louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04424173: Combined Hormone Therapy, C-reactive Protein(CRP) Levels and Life Quality in Natural Menopause Women
Official title: The Effect of Low Dose Combined Hormone Therapy (Estradiol And Norethindrone Acetate) on Serum CRP Levels and Life Quality in Natural Menopause Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CRP
Menopause
Keywords: CRP
Estradiol
Menopause-Specific Quality of Life questionnaire
Norethindrone Acetate.
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 45
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of cases, whose hormone therapy was planned due to menopausal symptoms in the menopause unit of our clinic, were evaluated in terms of admission, and non-acceptance criteria, during the study.

Brief summary: This study aims to assess the effect of low dose combined estradiol and norethindrone acetate hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural menopause women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5 mg Norethindrone acetate).


Eligibility criteria: Inclusion Criteria:

* Accepting consent to participate in the research and signing the form;
* Postmenopausal women 45-55 years old
* not having had menstruation for the past 6 months;
* Hormone results compatible with menopause (FSH\> 20 milli-International unit(mIU) / mL, E2 \<20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to severe);
* no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease), or no infectious disease in the past 2 weeks;
* not taking any hormone therapy or medication for at least 2 months;
* no contraindications for hormone therapy in routine menopause evaluation;
* Willingness to take hormone therapy
* No smoking.

Exclusion Criteria:

* Any systemic disease (DM, HT, hyperlipidemia, ischemic heart disease) presence
* Smoking
* Contraindications for hormone therapy
* Failure to follow-up
* Inability to complete three months of hormone therapy
* Stopping hormone therapy due to vaginal bleeding during hormone therapy

Primary outcomes:
measure: Blood was drawn for basal CRP from all patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03540173: Discomfort Score Identifies Painfulness During Unsedated Colonoscopy
Official title: A New Intubation Discomfort Score Identified Patients' Painfulness During Unsesated Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factors Associated With Painful Colonoscopy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were prescribed polyethylene glycol electrolyte for bowel preparation according to the preference of physicians. They were asked to drink the first 2L of PEG4000e at19:00-20:00 PM on the night before colonoscopy within 2 hours. Then, on the day of the examination, patients were asked to take the remaining 2L 5 hours before the procedure. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy. In addition, patients were instructed to have a regular meal for lunch and only liquid diets for dinner the day before the operation.

Brief summary: Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or special techniques to these patients would be an attractive option.

Detailed description: Here we prospectively collected the data during colonoscopy and investigated the possible risk factors associated with painful colonoscopy by using a step-wise multivariate regression model. Furthermore we developed a novel point score to predict whether the patients at high risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with the aid of special techniques to help the completion of procedure.

Eligibility criteria: Inclusion Criteria:

* patients who underwent unsedated colonoscopy

Exclusion Criteria:

* (1) no bowel preparation or colon cleansing by enema only; (2) no need to reach cecum; (3) prior finding of severe colon stenosis or obstructing tumor; (4) history of colectomy; (5) unstable hemodynamics; (6) pregnant; (7) unable to give informed consent.

Primary outcomes:
measure: The anxiety status
timeFrame: 1 year
Secondary outcomes:
measure: Abdominal pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Second People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
Clinical trial NCT04017273: Older Emergency Department Users and Hospitalization After an Index Visit: Results of ER2 Database
Official title: Older Emergency Department Users and Hospitalization After an Index Visit: Results of ER2 Database
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Conditions, Multiple
Medical Emergencies
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 10971
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study will be enrolled people who are 75 years and over, and who come at Emergency not only for medical reason but also for social.

Brief summary: This study evaluates the recommendations of a screening tool called: ER2 (Emergency Room Evaluation and Recommendations Form).This stool is used in Emergency Department by nurses, and it supposes to measure patient risk score.

Detailed description: Crowding and delay became chronic conditions in emergency departments (EDs) in high income countries. Emergency medicine has the mandate to provide care to any patient requesting treatment 24 hours a day. As there is a lack of primary care physicians who are able to provide the necessary care to patients, they are forced to seek care in ED. Among these ED users, more and more patients are aged over 65 and account for up to a quarter of all ED users. Older ED users comparted to their younger counterparts are more at risk for long length of stay in ED and hospital, and hospital admission during an index ED visit. The occurrence of these short-terms adverse events may be reduced if older ED users risk is assessed upon their ED arrival. Few studies have examined risk for short-terms adverse events. They suggested that clinical tools based on a brief geriatric assessment with timely appropriate interventions could reduce the occurrence of short-terms ED adverse events.

Eligibility criteria: Inclusion Criteria:

* Being 75 years and over
* Brought at Emergency on medical stretcher

Exclusion Criteria:

* Being less than 75 years old
* Never come at Emergency

Primary outcomes:
measure: Long length of hospital stay
timeFrame: Around 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997073: One Lung Ventilation
Official title: Effect of One-Lung Ventilation on Respiratory Gas Heat Content
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluate the Changes in Respiratory Heat Content During One Lung Ventilation
Keywords: Respiratory enthalpy
One Lung Ventilation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery.

Brief summary: Specific Aims: 1) Measure exhalation enthalpy in patients receiving conventional positive pressure ventilation during stable hemodynamic conditions. 2) Measure exhalation enthalpy in patients following change from two-lung ventilation to one-lung ventilation while minute ventilation remains constant.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective surgical procedures requiring one lung ventilation.

Exclusion Criteria:

* Age \<18 years. Pregnancy. Prisoners. Planned pneumoperitoneum.

Primary outcomes:
measure: Effect of One-Lung Ventilation on Respiratory Gas Heat Content
timeFrame: One year.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
Study officials:
affiliation: Professor, Director, Cardiovascular and Thoracic Anesthesiology
name: Neal W. Fleming, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06492473: Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital
Official title: Clinical Evaluation Of Ventricular Septal Defect (VSD) in Children at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Septal Defect
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies

Brief summary: ventricular septal defect(VSD) are one of the most common significant CHD and account for up to 40% of all cardiac abnormalities.VSD is commonly isolated defect as well as intrinsic component of several complex cardiac malformations including tetrology of fallot ,double- outlet right ventricle(RV),transposition of great vessles,aortic coartication or interruption ,and truncus arteriosus


Eligibility criteria: Inclusion Criteria:

* all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies

Exclusion Criteria:

-

Primary outcomes:
measure: size of VSD
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Saxena A, Mehta A, Sharma M, Salhan S, Kalaivani M, Ramakrishnan S, Juneja R. Birth prevalence of congenital heart disease: A cross-sectional observational study from North India. Ann Pediatr Cardiol. 2016 Sep-Dec;9(3):205-9. doi: 10.4103/0974-2069.189122.
citation: Soto B, Becker AE, Moulaert AJ, Lie JT, Anderson RH. Classification of ventricular septal defects. Br Heart J. 1980 Mar;43(3):332-43. doi: 10.1136/hrt.43.3.332.
citation: Soto B, Ceballos R, Kirklin JW. Ventricular septal defects: a surgical viewpoint. J Am Coll Cardiol. 1989 Nov 1;14(5):1291-7. doi: 10.1016/0735-1097(89)90430-0.
citation: Kirklin JK, Castaneda AR, Keane JF, Fellows KE, Norwood WI. Surgical management of multiple ventricular septal defects. J Thorac Cardiovasc Surg. 1980 Oct;80(4):485-93.
Clinical trial NCT02510573: Low Serum Ficolin-3 Levels on Admission Are Associated With Poor Outcomes After Severe Traumatic Brain Injury
Official title: Prognostic Value of Serum Ficolin-3 Levels After Severe Traumatic Brain Injury：A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Lead sponsor: Sanmen People's Hospital
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with isolated head trauma and postresuscitation Glasgow Coma Scale score of 8 or less.

Brief summary: The current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury.

Detailed description: Complement activation is one of the pathological mechanisms that contribute to the secondary brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement activation contribute to the pathogenesis of ischemic stroke and may be additive to complement-independent inflammatory processes. Lower serum ficolin-3 levels have been demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This prospective observatory study was designed to investigate the relationship between serum ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls. Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and 6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels, correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential to be the useful, complementary tool to predict short- or long- term clinical outcome after severe traumatic brain injury.

Eligibility criteria: Inclusion Criteria:

* Isolated head trauma
* Postresuscitation Glasgow Coma Scale score of 8 or less.

Exclusion Criteria:

* Less than 18 years of age
* Admission time \> 6 hours
* Previous head trauma
* Neurological disease including ischemic or hemorrhagic stroke
* Use of antiplatelet or anticoagulant medication
* Diabetes mellitus
* Hypertension
* Presence of other prior systemic diseases including uremia, liver cirrhosis, malignancy, and chronic heart or lung disease

Primary outcomes:
measure: Mortality after severe traumatic brain injury
timeFrame: Follow-up of 6 months
Secondary outcomes:
measure: Unfavorable outcome after severe traumatic brain injury
timeFrame: Follow-up of 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02745873: Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
Official title: Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Elevated Blood Lead Levels
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Pakistan Science Foundation
First posted: 2016-04-20
Enrollment: 144
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The toxic nature of lead has been recognized ubiquitous for than 2,000 years and today it is a persistent and common environmental contaminant in most parts of the world. Vitamin C is a strong antioxidant and a metabolic co factor playing an important role in many biological processes and biochemical functions (hydroxylation reactions). The research objective is to assess the effect of oral ascorbic acid supplementation 500mg and 250 mg once a day for 4 weeks on Blood Lead level among school going urban adolescents, using a cluster randomized trial study design. Ascorbic Acid (vitamin C) 250 and 500 mg will be administered in two study arms.


Eligibility criteria: Inclusion Criteria:

1-school going adolescents, aged 13-18 years.

Exclusion Criteria:

1. Children with history or presence of chronic illness or bleeding disorders, requiring red blood cell transfusion, dialysis
2. Using multivitamins
3. Those who planning to leave study place within 2 months of start of study

Primary outcomes:
measure: Blood Lead Level
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03597373: Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis
Official title: Variables Predicting Reintubation After Thymectomy in Patients With Myasthenia Gravis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myasthenia Gravis
Keywords: Prediction
Myasthenia gravis
Reintubation
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with myasthenia gravis undergoing thymectomy

Brief summary: Myasthenia gravis (MG) is an autoimmune disease that is characterized by muscle weakness and fatigue. The role of the thymus in MG has been suggested by the evidence that 10% to 15% of patients present with a thymoma and at least 60% with thymus hyperplasia or dysplasia.Beneficial effects of thymectomy in patients with MG have been described in 40% to 90%.Few studies have looked at the incidence of reintubation (not just within 24 hours after extubation), the factors associated with reintubation, and patient outcome.

Premature extubation may lead to hypercarbia, hypoxemia, pulmonary hypertension, right heart failure, and myocardial ischemia. Additionally, it subjects the patient to the physical risks of reintubation, including esophageal intubation, laryngeal trauma, and pulmonary aspiration. The purpose of the present study was to determine the incidence of reintubation, the variables associated with reintubation, and patient outcome

Detailed description: Inclusion was based on the availability of all the following possible predictive pre-operative variables: age, gender, weight, height, body mass index, diabetes, creatinine, duration of MG, severity of MG (based on Osserman's classification), pathological type of MG, history of myasthenic crisis, dose of pyridostigmine, use of a steroid hormone, and use of an immunosuppressant.operative variables: postoperative pulmonary infection, total duration of hospital stay, duration of ICU stay, and duration of postoperative hospital stay. Variables were collected by research assistants and maintained in a computer database.

Eligibility criteria: Inclusion Criteria:

* younger than 75 years
* absence of heart failure as the primary indication for mechanical ventilation •Acute Physiology and Chronic Health Evaluation (APACHE) II score less than 12 points on day of extubation
* body mass index less than 30

Exclusion Criteria:

•preoperative moderate-to-severe chronic obstructive pulmonary disease

Primary outcomes:
measure: Risk Factors for Reintubation
timeFrame: an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Genglong Liu
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Genglong Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670773: A Study of CAT-1004 Biomarkers in Healthy Subjects
Official title: A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Assessment of Mechanistic Blood Biomarkers in Healthy Humans
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results
* BMI between 18 and 30 kg/m2 inclusive

Exclusion Criteria:

* Viral or bacterial infection within 21 days prior to randomization
* Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization

Primary outcomes:
measure: Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation
timeFrame: Pre/post each of 3 Single doses
Secondary outcomes:
Other outcomes:
measure: Other biomarkers including select cytokines and RNA gene expression may also be assessed
timeFrame: Pre/post each of 3 Single doses
Locations:
city: Brighton
country: United States
facility: ProMedica
state: Massachusetts
Study officials:
affiliation: Catabasis
name: Joanne Donovan, MD, PhD
role: STUDY_DIRECTOR
References: