louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04487535: The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings
Official title: The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total knee arthroplasty
Cytokines
Proprioception
Pain
Functional Status
Lenght of Stay in hospital
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Karadeniz Technical University
First posted: 2020-07-27
Enrollment: 29
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Serum cytokines was assosiated with symptoms and progression of osteoartritis. It is unknown whether these cytokines have a predictive role on severity of symptoms after total knee arthroplasty (TKA) or not. The aim of this study is to investigate the relationships between the preoperative serum cytokine level (SCL) and lenght of stay in hospital, postoperative pain intensity, functional status, joint position sense and X ray.

Grade 4 osteoartritis degeneration who intern the hospital for total knee arthroplasty surgery. Serum Cytokine Levels (IL-6, TNFα, IL-1β) will be assessed before surgery. Pain intensity at rest/activity and valgite angle will be evaluated before surgery, postoperative 72 hour and postoperative 6 weeks. Functional status and joint position sense will be assessed before surgery and 6 weeks after surgery. Lenght of stay in hospital (LOS) will be recorded.


Eligibility criteria: Inclusion Criteria:

1. aged between 45-75
2. were scheduled for unilateral or bilateral TKA
3. were diagnosed of OA with a severity Grade 4 according to the Kellgren-Lawrence (KL) classification.

Exclusion Criteria:

1. neuropathic pain
2. presurgery for same lower extremity
3. vascular disease
4. any chronic disease related to kidney, heart, liver
5. cancer
6. chronic inflammatory disease

Primary outcomes:
measure: Pain intensty
timeFrame: pain intensity will be evaluated. It will determined pain intensity alteration from 2 weeks before surgery and at 72 hours and at 6 weeks following surgery
Secondary outcomes:
measure: Functional Status
timeFrame: Functional status will be assessed before surgery and 6 weeks after surgery
measure: Joint Position Sense
timeFrame: It will be evaluated before surgery and 6 weeks after surgery
measure: X-Ray
timeFrame: X-ray evaluated before surgery, 72 hour after surgery and 6 weeks ater surgery
measure: Serum Cytokine Level
timeFrame: Venous blood sample was collected 2 weeks before surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Universty
state: Sıhhıye
Study officials:
References:
Clinical trial NCT01903135: Prevalence of Obesity Hypoventilation Syndrome
Official title: Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Keywords: Obesity Hypoventilation Syndrome
Prevalence
Bicarbonate
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.

Detailed description: No additional description

Eligibility criteria: Inclusion Criteria:

* 18 years old ans more
* BMI over 30 kg/M2
* Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
* Addressed to a clinical labs for a blood check-up whatever the prescription

Exclusion Criteria:

* No social security
* Non cooperative patient, as judged by the investigator

Primary outcomes:
measure: Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
timeFrame: From date of inclusion until the end of the study currently planned (up to 2 years)
Secondary outcomes:
measure: Sensitivity and specificity of plasmatic [HCO3-] to detect OHS
timeFrame: From date of inclusion to the end of the study currently planned (2 years)
measure: Prevalence of metabolic and cardiovascular comorbidities in patients with OHS
timeFrame: From date of inclusion to the end of the study currently planned (2 years)
measure: To determine which medical specialties referred patients with OHS to clinical labs
timeFrame: From date of inclusion to the end of the study currently planned (2 years)
measure: Incidence of serious health events at 1 and 2-year follow-up
timeFrame: From time of OHS diagnostic to 1 and 2-year follow-up
Other outcomes:
Locations:
city: Echirolles
country: France
facility: Cabinet de Pneumologie Grenoble SUD
city: Echirolles
country: France
facility: Laboratoire MEDIBIO Les Cedres
city: Grenoble
country: France
facility: Hôpital Michallon, Laboratoire EFCR et Sommeil
city: Perpignan
country: France
facility: Cabinet de Pneumologie Perpignan
city: Thuir
country: France
facility: Laboratoire d'analyses medicales de Thuir
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis Pepin, Pr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05562635: CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Official title: Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Disorder
Myofascial Pain
Orofacial Pain
CBD
Bruxism
Keywords: temporomandibular disorder
orofacial pain
CBD
bruxism
masticatory muscles
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups parallel study: experimental and control group
Primary purpose: TREATMENT

Brief summary: The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.

Detailed description: Since the healing properties of CBD have been known for a long time, the assumption of the proposed research is to reduce the tension of the masseter muscles, reduce the bruxism index and occlusal strength, as well as reduce pain, from which patients with TMD suffer.

CBD intraoral application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska will be randomly divided into two groups: experimental and placebo. sEMG activity values will be compared during 14 and 30 days therapy with polymers. the efficacy of the cannabis cream used in the study. Positive results will confirm the efficacy of CBD relaxing properties used in the study, compared to placebo.

Eligibility criteria: Inclusion Criteria:

* Patient agreement to participate into the research study
* Age ≥18 and ≤ 60
* Good general health,
* Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
* Presence of all teeth (with the exception of the third molars)

Exclusion Criteria:

* Cannabis cream/ placebo cream allergy
* Hypersensitivity to substances to be used in the study
* Wounds intra oral cavity
* Addiction to cannabis
* Patients being treated with analgesic drugs and/or drugs that affect muscle function

Primary outcomes:
measure: Change in masseter muscle electromyographic activity- sEMG examination
timeFrame: 30 days
measure: Orofacial pain changes
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of TMD
Study officials:
References:
Clinical trial NCT02338635: Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
Official title: Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End-Stage Kidney Disease
Keywords: ER stress
Peritoneal Dialysis
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 55
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the investigators in-vitro study. In this study the researchers investigated the hypothesis that URSA protect peritoneal membrane damage.

Detailed description: Ursodeoxycholic acid (URSA) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 300 mg per day. Patients will be randomly assigned to URSA and placebo group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

Eligibility criteria: Inclusion Criteria:

* Maintenance peritoneal dialysis at least 3 months
* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria:

* Episode of peritonitis at least 3 months
* Episodes of admission due to other disease at lease 3 months
* Liver disease
* Allergic history with Ursodeoxycholic acid
* Nausea or vomiting after Ursodeoxycholic acid

Primary outcomes:
measure: Peritoneal membrane function
timeFrame: 6 months
Secondary outcomes:
measure: Residula renal function
timeFrame: 6 months
measure: Epithelial to Mesenchymal Transition, EMT
timeFrame: 6 months
measure: Oxydative stress
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Duk-Hee Kang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402635: Can the Point-Of-Care Chemistry Test (POCT) Solve the Emergency Department (ED) Crowding?
Official title: A Randomized Controlled Trial Comparing Central Laboratory and Point-of-care Chemistry Test for Solving the Emergency Department Crowding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowding
Keywords: crowding
Point-of-Care Systems
emergency medicine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 10244
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten Emergency Department (ED) length of stay (LOS).

Detailed description: ED crowding is one of the most serious problems in ED. POCT has shorter turn-around time compared to centralized laboratory system. If POCT introduce to ED, it may help to shorten LOS of ED patients.

Eligibility criteria: Inclusion Criteria:

* Patients older than 15 years
* clinically required to have chemistry lab tests
* ESI 2-5
* written agreement to participate

Exclusion Criteria:

* no agreement
* ESI level 1
* no chemistry lab

Primary outcomes:
measure: length of stay
timeFrame: average 7days from ED visit(up to time of discharge at ED or admission to ward)
Secondary outcomes:
measure: length of stay(subgroup)
timeFrame: average 7days from ED visit (up to time of discharge at ED or admission to ward)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Do Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee EJ, Shin SD, Song KJ, Kim SC, Cho JS, Lee SC, Park JO, Cha WC. A point-of-care chemistry test for reduction of turnaround and clinical decision time. Am J Emerg Med. 2011 Jun;29(5):489-95. doi: 10.1016/j.ajem.2009.11.020. Epub 2010 Apr 24.
Clinical trial NCT04218435: Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients
Official title: Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure NYHA Class IV
Heart Failure NYHA Class II
Keywords: chronickindeydisease, qualityoflife
Lead sponsor: Clinision
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 patients of heart failure with NYHA (II-IV)

Brief summary: The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering

Detailed description: Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).

Eligibility criteria: Inclusion Criteria:

1. Patients with heart failure (NYHA class II-IV).
2. LV EF(less than or equal to 40%).
3. eGFR (more than 30 ml/min /1.73m2).

Exclusion Criteria:

1. Symptomatic hypotension.
2. eGFR\<30 ml/min/1.73m2 .
3. Serum potassium \>5.2mmol/L
4. Angioedema

Primary outcomes:
measure: Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire
timeFrame: 1 year
measure: Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor
timeFrame: 1 year
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Doctors hospital and medical center
state: Punjab
Study officials:
affiliation: Doctors hospital and Medical center, Lahore
name: Shahryar Shiekh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06174935: Low Dose Atropine for Symptomatic Vitreous Floaters
Official title: Low Dose Atropine For Symptomatic Vitreous Floaters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Vitreous Floaters
Lead sponsor: Prism Vision Group
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to identify a potential pharmacologic option by assessing whether 0.01% atropine may be effective for treating bothersome floaters as measured by scores on a modified NEI VFQ-25.


Eligibility criteria: Inclusion Criteria:

* Adult patients within Prism Vision Group with ICD diagnosis of acute posterior vitreous detachment and none of the ocular comorbidities listed as exclusion criteria will be screened as potential study participants.

Exclusion Criteria:

* Patients with vitreous hemorrhage, other significant media opacity or vitreoretinal pathology, or history of pars plana vitrectomy will be excluded.

Primary outcomes:
measure: Symptom improvement assessed by questionnaire
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reston
country: United States
facility: Retina Group of Washington
state: Virginia
Study officials:
References:
Clinical trial NCT06178835: EPO for Postop Delirium in Elderly Patients
Official title: Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Delirium
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 76
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.


Eligibility criteria: Inclusion Criteria:

* Age 65 years and older
* Patients scheduled for elective total knee arthroplasty, total hip arthroplasty

Exclusion Criteria:

* Unable to communicate
* Cognitive impairment
* Unable to pre-screen delirium due to underlying central nervous system disease
* History of hypersensitivity related to erythropoietin and other anesthesia-related drugs
* History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease
* Uncontrolled high blood pressure
* Within one month of starting anti-hypertensive medication

Primary outcomes:
measure: Incidence of delirium
timeFrame: 2 days post surgery, 5 days post surgery
Secondary outcomes:
measure: Inflammatory biomarker
timeFrame: before surgery, after surgery, 3 days post surgery day 3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea
Study officials:
affiliation: Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea
name: Bon-Nyeo Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558935: The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Heart Disease
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2007-11-16
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of red wine on ABCA1 levels


Eligibility criteria: Inclusion Criteria:

* Healthy participants
* Aged 18-65 years
* Free of overt coronary disease
* BMI \< 35
* Fasting plasma glucose \<6.1 mmol
* Unmedicated
* No major illness

Exclusion Criteria:

* Unable to give informed consent
* Smokers
* Participants with alcoholism

Primary outcomes:
measure: measurements of dyslipidemia
timeFrame: 2 years
Secondary outcomes:
measure: lipid functionality
timeFrame: 2 years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart Research Institute
state: Victoria
Study officials:
affiliation: Baker Heart Research Institute
name: Bronwyn A Kingwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04174235: Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital
Official title: Fetal Congenital Anomalies Among Egyptian Pregnant Women Attending University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Anomaly
Keywords: Fetal anomalies
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 20225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attended Obstetrics and Gynecology Department of Beni-Suef University Hospital during the period (January 2016 to January 2019)

Brief summary: Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths. The aim is to assess the prevalence of fetal malformations in pregnant women attending University hospital

Detailed description: This prospective cohort study of 20225 pregnant women attended Obstetrics Department of Beni-Suef University Hospital during period (January 2016 to January 2019). A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit): ▪ Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.

Eligibility criteria: Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* Medical conditions, chronic drug intake.

Primary outcomes:
measure: prevalence of fetal malformations in pregnant women
timeFrame: Up to 37 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
Study officials:
References:
citation: Busby A, Abramsky L, Dolk H, Armstrong B; Eurocat Folic Acid Working Group. Preventing neural tube defects in Europe: population based study. BMJ. 2005 Mar 12;330(7491):574-5. doi: 10.1136/bmj.330.7491.574. No abstract available.
citation: GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.