louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01387191: Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
Official title: Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 748
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection

Brief summary: The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;

1. Unknown adverse reactions (especially, significant adverse reactions)
2. Adverse reaction onset status under practical drug use conditions
3. Factors possibly influential on safety
4. Factors possibly influential on efficacy
5. Patient's prognosis, efficacy and safety in long-term use


Eligibility criteria: Inclusion Criteria:

* Subjects with cardiovascular disease

Exclusion Criteria:

* Subjects with hypersensitivity to epoprostenol
* Subjects with right cardiac failure during an acute exacerbation
* Subjects with severe left ventricular systolic dysfunction
* Subjects with serious left ventricular dysfunction
* Subjects whose pulmonary edema getting worse during dose initiation

Primary outcomes:
measure: The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05344391: BFR Training on a Bike to Augment RC Strength, Leg Strength, and VO2 Peak
Official title: Can BFR Training on a Bike Augment RC Strength, Leg Strength, and VO2 Peak
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Can BFR Cycling Augment Strength and VO2peak
Lead sponsor: George Fox University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate if subjects who bike at 40% of heart rate reserve (HRR) with blood flow restriction (BFR) applied to bilateral thighs for 10 minutes (at 80% limb occlusion pressure) will experience greater gains in 10 rep max for dominant lower extremity leg press, greater gains in rotator cuff strength (hand held dynamometer testing for supraspinatus and external rotators) and greater gains in VO2 peak.

Detailed description: This study will randomize healthy adult subjects to one of two groups: a BFR biking group that performs 10 min of cycling at 40% heart rate reserve (HRR) with bilateral occlusion applied to the proximal thighs (80% LOP) or to a non-biking BFR group perform 10 min of cycling at 40% HRR. After each cycling session subjects will perform 3x15 of the scaption exercise and 3x15 sidelying external rotation with their dominant upper extremity. They will initially start training the shoulder at 30% of 1RM (estimated from an equation formula) for the first 2 weeks followed by increasing training load by 1lbs each exercise every 2 weeks. The training program will last 6 weeks (3x week for 6 weeks, total of 18 sessions).

Pretest and posttests will include: VO2 peak testing on a cycle using Cosmed metabolic cart, hand held dynamometry to measure strength of the supraspinatus and external rotators of the shoulder using traditional manual muscle test positions, and on a separate day 10RM testing on a leg press for the dominant lower extremity.

Eligibility criteria: Inclusion Criteria: healthy adults (18 yrs of age and older) -

Exclusion Criteria: no current musculoskeletal symptoms/injuries; no prior lower extremity or shoulder/upper extremity surgery (dominant) during the prior year; no contraindications to BFR training

-

Primary outcomes:
measure: VO2peak
timeFrame: 6 weeks
measure: Shoulder Strength
timeFrame: 6 weeks
measure: 10 RM unilateral leg press for the dominant lower extremity
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newberg
country: United States
facility: College of Physical Therapy / George Fox University
state: Oregon
city: Newberg
country: United States
facility: George Fox University School of Physical Therapy
state: Oregon
Study officials:
affiliation: George Fox University
name: JASON BRUMITT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06505291: Long-term Management of Patients With Ruptured HCC
Official title: Long-term Management of Patients With Ruptured HCC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with ruptured hepatocellular carcinoma

Brief summary: The main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008.

Detailed description: Retrospective, observational, multicenter study over the period from January 2008 to April 2024.

Cases had to be 18 years or older. They were identified by two different methodologies adapted to the 4 participating centers. In particular, a request for ICD10 C22.0 (CHC) codes associated with K66.1 (hemoperitoneum) was carried out by the medical information departments (DIM) of the Caen University Hospital and the Avicenne hospital. Secondly, the automated keyword selection tools "Cohort 360" and "i2b2" were used at the La Pitié Salpetrière and Paul Brousse hospital centers to identify the terms "CHC" and "ruptured" in the computerized patient files. Secondarily, duplicates and coding errors were excluded.

Eligibility criteria: Inclusion Criteria:

* Ruptured hepatocellular carcinoma with or without cirrhosis

Exclusion Criteria:

* Liver adenoma without histologically proven HCC
* Other benign or malignant liver tumors
* ATCD of potentially triggering interventional procedure in the previous month.
* Hemorrhagic ascites without tumor
* Intratumoral hemorrhages without hemoperitoneum or capsular rupture

Primary outcomes:
measure: Survival after rupture of hepatocellular carcinoma
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00872391: Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
Official title: Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uveal Melanoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of hypofractionated stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for the planning target volume (PTV) in patients with uveal melanoma. Patients will be followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity, secondary complications and survival.


Eligibility criteria: Inclusion Criteria:

* The initial height of the melanoma is 7 mm or higher.
* Juxtapapillary and/or juxtamacular melanomas with a height of 3 mm or higher and if the central tumor distance to the optic disc and/or the macula is 3 mm or less.
* If other forms of conservative treatment of the melanoma are not possible.

Exclusion Criteria:

* Prior/Concomitant Treatment.
* Extrascleral tumor extension is present.
* If the presence of neovascular glaucoma is detected before treatment.
* If metastasis is detected at baseline.
* Previous participation in any study of investigational drugs within 3 month preceding day 0.
* Pregnant women are not allowed to participate in the study.

Primary outcomes:
measure: local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary outcomes:
measure: histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna
Study officials:
affiliation: Department of Ophthalmology, Medical University of Vienna, Austria
name: Martin Zehetmayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267991: Corneal Densitometry Changes With Adenoviral SEI
Official title: Corneal Densitometry Changes With Adenoviral Keratoconjunctivitis Sub Epithelial Infiltrates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Disease
Keywords: adenoviral
infiltrates
PTK
tacrolimus
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 patients with adenoviral SEI

Brief summary: Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation.

Detailed description: first group of patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.S econd group underwent transepithelial PTK for subepithelial infiltrates. Baseline and post-treatment full ophthalmic examination was done.

Eligibility criteria: Inclusion Criteria:

* adenoviral SEI

Exclusion Criteria:

* Other corneal diseases

Primary outcomes:
measure: changes of corneal densitometry
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine
name: TAREK R ELHAMAKY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elhamaky TR. Pentacam corneal densitometry-guided treatment of adenoviral corneal subepithelial infiltrates: a comparative study between transepithelial phototherapeutic keratectomy and topical tacrolimus. Int Ophthalmol. 2021 Jan;41(1):67-77. doi: 10.1007/s10792-020-01553-8. Epub 2020 Aug 27.
Clinical trial NCT05564091: Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Official title: Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: Canaloplasty
Lead sponsor: Nova Eye, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nova Eye Medical GmbH
First posted: 2022-10-03
Enrollment: 78
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate, primary open angle glaucoma
* Characteristics consistent with mild to moderate glaucoma
* Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
* Visually significant cataract

Exclusion Criteria:

Any of the following prior treatments for glaucoma (study eye):

* Laser Trabeculoplasty
* Endocyclophotocoagulation (ECP) or Micropulse laser
* iStent or iStent Inject
* Hydrus Microstent
* Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
* Prior canaloplasty (ab-interno and ab-externo)
* Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
* Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
* Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
* Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma

Primary outcomes:
measure: Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
timeFrame: 12 months
measure: Reduction in number of glaucoma medications at 12 months compared to baseline
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline
timeFrame: 24 months
measure: Reduction in glaucoma medications at 24-months compared to baseline
timeFrame: 24 months
Other outcomes:
Locations:
city: Sugar Land
country: United States
facility: Berkeley Eye Center
state: Texas
city: Bonn
country: Germany
facility: University of Bonn Eye Clinic
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Köln
country: Germany
facility: Augencentrum Köln Ophthalmology
Study officials:
affiliation: Augencentrum Köln Ophthalmology
name: Norbert Koerber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06221891: Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography
Official title: Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Left Ventricular Systolic Dysfunction
Keywords: first phase ejection fraction;left ventricular systolic dysfunction;echocardiography;chronic kidney disease
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.

Brief summary: The goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are:

1. If first-phase ejection fraction（EF1）could early detect the left ventricular systolic dysfunction in patients with CKD.
2. Whether EF1 can detect left ventricular systolic dysfunction in patients with CKD more sensitively than speckle-tracking echocardiography and myocardial work.

Participants will need to cooperate to do an echocardiography. Researchers will compare healthy volunteers and patients with CKD to see if EF1 could early detect the left ventricular systolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
* LVEF≥50%.

Exclusion Criteria:

* Patients with primary hypertension, diabetes and congenital heart disease.
* Patients who are pregnant or lactating.
* Patients with the blurry ultrasound images.

Primary outcomes:
measure: first-phase ejection fraction
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03508791: Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide
Official title: Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilation Perfusion Mismatch
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery.

Detailed description: Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery. Arterial carbon dioxide partial pressure is assessed intermittently before, during, and after pneumoperitoneum. End-tidal and transcutaneous carbon dioxide partial pressure are continuously monitored.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing laparoscopic surgery (expected duration of pneumoperitoneum \> 1 hour) in the Trendelenburg or reverse Trendelenburg positions

Exclusion Criteria:

* hemodynamically unstable patients due to decompensated heart failure, sepsis, or symptomatic arrhythmia, etc.
* symptomatic pulmonary disease, chronic obstructive pulmonary disease

Primary outcomes:
measure: Difference between arterial and end-tidal carbon dioxide pressures
timeFrame: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Secondary outcomes:
measure: Agreement among arterial, end-tidal, and transcutaneous carbon dioxide partial pressure
timeFrame: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05304091: Characterization of Rhythmicity Profiles of Bradykinin-mediated Angioedema Attacks Using a Tracking Smartphone Application.
Official title: Rhythmicity Profiles of Bradykinin-mediated Angioedema.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bradykinin-mediated Angioedema
Keywords: Bradykinin
Angioedema
Smartphone
Application
Attack
Hereditary angioedema
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital.

Brief summary: Bradykinin-mediated angioedema is a rare and disabling disease, characterized by the occurrence of attacks marked by localized swelling of skin, but also of the airways, which can be life-threatening. The unpredictable nature of attacks is a key feature of angioedema, placing patients under constant threat. It seems that there are different patterns of yearly distribution for these attacks, but this is poorly described in the literature. The objectives of the study are to establish different rhythmicity profiles of patients according to the frequency of the attacks; and to identify factors potentially triggering the attacks. For this purpose, patients with bradykinin-mediated angioedema will be monitored daily using a smartphone application. Each day, the application will ask the patient if he or she is having an attack and, if so, the characteristics of the attack and the events preceding it


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bradykinin-mediated angioedema
* Age \> 18
* Having a smartphone
* Non opposition to answer the questionnaire

Exclusion Criteria:

* Patients with other type (histaminergic) angioedema
* Patient unable or unwilling to use a smartphone application
* Opposition to the research
* Minor or protected adult
* Person deprived of liberty

Primary outcomes:
measure: Average number of bradykinin-mediated angioedema attacks
timeFrame: Follow up during 1 year
Secondary outcomes:
measure: The average number of attack by time of year (months, seasons)
timeFrame: Follow up during 1 year
measure: The average duration of an attack episode
timeFrame: Follow up during 1 year
measure: The average duration between two attacks
timeFrame: Follow up during 1 year
measure: Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures and characteristics of these clusters in each and every cluster.
timeFrame: After a year of follow up
measure: Individual number of crisis
timeFrame: After a year of follow up
measure: Type of attack triggering events
timeFrame: After a year of follow up
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Sébastien SANGES, MD
role: PRINCIPAL_INVESTIGATOR
References: