louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05692414: Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
Official title: Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Carbohydrate Loading
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin resistance is a key feature of postoperative metabolism, leading to decreased glucose absorption in adipose tissue and skeletal muscle, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Development of insulin resistance is associated with increased length of hospital stay (LOS), morbidity, and mortality. One of the strategies employed to reduce the postoperative stress response and perioperative insulin resistance includes the reduction of the preoperative fasting time via preoperative carbohydrate oral (CHO) drink. Preoperative carbohydrate intake is an integral part of the Enhanced Recovery After Surgery (ERAS) protocol and previous studies have shown that preoperative carbohydrate loading can increase patient comfort. Although ERAS protocols are increasingly used and implemented in bariatric surgery centres specific components of these protocols, such as preoperative oral carbohydrate nutrition, have not yet been rigorously analyzed.

The aim of this prospective study is to compare the differences in patient outcomes between preoperative CHO loading and a conventional fasting protocol. The secondary aim is to perform a subgroup analysis of Roux-en-Y bypass and sleeve gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Patients who will undergo surgery at the Elective Surgery Clinic of the University Clinical Centre in Gdansk, Poland.

Exclusion Criteria:

* Patients who will be unable or will refuse to express informed concern

Primary outcomes:
measure: Glucose level
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: University Clinical Centre in Gdansk
state: Pomeranian
Study officials:
References:
Clinical trial NCT03030014: Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children
Official title: Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 238
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt.

Detailed description: * Evaluate participants satisfaction regarding the dental educational program(learning teeth brushing technique)
* Measure the oral hygiene index simplified to the participants at a different follow up periods for assessing the effect of the dental educational program on oral hygiene.

Eligibility criteria: Inclusion Criteria:

* Children aged from 6-12 years with mixed dentition.
* Institutionalized Deaf children in Cairo, Egypt.

Exclusion Criteria:

* Children above the age of 12 years and below the age of 6 years
* Patient un able to give informed consent
* Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
* Medically compromised patient
* Patient who were absent in the day of examination

Primary outcomes:
measure: patient satisfaction
timeFrame: 6 weeks
Secondary outcomes:
measure: oral hygiene index simplified
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03648814: Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
Official title: Efficacy and Safety of Intracameral Versus Intravitreal Bevacizumab Injection as an Adjunctive Therapy Before Trabeculectomy With Mitomycin-C in Neovascular Glaucoma: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Neovascular
Vascular Endothelial Growth Factor Overexpression
Keywords: Neovascular glaucoma
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 70
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: To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab.

Detailed description: The present study comparing the safety and efficacy of 1.25mg/0.05mL Bevacizumab injection via the intracameral route versus the intravitreal route in treating the neovascular glaucoma

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of neovascular glaucoma
2. The patients having IOP \> 21 mmHg, having the indication for trabeculectomy
3. The patients' age of at least 18-year-old
4. The patients having visual potential at least hand motion.
5. Present of NVI or NVA.
6. Willing and able to provide informed consent to participate in the study
7. Able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits

Exclusion Criteria:

1. One eye patient
2. Patients having severe corneal edema or total hyphema obscure NVI or NVA view.
3. Cannot obtain endothelial cell count.
4. History of bevacizumab or fluorescence dye allergy.
5. Active infectious ocular disease including endophthalmitis and corneal ulcer
6. History of systemic disease including ischemic heart disease, cerebrovascular disease, end-stage renal disease, liver failure, uncontrolled hypertension
7. Has or planning to be pregnant or breastfeeding

Primary outcomes:
measure: regression of nevolascularization
timeFrame: 2 months
Secondary outcomes:
measure: IOP reduction
timeFrame: 2 months
measure: Injection complication
timeFrame: 2 days
Other outcomes:
Locations:
city: Hat-yai
country: Thailand
facility: Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Assoc.Prof.Weerawat Kiddee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770614: Hydration and Contrast-Induced Nephropathy in Primary Angioplasty
Official title: Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Induced Nephropathy
Keywords: Contrast Induced Nephropathy
Lead sponsor: Ospedale Misericordia e Dolce
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.


Eligibility criteria: Inclusion Criteria:

* patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion Criteria:

* refusal to consent
* previous contrast exposure within 72 hours

Primary outcomes:
measure: Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
timeFrame: within 5 days after contrast exposure
Secondary outcomes:
measure: Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
timeFrame: 1 month
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce
Study officials:
affiliation: Ospedale Misericordia e Dolce, Prato
name: Mauro Maioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06649214: A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
Official title: A Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this \[clinical trial\] is to \[evaluate the safety and efficacy of olanzapine-samidorphan tablets\] in \[adults with schizophrenia\]. The main question\[s\] it aims to answer are:

* \[question 1\] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine.
* \[question 2\] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.


Eligibility criteria: Inclusion Criteria:

* Subject is age 18 to 55 years, inclusive.
* Subject has a BMI of 18.0 to 30.0 kg/m2, inclusive.
* Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia.
* PANSS total score ≥ 70.

Exclusion Criteria:

* Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder, or any other psychiatric condition that could interfere with participation in the study.
* Subject poses a current suicide risk in the opinion of the investigator.
* Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder.
* Subject has a history of diabetes.
* Subject has used olanzapine, clozapine, chlorpromazine, or thioridazine at any time during the 6 months prior to screening or long-acting injectable antipsychotic medication in the last 6 months.
* Subject has taken opioid agonists within the 14 days prior to screening and/or anticipates a need to take opioid medication during the study period, or has taken opioid antagonists within 60 days prior to screening.
* Subject is taking any weight loss agents or hypoglycemic agents at screening.
* Subject has had a surgical procedure for weight loss or is planning to have liposuction during the study.
* Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy.

Primary outcomes:
measure: Percent change from baseline in body weight at Week 24.
timeFrame: 24 weeks
measure: Proportion of subjects with ≥10% weight gain at Week 24.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04540614: Upper Cross Syndrome Rehabilitation Strengthening of the Dorsal Erector Muscles
Official title: Upper Cross Syndrome Rehabilitation by Means of Habitual Treatment Plus Strengthening of the Dorsal Erector Muscles. Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: chronic neck pain
upper crossed syndrome
rounded shoulder posture
Lead sponsor: Martín, Carlos García
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 60
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: The purpose of this study is to determine which treatment is more effective for chronic neck pain associated with Upper Cross Syndrome.

Detailed description: Patients will divided in two groups, control and intervention. Control Group will do exercises of strengthening of Deep Cervical Flexors, Shoulder External Rotators and Adduction of Scapulae.

Intervention group will do the same plus Strengthtening of Erector Thoracic.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain for at least 3 months
* 52º or less in the craniovertebral angle
* 50º or less in the shoulder angle

Exclusion Criteria:

* herniated disk, radiculopathy, diseases of the spine

Primary outcomes:
measure: Craniovertebral angle
timeFrame: 0 week
measure: Craniovertebral angle
timeFrame: 4 week
measure: Craniovertebral angle
timeFrame: 8 week
measure: Shoulder angle
timeFrame: 0 week
measure: Shoulder angle
timeFrame: 4 week
measure: Shoulder angle
timeFrame: 8 week
measure: VAS
timeFrame: 0 week
measure: VAS
timeFrame: 4 week
measure: VAS
timeFrame: 8 week
Secondary outcomes:
measure: Muscle Strenght
timeFrame: 0 week
measure: Muscle Strenght
timeFrame: 4 week
measure: Muscle Strenght
timeFrame: 8 week
measure: Muscle Activity
timeFrame: 0 week
measure: Muscle Activity
timeFrame: 4 week
measure: Muscle Activity
timeFrame: 8 week
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fisiosesto
Study officials:
affiliation: Fisiosesto
name: Carlos García
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952414: The Power of Self-efficacy-based Interventions in Fostering Caring Self-efficacy and Overcoming Job-related Stress and Perceived Stigma Among Psychiatric Nurses
Official title: The Power of Self-efficacy-based Interventions in Fostering Caring Self-efficacy and Overcoming Job-related Stress and Perceived Stigma Among Psychiatric Nurses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caring Efficacy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with high self-efficacy set goals to challenge and improve their task achievement rate; however, people with low self-efficacy tend to have fluctuation in their ways of thinking, which results in dampened spirits. Self-efficacy affects mental health. Therefore, psychiatric nurses' achievements that affect their self-efficacy may differ from those of general workers or other nurses. In such a situation, psychiatric nurses feel that uncertainty of care and an unmotivated appearance of the patient can lead to reduced self-efficacy. Consequently, nurses are likely to give up active involvement with patients who will not be leaving the hospital.

Detailed description: The intervention aims at increasing self-efficacy and consists of Cognitive Behavioural Therapy (CBT)-based exercises related to sources of self-efficacy beliefs: 1) mastery experiences, 2) vicarious experiences, 3) verbal persuasions, and 4) emotional and physiological states.

Eligibility criteria: Inclusion Criteria:

* Only psychiatric nurses.
* Still working at the time of data collection
* Willing to participate in the study

Primary outcomes:
measure: Caring Efficacy
timeFrame: 3 months
measure: Psychiatric Nurses Job Stress
timeFrame: 3 months
measure: perceived stigma
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria university
Study officials:
References:
Clinical trial NCT05983614: Effects of Body Structures and Function on Actıvıty and Partıcıpatıon in Patıents wıth Carpal Tunnel Syndrome
Official title: Investigation of the Effects of Pain, Proprioception and Electrodiagnostic Findings on Activity and Participation in Patients With Idiopathic Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Pain
Proprioception
Sensation
EMG
ICF
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who applied to the Physical Therapy Department of Kutahya Health Sciences University Hospital and were diagnosed with mild and moderate CTS according to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) will be invited to the study.

Brief summary: The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.

Detailed description: 50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand pressure sensitivity measurement will be applied to the participants. In order to examine the relationship between body structure and functions (Pain, Sensation, EMG findings) and activity and participation with the AMOS program, the maximum likelihood method will be selected and a structural equation model (SEM) will be established.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with mild-moderate CTS
* Being between the ages of 20-55
* Volunteering to participate in the study

Exclusion Criteria:

* Being diagnosed with severe CTS
* Have systemic inflammatory disease
* Having a disease that can cause polyneuropathy, such as diabetes mellitus
* Being receiving psychotherapy
* Illiteracy
* Have a hearing problem
* Have cognitive impairment
* Having a pacemaker

Primary outcomes:
measure: Leeds Assessment Neuropathic Symptoms and Signs (LANSS)
timeFrame: 7 minutes
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 12 minutes
measure: Q-DASH
timeFrame: 10 minutes
Secondary outcomes:
measure: Proprioception Assessment
timeFrame: 7 minutes
measure: Visual Analog Scale
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Sciences University
name: Emrah Afsar, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01525914: Response of Patients on Surveillance for Prostate Cancer to Dutasteride
Official title: Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
PSA kinetics
PSA doubling time
active surveillance
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Toronto Sunnybrook Regional Cancer Centre
First posted: 2012-02-03
Enrollment: 100
Sex: MALE
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: Subjects are a subset of the men with prostate cancer on surveillance for favorable risk prostate cancer cohort

Brief summary: Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men who harbor occult high grade prostate cancer.

The study will determine the prevalence of a secondary rise in PSA \> 0.5 ng/ml and the PSA doubling time in subjects on surveillance being treated with dutasteride.

Detailed description: This analysis is a subset of the data associated with the active surveillance cohort at Sunnybrook Health Sciences Centre. Approximately 150 subjects within the cohort have received dutasteride therapy from 6 months to 3 years. All subjects have had serial PSAs at regular intervals between 3 to 6 months, and all have had a biopsy performed within 1 to 3 years of initiating dutasteride. The prevalence of a secondary rise in PSA \> 0.5ng/ml will be calculated with the impact of dutasteride therapy on the PSA doubling time. This information will be correlated with baseline PSA value, prostate volume, extent of disease on initial biopsy and baseline PSA kinetics. PSA kinetics will be also correlated with Gleason score upgrading on repeat biopsy. The rate of negative biopsies in men on dutasteride therapy will be compared with a similar group of surveillance subjects not treated with dutasteride.

Eligibility criteria: Inclusion Criteria:

* Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.

Primary outcomes:
measure: change in serum PSA
timeFrame: change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months
Secondary outcomes:
measure: rate of secondary rise in serum PSA
timeFrame: at 6 months after starting dutasteride therapy
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Laurence Klotz, MD
role: PRINCIPAL_INVESTIGATOR
References: