louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03622450: The Effect of Colistin Inhalation on Ventilator Associated Pneumonia
Official title: The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2018-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria


Eligibility criteria: Inclusion Criteria:

* Age 18 years

Patients presenting with signs of infection 48 hours of intubation

Exclusion Criteria:

* Patients with documented bronchiectasis

Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.

Patients with creatinine clearance less than 30ml/min.

Primary outcomes:
measure: Assessment of Ventilatory status
timeFrame: 7 to 10 days
Secondary outcomes:
measure: Days of mechanical ventilation
timeFrame: 35 Days
measure: Time till the occurence of sepsis
timeFrame: 35 Days
measure: Mortality as an outcome of long stand untreatable ventilator associated pneumonia
timeFrame: 35 days
measure: Length of stay in the icu
timeFrame: 35 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04132050: A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Official title: A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.


Eligibility criteria: Inclusion Criteria:

* Japanese patients
* Patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent
* Patients with a platelet count averages \<30000/μL during screening period. Each platelet count should not exceed 35000/μL.
* Patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of ITP before informed consent (with or without splenectomy)

Exclusion Criteria:

* Patients with thrombocytopenia associated with other disease
* Patients with autoimmune hemolytic anemia
* Patients with poorly controlled hypertension
* Patients with a history or active coagulopathy

Primary outcomes:
measure: Percentage of patients with stable platelet response
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of patients with overall response
timeFrame: 12 weeks
measure: Duration of maintained platelet count
timeFrame: 52 weeks
measure: Percentage of patients with a platelet count ≥50000/μL
timeFrame: Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years
measure: Percentage of patients with a platelet count increase ≥20000/μL above baseline and ≥30000/μL
timeFrame: Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01370850: Clinical Validation Study of RTVue Features
Official title: Clinical Validation Study of RTVue Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Glaucoma
Keywords: Retina pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with various ocular pathology or no ocular pathology

Brief summary: To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Detailed description: Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

Eligibility criteria: Inclusion Criteria:

* Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
* Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
* Retina patients will have clinical exam results consistent with retina pathology.

Exclusion Criteria:

* Normal subjects will be free of any ocular pathology.
* Glaucoma patients will be free of any ocular pathology except glaucoma.
* Retina patients will be free of any ocular pathology except any type of retina pathology.

Primary outcomes:
measure: Retina measurement
timeFrame: at time of study visit (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Daly City
country: United States
facility: Pacific Eye Specialists
state: California
Study officials:
affiliation: Optovue
name: Mike Sinai, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06933550: PREMEDICAL is a Clinical Investigation Aiming to Create a Data Basis That Can be Used to Enrich Information Collected in the Course of the Classic Patient Journey. Patients in the Emergency Department Will be Asked to Answer Patient-related and Symptom-oriented Questions. Minimum Age is 18 Years
Official title: FFG PREMEDICAL (Clinical Investigation of a Medical Device According to MDR Article 82, Para.1 and Austrian Law §13 Para. 3 MPG, BGBI. I No. 122/2021 - Study Without Influence on Diagnostics/Therapy)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emergency Department Triage
Keywords: XUND
emergency department
symptom check
patient journey
Lead sponsor: XUND Solutions GmbH
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Graz
First posted: 2025-04-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German speaking, at least 18 years old, all gender patients in the emergency department (triage category 3, 4, or 5).

Brief summary: The goal of this clinical investigation is to create a new type of data basis that can be used to enrich information collected in the course of the classic patient journey, such as medical history forms and discharge letters. Therefore, it is planned to collect new, patient-related and symptom-oriented data on site and directly from patients in the emergency department (female/male; at least 18 years old).

The main question it aims to answer is:

- Can a detailed medical history with additional enriched information from XUND improve the quality of outpatient care?

Selected patients in the waiting area of the emergency department will record their symptoms on a tablet and answer the questions asked about their symptoms.


Eligibility criteria: Inclusion Criteria:

* a signed informed consent form;
* signed consent and admission to the emergency department of the emergency medicine clinic
* Triage category 3, 4 or 5 based on the triage procedure according to the Manchester triage system used in Austria
* the physical and mental ability to operate the tablet and answer the questions
* 18 years of age or older;
* knowledge of the German language.

Exclusion Criteria:

* not meeting all inclusion criteria

Primary outcomes:
measure: XUND Symptom Checker
timeFrame: through investigation completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medizinische Universität Graz, Universitätsklinik für Chirurgie
name: Lars-Peter Kamolz, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06875050: Antioxidant Supplements in Cystic Fibrosis Children
Official title: Effect of Antioxidant Supplements on Oxidative Stress, Disease Severity and Bacterial Infection in Cystic Fibrosis Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis (CF)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled clinical trial included 60 pediatric patients with cystic fibrosis (CF) assigned randomly into two arms; Arm 1(extra care arm):received a tailored dietary plan following Mediterranean diet to cover macronutrients needs according to recommended daily allowance (RDA) for age, with antioxidant supplements in specific doses in oral liquid form (200 mg vitamin E, 300 mg vitamin C, 90 μg Se, 500 μg vitamin A, 30 mg zinc, 3 mg copper and 2000 IU vitamin D) for 6 months. Arm 2: recieved tailored dietary plan following Mediterranean diet as Arm 1 with fat soluble vitamins supplementation (150 μg vitamin A, 2000 IU vitamin D, 100 mg vitamin E and 1000 μg vitamin K) for 6 months. This study aimed to evaluate the effect of antioxidants supplementation on the level of oxidative stress, as measured by 3-Nitrotyrosine, bacterial colonization and diseases severity among CF children.


Eligibility criteria: Inclusion Criteria:

* Patients with documented diagnosis of cystic fibrosis (CF) who were diagnosed according to CF Foundation guidelines based upon positive sweat tests and/or the presence of a mutation in the homozygous state or two heterozygous mutations on the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein

Exclusion Criteria:

* Patients with current pulmonary exacerbations.
* Patients with severe sepsis.
* Patients with comorbid systemic illnesses.

Primary outcomes:
measure: evaluate the effect of antioxidants supplementation on the level of oxidative stress among CF children..
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04388150: Efficacy of Narrow Band Spectrum Endoscopy for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis
Official title: Efficacy of Narrow Band Spectrum Endoscopy Versus Histopathology for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Antral Vascular Ectasia
Keywords: Narrow Band
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all cirrhotic patients undergoing Upper gastrointestinal endoscopy and they have antral erosions by endoscopy

Brief summary: the study aims to evaluate the role of similar technology of Narrow Band Imaging VIST video intelligent staining technology in the diagnosis of Gastric Antral Vascular ectasia in cirrhotic patients

Detailed description: VIST (Video intelligent staining technology) is used to the diagnosis of GAVE as the form of ectatic vessels in the antrum in instead of erosions in the antrum by White light endoscopy which can mislead the diagnosis to Portal hypertension gastropathy. Targeted biopsies are taken and examined histopathologically in order to see if matching with VIST view. In addition, CD61 is used to highlight the diagnosis for more confirmation. CD61 is an immunohistochemistry platelets marker.

Eligibility criteria: Inclusion Criteria:

* Patients with mucosal vascular lesions at the gastric antrum suspicious of GAVE of a linear striped form or a diffuse punctate form upon conventional WLE

Exclusion Criteria:

* Connective tissue disorders like systemic sclerosis.
* Chronic kidney disease.
* Recent use of proton pump inhibitors in the last 14 days.
* History of gastric surgery or gastric cancer.
* Pernicious anemia.
* Recent history of non-steroidal anti-inflammatory drugs intake

Primary outcomes:
measure: Efficacy of Narrow Band Spectrum endoscopy for the diagnosis of Gastric antral vascular ectasia in cirrhotic patients
timeFrame: it is estimated to be 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Internal Medicine, Hepatology Unit. Faculty of Medicine, Alexandria University
Study officials:
affiliation: Alexandria University
name: Randa Salah Eldin Abdelmoneim, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03580850: MRI Scan and Intra-labyrinthine Schwannoma
Official title: INTEREST OF INTRAVENOUS INJECTION OF GADOLINIUM IN EXPLORATION INTRA-LABYRINTHINE SCHWANNOMA IN MRI 3 TESLAS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schwannoma
Keywords: intra labyrinthine schwannoma
schwannoma
magnetic resonance imaging (MRI)
gadolinium
T2 weighted gradient echo
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having intra-labyrinthine schwannoma

Brief summary: Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Have intra-labyrinthine schwannoma
* Have benefited from an MRI with gadolinium injection on the MRI 3T with interpretable sequences of good quality
* Subject giving their consent for their participation
* Subjects who benefited, between 2009 and 2016, from an MRI of the external auditory canals, with gadolinous product injection and on the 3 Tesla MRI, in which a diagnosis of intra labyrinthine schwannoma was made

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA alone
timeFrame: 1 hour after the realization of the MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Francis VEILLON, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01056250: SILS Cholecystectomy: Cholangiography of the Biliary Tract
Official title: Performing Cholangiography During SILS Cholecystectomy: is it Feasible?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Keywords: cholelithiasis
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* cholecystolithiasis

Exclusion Criteria:

* acute cholecystitis

Primary outcomes:
measure: Feasibility of cholangiography during SILS cholecystectomy
timeFrame: at operation
Secondary outcomes:
measure: biliary tract injury
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: St John of God Hospital
Study officials:
affiliation: St John of God Hospital, Vienna
name: Bernhard Dauser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03773250: A FAMILY Program for Childhood Overweight and Obesity
Official title: A FAMILY Program for Childhood Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 164
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Childhood overweight and obesity is a health problem with lifelong implications related to diabetes, hypertension, cardiovascular disease, psychological disorders as well as other chronic conditions.

Detailed description: In Taiwan, the nationwide prevalence of overweight and obesity among school-age children aged 7 to 11 years has also increased over the past years. Sleep and weight are intricately related. School-age children requires at least 10 hours of sleep per night but children in Asian countries are on average obtaining shorter sleep than children in Caucasian countries.

Eligibility criteria: Inclusion Criteria:

* Children with overweight and obesity

Exclusion Criteria:

* Children with any other chronic or acute medical conditions

Primary outcomes:
measure: Child BMI-for-age z-score
timeFrame: Change from baseline to 12 months post intervention
Secondary outcomes:
measure: Child BMI
timeFrame: Change from baseline to 12 months post intervention
measure: Child percent body fat
timeFrame: Change from baseline to 12 months post intervention
measure: child sleep duration and sleep efficiency
timeFrame: Change from baseline to 12 months post intervention
measure: Parental sleep quality
timeFrame: Change from baseline to 12 months post intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Shao-Yu Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139450: Study of 0417 Ointment in the Treatment of Atopic Dermatitis
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 899
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent Body Surface Area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis

Primary outcomes:
measure: Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region
timeFrame: Baseline, 4 weeks
measure: The Mean Change From Baseline in Pruritus
timeFrame: Baseline, 4 weeks
measure: The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Melville
country: United States
facility: Fougera Pharmaceuticals Inc.
state: New York
Study officials:
References:
Clinical trial NCT03865550: Post-op Ketamine Study
Official title: Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* 18 - 85 years of age
* ASA I - IV
* Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia

Exclusion Criteria:

* BMI over 40\*
* Contraindication or allergy to opioid pain medication or ketamine\*
* Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg\*
* Ejection fraction (EF) less than 30%
* Creatinine clearance less than 30 mL/min\*
* History of chronic liver failure
* Desire for nerve block or general anesthesia
* Any neurologic or psychiatric disorder (including bipolar disorder, post traumatic stress disorder, schizophrenia)
* Prior surgery on ipsilateral knee within the last 6 months
* Alcohol abuse

Primary outcomes:
measure: Pain as reported on Visual Analog Scale
timeFrame: Up to 6 weeks post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References: