louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04570787: Bladder Catheterization After Mini-PCNL
Official title: Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Keywords: Urolithiasis
PCNL
Bladder catheterisation
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients

Inclusion Criteria:

* age from 18 to 70 years
* Indications for mini-PCNL
* ASA score: 1-3
* Single percutaneous access to pyelocaliceal system
* Size of solitary calculus up to 2.5 cm

Exclusion Criteria:

* Active urinary tract infection
* Coagulopathy
* Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)

Detailed description: 60 patients after PCNL will be recruited and randomized into 2 groups (30 vs 30):

* No Catheterization after mini-PCNL (study) - the bladder catheterization is not performed.
* Catheterization after mini-PCNL (control) - the bladder will be drained with the urethral catheter.

All patients will fill out the VASP in 2, 6, 12, 24 hours after mini-PCNL. Ultrasound examination of urinary bladder will be performed after mini-PCNL. All the AE will be registered.

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years
* Indications for mini-PCNL
* ASA score: 1-3
* Single percutaneous access to pyelocaliceal system
* Size of solitary stone up to 2.5 cm

Exclusion Criteria:

* Active urinary tract infection
* Coagulopathy
* Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)

Primary outcomes:
measure: To measure the level of pain in patients
timeFrame: 1 day
Secondary outcomes:
measure: To register the AE regarding catheterization or absence of catheterization
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov Saint Petersburg University
Study officials:
References:
Clinical trial NCT03157687: Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation
Official title: Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation Under Mixed Diet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Microbiome
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy controls patients with inflammatory bowel disease patients with liver disease (liver cirrhoses) and indication for LTX-evaluation

Brief summary: This study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.Therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. Additionally the bacterial composition of healthy persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis) will be compared to detect influence of local and systemic inflammation on microbiome.

Detailed description: A dysbiosis of human gut microbiome is discussed in the pathogenesis of many disorders, also including gastrointestinal (e.g. inflammatory bowel disease, IBD) or liver diseases (e.g. liver cirrhosis) . A detailed analysis of intestinal bacterial patterns might reveal important findings for understanding disease pathogenesis. Thereby many studies only analysed the luminal microbiome of stool samples, whereas mucosa-associated bacteria have possibly a greater impact on human health and immune system .

To determine the differences of luminal and mucosa-associated bacteria, stool and mucosa samples (via biopsies) will be collected. Thereby biopsies are taken of different intestinal locations (small intestine and colon) to detect variations along intestinal tract. An additional comparison of bacterial patterns in patients with chronic, local (IBD) and systemic inflammation (with liver cirrhosis) or without intestinal inflammations (healthy controls) should reveal the influence of microbiome on or by inflammation processes.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers with indication for cancer screening without gastrointestinal symptoms
* patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis)
* patients with indication for evaluation of liver transplantation (LTX)

Exclusion Criteria:

* other gastrointestinal disease, e.g. celiac disease, gastrointestinal tumors
* antibiotic treatment within 6 weeks before gastroscopy / colonoscopy

Primary outcomes:
measure: bacterial composition
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University hospital Erlangen
state: Bavaria
Study officials:
References:
Clinical trial NCT01179087: Sleep Disordered Breathing and Lung Transplantation
Official title: Sleep Disordered Breathing and Lung Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disordered Breathing
Lung Transplantation
Keywords: sleep disordered breathing
lung transplantation
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing lung transplantation

Brief summary: The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.

Detailed description: All patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled.

We collect:

* Medical history
* Blood pressure
* Anthropometrics
* Pulmonary function
* Arterial blood gas
* Questionnaire (QOL, ESS)
* Sleep diary
* Polysomnography

Eligibility criteria: Inclusion Criteria:

* Patients with end-stage respiratory failure who are referred for lung transplantation
* Informed consent from patient

Exclusion Criteria:

* Patients who are declined for lung transplantation
* Patients \< 18 years old

Primary outcomes:
measure: Prevalence of sleep disordered breathing
timeFrame: 1 month after lung transplantation
measure: Prevalence of sleep disordered breathing
timeFrame: 1 year after lung transplantation
Secondary outcomes:
measure: Pulmonary function
timeFrame: 1 year after lung transplantation
measure: Investigate possible relationship between SDB and patient medical history
timeFrame: 1 year after lung transplantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Bertien MA Buyse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00648687: Pain Response During Examination for Retinopathy of Prematurity
Official title: Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Keywords: prematurity
retinopathy of prematurity
pain
very low birth weight infants
Lead sponsor: National Bioethics Commission of Brazil
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). NIPS scale will be applied two minutes before examination and two minutes after examination.


Eligibility criteria: Inclusion Criteria:

* all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age

Exclusion Criteria:

* the ones that died before 6 weeks old

Primary outcomes:
measure: Pain secondary to eye examination
timeFrame: 2 minutes after the exam
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Renato S Procianoy, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa MC, Eckert GU, Fortes BG, Fortes Filho JB, Silveira RC, Procianoy RS. Oral glucose for pain relief during examination for retinopathy of prematurity: a masked randomized clinical trial. Clinics (Sao Paulo). 2013;68(2):199-204. doi: 10.6061/clinics/2013(02)oa13.
Clinical trial NCT00707187: Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
Official title: Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
scleroderma
raynaud phenomenon
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2008-06-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma


Eligibility criteria: Inclusion Criteria:

* Female with diagnosis of scleroderma
* Stable sexual relationship with male partner or be sexually active
* Raynaud phenomenon at least 6 times per week
* Willing to attempt sexual activity 1/month during study period

Exclusion Criteria:

* Severe internal organ problems related to scleroderma
* Other gynecologic problems
* Serious depression
* Receiving other experimental and Raynaud treatments

Primary outcomes:
measure: Number of Raynaud attacks
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ
state: New Jersey
Study officials:
References:
Clinical trial NCT05753787: Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
Official title: Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Surgical Injury
Healing Wound
Lead sponsor: Spektrum Center of Clinical Ophthalmology
Sponsor class: OTHER
Collaborators: name: Wrocław University of Science and Technology
First posted: 2023-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface.

The main question is to learn about an effect of preservatives on the eye surface. The study aims to answer some important questions:

* if the usage of preservatives has an impact on the eye surface healing process after cataract surgery
* if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops.

Participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state.

Researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.


Eligibility criteria: Inclusion Criteria:

* cataract surgery required defined previously by the eye-care specialist
* good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity)
* consent to the study protocol

Exclusion Criteria:

* diagnosed glaucoma
* diagnosed previous allergy
* diagnosed diabetic retinopathy or maculopathy
* previously diagnosed dry eye disease that requires treatment with multiple artificial tears
* permanent usage of the eye drops other than artificial tears
* non-compliance to the study protocol

Primary outcomes:
measure: Best corrected visual acuity result
timeFrame: up to 21 days post-surgery
measure: Ocular staining score result
timeFrame: up to 21 days post-surgery
measure: Ocular Surface Disease Index survey result
timeFrame: up to 21 days post-surgery
Secondary outcomes:
measure: Fluorescein Break-up Time assessment
timeFrame: up to 21 days post-surgery
measure: SICCA scale assessment
timeFrame: up to 21 days post-surgery
measure: Shirmer test 1 measurement
timeFrame: up to 21 days post-surgery
measure: Intraocular pressure measurement
timeFrame: up to 21 days post-surgery
measure: Anterior chamber cell intensity measurement
timeFrame: up to 21 days post-surgery
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Spektrum Clinic of Ophthalmology
Study officials:
affiliation: Spektrum Clinic of Ophthalmology
name: Maria Muzyka-Woźniak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02577887: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
Official title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Standard Bradycardia Pacing Indication
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 2101
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 a standard bradycardia pacing indication and implanted with a St. Jude Medical pacemaker

Brief summary: The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.

Detailed description: The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers.

The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.

Eligibility criteria: Inclusion Criteria:

* Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days.
* Patient is geographically stable and willing to comply with the required follow-up schedule.
* Patient is not pregnant or planning to become pregnant during the course of the study.
* Patient is \> 18 years of age

Exclusion Criteria:

* Patient's life expectancy is less than 1 year

Primary outcomes:
measure: Percentage of Participants With Complications in the General Pacemaker Population
timeFrame: 1 year
Secondary outcomes:
measure: Number of Subjects Programmed With Advanced Pacemaker Features
timeFrame: 1 year
measure: Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
timeFrame: 1 year
measure: Number of MRI Scans by Country
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: 114 Avenue d'Arès
city: Erlangen
country: Germany
facility: Kliniken der Friedrich-Alexander-Universität
city: Catania
country: Italy
facility: Via Palermo 636
city: Suita
country: Japan
facility: 2-15 Yamadaoka
Study officials:
affiliation: Abbott Medical Devices
name: Grant Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00915187: Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly
Official title: A Phase II Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly, a Double-blind Randomized, Controlled Single Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Vaccination, influenza prevention
Lead sponsor: NasVax Ltd
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol \[CCS/C\]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).


Eligibility criteria: Inclusion Criteria:

* 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
* able to comply with all the study requirements;
* in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
* Have adequate renal function (renal clearance of at \> 30ml/min)
* Have normal liver function (hepatic transaminases \[ALT and AST\] \< 43 U/L)
* Have hemoglobin \> 11.5 g/L

Exclusion Criteria:

* Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
* Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at \< 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
* Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination

Primary outcomes:
measure: Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate
timeFrame: Day 28 following vaccination
Secondary outcomes:
measure: Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate
timeFrame: Day 90 following vaccination
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital
Study officials:
affiliation: Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883387: CT-Angiography Prior to DIEP Flap Breast Reconstruction
Official title: CT-Angiography Prior to DIEP Flap Breast Reconstruction a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: DIEP flap
Deep inferior epigastric artery perforator flap
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 39
Sex: FEMALE
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: This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).


Eligibility criteria: Inclusion Criteria:

* Planning breast reconstruction with DIEP flap
* Age 18 to 75 years

Exclusion Criteria:

* Mild to moderate loss of kidney function (Estimated Glomerular Filtration Rate (eGFR) \< 60)
* Decisionally challenged
* Pregnant
* Hepatic failure

Primary outcomes:
measure: Total Operative Time
timeFrame: Time of incision to incision closure
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David W Mathes, MD
role: PRINCIPAL_INVESTIGATOR
References: