louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00332410: Intravenous Voriconazole in Patients With Renal Compromise
Official title: Intravenous Voriconazole in Patients With Renal Compromise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant
Keywords: Voriconazole
renal transplant
kidney function
kidneys
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: solid organ transplant receiving voriconazole with serum creatinine level \>2

Brief summary: The purpose of this study is to determine whether patients with compromised renal function (CrCl \< 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran.

Detailed description: The purpose of this study is to determine whether patients with compromised renal function (CrCl \< 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran. t has been previously shown by a large multi-centered, prospective, randomized study that voriconazole is superior to the then gold standard amphotericin B in the treatment of patients with invasive aspergillosis - a disease with significant morbidity and mortality. In patients with these infections who have severe renal insufficiency may be denied the best therapy due to the accumulation of a diluent with unknown clinical consequences. Qualifying and or quantifying these consequences are important to these patients so that potentially life-threatening therapy should not be unduly denied.

Eligibility criteria: Inclusion Criteria:

- Patients \> 18 years old receiving voriconazole with a serum creatinine of \> 2mg/dl (a proxy marker for Creatinine clearance \< 50ml/min). Control group in this study will have serum creatinine \< 1.5mg/dl. Solid organ transplant patient. Patient that received at least 2 doses of voriconazole.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Potoski, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06036810: Spanish Decision Tool for Ovarian Cancer Maintenance Therapy
Official title: Engaging Patients in Decision Making: The Development and Pilot Testing of a Low Literacy Spanish Language Shared Medical Decision Tool for Ovarian Cancer Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy

Detailed description: Objectives:

* Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer maintenance therapy for Spanish speaking individuals.
* To explore the feasibility and acceptability of incorporating the SDM tool into routine clinical care for Spanish speaking individuals.
* To estimate the effectiveness of the SDM tool on quality of the decision making in patients with ovarian cancer who are making decisions about maintenance therapy through a pilot study.

Eligibility criteria: Study population: This study will enroll patients and clinical providers.

Inclusion criteria: Patients

• Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or have completed platinum-based chemotherapy for ovarian cancer and are potentially eligible to receive maintenance therapy; 2) able to understand, speak or read in Spanish.

Exclusion criteria: Patients

• Inability or unwillingness to sign informed consent

Inclusion criteria: Clinicians

• Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced practice providers who practice at the Houston Area Locations (HALs), MD Anderson Cancer Center, or our county safety net hospital, The Harris Health System (LBJ Hospital).

Exclusion criteria: Clinicians

• Inability or unwillingness to sign informed consent

Primary outcomes:
measure: Decision Regret Scale questionnaire
timeFrame: through study completion; an average of 2 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Larissa Meyer, Meyer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00299910: Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
Official title: Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Disordered Breathing
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2006-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess in a double blind placebo controlled fashion the effects of a 12 week course of oral montelukast/placebo on polysomnographic and radiological findings and will characterize the systemic (serum,urine) and local (upper airway collected biological samples) inflammatory response in children (2-10 years of age) with sleep disordered breathing, fittingthe inclusion and exclusion criteria.


Eligibility criteria: Inclusion Criteria:2-10 years old

1\<AHI\<8 measured in an overnight PSG

-

Exclusion Criteria:

Asthma Previous use or allergy to montelukast Use of antibiotics in the previous 3 weeks Use of corticosteroids in the previous 3 months Craniofacial dysmorphism Genetic or metabolic defined illnesses Adenotonsillectomy or adenoidectomy in the past

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Pediatric Sleep Center, Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Asher Tal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldbart AD, Goldman JL, Veling MC, Gozal D. Leukotriene modifier therapy for mild sleep-disordered breathing in children. Am J Respir Crit Care Med. 2005 Aug 1;172(3):364-70. doi: 10.1164/rccm.200408-1064OC. Epub 2005 May 5.
Clinical trial NCT01992510: The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silicone Tamponade
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 22
Sex: ALL
Minimum age (years): 33
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: silicone tamponade patients

Brief summary: The study was conducted to investigate how postural changes including sitting, supine, and LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes and the fellow eyes in each body position.


Eligibility criteria: Inclusion Criteria:

* patients who had a 23-gauge pars plana vitrectomy
* must be done with SO(silicone oil,5,000 centistrokes) endotamponade using the Accurus system (Alcon Laboratories, Inc, Hünenberg,Switzerland)

Exclusion Criteria:

* previous history or presence of glaucoma or uveitis
* IOP of ≥24 mmHg
* use of any antiglaucoma agents
* narrow angles
* corneal abnormality or diseases that could affect IOP
* refractive error exceeding a spherical equivalent of 6 diopters.

Primary outcomes:
measure: Mean IOP(intraocular pressure) at each time point during the change in body position
timeFrame: 100 minutes
Secondary outcomes:
measure: IOP(intraocular pressure)differences between the SO(silicone oil)-filled eye and the fellow eyes at each time point during the change in body position
timeFrame: 100 minutes
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Department of Ophthalmology, School of Medicine, Kyungpook National University
state: Jung-gu
Study officials:
References:
Clinical trial NCT04358510: COVID-19 Mortality Prediction Model
Official title: Mortality Prediction Model for the Triage of COVID-19, Pneumonia and Mechanically Ventilated ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pneumonia
Mechanical Ventilation
Keywords: machine learning
COVID-19
mortality
prediction
pneumonia
mechanical ventilation
Lead sponsor: Dascena
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The community hospital patient dataset included 114 patients positive for SARS-COV-2 by PCR test.

Brief summary: The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.

Detailed description: Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The NPH patient dataset includes 114 patients positive for SARS-COV-2 by PCR test.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Record of ICU stay

Exclusion Criteria:

* Patients aged less than 18 years
* Patients for which there were no records of raw data or no discharge or death dates.

Primary outcomes:
measure: Mortality outcome in COVID-19 ICU patients
timeFrame: Through study completion, an average of 2 months
measure: Mortality outcome in mechanically ventilated ICU patients
timeFrame: Through study completion, an average of 2 months
measure: Mortality outcome in pneumonia ICU patients
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Dascena
state: California
Study officials:
References:
Clinical trial NCT04496310: Tele-epic (Telemedicine for Epilepsy Care)
Official title: Telemedicine With Mobile Internet Devices for Innovative Care of Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Epileptic Encephalopathy
Refractory Epilepsy
Keywords: Telemedicine
Epilepsy
Antiepileptic drugs monitoring
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2020-08-03
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control, surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side effects. Patients may encounter difficulties to be assessed adequately and the disease burden is increased by the need for travelling across the country for medical consultations. Driving restrictions are a further limit to access specialized Centers able to provide an integrated approach focused on patient needs. Telemedicine (TM) offers an invaluable support to patient follow-up, joining the sparse distribution of patients in the country with the prompt availability of a team of experts. The project assesses, through a randomized controlled trial, the non-inferiority of TM in monitoring seizure control compared to usual (face-to-face) care. This approach, coupled with a new self home-sampling method for the measurement of AED levels, will reduce health care costs and simplify patients management.


Eligibility criteria: Inclusion Criteria:

* adult (age\>18 yrs) and pediatric (age\<18yrs) outpatients with established diagnosis of epilepsy.

Primary outcomes:
measure: Seizures control through seizure diary
timeFrame: 3 years
Secondary outcomes:
measure: Adherence to treatment
timeFrame: 3 years
measure: ADRs - Adverse Events Profile-AEP
timeFrame: 3 years
measure: Quality of life (QoL)
timeFrame: 3 years
measure: Pediatric quality of life (PedsQL)
timeFrame: 3 years
measure: Mood-disorders - Beck Depression
timeFrame: 3 years
measure: Mood-disorders - State-Trait Anxiety
timeFrame: 3 years
measure: Mood-disorders - Child Behavior
timeFrame: 3 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda USL di Bologna
city: Bologna
country: Italy
facility: Azienda USL di Bologna
Study officials:
References:
citation: Licchetta L, Trivisano M, Baldin E, Mohamed S, Raschi E, Mostacci B, Zenesini C, Contin M, Vigevano F, Bisulli F, Tinuper P, Vignatelli L. TELEmedicine for EPIlepsy Care (TELE-EPIC): protocol of a randomised, open controlled non-inferiority clinical trial. BMJ Open. 2021 Dec 3;11(12):e053980. doi: 10.1136/bmjopen-2021-053980.
Clinical trial NCT05626010: Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy
Official title: Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Disease
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after thyroidectomy.

Detailed description: Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after thyroidectomy. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed

Eligibility criteria: Inclusion Criteria:

* the patients undergoing scheduled thyroidectomy
* American Society of Anesthesiologists status 1 or 2

Exclusion Criteria:

* refusal to be enrolled in the study
* emergency surgery
* hepatic or renal disease
* on chronic pain medications
* psychiatric disorders
* pregnancy, lactation
* allergy or contraindication to the study drug

Primary outcomes:
measure: postoperative pain
timeFrame: during 30 minutes after surgery
Secondary outcomes:
measure: pain killer requirement
timeFrame: during 30 minutes after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: youngeun moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01936610: the Effect of Instructional Method on Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pregnancy
Keywords: Lecture
Role-playing
Knowledge
Attitude
Decision making
Type of delivery
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 67
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week were selected using multi-stage sampling and assigned into two groups randomly. Decision-making (before, two weeks after and at admission in maternity department) was tested by a researcher -made questionnaire. In experiment group, advantages and disadvantages of normal delivery and cesarean-section delivery were presented by role-playing in three 90-min scenarios. It was also presented in a 90-min lecture. Data were analyzed using SPSS by mean difference test, exact fisher test, independent t-test and paired t-test.


Eligibility criteria: Inclusion Criteria:

primipara , single pregnancy , gestational age of 34-36 weeks ,age of 18-35 years old, no history of infertility, no indication for cesarean section, no passing educational course for delivery methods

Exclusion Criteria:

medical condition in pregnant woman, diagnosis of abnormal fetus / no possibility for delivery fetus by sonography, abnormal volume of amniotic fluid or placenta

Primary outcomes:
measure: Decision making
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00519610: Assessing Outcome After H-graft Shunt Placement
Official title: A Study Assessing Patient Outcomes After Placement of H-graft Portacaval Shunts for the Treatment of Portal Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Keywords: portal hypertension, H-graft shunt
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2007-08-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with portal hypertension

Brief summary: The objective of this study is to evaluate the pre-operative symptoms and medical history of patients with portal hypertension who have undergone placement of H-graft portacaval shunts and correlate this with patient outcomes.

Detailed description: Research data will be collected by accessing the Tampa General Hospital medical record charts as well as the Harbourside medical charts, and extracting the necessary research data. The charts will be reviewed for the relevant medical information in order to assess outcomes in patients having H-graft shunts placed for the treatment of portal hypertension.

Eligibility criteria: Inclusion Criteria:

* Patients who have had H-graft shunts placed for the treatment of portal hypertension.

Exclusion Criteria:

* Patients under the age of 18 will not be included in this study.

Primary outcomes:
measure: The objective of this study is to evaluate the pre-operative symptoms and medical history of patients with portal hypertension who have undergone placement of H-graft portacaval shunts and correlate this with patient outcomes.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital/University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Alexander S Rosemurgy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529810: Characteristics and Consequences of Coronary Angiograms Performed in Intensive Care Patients
Official title: Characteristics and Consequences of Coronary Angiograms Performed in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Coronary angiography
Cardiogenic shock
Cardio-respiratory arrest
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) hospitalized in Intensive Medicine - Resuscitation between January 1, 2015 and January 1, 2020 in whom a coronary angiography was performed.

Brief summary: Coronary angiography is a key examination in the management of many patients hospitalized in intensive care units. The most frequent indication remains the performance of a gesture of unblocking of part of the coronary network in the context of an acute coronary syndrome (ACS) complicated by cardiogenic shock (CS) and/or cardiac arrest. cardio-respiratory (ACR). However, there are other indications in intensive care, in particular for diagnostic purposes. Given the lack of harmlessness of this procedure in itself and the consequences of intra-hospital transport outside intensive care units for patients who are sometimes very unstable, the risk-benefit balance before performing a coronary angiography requires always be properly assessed by the resuscitating physician.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Patients hospitalized in Intensive Medicine - Resuscitation between January 1, 2015 and January 1, 2020 in whom a coronary angiography was performed.
* Patient not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

• Patient who has expressed his opposition to the reuse of his data for scientific research purposes.

Primary outcomes:
measure: Number of complications occurring in the 3 days following the performance of a coronary angiography during their stay in the intensive care unit
timeFrame: 3 days following the performance of a coronary angiography during their stay in the intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France
Study officials:
References: