* Aged 18-80 years
* Willing to have electrodes placed in the external ear (ABVN arm)
* Willing to perform vagal activity maneuver (Vagal arm)
* Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points

Inclusion Criteria gastroparesis subjects

* Gastroparesis subjects with a confirmed diagnosis of gastroparesis from a GI physician
* Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
* Aged 18-80 years
* Willing to have electrodes placed in the external ear (ABVN arm)
* Willing to perform vagal activity maneuver (Vagal arm)
* Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points

Exclusion Criteria:

* Unable to provide consent
* Pregnant females
* Prisoners

Primary outcomes:
measure: Amplitude of vagal nerve compound action
timeFrame: 3 hours
measure: Respiratory Changes in heart rate during stimulation
timeFrame: 3 hours
measure: Changes in amplitude of the surface electrogastrogram
timeFrame: 3 hours.
measure: Changes in gastric hormones
timeFrame: 3 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Thomas V Nowak, MD
role: PRINCIPAL_INVESTIGATOR
References: