louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06322433: Follow up of High Myopic Eyes
Official title: Long Term Follow-up of Eyes With High Myopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pathologic Myopia
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 138
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: cohort of patients presenting at our Institution with eye myopia

Brief summary: In this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered Changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied.


Eligibility criteria: Inclusion Criteria:

- high myopia

Exclusion Criteria:

* acute ischemic optic neuropathy
* macular and peripapillary atrophy
* other forms of maculopathy

Primary outcomes:
measure: Proportion of subjects with neovascularization at follow-up visit
timeFrame: at 5 years of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
References:
Clinical trial NCT04026633: Attitudes & College Experiences
Official title: Using Counter Attitudinal Advocacy to Change Drinking Behavior & Related Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Alcohol Intervention
College Students
Lead sponsor: Brooklyn College of the City University of New York
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High volume drinking by young adults has proven resistant to long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy activity on subsequent drinking and negative consequences.

Detailed description: The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. Current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms. The investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention. Informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention context.

Eligibility criteria: Inclusion Criteria:

* 18-24 years of age
* Enrolled in the university's undergraduate four-year degree program
* Past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day)
* At least two self-reported negative consequence from drinking in the past month

Exclusion Criteria:

• Status as a graduating senior

Primary outcomes:
measure: Change in Alcohol Consumption from Baseline to 1-Month
timeFrame: 1 month after baseline
measure: Change in Alcohol-related consequences from Baseline to 1- and 3-Months
timeFrame: 1 month and 3 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn College
state: New York
Study officials:
References:
Clinical trial NCT02984033: Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer
Official title: Quality of Life and Psychological Evaluation of Patients Affected by Head and Neck Cancer Treated With Curative Intent: Multicentric Prospective Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Quality of Life
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 0
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: Patients affected by head and neck tumor

Brief summary: The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

Detailed description: The multicentric prospective trial is to evaluate the quality of life and psychological effects in patients with head and neck tumor treated by curative intent radiation therapy. The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.

Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) in non-metastatic staging;
* curative intent treatment (radiation therapy associated or not to chemotherapy; surgery associated or not to post-operative radiotherapy and chemotherapy);
* performance status \< 2;
* age ≥ 18 years;
* good knowledge of italian language;
* written informed consent

Primary outcomes:
measure: Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milano
Study officials:
affiliation: Humanitas Cancer Center
name: Ciro Franzese, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05786833: Dexmedetomidine vs Ketofol on Delirium in Children Undergoing Congenital Inguinal Hernia Repair
Official title: Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dexmedetomidine
Ketofol
Delirium
Hernia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.

Detailed description: Emergence delirium (ED) is a disturbance in a child's awareness or attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behaviour in the immediate post anesthesia period.

Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action \[12\]. Ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia.

Combination of ketamine with propofol reduces the sedative dose of propofol. The complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. Ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation \[13,14\]. This combination is also effective to prevent ED in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability.

Dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. Dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.

Eligibility criteria: Inclusion Criteria:

* 60 children aged from 2 to 5 years
* presented with congenital inguinal hernia
* the American Society of Anaesthesiologists classification ASA I-II.

Exclusion Criteria:

* Past medical history of mental illness or neurological illness.
* Renal or hepatic diseases.
* Severe hearing or visual impairment which may interfere with communication and physical decline.
* Congenital heart disease.
* History of allergy to any of the study drugs.

Primary outcomes:
measure: Incidence of postoperative emergence delirium
timeFrame: 5 -15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Nada Maged Shaheen
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02103933: Pilot Study to Evaluate the Knowledge and Understanding on Surgery for Patients With Hysterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Cancer
Myoma
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2014-04-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who underwent hysterectomy at National Cancer Center, Korea

Brief summary: The purpose of this study is to assess the level of knowledge of surgery for women who underwent hysterectomy


Eligibility criteria: Inclusion Criteria:

* Women who underwent hysterectomy at National Cancer Center, Korea
* Age \> 20 years

Exclusion Criteria:

* The patients who refuse to participate or give consent to the procedure

Primary outcomes:
measure: Knowledge of hysterectomy
timeFrame: No more than 5 years after hysterectomy
Secondary outcomes:
measure: Decision conflict with hysterectomy
timeFrame: No more than 5 years after hysterectomy
Other outcomes:
measure: Decision satisfaction with hysterectomy
timeFrame: No more than 5 years after hysterectomy
Locations:
Study officials:
affiliation: National Cancer Center, Korea
name: Myong Cheol Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06639633: 3D Printed Enlarged Carpal Models for Anatomy Training
Official title: Investigation of the Effect of Magnified Carpal Bones Produced With High Resolution 3D Resin Printer on Students' Theoretical and Practical Anatomy Grades and Learning Levels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomical Pathological Condition
Educational Problems
Keywords: Resin
Segmentation
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-10-15
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective parallel group with single-blinded design
Primary purpose: OTHER

Brief summary: 3D modeling enables medical professionals or students to better understand complex structures. In many studies, 3D printed models have been used in the training, treatment and surgery of medical disciplines such as neuroscience, cardiovascular surgery and otolaryngology. In addition, 3D modeling allows patients' magnetic resonance imaging (MRI) and computed tomography (CT) images to be transferred to 3D printers to print these complex structures.


Eligibility criteria: Inclusion Criteria:

* Willing to participate
* Titmus stereopsis score \>40 arc/s

Exclusion Criteria:

* Previous experience of carpal bones models either in real world or virtual reality
* History of upper extremity trauma in past 6 months
* Total or partial eye sight lost

Primary outcomes:
measure: Quiz Scores
timeFrame: 1 hour
Secondary outcomes:
measure: Model rating with Visual Analogue Scale
timeFrame: 1 hour
measure: Academic motivation Scale
timeFrame: 1 hour
measure: Test Anxiety Inventory
timeFrame: 1 hour
measure: Enjoyment and Ease of Use Assessmen
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences Bolu Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01429233: Real Life Experience of the Use of Isomers as ALENCAL (Levamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients
Official title: Real Life Experience of the Use of Isomers as ALENCAL(Levoamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Observational
Colombia
Lead sponsor: Closter Pharma
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care adults in Colombia

Brief summary: This is a Phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8, or clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with Levamlodipine.

Primary outcomes:
measure: Effect of therapy in the management of hypertension and other cardiovascular diseases
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Country Club Bogota
Study officials:
References:
Clinical trial NCT00690833: Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Official title: Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.

Detailed description: To assess the efficacy of a desonide hydrogel 0.05% in both young children (age \<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis

Eligibility criteria: Inclusion Criteria:

* Male or female, age 3 months or greater.
* Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator (a 2 or 3 on the IGA scale).
* Subjects must have \>2% BSA involvement to be enrolled.
* Informed consent of participation must be given by parent or guardian if he or she is \<7 years old. Children who are 7 to 18 years old will be given an assent form to sign.
* Moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study.

Exclusion Criteria:

* Known allergy or sensitivity to topical desonide hydrogel in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Other than stable use of over the counter non-medicated moisturizers, all other topical treatments for AD must be stopped prior to study drug initiation. There will be no required washout for any topical therapies. Stable use of systemic therapies may be continued throughout the study.
* Requiring \>130 gm of cream in a 4 week period.
* Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. Use of desonide in pregnant subjects is controversial and is only to be used when benefits outweigh the risks.

Primary outcomes:
measure: Investigator Global Assessment at Week 4
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154933: Exeantide in Type 2 Diabetes on Insulin
Official title: The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
obesity
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2010-07-01
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.

The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.


Eligibility criteria: Inclusion Criteria:

* Males or females 20-75 years of age inclusive.
* Type 2 diabetes
* On insulin therapy
* HbA1c ≥7.5% and ≤ 9%
* BMI ≥ 30 kg/m2
* Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.

Exclusion Criteria:

* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
* Pregnancy
* Hepatic disease (abnormal LFT's)
* Use of DPP4 inhibitors.
* Renal impairment (serum creatinine \> 1.5)
* Participation in any other concurrent clinical trial
* Any other life-threatening, non-cardiac disease
* Uncontrolled hypertension (BP \> 160/100 mm of Hg)
* Congestive Heart Failure.
* Use of an investigational agent or therapeutic regimen within 30 days of study

Primary outcomes:
measure: Fasting Insulin
timeFrame: after 24 hours fast at baseline and 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: value at 12 weeks minus value at baseline
measure: HbA1c
timeFrame: value at 12 weeks minus value at baseline
measure: Intranuclear NFκB Binding Activity
timeFrame: measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Millard Fillmore Gates Hospital
state: New York
Study officials:
affiliation: SUNY at Buffalo
name: Paresh Dandona, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2-Keap-1-Regulated Antioxidant Enzymes: Relevance to beta-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343.
Clinical trial NCT05244733: Culture and Well-Being for Latinos
Official title: Culture and Well-Being for Latinos: Study Protocol for Cultural-Social Engagement and Suicide Among Hispanics (K23MH125078)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Isolation
Loneliness
Suicidal Ideation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-02-17
Enrollment: 65
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: The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.


Eligibility criteria: Inclusion Criteria:

* Identify as Hispanic/Latino adult (age 18+);
* Primary Spanish-Speaker;
* Patient in the UR health system;
* Low cultural-social engagement (i.e., score ≤ 2 on the adapted Berkman-Syme Social Network Index);
* Elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).

Exclusion Criteria:

* Medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).

Primary outcomes:
measure: Change in Cultural-Social Engagement (A)
timeFrame: Baseline and 10 weeks
measure: Change in Cultural-Social Engagement (B)
timeFrame: Baseline and 10 weeks
measure: Change in Cultural-Social Engagement (C)
timeFrame: Baseline and 10 weeks
measure: Change in Cultural-Social Engagement (D)
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Change in Suicide Risk (A)
timeFrame: Baseline and 10 weeks
measure: Change in Suicide Risk (B)
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: