louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03951779: Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
Official title: Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shortness of Breath
Cardiac; Dyspnea
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath).


Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged ≥18 years years with suspected cardiac dyspnea who are scheduled to undergo right heart catheterization as dictated by a comprehensive examination and echocardiography will be included for enrollment.

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Mechanical ventilation
* Acute or chronic renal failure (creatinine clearance \<30 ml/min or requiring renal replacement therapy)
* Inability to perform MRI (i.e. claustrophobia, severe obesity (\>150 kg), device incompatible with MRI)
* Inability to exercise
* Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
* Prior heart or lung transplantation
* Left ventricular systolic (ejection fraction \<50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
* Significant left-sided valvular disease (≥moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery

Primary outcomes:
measure: Ejection Fraction
timeFrame: Baseline
measure: Stroke Volume
timeFrame: Baseline
measure: Longitudinal Strain Assessment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian P Shapiro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05173779: Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis
Official title: A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and Severe Atrial Fibrosis: a Chinese Registry Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Persistent Atrial Fibrillation
Severe atrial fibrosis
Left atrial isolation
catheter ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Detailed description: This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 80 years old
2. Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter \> 50mm
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug
4. CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. Having moderate-to-severe pulmonary hypertension;
4. With myocardial infarction or stroke within 6 months of screening;
5. With Significant congenital heart disease;
6. Ejection fraction was \<40% measured by echocardiography;
7. Allergic to contrast media;
8. Contraindication to anticoagulation medications;
9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
10. Left atrial thrombus;
11. Having any contraindication to right or left sided heart catheterization

Primary outcomes:
measure: Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
timeFrame: up to 18 months after enrollment
Secondary outcomes:
measure: Postoperative AF recurrence rate
timeFrame: up to 18 months after enrollment
measure: Postoperative AFL/AT rate
timeFrame: up to 18 months after enrollment
measure: Incidence of complications
timeFrame: up to 18 months after enrollment
measure: Changes in the diameter of the left atrium and the left ventricular ejection fraction
timeFrame: up to 18 months after enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02376179: Endotracheal Tube Intracuff Pressure and Leak
Official title: Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otolaryngological Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 84
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

Brief summary: We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.


Eligibility criteria: Inclusion Criteria:

* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube.
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

Primary outcomes:
measure: Changes in the Intracuff Pressure
timeFrame: during time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9.
Clinical trial NCT01280279: Necessity for Repetitive Education of Behavioral Modification
Official title: Short-term Effects of Systematized Behavioral Modification Program (SBMP) for Nocturia: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Who Had the Urine Volume at Nighttime More Than One Third of Total Daily Urine Volume (NPU) and Voided More Than Two Times at Nighttime (Nocturia)
Keywords: Behavior modification, Behavior therapy, Nocturia, Polyuria, Quality of life
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had the urine volume at nighttime more than one third of total daily urine volume (NPU) and voided more than two times at nighttime (nocturia)

Brief summary: Few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with NPU and to show whether a single education for behavioral modification is sufficient for the patients.

Detailed description: Even though behavioral modification therapy seems to be effective, it is not usually recommended for patients with nocturia because much patience and understanding is required for the patients to follow the therapy. Few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturia and nocturnal polyuria (NPU). Furthermore, no report demonstrated the evidence about how many times or how long the education for behavioral therapy should be performed and how long will the education effect would continue. The aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with NPU and to show whether a single education for behavioral modification is sufficient for the patients.

Eligibility criteria: Inclusion Criteria:

* the urine volume at nighttime more than one third of total daily urine volume
* voided more than two times at nighttime

Exclusion Criteria:

* postvoid urine volume more than 100 ml
* sleep disturbance including sleep apnea
* diabetes mellitus
* diabetes insipidus
* neurogenic bladder
* congestive heart failure
* indwelling catheters
* urinary tract infection or urinary stones

Primary outcomes:
measure: decrease of nocturnal urine volume
timeFrame: 1 month after education
Secondary outcomes:
measure: improvement of symptoms and quality of life
timeFrame: 1 month after education
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung Yong Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00903279: Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery
Official title: Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Orthopedic Procedures
Methicillin-resistant Staphylococcus Aureus
Keywords: MRSA colonization
Orthopedic Surgery
Altabax
Placebo
Lead sponsor: Bay Pines VA Healthcare System
Sponsor class: FED
First posted: 2009-05-18
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.

Detailed description: Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.

Eligibility criteria: Inclusion Criteria:

* Patients who are admitted for an orthopedic surgical procedure
* All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA

Exclusion Criteria:

* Pregnancy
* Serious systemic illness due to renal, cardiac or hepatic disease
* Inability to complete follow-up assessments
* Allergy or intolerance to retapamulin
* BMI \> 30
* Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
* Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
* Antibiotics administered during the course of the study will be recorded (name, dose and dates)

Primary outcomes:
measure: Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
timeFrame: 30 days
Secondary outcomes:
measure: Identify a predominant clone among the MRSA isolates in this study
timeFrame: 2 years
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VAHCS
state: Florida
Study officials:
affiliation: Bay Pines VAHCS
name: Suzane Silbert, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04228679: Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.
Official title: The Affect of Erbium Laser Treatments on Vaginal Looseness and Sexual Dysfunction in Pre-menopausal Female Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 106
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

Detailed description: Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.

Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

Follow up after treatment cessation will be for 12 months post-treatment.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women.
* Women with vaginal looseness and sexual dysfunction as a primary complaint.

Exclusion Criteria:

* Vaginal bleeding of unknown source.
* Repeated vaginal infections.
* Known or suspected cervical pre-malignant neoplasia.
* Previous treatment with vaginal laser or other forms of energy-based treatment modalities.
* Pregnancy.
* Current pelvic inflammatory disease or urinary tract infection.
* Vaginal surgery during the year preceding study participation.
* Treatment with systemic or vaginal hormone replacement therapy.
* Current pelvic floor physiotherapy.

Primary outcomes:
measure: Female sexual function index.
timeFrame: From recruitment up to 15 months.
Secondary outcomes:
measure: Vaginal health index
timeFrame: From recruitment up to 15 months.
measure: Pelvic floor disability index.
timeFrame: From recruitment up to 15 months.
measure: Vaginal laxity questionnaire.
timeFrame: From recruitment up to 15 months.
measure: Monthly sexual intercourse rate
timeFrame: From recruitment up to 15 months.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06053879: Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
Official title: Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence in Children
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: pretest post test
Primary purpose: TREATMENT

Brief summary: most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears.

Detailed description: most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears so this study aims prevent faecal incontinence so continue life time without any interference with social life and activities

Eligibility criteria: Inclusion Criteria:

* Age from 10-13 years old
* Reliable females
* Able to understand verbal commands
* Normal vision and hearing

Exclusion Criteria:

* Neuromuscular or musculoskeletal disorders
* Behavioural disorders
* Psychological disorders

Primary outcomes:
measure: EMG biofeedback assessment for contraction of anus and puborectalis muscle
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Badr
country: Egypt
facility: Badr university in cairo
state: Cairo
Study officials:
affiliation: Lecturer of PT for surgery and burn
name: Reham A Elkalla, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ass.Prof. of PT for paediatric
name: Mostafa S Ali, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ass.Prof. of PT for paediatric
name: Radwa S Mahmoud, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer of PT for women health
name: Noha A Abd el rahman, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00927979: Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy
Official title: Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, During Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gynecological Laparoscopy
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

Detailed description: Outcome Measures :

* VAS score
* Use of analgesics during operation and postoperative period

Eligibility criteria: Inclusion Criteria:

* Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy
* Patient not participating in other medical study at present or during the last 30 days
* Patient is capable of reading, understanding and signing on an informed consent
* Age 18 years and above
* ASA physical status grade 1-2

Exclusion Criteria:

* Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol
* Acute pelvic inflammatory disease
* Coumadin or aspirin treatment
* Significant arrythmias
* Analgesic treatment for chronic pain
* BMI\>35

Primary outcomes:
measure: Visual Analog Score (VAS)
timeFrame: 24 hours
Secondary outcomes:
measure: Use of Analgesics
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01628679: Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
Official title: Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Provoked Vulvar Vestibulodynia
Keywords: provoked
vulvar
vestibulodynia
vestibulitis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 125
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis:

1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastrophizing behaviour in women with provoked vulvar vestibulodynia.

   This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions.
2. A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone.

Results of physiotherapy intervention alone will be compared to results of those treated with physiotherapy, group educational sessions and group cognitive behavioural therapy at a separate treatment centre. Physiotherapy interventions and outcome measures are the same between both groups.

Justification:

Standard treatment is hard to identify as many approaches are taken, none with any evidence to support them. This study aims to look at specific techniques (pelvic floor coordination and relaxation exercises, education on female sexual response and pain pathophysiology education) to see if there is a benefit.


Eligibility criteria: Inclusion Criteria:

* 40 years and under
* diagnosis of provoked vulvar vestibulodynia

Exclusion Criteria:

* early menopause
* have had a total or partial hysterectomy
* are on estrogen suppression medication
* have a primary arousal disorder
* declined admission to the Multidisciplinary Vulvodynia Program at Vancovuer General Hospital

Primary outcomes:
measure: Upon completion of data analysis, establishment of the efficacy of pelvic floor physiotherapy for the treatment of Provoked Vulvar Vestibulodynia will be determined
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dayan Physiotherapy and Pelvic Floor Clinic
state: British Columbia
Study officials:
affiliation: Clinical Instructor, Dep't of Physical Therapy, Faculty of Medicine, University of British Columbia
name: Marcy L Dayan, BSc Rehab
role: PRINCIPAL_INVESTIGATOR
References: