louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06375070: Anticoagulants for PFO Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Foramen Ovale
Keywords: patent foramen ovale
migraine
stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 277
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible participants had their PFO diagnosis confirmed via transoesophageal echocardiography (TEE), bubble transcranial Doppler (Bubble-TCD), or contrast echocardiography of the right heart and gave their informed consent to participate

Brief summary: Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.


Eligibility criteria: Inclusion Criteria:

1. verified PFO diagnosis through TEE, Bubble-TCD, or contrast echocardiography of the right heart;
2. ages range between 16 and 65;
3. no restrictions on sexual orientation;
4. stroke patients with cryptogenic strokes as per the TOAST classification;
5. no other likely causes for migraines, with the exception of PFO;
6. no multiple risk factors for cerebrovascular disease, such as hypertension, diabetes, or smoking.

Exclusion Criteria:

* 1)severe, acute, or life-threatening conditions including acute cardio-cerebrovascular diseases, significant organ failure, or infections; 2)magnetic resonance imaging (MRI) contraindications, especially with contrast enhancement; 3) presence of cerebral artery stenosis, internal carotid artery stenosis, or atherosclerosis; 4) hypercoagulability or venous thrombosis; 5) contraindications associated with PFO closure and anticoagulants; 6) obstructive sleep apnea.

Primary outcomes:
measure: whether occur recurrent stroke or migraine relief
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00642070: Host Response to Urinary Tract Infection in Women
Official title: Host Response to Urinary Tract Infection in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Keywords: Current symptoms of urinary tract infection
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-03-24
Enrollment: 326
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the ages of 18-49 with symptoms of a urinary tract infection for fewer than 7 days

Brief summary: This study is being done to identify those elements of the immune response that may predispose a woman to recurrent urinary tract infection. We suspect that lesser effectiveness of certain components of the host response will lead to recurrent urinary tract infection. We will also evaluate the role that the bladder reservoir may play in recurrent urinary tract infection.

Detailed description: Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of urinary tract infection. They will be asked to provide a clean catch urine sample. We will collect periurethral, vaginal and rectal swabs. Blood will collected. They will be given a diary to take home and record all episodes of sexual intercourse, contraceptive use, vaginal and urinary symptoms and medication use.

They will be given standard treatment for the current urinary tract infection. Follow-up visits will be scheduled 2 weeks,one month,two month and three month after initial visit.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-49 years
* Able to provide written informed consent
* diagnosis of acute cystitis with symptoms for fewer than 7 days

Exclusion Criteria:

* Not pregnant or planning pregnancy in next 3 months
* No chronic illness requiring medical supervision (e.g. diabetes mellitus)
* No known anatomic or functional abnormalities of the urinary tract
* No signs or symptoms suggestive of pyelonephritis (flank pain or tenderness, temperature over 100 degrees F, nausea or vomiting)

Primary outcomes:
measure: Determine elements of the immune response that may predispose a woman to recurrent urinary tract infection
timeFrame: 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington/Hall Health Primary Care Center
state: Washington
Study officials:
affiliation: University of Washington
name: Ann E Stapleton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820742: Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
Official title: The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neovascular Age-related Macular Degeneration
Keywords: A5751025
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Study population: Male of female 50 years and older, diagnosed with age-related macular degeneration

Brief summary: An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.

Detailed description: Open-label, non-comparative, non-interventional study

Eligibility criteria: Inclusion Criteria:

* Must have at least one eye which was diagnosed with neovascular degeneration

Exclusion Criteria:

* Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis

Primary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in visual acuity in the study eye at 6 months from baseline
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03899870: Factors Predicting Recurrence in Rectal Cancer After Surgery
Official title: Factors Predicting Recurrence After Curative Resection for Rectal Cancer: a 16-year Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Rectal Adenocarcinoma
Keywords: rectal adenocarcinoma
recurrence
prognosis
Lead sponsor: Université de Sousse
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectal adenocarcinoma who underwent curative resection

Brief summary: Colorectal cancer is one of the most frequently diagnosed cancers and a major cause of cancer deaths worldwide. Recurrence after curative surgery is one of the major factors affecting the long-term survival and its frequency is estimated to be 22.5% at 5 years. of which 12% have local recurrence. The overall survival in case of recurrence of 11% at 5 years.

Several patient-, tumor-related and treatment-related prognostic factors have been found to be associated with the risk of recurrence of rectal adenocarcinoma. Some of these factors such as TNM stage, lymphatic and perineural invasion and vascular emboli have been found to affect recurrence free survival in most studies. While the impact of other factors such as distal resection margin, tumor size, extra capsular spread and neoadjuvant chemoradiotherapy on recurrence remains controversial. Moreover, most of the previous studies on prognostic factors have been from American and European countries with very little data from African countries. Recognition of these factors helps in identification of high-risk patients who require close and more rigorous postoperative surveillance. Hence this study was conducted to determine the factors affecting recurrence after curative resection of rectal cancer in African population.


Eligibility criteria: Inclusion Criteria:

- all the patients who underwent curative resection for rectal adenocarcinoma between January 2000 and December 2015 at the Department of Digestive and Visceral Surgery of Sahloul Hospital, Sousse, Tunisia

Exclusion Criteria:

* patients who underwent palliative surgery
* patients with microscopically or macroscopically positive resection margin
* patients with tumors other than adenocarcinoma
* patients who died in the postoperative period due to complications.

Primary outcomes:
measure: Recurrence
timeFrame: through study completion at average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Farhat W, Azzaza M, Mizouni A, Ammar H, Ben Ltaifa M, Lagha S, Kahloul M, Gupta R, Mabrouk MB, Ali AB. Factors predicting recurrence after curative resection for rectal cancer: a 16-year study. World J Surg Oncol. 2019 Oct 28;17(1):173. doi: 10.1186/s12957-019-1718-1.
Clinical trial NCT01233570: Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
Official title: Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: Cutaneous Crohns Disease
Topical Tacrolimus
Protopic
Metastatic Crohns Disease
Pyoderma Gangrenosum
Granulomatous chelitis
Oral crohns disease
Perianal crohns disease
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease


Eligibility criteria: Inclusion Criteria:

* willingness and capability to follow the study procedure
* confirmed diagnosis of Crohn's Disease of at least 3 months duration confirmed by radiography, endoscopy or pathological examination
* required to have a skin manifestation of Crohn's disease
* required to give written informed consent
* both male and female subjects with reproductive potential required to be on an acceptable form of birth control for the duration of the study
* long-standing, concomitant immunosuppressive therapy was allowed if the dose was stable and not controlling the skin problem

Exclusion Criteria:

* known sensitivity to tacrolimus
* change in aminosalicylate dosage in the four weeks prior to screening
* on oral steroids at over 40mg per day
* been commenced on methotrexate, azathoprine or ciclosporin within the last two months
* commenced on a a TNF-alpha monoclonal antibody within the three months prior to screening
* patients having had a stoma fashioned less than three months before enrolment
* patients with an immunocompromising disease
* patients with a diagnosis of malignancy within the last five years
* patients with any other condition, past or present treatment thought by the investigator to render the subject ineligible for the study

Primary outcomes:
measure: Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment
timeFrame: At 12 weeks of treatment, optionally extended to 52 weeks
Secondary outcomes:
measure: Global Self Assessment
timeFrame: 12 weeks, optionally extended to 52 weeks
measure: Perineal Disease Activity Index
timeFrame: 12 weeks, optionally extended to 52 weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen, Aberdeen Royal Infirmary
state: Grampian
Study officials:
affiliation: University of Aberdeen
name: Anthony D Ormerod, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02746770: Physiotherapy in Vestibular Disorders
Official title: Physiotherapy in Vestibular Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disorder
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spanish population with unilateral peripheral vestibular disorders.

Detailed description: Participants with peripheral vestibular disorders will be allocated to a Cawthorne and Cooksey exercises protocol or control group. The Cawthorne and Cooksey exercises consist in some head mobilization and positioning tasks which are related with a restoration of vestibular disorders.

Eligibility criteria: Inclusion Criteria:

* Participants with with unilateral peripheral vestibular disorders

Exclusion Criteria:

* Bilateral vestibular disorders
* Fluctuating or active unilateral vestibular disease
* Or other medical conditions in the acute phase were excluded from the study.

Primary outcomes:
measure: Activities-specific Balance Confidence scale (ABC)
timeFrame: Baseline and after 6 weeks of intervention
Secondary outcomes:
measure: UCLA Dizziness Questionnaire (UCLA-DQ)
timeFrame: Baseline and after 6 weeks of intervention
measure: Dizziness Handicap Inventory (DHI),
timeFrame: Baseline and after 6 weeks of intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05614570: SSVEP Evaluation of Brain Function
Official title: SSVEP Evaluation of Brain Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Keywords: Mild Traumatic brain injury
Concussion
Steady state visual evoked potential
Electroencephalography
Sports Concussion
Sports Medicine
Lead sponsor: Headsafe MFG
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population contained individuals 14 years or older who play sport. They were requited from a large variety of sport types and facilities including local clubs, medical centres and schools.

Brief summary: The investigational device used in this clinical investigation, the Nurochek Headset, is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a smartphone which processes the signals and transmits them to a secure cloud server for analysis and storage of the data.

The primary objective of this clinical investigation was to evaluate the performance of the investigation device (NCII) against clinical diagnosis and SCAT 5, in the accurate detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion

The aim of this study was to collect data from 100 readings from individuals with concussion. It was estimate that approximately 10-20% of baselined players would suffer a concussion during the season. There it was estimated there would be a need to baseline 500-1000 individuals in order to achieve the number of concussions required. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were required from sporting clubs, medical clinicals and schools.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 14 years and older, participating in sport-related activities.

Exclusion Criteria:

* Individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

Primary outcomes:
measure: Steady State Visual Evoked Potential
timeFrame: 30 days
measure: SCAT5 Score
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Headsafe
Study officials:
affiliation: Principal Investigator
name: Craig Donaldson, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03773770: Expanded Access to Triheptanoin
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Long Chain Fatty Acid Oxidation Disorders
Keywords: Expanded Access
Compassionate Use
Carnitine Palmitoyltransferase Deficiency
CPT I
CPT II
Very Long Chain acyl-CoA Dehydrogenase Deficiency
VLCAD
Long Chain 3-hydroxy-acyl-CoA Dehydrogenase Deficiency
LHCAD
Trifunctional Protein Deficiency
TFP
Carnitine-acylcarnitine Translocase Deficiency
CACT
LC-FAOD
Lead sponsor: Ultragenyx Pharmaceutical Inc
Sponsor class: INDUSTRY
First posted: 2018-12-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access may be provided for qualified patients who have limited treatment options and are not eligible for a clinical trial.

Detailed description: Long Chain Fatty Acid Oxidation Disorders (LC-FAOD) and other Non-FAOD conditions, where applicable: Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies.

For full details, please visit the links provided below.

Eligibility criteria: - The participant must not be eligible for a UX007 clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ultragenyx Pharmaceutical Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04064970: Patient Satisfaction Survey of Non-surgical Urinary Incontinence Treatment
Official title: Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 125
Sex: FEMALE
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: Eligible subjects will be women over the age of 18 who desire nonsurgical management of stress urinary incontinence.

Brief summary: The purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms.


Eligibility criteria: Inclusion Criteria:

* Adult women (\> 18 years) seeking care for stress urinary incontinence at the URMC in Rochester, NY, DUMC in Durham, NC, Western New York (WNY) Urology Associates in Cheektowaga, NY, or at the UTMB in Galveston, TX.
* English-speaking
* Possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries

Exclusion Criteria:

* Women who decline to participate in the study
* Women were unable to complete electronic patient reported outcome questionnaires
* Women with greater than stage II uterovaginal prolapse or post-hysterectomy prolapse.
* Women considered citizens of the European Union (EU), including EU citizens living in the United States.

Primary outcomes:
measure: number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the anchor-based method of analysis
timeFrame: baseline to 6 weeks
measure: Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the distribution-bases method of analysis
timeFrame: 6 weeks
measure: Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the anchor-based method of analysis
timeFrame: baseline to 6 weeks
measure: Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the distribution-bases method of analysis
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University Urogynecology Associates
state: New York
Study officials:
References: