louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03338127: Outcomes of Acute Kidney Injury in Critically Ill Patients
Official title: Outcomes of Acute Kidney Injury in Critically Ill Patients in Luxor International Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient willl be recruited from critical care units in Luxor international hospital

Brief summary: this study to evaluate the frequency of acute kidney injury in critically ill patients in intensive care units.

Detailed description: Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (ICU), making it among the most common organ dysfunctions among the critically ill . Depending on severity, Acute kidney injury (AKI) contributes to short-perimortality rates between 40% and 70% , and survivors are at increased risk for chronic kidney disease (CKD) and late death.

The diagnosis of Acute kidney injury (AKI) is only considered after achieving an adequate status of hydration and after excluding urinary obstruction; Acute kidney injury (AKI) is defined by the sudden decrease (in 48 h) of renal function, defined by an increase in absolute serum creatinine of at least (0.3 mg/dL) or by a percentage increase in serum creatinine ≥50% (1.5× baseline value), or by a decrease in the urinary output (documented oliguria \<0.5 mL/kg/h for more than 6hours).

The purpose of this study was to benchmark the outcomes of acute kidney injury in a critically ill surgical patients.We hypothesized that renal dysfunction in this population is common and is associated with a significantly higher burden of morbidity, mortality, and resource utilization

Eligibility criteria: Inclusion Criteria:

• All patient with acute kidney injury in critical care units in Luxor international hospital

Exclusion Criteria:

* Patients on chronic dialysis
* Previous acute kidney injury
* Nephrectomy
* Organ transplant
* Chronic kidney disease

Primary outcomes:
measure: Acute kidney injury in critically ill patients
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: professor of internal medicine
name: Ahmed M Aly, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00180427: VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Official title: VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Fibrillation
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: "The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD."

Detailed description: "Background: Studies have shown that bradycardia and irregular heart rates may increase the incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias by rate responsive pacing may be a way to reduce these arrhythmias.

This is a prospective, open-label, randomized multicenter study. Inclusion criteria: Patients with an indication for an ICD according to the AHA/ACC-guidelines who get a rate response system and have more than 5 % rate adaptive pacing during a one month screening phase may be included if they have given written informed consent. Rate adaptive pacing must not be contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA IV and should have a life expectancy of more than 18 months.

Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups, ICD stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and compared."

Eligibility criteria: Inclusion Criteria:

* indication for an ICD according to ACC/AHA guidelines
* ICD with rate response function implanted
* at least 5% rate response ventricular pacing during the one month screening phase
* signed informed patient consent"

Exclusion Criteria:

* rate responsive pacing contraindicated
* patient not able to perform 6 min walktest
* heart failure NYHA IV
* life expectancy below 18 months"

Primary outcomes:
measure: frequency of ventricular arrhythmias at 6 and 12 months follow ups
Secondary outcomes:
measure: medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Klinik der Medizinischen Hochschule
Study officials:
affiliation: Hannover Medical School
name: Michael Niehaus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02207127: Magnetic Resonance Imaging in Obstructive Sleep Apnea
Official title: Magnetic Resonance Imaging in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
sleep apnea
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be adults with obstructive sleep apnea undergoing surgery. All participants will undergo magnetic resonance imaging (MRI) and drug-induced sleep endoscopy (DISE).

Brief summary: There is a fundamental gap in the investigators ability to design effective surgical treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful outcome ranging from 5% to 65% for individual or combination procedures. To predict - and thereby to improve - outcomes, the investigators must determine what predicts surgical success. This project will compare findings from two evaluations: drug-induced sleep endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated important benefits, but it has important limitations. Upper airway MRI is the most complete evaluation performed during wakefulness, making it conducive to broad application and less expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe OSA. In addition to history, physical examination, and polysomnogram (sleep study), all subjects will undergo DISE and MRI to characterize the pattern of obstruction. The investigators will examine the association between DISE and MRI, focusing on specific DISE findings that have been associated with surgical outcomes. The investigators multidisciplinary team has substantial expertise and experience in OSA investigation, DISE, and upper airway MRI.


Eligibility criteria: Inclusion Criteria:

* age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)
* body mass index \<40 kg/m2.

Exclusion Criteria:

* prior OSA surgery
* known neurologic, cardiac, pulmonary, renal, or hepatic disorders
* psychiatric problems except for treated depression or mild anxiety
* co-existing sleep disorder other than OSA
* other contraindication to DISE or MRI such as propofol allergy.

Primary outcomes:
measure: Surgical results
timeFrame: 6 months
Secondary outcomes:
measure: Sleep-Related Quality of Life
timeFrame: 6 months
measure: Daytime Sleepiness
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
Study officials:
References:
Clinical trial NCT01438827: Avanz Phleum Pratense Maintenance Dose
Official title: Avanz Phleum Pratense Maintenance Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Rhinoconjunctivitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.


Eligibility criteria: Inclusion Criteria:

* A history of grass pollen allergy
* Positive skin prick test to grass
* Positive Immunoglobulin E test to grass

Exclusion Criteria:

* Other allergies overlapping the grass pollen season
* Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)

Primary outcomes:
measure: Recording of rhinoconjunctivitis symptoms
timeFrame: Daily recordings during the grass pollen season 2012
measure: Recording of symptomatic allergy medication use
timeFrame: Daily recordings during the grass pollen seasons 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: UntersuchungsZentrum für Dermatologie, Allergologie und Asthma
Study officials:
affiliation: Clinical Research Center for Dermatology, Allergy and Asthma
name: Jörg Kleine-Tebbe, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622427: Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Official title: Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD With Sleep Onset Insomnia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2008-02-25
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.

Detailed description: Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD and insomnia-
* 19-65 years of age
* In good general health
* Negative pregnancy test

Exclusion Criteria:

* Current primary psychiatric diagnosis other than ADHD
* Positive urine drug screen for any sedative hypnotic or drugs of abuse
* Unstable medical condition
* HIV positive
* Seizure disorder
* Known hypersensitivity to Ramelteon

Primary outcomes:
measure: Change in Baseline to 2 Weeks ADHD Rating Scale
timeFrame: day 1 to day 14 of study drug
Secondary outcomes:
measure: Change in Clinical Global Impression (CGI)
timeFrame: day 1 to day 14 of study drug
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT02573727: To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure
Official title: ''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury

Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed.

If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.


Eligibility criteria: Inclusion Criteria:

1. Patients with acute on chronic liver failure presenting with hepatorenal syndrome
2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

1. Age less than 18 years
2. Decompensated cirrhotics
3. Evidence of chronic kidney disease
4. Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation).
5. Post liver transplantation patients.
6. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
7. Patients with obstructive uropathy.
8. Patient who withdrew or non complaint to the study protocol.

Primary outcomes:
measure: Response to treatment in each intervention group
timeFrame: 14 days
Secondary outcomes:
measure: Survival
timeFrame: 28 days
measure: Drug related Side effects/complications
timeFrame: 28 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Vinod Arora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03280927: Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
Official title: A Multicenter, Open-label, Non-controlled, Single-arm Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild to Moderate Onychomycosis Due to Dermatophyte
Keywords: Onychomycosis
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 97
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 antifungal efficacy and safety of Jublia® topical solution will be assessed through an administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due to dermatophyte.

Detailed description: Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate toenail onychomycosis caused by dermatophytes that received a 48-week administration of efinaconazole.

Eligibility criteria: Inclusion Criteria:

* Adult male and female subjects of ages in the range over 19.
* The subjects diagnosed with onychomycosis in up to 6 toenails at least

  1 great toenail woth no fingernails
* The subjects diagnosed with a mild to moderate onychomycosis (20% to 50% of surface of target nail without nail matrix infection or dermatophytoma)
* The subjects having target nails less than 3mm in thickness and over 3mm in length
* Positive indication on KOH Direct Microscopic Inspection on target nail
* Positive dermatophyte or dermatophyte/candida on Fungi Cultivation Inspection on target nail
* The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent.

Exclusion Criteria:

* The subjects suffering other diseases that may cause nail abnormalities or are supposed to be affecting the assessment of the efficacy of study agent by the judgment of investigators
* The subjects having a case history of hypersensitivity reaction to the component of Jublia® topical solution or Azole derivatives.
* The pregnant, lactating, or fertile woman free from pertinent contraception

Primary outcomes:
measure: Completely cured subjects
timeFrame: 52 weeks
Secondary outcomes:
measure: Complete or almost complete cure rates
timeFrame: 52 weeks
measure: Mycologic cure rates
timeFrame: 52 weeks
measure: Clinical efficacy rates
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References:
Clinical trial NCT01210027: A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
Official title: A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have one of the following: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver.

Brief summary: Researchers at the the University of Michigan are conducting a research project to assess how a course of radiation therapy changes the way blood flows through the liver. To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each occasion, you will be injected with a fluid called gadolinium (a contrast agent) before getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.


Eligibility criteria: Inclusion Criteria:

* Patients must be ≥18 years of age.
* The patient's planned cancer management is radiation to the liver with or without chemotherapy.
* Patients must have a performance status of 0-2 and a life expectancy of at least 3 months.
* Patients should have no contraindications to having a contrast enhanced MRI scan.

Exclusion Criteria:

* Women who are pregnant or breastfeeding are excluded.
* Prisoners are excluded

Primary outcomes:
measure: Measure of Liver Function Before, During and After Radiation
timeFrame: 2-3 months for treatment; indefinite for follow-up
Secondary outcomes:
measure: Measure of Liver Perfusion
timeFrame: Follow-up - Approximately 7 Years
measure: Association Between Liver Perfusion and Changes in Tumor and Clinical Outcomes
timeFrame: Follow-up - Approximately 7 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Theodore Lawrence, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593627: Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
Official title: Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Heart Valve Surgery
Keywords: lithium carbonate
polysomnography
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery.

Detailed description: This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing heart valve surgery with cardiopulmonary bypass will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the postoperative night sleep quality. Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00. Mini-Mental State Examination (MMSE) score was performed on the seventh postoperative day

Eligibility criteria: Inclusion Criteria:

* Ethnic Chinese;
* Age, 18 to 65 years old;
* Patients undergoing heart valve surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* Body mass index exceeding 30 kg/m2
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine

Primary outcomes:
measure: sleep quality
timeFrame: on the second postoperative night from 20:00 to 6:00
Secondary outcomes:
measure: serum metabolites
timeFrame: from baseline to postoperative 72 hours
Other outcomes:
measure: Cognitive function
timeFrame: on the seventh postoperative day
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References: