louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01532583: The Outcome of the Transobturator Tape (TOT) Procedure
Official title: The Outcome of the Transobturator Tape (TOT) Procedure During the Follow-up of 6.5 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2012-02-14
Enrollment: 139
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 191 female patients with genuine or recurrent stress urinary incontinence or mixed incontinence operated on with the TOT procedure at the mean of 6.5 years ago

Brief summary: The aim of our study is to report the subjective and objective outcome of outside-in transobturator technique (TOT) (Monarc®) in long-term follow-up.

This is a follow-up study concerning 191 patients operated on in Turku University Hospital between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an absence of reoperation for SUI during the follow-up period.


Eligibility criteria: Inclusion Criteria:

* 191 patients operated on with the TOT procedure between May 2003 and December 2004 at the Department of Obstetrics and Gynecology in the Turku University Hospital.

Exclusion Criteria:

Primary outcomes:
measure: Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.
timeFrame: 8 years
Secondary outcomes:
measure: Subjective outcome of the TOT operation which was assessed with evaluated questionnaires.
timeFrame: 8 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku university hospital
Study officials:
References:
Clinical trial NCT01900483: Brain Functions in Patients Before and After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adiposity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volunteers pre and post bariatric surgery

Brief summary: The project will specifically focus on the examination of the influence of substantial weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and inhibitory networks in diabetic subjects. Therefore the investigators will conduct a functional magnetic resonance imaging (fMRI) study investigating functional measures.


Eligibility criteria: Inclusion Criteria:

* bariatric surgery in the past or in the future
* diabetes (at least before surgery)

Exclusion Criteria:

* fMRI contraindications
* claustrophobia

Primary outcomes:
measure: Differential brain functions
timeFrame: at least 6 months after bariatric surgery (experimental group)
Secondary outcomes:
Other outcomes:
measure: Behavioral measurements
timeFrame: pre surgery (group 1) and at least 6 months after surgery
Locations:
city: Tuebingen
country: Germany
facility: University Clinic of Tuebingen, MEG Center
Study officials:
References:
citation: Frank S, Heinze JM, Fritsche A, Linder K, von Feilitzsch M, Konigsrainer A, Haring HU, Veit R, Preissl H. Neuronal Food Reward Activity in Patients With Type 2 Diabetes With Improved Glycemic Control After Bariatric Surgery. Diabetes Care. 2016 Aug;39(8):1311-7. doi: 10.2337/dc16-0094. Epub 2016 Jun 12.
Clinical trial NCT05488483: A Study of Tumor Imaging With Multispectral Optoacoustic Tomography
Official title: A Feasibility Study of Multispectral Optoacoustic Tomography (MSOT) Imaging in Patients With Tumors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Melanoma
Keywords: Multispectral Optoacoustic Tomography Imaging
MSOT
Memorial Sloan Kettering Cancer Center
21-374
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 12
Sex: FEMALE
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: Participants with a suspicious breast imaging finding detected on either mammography, ultrasound or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) who are scheduled for ultrasound-guided breast biopsy by the Memorial Sloan Kettering Department of Radiology Breast Imaging Service will be included.

Brief summary: Participants in this study will have Multispectral Optoacoustic Tomography/MSOT imaging of both breasts immediately before their ultrasound-guided breast biopsy procedure begins. After the MSO imaging is completed, participation in the study will end.


Eligibility criteria: Inclusion Criteria:

* Participant is a female or male who is 18 years of age or older.
* Participant must meet one of the following:

  * Suspicious breast imaging finding detected on either mammography, ultrasound, or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy)
  * No previous treatment for breast cancer
  * Diagnosis of melanoma

Exclusion Criteria:

* Life expectancy \< 3 months

Primary outcomes:
measure: Number of participants where tumors were visualized
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: Munich
country: Germany
facility: Helmholtz Institute (Data Analysis Only)
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jan Grimm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819883: Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Official title: Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2013-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty-two study subjects will be studied: 1) patients with active acromegaly, and 2) healthy controls. Study subjects with acromegaly will be prescribed treatment for acromegaly by their healthcare providers, and this study will not interfere in anyway with clinical care and will not provide surgery, medications or other forms of clinical care.

Brief summary: This study investigates fat distribution in people with acromegaly. The investigator is also investigating the change of fat distribution before and after treatment of acromegaly. The investigator will compare the results of people with acromegaly to the results of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Ages 18 - 75 yr (both groups)
* Study subjects with active acromegaly
* Healthy controls

Exclusion Criteria:

* Serum creatinine or alanine aminotransferase (ALT) \> 2 times the upper limit of normal, metastatic cancer.
* Controls will be receiving no medications and have no chronic diseases, including cancer, hypertension or diabetes mellitus.
* Contraindications to MRI imaging (both groups) like those with certain metal implants, surgical clips or pacemakers.
* Pregnant women

Primary outcomes:
measure: Change in Liver Fat
timeFrame: Baseline and 3-month follow-up visit
measure: Change in Thigh Muscle Cross-sectional Area
timeFrame: Baseline and 3-month follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04009083: Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
Official title: CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: 18F-Fluciclovine PET imaging
Focal Cryo Ablation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.

Detailed description: The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.

The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .

Eligibility criteria: Inclusion Criteria:

* FCA at NYU Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
* No prostate cancer specific treatment following FCA
* Consented to undergo reflex MRI and prostate biopsy two years following FCA.

Exclusion Criteria:

* Any contraindication to prostate biopsy
* Prior allergic reaction to 18F-Fluciclovine
* Patient refuses MRI and prostate biopsy two years following FCA.

Primary outcomes:
measure: Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Herbert Lepor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238783: Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Bacterial Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Male and female patients of any race
* 5 years of age and older at the time of the Day 1 visit
* with a primary clinical diagnosis of bacterial conjunctivitis.

Exclusion Criteria:

* Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
* Presence of punctal plug or punctal occlusion
* Visual Acuity worse than 20/80
* Upper respiratory infection

Primary outcomes:
measure: Sustained Clinical Cure rate
timeFrame: Day 3
measure: End of therapy Clinical Cure rate
timeFrame: Day 4
Secondary outcomes:
measure: Sustained bulbar conjunctival injection
timeFrame: Day 3
measure: Microbiological Success
timeFrame: Day 4
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04542083: Covid-19, Acute Myocardial Infarctions and Strokes in France
Official title: Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Acute Cardiovascular Condition
Acute Neurovascular Condition
Stroke
Acute Myocardial Infarction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 911
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care.

Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.


Eligibility criteria: Inclusion criteria:

- Adults admitted in 2018, 2019 or 2020 in a French hospital for acute coronary syndrom or stroke

Exclusion criteria:

- None

Primary outcomes:
measure: Daily number of admissions for acute cardio- and neurivascular conditions in France.
timeFrame: 1 day
Secondary outcomes:
measure: Specific mortality rate.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Grégoire Mercier, PU PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227083: 2nd_Computerized Asthma Specific Quality of Life(cAQOL)
Official title: Comparison of the Responsiveness of Two Different Asthma-specific QOL Measures (AQLQ and cAQOL) in Korean Patients With Persistent Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Asthma Patient
Keywords: AQLQ and cAQOL
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Yonsei University
name: Inha University Hospital
name: Dong-A University
First posted: 2010-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: asthma control patient

Brief summary: Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and cAQOL) in Korean patients with persistent asthma


Eligibility criteria: Inclusion Criteria:

* Patient aged 20-70 years
* Patient diagnosed with asthma over six months ago
* Asthma diagnosis

  * Airway reversibility, FEV1 ≥ 12% and 200mL or
  * Airway hyper-responsiveness, PC20 \< 16 mg/mL or
  * More than two weeks, more than 2 times a day in excess of 20% PEFR diurnal variability patient
* FEV1 55-100% of predicted value patient
* Inhaled corticosteroids alone or inhaled corticosteroids and beta agonists used patient
* Currently, at least if you have one or more asthma symptoms, asthma control test (ACT • Asthma Control Test) score of less than 19 characters
* Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial

Exclusion Criteria:

* Current smoking or smoking in the past 15packyears
* Patients who show a symptom of an acute disease within 14 days before the beginning of this trial (administration of trial medication)
* Recent changes in asthma treatment for 28days
* Chronic diseases that affect the quality of life

Primary outcomes:
measure: Two asthma quality of life measurement tool
timeFrame: 24 weeks treatment
Secondary outcomes:
measure: Correlation between cAQOL/AQLQ
timeFrame: treatment screening, week1,week12,week24
measure: Association of asthma control therapy and a questionnaire
timeFrame: 24 weeks treatment
measure: asthma patient genotypes
timeFrame: Screening
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
Study officials:
affiliation: Ajou University School of Medicine
name: Hae-Sim Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05223283: Limb Salvage Post Venous Injury:Case Series
Official title: Limb Salvage Related to Venous Injury: Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb Salvage
Keywords: limb salvage
venous injury
edema
amputation
fasciotomy.
Lead sponsor: Jabir Ibn Hayyan Medical University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All limb injured patient

Brief summary: The venous injury diagnosis depends on history of trauma with symptoms and signs suggestive of venous injuries and color flow duplex study is of increasing value as a screen for detection of an occult venous injuries. It is associated with arterial, peripheral nerve injuries and bone fractures. Within this study of one-year duration, a seventy-five patients with acute venous injuries were included. The injured vein was either repaired or ligated according to hemodynamic state of patient and site and type of injury.

Detailed description: This is a retrospective cross section study of one-year duration from January 2017 and January 2019 at Najaf Teaching medical city/Iraq . The study included a Seventy-five patients with acute venous injuries. The Venous surgical interference for late complicated vascular injuries and iatrogenic venous injuries were excluded and the information was obtained from the hospital records and direct evaluation of patients.

Eligibility criteria: Inclusion Criteria:

All in surgical emergency departments

Exclusion Criteria:

nil

Primary outcomes:
measure: Limb salvage or amputation
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01600183: Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
Official title: Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metatarsus Adductus
Metatarsus Varus
Keywords: MTA
metatarsus
Metatarsus Adductus, also known as Metatarsus Varus
Lead sponsor: Unfo Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard casting or using the UNFO-s device for total time of 20 weeks.


Eligibility criteria: Inclusion Criteria:

* Subjects with an acute MTA that did not receive any treatment for this condition
* Consenting parents
* Ages 1-4 months

Exclusion Criteria:

* Participation in another clinical trial.
* Neuromuscular disorders
* Any condition which in the opinion of the investigator renders the subject ineligible for study participation.

Primary outcomes:
measure: Healing of the MTA
timeFrame: 20 weeks
Secondary outcomes:
measure: safety of the UNFO-s device
timeFrame: 7 months
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka MC
Study officials:
affiliation: Soroka MC
name: Dan Atar, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04271683: Safe Use of CPAP and PEEP During Induction of General Anesthesia
Official title: Safe Use of CPAP During Preoxygenation and PEEP After Apnoea During Induction of General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Positive end-expiratory pressure
Mechanical ventilation
Induction of anesthesia
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study compares the safety of using pressure controlled ventilation with a positive end-expiratory pressure (PEEP) during induction of general anaesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.

Detailed description: Using a continuous positive pressure (CPAP) during preoxygenation, followed by pressure controlled ventilation with PEEP after apnoea during induction of general anesthesia, might offer several benefits but safety issues needs more investigation. This study compares the safety of using pressure controlled with PEEP during induction of general anesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.

Eligibility criteria: Inclusion Criteria:

* Normal or overweight patients scheduled for day case surgery in general anesthesia.
* American Society of Anesthesiologists functional class I-III.
* Body Mass Index 18.5-30.

Exclusion Criteria:

* Increased risk of regurgitation of gastric content.
* Symptomatic asthma, COPD or heart failure.
* Peripheral oxygen saturation (SpO2) breathing air \<94 %
* Anticipated difficult airway.
* Beard.
* Anatomical features making it difficult to keep a tight seal during maskventilation.

Primary outcomes:
measure: Number of breaths until return of CO2.
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Lennart Edmark
Study officials:
affiliation: Region Västmanland
name: Lennart Edmark, PhD
role: PRINCIPAL_INVESTIGATOR
References: