louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02971332: Long Term Results of STARR With Contour Transtar
Official title: STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Prolapse
Rectocele
Intussusception of Rectum
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with symptomatic ODS after failure of medical and dietary therapy and with the presence determined through cinedefecography of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception, in the absence of anal sphincter contractile deficiency

Brief summary: Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.


Eligibility criteria: Inclusion Criteria:

* ODS
* presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception.

Exclusion Criteria:

* anal sphincter contractile deficiency
* previous rectal resection

Primary outcomes:
measure: degree of constipation
timeFrame: 6 months
measure: degree of constipation
timeFrame: 5 years
Secondary outcomes:
measure: Surgical Complications
timeFrame: 0-6 months
Other outcomes:
measure: Defecatory aids
timeFrame: 6 months
measure: Defecatory aids
timeFrame: 5 years
Locations:
Study officials:
References:
citation: Mari FS, Pezzatini M, Gasparrini M, Antonio B. STARR with Contour Transtar for Obstructed Defecation Syndrome: Long-Term Results. World J Surg. 2017 Nov;41(11):2906-2911. doi: 10.1007/s00268-017-4084-6.
Clinical trial NCT05443932: Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients
Official title: Dapagliflozin and Hydrochlorothiazide Treatment in Recurring Kidney Stone Patients - a Randomised Single Center Cross-over Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Urolithiasis
Hyperoxaluria
Keywords: Urolithiasis
Hyperoxaluria
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There won´t be comparator arms in our study. Instead, the investigators plan to do blood- and 24h-urine screenings including oxalate and citrate as well as metabolomics tests out of blood and urine samples at crucial points of time of the study to get baseline and therapeutic data of the participants.
Primary purpose: PREVENTION

Brief summary: Current prevention strategies in patients with recurrence of kidney stones show especially in high-risk patients a diversely and in the long-term not successful outcome in a sustainable number of cases. Recent studies have revealed that Dapagliflozin has the potential to decrease risk and incidence of urolithiasis events especially in patients suffering from Diabetes. The investigators propose that Dapagliflozin has the potential to increase the metabolic situation of hyperoxaluric patients with recurrence of urolithiasis. The investigators therefore test whether Dapagliflozin can decrease the oxalate excretion compared to the current strategy with Hydrochlorothiazide. The study may open up a new way of preventing urolithiasis in patients with high-risk of recurring urolithiasis.


Eligibility criteria: Inclusion Criteria:

• Calcium-oxalate stone formers with high risk of reoccurrence defined as:

* At least two symptomatic or surgically treated kidney stones within the last 10 years and/or
* Single stone kidney formers with risk factors including: a.) Positive medical family history on kidney stone formations of at least one blood related relative in the first degree or at least two blood related relatives in the second degree and/ or b.) Onset of kidney stone formations within the third life decade or earlier and/ or c.) Metabolic syndrome d.) Obesity (BMI ≥ 30 kg/m²)

Exclusion Criteria:

* Age \< 18 years
* Malabsorption disorder
* eGFR \< 30 ml/min/1,73 m2

Primary outcomes:
measure: Δ of urinary oxalate excretion
timeFrame: 8 weeks
Secondary outcomes:
measure: Δ of urinary calcium excretion
timeFrame: 8 weeks
measure: Change of serum kreatinine
timeFrame: 8 weeks
measure: Frequency of urolithiasis
timeFrame: 12 months
measure: Tolerability of SGLT-2inhibitor therapy
timeFrame: 8 weeks
measure: Change of eGFR
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT04160832: Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps
Official title: Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients with Advanced Colorectal Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasm
Keywords: genetics
polyps
cancer
multi-gene panel
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females aged 18 - 89, who have been diagnosed with advanced colorectal polyps.

Brief summary: The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.


Eligibility criteria: Inclusion Criteria:

* Provision to sign and date the consent form
* Stated willingness to comply with all study procedures and be available for the duration of the study
* Be a male or female aged 18-89
* Undergone colonoscopy
* At least one advanced colorectal polyp, defined as having any of the following:
* Any polyp ≥ 1cm (adenoma or serrated polyp)
* Any polyp with villous architecture
* Any polyp with high-grade dysplasia
* Sessile serrated polyps with any dysplasia
* Traditional serrated adenoma

Exclusion Criteria:

* Known hereditary cancer syndrome
* Personal history of inflammatory bowel disease
* Personal history of colorectal cancer
* Polyp histology or size unavailable or not documented

Primary outcomes:
measure: Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps
timeFrame: 3 years
Secondary outcomes:
measure: Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps
timeFrame: 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Swati Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06546332: Post Market Clinical Follow-Up KeriFuse®
Official title: Effectiveness and Safety of the KeriFuse® Intramedullary Arthrodesis Implant and Associated Instruments in the Treatment of IP or DIP Arthritis: a Post Market Clinical Follow-up.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis
Lead sponsor: Keri Medical SA
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The intended target population for the KeriFuse® and associated instruments is an adult population requiring a surgical treatment claimed by the device and presenting bone quality deemed satisfactory by the surgeon.

Brief summary: The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years,
* Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.

Exclusion Criteria:

* Pregnant or nursing women,
* Patients with intellectual disabilities who cannot follow the instructions of their surgeon,
* Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®,
* Patients with acute or chronic infections, local or systemic,
* Patients with sensitivities or allergies to the implant components (Nickel, Titanium).

Primary outcomes:
measure: Pain and radiological assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre de la main du Pays d'Aix
city: Beaumont
country: France
facility: Clinique de la Chataigneraie
city: Bourgoin-Jallieu
country: France
facility: Centre Ostéo Articulaire Fleming
city: Caen
country: France
facility: Clinique de la main
city: Nice
country: France
facility: Clinique Saint François
city: Perpignan
country: France
facility: Clinique Mutualiste Catalane
city: Périgueux
country: France
facility: Clinique du Parc
Study officials:
References:
Clinical trial NCT01394432: "ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Official title: Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Heart Failure
Keywords: Endocardial Stem Cells Injection
Percutaneous Coronary Intervention
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs
* Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)
* Left ventricle ejection fraction (LVEF) \< 50% measured by Echo

Exclusion Criteria:

* Thrombolysis of pyrrolase or streptokinase
* Surgical unsignificant stenosis of LAD
* Indications for CABG
* Cardiogenic shock
* Uncontrolled hypertension
* Thrombocytopenia
* Ongoing bleeding
* Anemia \< 100 g/l
* Oncology
* Patients, who required anticoagulation therapy at the time of inclusion
* Obesity, BMI\>40
* Severe comorbidities
* Unwillingness to participate

Primary outcomes:
measure: Reduction in left ventricle systolic volume on 15% mesured by MRI
timeFrame: 12 months
Secondary outcomes:
measure: All-cause death
timeFrame: 12 months
measure: number of patients with thromboembolic events
timeFrame: 12 months
measure: number of heart failure hospitalizations
timeFrame: 12 months
measure: Distance during 6-minute walking test
timeFrame: 12 months
measure: number of patients with life-threatening arrhythmias
timeFrame: 12 months
measure: BNP level
timeFrame: 12 months
measure: SPECT and Echo data
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05874232: The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
Official title: The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Satisfaction With Life
Loneliness
Lead sponsor: Heartfulness Institute
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 203
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.

Detailed description: The specific aim of this study is to assess changes in scores measuring symptoms of anxiety using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA Loneliness Scale (Version 3).

Eligibility criteria: Inclusion Criteria:

* High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study.

Exclusion Criteria:

* Non-English speaking high school students and staff and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.

Primary outcomes:
measure: Assess the current level of Anxiety
timeFrame: Week 0
measure: Changes level of Anxiety
timeFrame: Week 4 and Week 8
measure: Assess the current level of Satisfaction with Life
timeFrame: Week 0
measure: Changes level of Satisfaction with Life
timeFrame: Week 4 and Week 8
measure: Assess the current level of Loneliness
timeFrame: Week 0
measure: Changes in Loneliness levels
timeFrame: Week 4 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ranjani B Iyer
state: Michigan
Study officials:
References:
Clinical trial NCT01508832: Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
Official title: Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Onset and Duration of a Digital Nerve Block
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.

Detailed description: The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.

Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.

We previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.

Eligibility criteria: Inclusion Criteria:

* Non-smokers

Exclusion Criteria:

* History of allergic response to local anesthetics
* BMI \>25
* Pregnant of nursing
* Current smokers or past smokers of \> 1 pack year history
* Neurological deficit and/or injury in the upper extremities
* Current respiratory infection
* Per investigator judgement, would not be suitable for study

Primary outcomes:
measure: The Change in the Average Finger Temperature From Baseline to Post-intervention.
timeFrame: 30 minutes prior and 240 minutes post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05063032: Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation.
Official title: Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmias, Cardiac
Keywords: Left atrial flutter
Linear ablation
High-density mapping
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 parallell, randomized, controlled, open-label, single center clinical trial.
Primary purpose: TREATMENT

Brief summary: Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.


Eligibility criteria: Inclusion criteria

* Left atrial flutter1 inducible during electrophysiological evaluation.
* Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.
* Informed consent.

  1. Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above.

Exclusion criteria

* Previous ablation of LAFL.
* Previous linear ablation in the LA except for pulmonary vein isolation.
* Absolute contraindication for oral anticoagulation.
* Stroke or acute coronary syndrome less than 3 months before ablation.
* Complex congenital heart disease.

Primary outcomes:
measure: Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Acute success.
timeFrame: Acute intraprocedural.
measure: Non-inducibility.
timeFrame: Acute intraprocedural.
measure: Procedure duration.
timeFrame: Acute intraprocedural.
measure: Left atrial dwell time.
timeFrame: Acute intraprocedural.
measure: Safety.
timeFrame: Acute a 1 month after ablation (procedure-related complications).
measure: Hospitalization.
timeFrame: 1 year.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital, Department of Cardiology
Study officials:
References:
Clinical trial NCT01675232: A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Official title: A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Topical corticosteroid
Pediatric
Eczema
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
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 of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).


Eligibility criteria: Inclusion Criteria:

* Meet the clinical criteria for the diagnosis of atopic dermatitis
* Have disease over at least 5% of their total body surface area.
* Less than 18 years of age.
* Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
* Parents/guardians able to understand and willing to sign a parental permission form.
* Children between the ages of 7-17 years willing to sign an age-appropriate assent form.

Exclusion Criteria:

* Patients who are allergic or intolerant of the topical medications employed in this study.
* Lack of follow-up after initial visit or regimen noncompliance.
* Patients who do not have access to a bathtub.

Primary outcomes:
measure: Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
timeFrame: 2 weeks
Secondary outcomes:
measure: Effect of corticosteroid ointment application regimens on serum cortisol
timeFrame: 2 weeks after application of topical corticosteroids
measure: Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen
timeFrame: 3 months
measure: Adverse effects associated with each corticosteroid application regimen
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard J Antaya, MD
role: PRINCIPAL_INVESTIGATOR
References: