louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02916043: Neutrophil, Lymphocyte and Platelet as a Predictor for AKI and Mortality
Official title: Risk Factor of Acute Kidney Injury After Open Heart Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
cardiovascular surgery
mortality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 1099
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015

Brief summary: Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Detailed description: Acute kidney injury (AKI) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. The incidence of AKI after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (RRT) to be up to 8 %.

Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015

Exclusion Criteria:

* Missing preoperative serum creatinine (sCr) values
* Missing preoperative platelet, neutrophil and lymphocyte counts
* Patients who underwent preoperative hemodialysis

Primary outcomes:
measure: Acute kidney injury
timeFrame: postoperative day seven
Secondary outcomes:
measure: All-cause mortality
timeFrame: postoperative seven years
Other outcomes:
measure: Postoperative length of hospital stay
timeFrame: postoperative two month
measure: Postoperative length of ICU stay
timeFrame: postoperative two months
measure: Postoperative incidence of complications
timeFrame: postoperative two months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01460043: Trial of Homeopathy on Management of Menorrhagia
Official title: Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal \& back pain, General health and overall satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age between 35-49 years with regular heavy menstrual bleeding
* menstrual loss requiring more than 5 Pads/tampons per day
* menstrual cycle longer than 6 days

Exclusion Criteria:

* Organic causes of menorrhagia
* History of renal or hepatic impairment,
* Endocrine disorder including diabetes, thyroidism
* Thromboembolic disease,
* Inflammatory bowel disease,
* Peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and --Malignancy.

Primary outcomes:
measure: daily assessment of bleeding
timeFrame: change from baseline over 3 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: change from baseline over 3 months
Other outcomes:
Locations:
Study officials:
affiliation: NMP Medical Research Institute
name: Neha Sharma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892943: Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leber Hereditary Optic Neuropathy (LHON)
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: European Vision Institute Clinical Research Network
First posted: 2013-07-08
Enrollment: 306
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with genetically confirmed diagnosis of LHON

Brief summary: The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.


Eligibility criteria: Inclusion Criteria:

* patients with genetically confirmed diagnosis of LHON

Primary outcomes:
measure: Visual acuity
timeFrame: average 0 to 10 years (retrospective)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Glostrup
country: Denmark
facility: Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Paris
country: France
facility: CIC/CMR CHNO des Quinze-Vingts
city: Bari
country: Italy
facility: Universty of Bari
city: Rome
country: Italy
facility: Fondazione G.B. Bietti
city: Segrate
country: Italy
facility: San Raffaele Hospital
city: Ljubljana
country: Slovenia
facility: University Eye Clinic
Study officials:
affiliation: Centre de Recherche Institut de la Vision INSERMN
name: Jose-Alain Sahel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05912543: A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child
Official title: A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index (ORi™) During One-lung Ventilation in the Pediatric Patient: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperoxemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 70
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation.

Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned.

The researchers will compare whether blood oxygen levels were lower in the ORI group.


Eligibility criteria: Inclusion Criteria:

* Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
* Children with American Society of Anesthesiology physical status I, II, III

Exclusion Criteria:

* Patient who have chronic respiratory failure
* Patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis
* Patient whose initial Oxygen Reserve Index value is zero
* Patient who need supplementary oxygen before surgery

Primary outcomes:
measure: The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)
timeFrame: 30 minutes after initiation of one-lung ventilation
Secondary outcomes:
measure: average Oxygen Reserve Index value
timeFrame: during one lung ventilation
measure: time-weighted average inspired oxygen fraction
timeFrame: during one lung ventilation
measure: incidence of hypoxemia
timeFrame: perioperative period
measure: incidence of perioperative complications
timeFrame: perioperative period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04954443: Urinary Retention After Removing Urinary Catheter at 24 Hour Versus 48 Hour in Patients With Vaginal Surgery
Official title: Urinary Retention After Removing Urinary Catheter at 24 Hour Comparison With 48 Hour in Patients With Vaginal Surgery of Pelvic Organ Prolapse, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Pelvic Organ Prolapse
Keywords: Urinary Retention
Pelvic Organ Prolapse
Vaginal surgery
Urinary catheter
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2021-07-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison incident of urinary retention in patients with vaginal surgery of pelvic organ prolapse, who removed urinary catheter at 24 hours versus 48 hours after surgery

Detailed description: Vaginal surgery of pelvic organ prolapse needs to insert urinary catheter for monitoring post-operative complication, hemodynamic status, and prevention post-operative urinary retention. Urinary retention occur 2.4 - 43% after pelvic organ prolapse surgery, whereas retaining urinary catheter is common cause of urinary tract infection, often hospital-acquired infection. At Rajavithi hospital always remove urinary catheter at 48 hour after surgery. Accordingly, appropriated time for removing urinary catheter in patients with vaginal surgery of pelvic organ prolapse is unclear. This study aims to reduce timing for removing urinary catheter after vaginal surgery, not increase urinary retention and re-catheterization and reduce urinary tract infection and day of hospital stay.

Eligibility criteria: Inclusion Criteria:

* Woman with pelvic organ prolapse, who undergoing vaginal surgery and agrees to participate in this study
* Able to understand and communicate Thai language

Exclusion Criteria:

* Woman with diabetes mellitus with HbA1C \> 10.9%
* Woman with stroke
* Woman with urinary tract infection before surgery
* Woman with urinary retention before surgery
* Woman, who experienced surgery for urinary incontinence
* Woman, with operative complication including of hemorrhagic shock (Blood pressure \< 90/60 mmHg, Heart rate \> 120 beats per minute, Intra-operative blood loss \> or = 750 ml), urinary tract injury, bowel injury

Primary outcomes:
measure: Urinary retention
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Re-catheterization after removing urinary catheter
timeFrame: Through study completion, an average of 1 year
measure: Urinary tract infection
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT01588743: Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
Official title: Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 130
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.


Eligibility criteria: Inclusion Criteria:

* Age: 25 to 60 years old
* Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
* Fasting blood glucose is above 11.0mmol/L.
* Half of the patients with BMI below 24 and the other half with BMI above 24.

Exclusion Criteria:

* type 1 diabetes mellitus
* type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
* Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.

Primary outcomes:
measure: AUC75-120 of Glucose Infusion Rate (GIR)
timeFrame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
Secondary outcomes:
measure: AUC0-10 of Acute Insulin Response (AIR) during IVGTT
timeFrame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Guangwei Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang H, Kuang J, Xu M, Gao Z, Li Q, Liu S, Zhang F, Yu Y, Liang Z, Zhao W, Yang G, Li L, Wang Y, Li G. Predictors of Long-Term Glycemic Remission After 2-Week Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2153-2162. doi: 10.1210/jc.2018-01468.
Clinical trial NCT02169843: Small Doses of Dexmedetomidine for Emergence Agitation
Official title: Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emergence Agitation
Keywords: Dexmedetomidine,
agitation,
AFPS,
NRS,
mean arterial pressure
heart rate(HR)
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(\>64 years) after using sevoflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

1. obtain informed consent;
2. patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time \> 2h;
3. the American society of anesthesiologists (ASA) class I-II;
4. age\>64 years old;
5. BMI\<28kg/㎡;

Exclusion Criteria:

1. systolic pressure≥180mm Hg or\<90mm Hg, diastolic pressure≥110mm Hg or\< 60mm Hg;
2. serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
3. patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
4. HR\<50times/min
5. a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
6. a history of alcoholism
7. diseases of the neuromuscular
8. a tendency to malignant hyperthermia
9. allergy to test drugs or have other contraindications
10. participated in other clinical drug researches over the past 30 days

Primary outcomes:
measure: evaluation of agitation
timeFrame: the duration of PACU room stay,expect 30 minutes
measure: evaluation of pain
timeFrame: the duration of PACU room stay,expect 30 minutes
measure: the amount of drugs
timeFrame: the duration of hospital stay,expect 5 weeks
measure: number of agitation
timeFrame: the duration of hospital stay,expect 5 weeks
Secondary outcomes:
measure: the mean arterial pressure
timeFrame: from the beginning of induction to skin closure, up to 1 hour
measure: heart rate
timeFrame: from the beginning of induction to skin closure, up to 1 hour
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
Study officials:
References:
Clinical trial NCT03529643: Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP
Official title: Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy: Comparison of Sevoflurane-remifentanil and Sevoflurane-remifentanil-dexmedetomidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 128
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed description: The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Undergone a robot-assisted laparoscopic prostatectomy with a prostate - cancer
* 20 years of age or older and under 80 years of age
* Agree to participate in this study

Exclusion Criteria:

* History of cerebral hemorrhage or cerebral infarction
* \< 20 years of age
* ≥ 80 years of age
* Glaucoma
* Unexpected hemodynamic instability during surgery
* Failure to measure optic nerve sheath diameter
* Convert to open surgery

Primary outcomes:
measure: Difference in optic nerve sheath diameter
timeFrame: 60 minutes after pneumoperitoneum and steep Trendelenburg position
Secondary outcomes:
measure: Difference in optic nerve sheath diameter
timeFrame: 30 minutes after pneumoperitoneum and steep Trendelenburg position
measure: Difference in optic nerve sheath diameter
timeFrame: 10 minutes after anesthesia induction
measure: Difference in optic nerve sheath diameter
timeFrame: At skin closure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05868590: Evaluation of Toothpaste on Dental Plaque
Official title: Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Plaque
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.

Detailed description: The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.

Eligibility criteria: Inclusion Criteria:

* Patients aged 9-12 years
* The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
* Absence of orthodontic appliances/brackets
* No physical limitations
* No previous trauma history
* It was determined as the absence of soft-hard tissue pathology.

Exclusion Criteria:

* Patients not between 9-12 years
* The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
* Presence of orthodontic appliances/brackets
* Physical limitations
* Previous trauma history
* It was determined as the presence of soft-hard tissue pathology.

Primary outcomes:
measure: Active Magnesium Containing Toothpaste (ROCS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: