louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00658944: Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence
Official title: Preoperative MUCP and VLPP Failed to Predict Long Term (4-Years) Outcome in Patients Who Underwent Transobturator Mid-Urethral Slings. a Prospective Observational Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence
Mixed urinary incontinence
surgery
trans obturator tape
Maximum urethral closure pressure
Valsalva leak point pressure
outcome
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stress or mixed urinary incontinence (stress component clinically predominant), defined according to ICS guidelines, associated or not with urethral hypermobility

Brief summary: To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak point pressure in predicting outcome in patients who underwent trans-obturator tape for the treatment of female stress urinary incontinence.

Detailed description: A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or \> 40 cmH20 and ≤ or \> 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

Eligibility criteria: Inclusion Criteria:

* Mixed urinary incontinence (stress component clinically predominant)

Exclusion Criteria:

* \> grade II uro-genital prolapse in any vaginal compartment
* Previous incontinence surgery
* Urine retention, neurogenic bladder, benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
* Active pelvic inflammatory disease
* Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
* Pregnancy or lactation; AND
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Department of Urology
Study officials:
affiliation: University Of Perugia
name: Elisabetta Costantini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05562544: EEG Diagnostic for Repetitive Sub-concussive Head Impacts
Official title: Development of an EEG Diagnostic for Repetitive Sub-concussive Head Impacts: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Spark Neuro Inc.
First posted: 2022-09-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Soccer players between 18 and 38 years old.

Brief summary: The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts.

Detailed description: This prospective study will investigate the potential effects of soccer ball heading on EEG and oculomotor measurements.

Eligibility criteria: Inclusion Criteria:

* 18 - 38 years of age.
* Have at least 1 year of experience playing soccer.
* Played soccer within the prior year.
* Head soccer ball during practice and/or games.

Exclusion Criteria:

* Subjects with a history of TBI during the prior 12 months.
* History of moderate or severe Traumatic Brain Injury (TBI).
* History of seizures.
* Medical or psychiatric history the precludes participation.
* Currently receiving treatment in another research study.
* History of a condition with vestibular, ocular, or vision dysfunction.

Primary outcomes:
measure: Change in EEG Signals
timeFrame: Baseline, 45 minutes post-heading, 24 hours post-heading
Secondary outcomes:
measure: Change in Eye Tracking Parameters
timeFrame: Baseline, 45 minutes post-heading, 24 hours post-heading
measure: Change in King-Devick Testing Scores
timeFrame: Baseline, 45 minutes post-heading, 24 hours post-heading
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Todd Schwedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03988244: HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF
Official title: Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the original HeartLight catheter in the treatment of persistent atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* early persistent AF, failure of at least one AAD, others

Exclusion Criteria:

* overall good health as established by multiple criteria

Primary outcomes:
measure: Ablation time
timeFrame: Acute - at the end of the index procedure
Secondary outcomes:
measure: Procedure time
timeFrame: Acute - at the end of the index procedure
measure: PV Isolation
timeFrame: Acute - at the end of the index procedure
measure: PAE Rate
timeFrame: 30 Days
measure: AF Free Rate
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
Study officials:
affiliation: CardioFocus, Inc.
name: Burke T. Barrett
role: STUDY_DIRECTOR
References:
Clinical trial NCT00231244: Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Official title: Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female patient minimum 18 years of age
2. There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
3. Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
4. Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;

Exclusion Criteria:

1. There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
2. The study target lesion has definite or possible thrombus present by angiographic criteria.

Primary outcomes:
measure: The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years.
timeFrame: 30 days, 6mo, 12mo, 2, 3, 4, and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: LaJolla
country: United States
facility: Scripps Clinic and Research
state: California
Study officials:
affiliation: Scripps Clinic and Research
name: Paul Teirstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa M, Angiolillo DJ, Teirstein P, Gilmore P, Leon M, Moses J, Yakubov S, Carter A, Fischell T, Zenni M, Bass T. Sirolimus-eluting stents for treatment of complex bypass graft disease: insights from the SECURE registry. J Invasive Cardiol. 2005 Aug;17(8):396-8.
Clinical trial NCT03849144: The Effect of a Therapy Dog Activity on Employees' Stress, Mood, and Job Satisfaction and Commitment
Official title: The Effect of a Therapy Dog Activity on Employees' Stress, Mood, and Job Satisfaction and Commitment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress
Mood
Job Satisfaction
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Pet Partners
name: Aetna, Inc.
First posted: 2019-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of the current study is to determine if participating in a therapy dog activity is associated with changes in perceived stress, mood, and job satisfaction and commitment. A secondary goal is to explore a potential dose effect of multiple treatments as well as control for novelty effect.

Detailed description: This study will be conducted at Aetna Headquarters in Hartford, Connecticut. A pre-post repeated measures design will be used to compare study participant outcomes between a treatment (therapy dog activity) and comparison (low impact physical activity) condition. Outcome variables of interest are perceived stress measured by a stress visual analog scale (SVAS), mood measured by the Positive and Negative Affect Scale (PANAS), and job satisfaction and commitment measured by an investigator-developed Job Satisfaction Survey (consisting of a combination of existing validated scales). Pet ownership, attitudes toward dogs measured by the Dog Attitude Scale, and trait stress, measured by the Perceived Stress Scale, will be assessed as moderating variables.

Eligibility criteria: Inclusion Criteria:

* Current Aetna employees

Exclusion Criteria:

* Individuals not employed by Aetna. Note:employees are self-selecting to participate, therefore dog fears or allergies are not listed as exclusion criteria.

Primary outcomes:
measure: Single Item Stress Measure
timeFrame: Baseline to week 3
measure: 20-item Positive and Negative Affect Schedule
timeFrame: Baseline to week 3
Secondary outcomes:
measure: Single Item Stress Measure
timeFrame: Baseline to week 5
measure: 20-item Positive and Negative Affect Schedule
timeFrame: Baseline to week 5
measure: 9-item Job Satisfaction and Commitment Scale
timeFrame: Baseline to week 5
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Sandra Barker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881244: Study of AS1411 in Advanced Solid Tumours
Official title: Phase I Open Label Study of AS1411 in Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Antisoma Research
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I open label study of AS1411 in advanced solid tumours. Objectives include determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain preliminary evidence of clinical and biological responses to AS1411 therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced solid tumours that were refractory to conventional/standard treatment
* Age \>/ 18 years
* ECOG performance status \</ 2 (Karnofsky \>/60%
* Life expectancy \>/ 8 weeks
* Adequate organ and marrow function

Exclusion Criteria:

* Radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for nitrosourea or mitomycin C
* Lack of recovery from adverse events (AEs) caused by agents administered before study entry; current use of other investigational agent(s)
* Uncontrolled brain metastases including a need for corticosteroid therapy
* Pregnancy
* Uncontrolled intercurrent illness
* Psychiatric illness/social situations that could limit compliance

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of AS1411
Secondary outcomes:
measure: To determine the pharmacokinetic (PK) distribution and profile of AS1411
measure: To obtain preliminary evidence of clinical and biological responses to AS1411
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center, University of Louisville
state: Kentucky
Study officials:
References:
Clinical trial NCT06523244: Comparing Photodisinfection of Chitosan NP Enriched ICG Over ICG as Adjunct to OFD: RCT
Official title: Comparison of Photo Disinfection With Chitosan Nanoparticles Enriched ICG Over ICG as an Adjunct to Open Flap Debridement in Stage II/III Grade B/C Periodontitis. RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontal Pocket
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis.

Detailed description: A total of 24 patients fulfilling inclusion criteria will be randomly assigned into two treatment groups (Test and Control). Open flap debridement followed by photodynamic therapy using dyes is carried out.

Test group (n=12) - PDT with Chitosan nanoparticles enriched ICG Control group(n=12) - PDT with ICG Microbial levels of P.gingivalis is analysed with PCR analysis on baseline and 3 months after intervention.

Eligibility criteria: Inclusion criteria:

* Systemically healthy subjects
* Age group 30-55yrs.
* Diagnosed with Stages II/III grade B/C periodontitis.
* Presenting with persistent pocket depth ≥5mm after initial non-surgical therapy.
* Optimal plaque control
* Good compliance

Exclusion criteria:

* Subjects on antibiotic therapy within last six months of enrollment
* Previous history of periodontal surgery
* Allergy to drugs and materials used in this study
* Pregnant woman
* Subjects with deleterious habits like smoking, tobacco chewing.

Primary outcomes:
measure: MICROBIAL ANALYSIS
timeFrame: 3 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05401344: The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective
Official title: The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Self Evaluation
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 23
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Overall, 20 patients (13 men and seven women) with dry nose and 100 controls (47 men and 53 women) were recruited for the study. The ages of the participants ranged from 23 to 73 years (mean = 47.7 years).

Brief summary: In the present study, we propose objective diagnostic criteria for dry nose (DN) and investigate its characteristics. Questionnaires were completed by each participant during recruitment to record demographic data. DN test strips were used to evaluate the severity of DN at five time points and allergic status was assessed based on serum sIgE levels. Nasal secretions were collected and vasomotor rhinitis was diagnosed using the cold dry air test. The diagnosis of allergic rhinitis (AR) was based on the criteria of the Allergic Rhinitis and its Impact on Asthma consensus statement. Data are expressed as median and interquartile range, unless otherwise specified. Statistical significance was set at P \< 0.05. The reference range (RR) of the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were determined for each test strip length at each time point. This study aimed to investigate the characteristics of and propose objective diagnostic criteria for DN.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of dry nose patients.

Exclusion Criteria:

* chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.

Primary outcomes:
measure: The length of the test strip.
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yifan Meng
state: Beijing
Study officials:
References:
Clinical trial NCT06969144: Subtotal Cholecystectomy for Difficult Gall Bladder Due to Chronic Cholecystitis
Official title: Subtotal Cholecystectomy for Difficult Gall Bladder Due to Chronic Cholecystitis: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 1149
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing laparoscopic cholecystectomy

Brief summary: Subtotal cholecystectomy (STC) is a valuable technique when severe inflammation, fibrosis, or anatomical variations obscure the critical view of safety essential for identifying the cystic duct and artery. It helps reduce the risk of bile duct injuries and other complications that arise during a total cholecystectomy (TC) when these structures are not visible. This study evaluates the safety and outcomes of subtotal cholecystectomy in chronic cholecystitis.

Detailed description: A retrospective analysis was conducted in all patients who underwent a cholecystectomy between May 2021 and November 2024. Indications, complications, and perioperative outcomes of STC were compared with those of standard TC.

The investigators concluded STC is an important bailout procedure in a difficult laparoscopic cholecystectomy associated with higher early postoperative complications but lower bile duct injury.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cholelithiasis planned for laparoscopic cholecystectomy
* Clinical diagnosis of gallbladder polyp planned for laparoscopic cholecystectomy

Exclusion Criteria:

* Gall bladder malignancy
* Cholelithiasis and gallbladder polyp cases managed non-operatively
* additional procedures along with cholecystectomy like bile duct exploration, bile duct excision for choledochal cyst.

Primary outcomes:
measure: postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC)
timeFrame: upto 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital, Kathmandu, Nepal
Study officials:
References:
Clinical trial NCT01346644: Safety of Lactobacillus Fermentum in Newborn Infants
Official title: Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Keywords: Probiotic
infant nutrition
safety
infections
Lead sponsor: Puleva Biotech
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 137
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.


Eligibility criteria: Inclusion Criteria:

* Healthy 1 month infants exclusively formula-fed

Exclusion Criteria:

* gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
* gastrointestinal surgery
* cow's milk protein allergy
* metabolic disorders (diabetes, lactose intolerance)
* immune deficiency
* antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics

Primary outcomes:
measure: average weight gain
timeFrame: 4 months
Secondary outcomes:
measure: growth and health of infants
timeFrame: 2,4,6,12 and 36 months of life
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Biosearch Life
Study officials:
affiliation: Hospital Reina Sofía de Córdoba (Spain)
name: Mercedes Gil, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maldonado-Lobon JA, Gil-Campos M, Maldonado J, Lopez-Huertas E, Flores-Rojas K, Valero AD, Rodriguez-Benitez MV, Banuelos O, Lara-Villoslada F, Fonolla J, Olivares M. Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial. Pharmacol Res. 2015 May-Jun;95-96:12-9. doi: 10.1016/j.phrs.2015.01.006. Epub 2015 Feb 16.