louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01770054: Prevalence of Metabolic Syndrome in Atahualpa
Official title: Evaluation of the Prevalence of Metabolic Syndrome in Atahualpa Residents Aged 40 Years or More.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
diabetes mellitus
Lead sponsor: Hospital Clínica Kennedy
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 517
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all Atahualpa residents aged 40 years or more

Brief summary: A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the metabolic syndrome in adults aged 40 years or more living in this rural village of coastal Ecuador.

Detailed description: Several studies have shown that the occurrence of the metabolic syndrome is a risk factor for the development of cerebrovascular and ischemic heart disease. To evaluate the prevalence of the metabolic syndrome, we will invite all Atahualpa residents aged 40 years or more to participate in this study. For the purposes of this study we will obtain the waist circumference of all individuals, will measure their blood pressure using a standard protocol, and will take a blood sample to determine fasting glucose levels, HDL cholesterol levels, triglyceride levels, and plasma insulin levels.

Eligibility criteria: Inclusion Criteria:

* Atahualpa resident aged 40 years or more

Exclusion Criteria:

* non-consenting persons

Primary outcomes:
measure: Prevalence of metabolic syndrome
timeFrame: 5 months
Secondary outcomes:
measure: Genetic testing
timeFrame: 5 months
Other outcomes:
measure: determination of the prevalence of hyperinsulinemia
timeFrame: 5 months
Locations:
city: Atahualpa
country: Ecuador
facility: Center of Health
state: Santa Elena
Study officials:
affiliation: Universidad de Especialidades Espiritu Santo
name: Oscar H Del Brutto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05967754: Correlation Between Serum Uric Acid and Pulmonary Hypertension in Obstructive Sleep Apnea Syndrome
Official title: Correlation Between Serum Uric Acid and Pulmonary Arterial Hypertension Based on Echo Probability in Patients With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study aimed to correlate serum uric acid levels and PAH in OSAHS patients.

Detailed description: Obstructive sleep apnea-hypopnea syndrome is the most common form of SRBDs. Recurrent hypoxia, that accompanies OSAHS increases the degradation of ATP, which in turn increase uric acid concentration that can be used as a biomarker of tissue hypoxia in OSAHS. There is still debate about whether OSAHS is an independent contributor to pulmonary arterial hypertension.

AIM OF THE WORK This study aimed to correlate serum uric acid levels and PAH in OSAHS patients. Methods We enrolled 100 patients diagnosed with OSAHS using polysomnography. Patients were divided into three severity groups: mild OSA (5 ≤ AHI \< 15), moderate OSA (15 ≤ AHI \< 30), and severe (30 ≤ AHI \< 60). Serum uric acid was measured the morning after polysomnography. All patients underwent standard echocardiograms, and Pulmonary artery systolic pressure calculation was done.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of OSAHS by overnight polysomnography (AHI ≥ 5/ hr)
* ≥18 years old.

Exclusion Criteria:

* Other sleep disorders as narcolepsy or hypersomnia were excluded as well as Patients with neuropsychiatric disorders.
* Hemodynamically unstable patients
* Patients with other chronic respiratory or cardiac diseases
* Patients with other known causes of pulmonary hypertension
* Patients with any disease or on medication that could alter excretion or urinary metabolism of uric acid such as Excessive uric acid production

Primary outcomes:
measure: This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
timeFrame: one Year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rania Ahmad Sweed
Study officials:
affiliation: alex
name: rania A SEWIED, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06342154: Does Endorphin Massage Reduce the Anxiety of Pregnant Women?
Official title: Does Endorphin Massage Applied Before Cesarean Section Reduce the Anxiety of Pregnant Women?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: endorphin massage
cortisol level
stress
pregnant women
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized study with experimental and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage.

Detailed description: The sample size of the research was calculated using G\*Power 3.1.9.4 software as a minimum of 34 with 95% power, 0.01 alpha, and 0.9 effect size. The sample size was planned as experimental (n=34) and control (n=34) groups. To ensure the equality of the samples in both groups, a simple randomization method was used, where pregnant women with odd hospital protocol numbers will be included in the experimental group and those with even numbers will be included in the control group. Pregnant women who are admitted for pre-cesarean section care will be informed about the study, and their voluntary consent will be obtained both in written and verbal form. Pre-tests will be administered to both the experimental and control groups at 08:00, and blood samples will be taken to measure cortisol levels. Subsequently, an intervention will be applied to those in the experimental group, while those in the control group will receive routine nursing care. At 09:00, post-tests will be administered to both the experimental and control groups, and blood samples will be taken again to measure cortisol levels. The pre-test and post-test results, as well as the mean cortisol levels, will be compared between the experimental and control groups.

Eligibility criteria: Inclusion Criteria:

* Being admitted to the hospital for cesarean section
* Being willing to participate in the research

Exclusion Criteria:

* Having psychiatric illness
* native language not Turkish

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: one hour after intervention
measure: State and Trait Anxiety Scales
timeFrame: one hour after intervention
measure: cortisol level
timeFrame: one hour after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi
Study officials:
affiliation: Manisa Celal Bayar University
name: Yonca Çicek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00460954: A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects
Official title: An Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this clinical research study is to determine if different dosage regimens of Sinemet® CR (Carbidopa/levodopa) are dose proportional


Eligibility criteria: * Key inclusion and exclusion criteria for healthy volunteers will be used
* Males and females aged 50-75

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04008654: Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse
Official title: Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Pelvic Organ Prolapse
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Detailed description: ERAS protocols containing several preoperative, intraoperative and postoperative measures have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay in patients undergoing surgery. However, data concerning the role of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Eligibility criteria: Inclusion Criteria:

* Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse

Exclusion Criteria:

* Insulin dependent diabetes

Primary outcomes:
measure: Ambulation
timeFrame: Up to 1 week
measure: Hospital stay
timeFrame: Up to 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Huseyin Kiyak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146354: The Effects of a Results Management System on Physician Awareness of Post-Discharge Test Results
Official title: The Effects of a Results Management System on Physician Awareness of Post-Discharge Laboratory and Radiology Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Medical Record Systems, Computerized
Keywords: Electronic Medical Record
Electronic Results Tracking
Patient Safety
Post-Discharge Test Results
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Risk Management Foundation
First posted: 2005-09-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: This project aims to define the problem of results that return after patient discharge and to study the implementation of an Electronic Medical Record (EMR)-based system for tracking these results.

Detailed description: The transfer of care at hospital discharge is complex and requires the transmission of large amounts of data between inpatient physicians (hospitalists) and outpatient physicians (PCPs), including information about pending tests. Frequently, laboratory and radiology tests are not finalized until after a patient is discharged, and when the responsibility for these pending results is not clearly defined, they can be missed. Our project aims to define the problem of these post-discharge results and to study the implementation of an EMR-based system (Hospitalist Results Manager, HRM) for tracking these results on the hospitalist services at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH). The project consists of two phases: a cross-sectional study before intervention to define the epidemiology of post-discharge results, and a randomized trial of HRM to determine its effect on physician awareness of these results.

Eligibility criteria: Inclusion Criteria:

* Admitted under enrolled study Attendings at the two study locations
* Patient had test result finalized after discharge and prior to subsequent admission

Exclusion Criteria:

* Test result noted in discharge summary
* Test result not clinically actionable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Tejal K Gandhi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06257654: One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.
Official title: One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 71
Sex: MALE
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male patients with prostate symptoms

Brief summary: Objective: Rezūm vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezūm is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, it is unclear how effective Rezūm is for men in urinary retention. The investigators sought to determine whether Rezūm is effective in the treatment of catheter-dependent urinary retention secondary to BPH.

Detailed description: The data of participants who underwent Rezūm operation with the diagnosis of BPH between 2021 and 2023 were evaluated retrospectively. The investigators evaluated procedure details and evaluated pre- and post-Rezūm (including International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QOL), prostate volumes, maximum flow (Qmax), post-void residual urine volume, IEEF-5, ejaculation dysfunction). The investigators examined variables at 6 and 12 months).

Eligibility criteria: Inclusion Criteria:

-Benign prostatic hyperplasia

Exclusion Criteria:

* Prostate cancer
* Parkinson's disease,
* Neurogenic bladder
* Overactive bladder
* Bladder calculus,
* Bladder Tumor
* Urinary infection
* Alzheimer's disease

Primary outcomes:
measure: International Prostate Symptom Score,
timeFrame: 1 years
measure: quality of life index
timeFrame: 1 years
measure: q max
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basri Cakiroglu
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
References:
Clinical trial NCT00509054: Prevention of Parastomal Hernia With a Mesh
Official title: Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parastomal Hernia
Keywords: Parastomal hernia, wound infection, stoma care.
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2007-07-31
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Detailed description: Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.

A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.

Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.

Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.

Eligibility criteria: Inclusion Criteria:

* Clinical need of an enterostoma

Exclusion Criteria:

* Patients denies inclusion in the trial.

Primary outcomes:
measure: Wound infection,mesh infection, parastomal hernia.
timeFrame: Within five years
Secondary outcomes:
measure: Fistula formation, stenosis,pain.
timeFrame: Within five years
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Kirurgkliniken Sundsvalls sjukhus
Study officials:
affiliation: Umea University
name: Leif A Israelsson, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.
Clinical trial NCT02992054: An Innovative Occupational Program Using New Technologies (KODRO) Life of Nursing
Official title: Randomized Controlled Trial for Assessing the Effects Resulting From an Innovative Occupational Program Using New Technologies (KODRO) on Nursing Home Residents' Quality of Life (Pilot Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Home Residents
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 239
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nursing home residents

Brief summary: Randomized controlled trial for assessing the effects resulting from an innovative occupational program using new technologies (KODRO) on nursing home residents' quality of life

Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a national priority (2010 report from French ANESM).

Detailed description: KODRO stimulation program makes available stimulating activities through the use of a tactile tablet computer. These tablets are linked to an internet-based service platform The project main objective is to demonstrate by way of a randomized controlled trial the significance of the improvement of residents' QOL achieved by 2 one-hour KODRO sessions per week during 6 months (KODRO nursing homes) when compared with the usual stimulation activity program (nursing homes "controls") (difference for the QOL-AD score \> 2 points).At last, the objective of the study is also observational, i.e. to determine the quality of life of NHR at baseline, in its differents aspects.Subjects \& methods Analysis will be conducted to compare quantitative parameters at the beginning of the trial to verify the comparability of the two groups and of the mean average change between parameters measured at baseline, 3 months, and 6 months in both groups.

Eligibility criteria: Inclusion Criteria:

* Nursing home residents

Exclusion Criteria:

* Not able to participate in the ocupational therapy using KODRO (Demential end of life ...)

Primary outcomes:
measure: Quality of life: QOL-AD score: questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Different aspects of QOL score: questionnaire
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: Hubert BLAIN, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01866254: Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Official title: Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Hydromorphone
Morphine
cesarean delivery
pain management
respiratory depression
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2013-05-31
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.

Detailed description: Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.

One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.

Eligibility criteria: Inclusion Criteria:

* Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
* ASA status of I-III
* BMI \< 40
* Able to understand and sign informed consent

Exclusion Criteria:

* Severe pre-eclampsia
* Conversion to general anesthetic
* History of chronic opioid use
* Allergy to morphine, or hydromorphone
* Hyperemesis gravidarum
* Emergency case
* Patients who have an infection at the intended site of spinal insertion

Primary outcomes:
measure: Change in Pain Scores
timeFrame: from Baseline to 24 Hours
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: up to 24 Hours
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Grace Shih, MD
role: PRINCIPAL_INVESTIGATOR
References: