louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01508962: PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
Official title: PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Disease onset
Disease progression
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 100
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: People affected with ALS (either familial or sporadic) and healthy controls

Brief summary: The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.


Eligibility criteria: Inclusion Criteria

ALS group:

* Subject is a male or female, aged at least 18 years.
* Subject is affected with ALS (familial or sporadic).
* Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction.
* Subject is willing and able to comply with all study procedures.
* Subject agrees to provide signed and dated informed consent form.

Control group:

* Subject is a male or female, aged at least 18 years.
* Subject is not affected with ALS or an ALS-related disorder.
* Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder.
* Subject is willing and able to comply with all study procedures.
* Subject agrees to provide signed and dated informed consent form.

Exclusion Criterion

• Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere significantly with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Primary outcomes:
measure: Phenoconversion
timeFrame: Every three months over the course of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References:
Clinical trial NCT01441362: Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries
Official title: A Comparison of Two Methods for Intubation With Double-lumen Endobronchial Tube to Reduce Laryngeal Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Injuries
Keywords: during double-lumen
tube intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Preoperative hoarseness or sore throat
* History of upper airway diseases
* Anticipated difficult airway
* Operation time longer than 6 hours

Primary outcomes:
measure: postoperative hoarseness
timeFrame: up to 3 days
Secondary outcomes:
measure: postoperative sore throat
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Seo JH, Kwon TK, Jeon Y, Hong DM, Kim HJ, Bahk JH. Comparison of techniques for double-lumen endobronchial intubation: 90 degrees or 180 degrees rotation during advancement through the glottis. Br J Anaesth. 2013 Nov;111(5):812-7. doi: 10.1093/bja/aet203. Epub 2013 Jun 20.
Clinical trial NCT02424162: Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction \[MR\]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.


Eligibility criteria: Inclusion Criteria:

* age \>= 18
* cataract patients with lens opacities classification higher than grade III
* patients who desire to be spectacle indepence for distance and near vision

Exclusion Criteria:

* previous ocular surgery or trauma
* presence of corneal opacities
* fundus abnormalities
* glaucoma
* uveitis
* amblyopia
* systemic disease
* posterior capsule rupture during cataract surgery

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 months
Secondary outcomes:
measure: Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
timeFrame: 3 months
measure: internal aberration measured by the ray-tracing aberrometer
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06377462: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
Official title: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: VEXAS Syndrome
Keywords: VEXAS
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: University Hospital Munich
First posted: 2024-04-22
Enrollment: 500
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: * Planned recruitment: 20-30 patients/year
* Number of planned study centres: 15-20

Brief summary: The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers

Detailed description: see brief summary

Eligibility criteria: Inclusion Criteria:

* Patients with established or suspected (clinical and hematological criteria) VEXAS Syndrome
* Age ≥18 years
* Signed informed consent form

Exclusion Criteria:

* patients who are not in a position to understand the nature and scope of participation in this register

Primary outcomes:
measure: Collection of epidemiological data on VEXAS
timeFrame: enrollment
measure: Collection and monitoring of initial disease manifestations
timeFrame: 5 years
measure: Documentation of the treatment approaches and therapy sequences
timeFrame: 5 years
measure: Analysis of clinical-relevant clinical endpoints
timeFrame: 5 years
Secondary outcomes:
measure: Describe disease cluster
timeFrame: 5 years
measure: Laboratory diagnostics
timeFrame: 5 years
measure: Correlation clinical endpoints with treatment approaches
timeFrame: 5 years
measure: Quality of life data (QoL), fatigue questionnaire (Facit-F)
timeFrame: 5 years
measure: Accompanying translational research
timeFrame: 5 years
measure: Collection of Biospecimens
timeFrame: 5 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
Study officials:
affiliation: TU Dresden
name: Katja Sockel, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT02053662: Biomarker Identification for Bladder Cancer Patients
Official title: Biomarker Identification for Bladder Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 179
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 suspected muscle-invasive bladder cancer and appropriate control population

Brief summary: To develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. To develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after treatment. This will include looking for changes in proteins and genes that might play a role in bladder cancer biology. The investigators will then compare the information obtained from the studies of blood, urine and cancer tissue between patients that are cured and those whose cancer comes back. The knowledge about these differences between patients can then potentially be used to develop a blood or urine test to tell us who has a high risk for having bladder cancer come back.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years old.
* Patients suspected, clinically diagnosed, or histologically diagnosed bladder cancer.
* Patients undergoing cystoscopy without cancer suspicion.
* Ability to give an informed consent.

Exclusion Criteria:

* Patients receiving concurrent therapy for a second malignancy.
* \< 18 years old.
* Inability to give an informed consent.

Primary outcomes:
measure: Identify novel biomarkers for bladder cancer
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Ohio State University Cancer Center
name: Arna Chakravarti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03527862: Perioperative Lung Ultrasonography for Fast-track Cardiac Surgery
Official title: The Effect of Perioperative Lung Ultrasonography on Postoperative Outcomes in Children Undergoing Fast-track Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 35
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators evaluate the usefulness of lung ultrasonography in the perioperative period for postoperative outcomes in children undergoing fast track cardiac surgery.

Detailed description: Some appropriate intervention such as recruitment maneuver, chest tube insertion, or diuretics will be applied depending on lung ultrasound findings.

Eligibility criteria: Inclusion Criteria:

* Children receiving fast track cardiac surgery protocol
* = or \< 5 years old
* Children with acyanotic heart disease

Exclusion Criteria:

* Previous history of lung resection surgery
* Preoperative chest x-ray abnormalities
* Postoperative cyanosis

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Up to postoperative day 5
Secondary outcomes:
measure: Duration of the use of inotropes
timeFrame: Up to postoperative day 5
measure: Length of intensive care unit stay
timeFrame: up to postoperative day 5
measure: Lung ultrasonography findings
timeFrame: until 4 hours after surgery
measure: ABGA result
timeFrame: within 4 hours after extubation
measure: Duration of oxygen therapy
timeFrame: Up to postoperative day 5
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870662: A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
Official title: A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Ascites
Lead sponsor: NovaShunt AG
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 7
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 determine whether the Automatic Fluid Shunt (AFS) can reduce the number of paracentesis procedures in patients with refractory ascites.


Eligibility criteria: Inclusion Criteria:

* Female or male patients ≥ 18 years of age
* Removal of at least 10 L of ascites in the preceding 2 months for symptom relief
* Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
* Dietary sodium restriction \<90 mcg/d.
* Serum creatinine levels of less than 1.8 mg/dL for at least 7 days before study entry.
* Total bilirubin levels of less than 3 mg/dL.
* Expected survival of greater than 6 months
* Written informed consent

Exclusion Criteria:

* Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
* Presence of peritoneal carcinomatosis
* Evidence of extensive ascites loculation
* Obstructive uropathy
* Coagulopathy that could not be corrected to a prothrombin time INR \<1.8,
* Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
* Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
* Any condition requiring emergency treatment
* Pregnancy
* Inability to obtain informed consent

Primary outcomes:
measure: Number of paracentesis procedures required
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze
city: Prague
country: Czech Republic
facility: IKEM
Study officials:
References:
Clinical trial NCT03825562: Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
Official title: Acceptance and Value Based Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes / Hyväksyntä- ja Arvopohjaiset menetelmät Diabetesta Sairastavien Nuorten Hyvinvoinnin edistämisessä
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: type 1 diabetes
ACT
adolescents
value based methods
acceptance
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: University of Jyvaskyla
name: Finnish Diabetes Association
First posted: 2019-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to study how using acceptance and value based group intervention helps the wellbeing of teenagers with type in diabetes.

The investigators created an ACT-group intervention consisting of five sessions, based on earlier research. 12-16 years- old diabetics who are treated at KSSHP pediatric policlinic are invited to join the groups. The participants are randomized to research and control groups. The HbA1c-level is monitored for both groups as well as the psychological flexibility, diabetes related acceptance, depression and quality of life.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* weekly psychiatric appointments

Primary outcomes:
measure: Glycemic control
timeFrame: up to 8 months
Secondary outcomes:
measure: Quality of life assessed by KINDL-r Questionnaire
timeFrame: up to 8 months
measure: Diabetes Related Psychological flexibility assessed by DAAS
timeFrame: up to 8 months
measure: Depressive symptoms assessed by RBDI
timeFrame: up to 8 months
measure: Psychological flexibility assessed by CAMM
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Iina Alho
Study officials:
affiliation: supervisor
name: Raimo Lappalainen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05016362: Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty
Official title: Patient Satisfaction After Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eyelid Diseases
Keywords: upper eyelid pad fat
blepharoplasty
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 50
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: at least 18 years old participant with dermtochlasis

Brief summary: Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty

Detailed description: Blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery or orbitoglabellar groove

Eligibility criteria: Inclusion Criteria:

* upper eyelid medial pad of fat bulge

Exclusion Criteria:

* Other eyelid diseases and previous eyelid surgery

Primary outcomes:
measure: global aesthetic improvement scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine
name: Tarek Elahamky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05782062: Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage
Official title: Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dialysis Access Malfunction
Dialysis; Complications
Keywords: Thrombosis of dialysis access
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Argon Medical Devices
First posted: 2023-03-23
Enrollment: 0
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: The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. The wire like device is called the Cleaner XT and has already been approved by the government/Food and Drug Administration (FDA) for this purpose.

Blood clots in your dialysis access can be fairly common and prevent you from being able to get dialysis. Procedures for opening this blockage must then be performed which is why you have been sent to the hospital today. There are different ways of opening up this blockage which can including blowing up a balloon in multiple areas of the graft/fistula to squeeze the blood clot to break up the blockage or using a wire like device to break up the clot in small pieces and try to remove all of the clot from the wall of the graft/fistula.


Eligibility criteria: Inclusion Criteria:

* End stage renal disease on hemodialysis
* Age greater than 18
* Upper extremity dialysis graft/fistula

Exclusion Criteria:

* Pregnant
* Incarcerated
* Age under 18
* Inability to consent for self
* Graft/fistula in a location other than upper extremity
* Peritoneal dialysis
* Catheter dialysis

Primary outcomes:
measure: Secondary patency
timeFrame: 6 months post procedurally
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06035562: Promoting Positive Emotional Functioning in Police and Military Populations
Official title: Promoting Positive Emotional Functioning in Police and Military Populations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anhedonia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 65
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: This study will examine whether actively serving and veteran members of the Canadian Armed Forces (CAF) and Royal Canadian Mounted Police (RCMP) who complete a treatment targeting anhedonia symptoms and amplifying positive emotional processing: 1) experience significant symptom reductions in anxiety, trauma, and depressive symptoms; 2) report increased experience of positive emotions; 3) report improvements to broad functioning and quality of life; and 4) find the treatment to be highly tolerable.


Eligibility criteria: Inclusion Criteria:

* Be an actively serving or veteran member of the CAF and RCMP;
* Have been referred to receive the treatment protocol at the OSIC at Deer Lodge Centre by a doctor or psychologist;
* Have previously participated in at least one evidence-based psychological treatment for depressive, anxiety, or trauma-and-stressor-related condition at OSIC but remain clinically symptomatic;
* Be able to speak, read, and write in English;
* Have no current psychosis, untreated bipolar disorder, or current suicidal ideation with plan and intent;
* Be on a stable medication regime and agree to not make changes for the duration of the treatment.

Primary outcomes:
measure: Change in depression symptoms
timeFrame: 6 weeks
measure: Change in anxiety symptoms
timeFrame: 6 weeks
measure: Change in PTSD symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in positive and negative affect
timeFrame: 6 weeks
measure: Change in quality of life
timeFrame: 6 weeks
measure: Psychotherapy progress
timeFrame: 6 weeks
measure: Treatment acceptability
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
References: