louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05672277: Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder
Official title: Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is a comparison of the effects of transcutaneous electrical nerve stimulation (TENS) protocols in women with overactive bladder (OAB).

Detailed description: OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. TENS has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Eligibility criteria: Inclusion Criteria:

* Being in the age range of 18-65 ,
* Having diagnosed with OAB,
* Being a volunteer

Exclusion Criteria:

* Being pregnant,
* presence of severe pelvic organ prolapse,
* malignant disease,
* urinary infection,
* neurological disease,
* have electronic and metal implant,
* loss of sensation,
* lumbosacral peripheral nerve lesion

Primary outcomes:
measure: Overactive bladder symptoms
timeFrame: change from baseline at 3 weeks and 6 weeks
Secondary outcomes:
measure: Urgency severity
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Bladder functions
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Life quality
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Strength of pelvic floor muscle
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Perception of recovery
timeFrame: change from baseline at 3 weeks and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628277: Methods of Weight Loss in Overweight Coronary Patients
Official title: Methods of Weight Loss in Overweight Coronary Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
coronary heart disease
coronary risk factors
weight loss
exercise
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

Detailed description: We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

The study population consists of overweight (BMI \>27) patients with established coronary heart disease. The exercise and counseling program was of 4 months duration with extended follow up at 1 year.

Eligibility criteria: Inclusion Criteria:

* Coronary heart disease
* BMI \> 27
* Peak Vo2 \> 14.4 ml/kg/min

Exclusion Criteria:

* Presence of diabetes

Primary outcomes:
measure: Fat Mass
timeFrame: 4 months, 12 months
Secondary outcomes:
measure: Intrabdominal (visceral) fat
timeFrame: 4 months
measure: Insulin stimulated glucose disposal
timeFrame: 4 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
affiliation: University of Vermont
name: Philip A Ades, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ades PA, Savage PD, Lischke S, Toth MJ, Harvey-Berino J, Bunn JY, Ludlow M, Schneider DJ. The effect of weight loss and exercise training on flow-mediated dilatation in coronary heart disease: a randomized trial. Chest. 2011 Dec;140(6):1420-1427. doi: 10.1378/chest.10-3289. Epub 2011 Jul 21.
citation: Ades PA, Savage PD, Toth MJ, Harvey-Berino J, Schneider DJ, Bunn JY, Audelin MC, Ludlow M. High-calorie-expenditure exercise: a new approach to cardiac rehabilitation for overweight coronary patients. Circulation. 2009 May 26;119(20):2671-8. doi: 10.1161/CIRCULATIONAHA.108.834184. Epub 2009 May 11.
Clinical trial NCT00617877: Antihypertensive Response to Losartan and Genetic Polymorphisms
Official title: Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antihypertensive response of treatment with losartan with reference to genetic polymorphisms.


Eligibility criteria: Inclusion Criteria:

* Both gender less than 60 years old, with mild-moderate hypertension (SBP greater than and DBP equal or greater than 90 mmhg, BP \< 180/110)
* Never treated for hypertension or who have taken antihypertensive agents sporadically (not more than 15 days total therapy) but not in the 30 days prior to the first visit
* Patient in therapeutic wash out for 6 months
* Patient is asymptomatic, absence of significant concomitant diseases, except for non-familial hypercholesterolemia, absence of systemic diseases
* Women with menopause not treated with hormone replacement therapy or women of reproductive age who do not make use of estro-progestagen agents but who use another safe contraceptive method
* BMI \< 30 for men and \< 28 for women

Exclusion Criteria:

* Secondary or malignant hypertension, Na \<130 mmol/l, K \>5,5 mmol/l, or \< 3,0 mmol/l
* Cardiac disease such as ischemic, HF, arrhythmia, cardiac surgery
* Pregnant, breast feeding
* History of nephropathy, metabolic disease, liver disease
* Alcohol or drug abuse
* History of angioedema
* Has a known hypersensibility to study drug(s)

Primary outcomes:
measure: Blood pressure reduction with reference to genetic polymorphisms.
timeFrame: Over 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05639777: Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection
Official title: The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dexmedetomidine
Adenotonsillectomy
Respiratory Tract Infections
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.

Detailed description: Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE).

Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.

Eligibility criteria: Inclusion Criteria:

1. Children with recent mild URI or asthma.
2. aged from 3 to 10 years
3. ASA Physical Status II,
4. undergoing adenotonsillectomy

Exclusion Criteria:

1. Parental refusal of participation
2. Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
3. Lower respiratory tract infection
4. Congenital heart diseases
5. Known hypersensitivity to specific anesthetic agent
6. Liver or renal disease

Primary outcomes:
measure: The incidence of peri-operative respiratory adverse effects (PRAE).
timeFrame: From induction to emergence from general anesthesia.
Secondary outcomes:
measure: Sedating effects of this drug.
timeFrame: 15 and 30 min after sedation
measure: Ease of parental separation.
timeFrame: 15 and 30 min after sedation
measure: Face mask acceptance.
timeFrame: 15 and 30 min after sedation
measure: Hemodynamic stability
timeFrame: 15 and 30 min after sedation
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Eman Ahmed Azzam
state: El-Gharbia
Study officials:
affiliation: Anesthiology' Surgical Intensive care and Pain Medicine
name: Ayman A Yousef, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor Anesthiology' Surgical Intensive care and Pain Medicine
name: Gehan M Eid, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthiology' Surgical Intensive care and Pain Medicine
name: Wail E Messbah, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03493477: Evaluation of Gingival Biotypes of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations
Official title: Evaluation of Gingival Biotypes and Width of Keratinized Gingiva of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormal Jaw Relations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending the orthodontic clinic in the orthodontic department, Faculty of Dentistry, Cairo University , who have either skeletal class II or class III maxillo-mandibular jaw relations

Brief summary: The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in the anterior region of adults with abnormal skeletal jaw relations.

Detailed description: This study will include consecutive adult patients seeking orthodontic treatment with skeletal Class II and Class III jaw relations based on clinical and cephalometric values. Each group will be further divided according to their vertical skeletal pattern. Gingival biotype will be determined -using the probe transparency method- into either thick or thin biotype for all anterior teeth in both jaws. Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm. Statistical analysis will be applied to see the correlation between gingival biotypes , width of keratinized gingiva , and abnormal skeletal jaw relations.

Eligibility criteria: Inclusion Criteria:

1. Adult patients having an age range of 18 -30 years.
2. Adults with skeletal Class II and Class III jaw relation
3. Fair oral hygiene with absence of any active periodontal disease.
4. Patients with full permanent dentition (with the exception of third molars) with acceptable alignment of teeth.
5. Absence of systemic disease (medically free patients).

Exclusion Criteria:

1. Patients with extensive restorations on the anterior teeth.
2. Subjects taking medication affecting the periodontal tissues
3. History of previous periodontal surgery or orthodontic treatment.
4. Pregnant or lactating female patients
5. Syndromic patients

Primary outcomes:
measure: Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations.
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between width of keratinized gingiva in the anterior region and abnormal sagittal skeletal jaw relation
timeFrame: 6 months
measure: Correlation between gingival biotypes and abnormal vertical skeletal jaw relations.
timeFrame: 6 months
measure: Correlation between width of keratinized gingiva and abnormal vertical skeletal jaw relations.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03255577: Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer
Official title: Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Locally Advanced Breast Cancer
Keywords: Sentinel Lymph Node Biopsy
17-384
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a prospective single-arm study design.
Primary purpose: TREATMENT

Brief summary: This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female patients over 18 years of age with biopsy-proven breast cancer
* Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging
* Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies
* Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam

Exclusion Criteria:

* Patients with a prior history of ipsilateral breast cancer
* Pregnant patients
* Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam
* Patients not consenting to ALND

Primary outcomes:
measure: The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: BAPTIST ALLIANCE - MCI (Data Collection Only)
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only and Follow Up)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only and Follow Up)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Barrio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00178477: Study of Breath-holding as a Means to Reduce Tumor Motion From Breathing
Official title: Feasibility Study for Gated External-Beam Radiotherapy for Patients With Internal, Extra-cranial Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neoplasm, Metastatic
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate typical tumor motion caused by breathing using MRI and can help determine whether simple passive breathing and/or breath-holding could be used for the future treatment of similar lung and liver tumors using radiation therapy radiosurgery techniques.


Eligibility criteria: Inclusion Criteria:

* The patient is enrolled on U8700 RSRB # A Phase II Study For Using Radiosurgery On Limited Metastases Of Breast Cancer or U9700 A Pilot Study For Using Radiosurgery On Limited Metastases.
* ≥ 18 years of age
* has given Informed consent

Exclusion Criteria:

-Contraindications for any MRI procedure

Primary outcomes:
measure: Tumor Motion Related to Breathing as Determined From MRI Images
timeFrame: 20 - 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Department of Radiation Oncology
state: New York
Study officials:
affiliation: University of Rochester
name: Walter O'Dell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05243277: Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm
Official title: Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visual Fatigue
Keywords: virtual reality
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of healthy subjectfs with no history of visual disorders.

Brief summary: Operational military personnel are increasingly using virtual or augmented reality headsets in the field or in training. However, these devices cause a conflict between accommodation (focus to see clearly) and vergence (alignment of both eyes on the object being viewed) that can be a source of visual fatigue and altered visual and perceptual abilities. Although techniques exist to limit this conflict for screen-based stimuli, the use of helmet visuals (or immersive headsets) adds technological complexity. Indeed, since accommodation on the screen of the helmet visual is impossible (i.e., distance too small) for the human visual system, lenses are used to virtually shift the image (referred to as a collimated image) so that accommodation can occur much further away. However, this material configuration also modifies the vergence, thus causing a conflict between accommodation and additional vergence that persists regardless of the attenuation technique used.

In this study, the investigator proposed to modify the image display to take into account the technical features of the helmet to correct this techno-dependent conflict. This study is aimed at determining whether the setting recommended by the algorithm developed by the investigator limits visual fatigue better than the conventional setting recommended by manufacturers or a subjective setting controlled by the user.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Non-presbyopic
* Stereoscopic acuity ≤ 60 min of arc

Exclusion Criteria:

* Accommodative insufficiency (APP ≤ 13-"age"/4, in diopters)
* Accommodative inertia (+ and - block in binocular)
* Compensation by orthokeratology
* Present or past binocular pathology: strabismus or amblyopia

Primary outcomes:
measure: Evolution of oculomotor response to a stimulation generating jumps in vergence demand
timeFrame: Until the end of the study (20 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT05438277: Pain Increases After Shoulder Injection
Official title: Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Pain
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.

Detailed description: Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space.

Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.

Eligibility criteria: Inclusion Criteria:

* Subacromial or glenohumeral shoulder pain to be treated with steroid injection
* Fluent in written and oral English
* Willing and able to provide written consent
* Willing to complete follow up pain scores (visual analog score)

Exclusion Criteria:

* Unable to provide written consent
* Chronic pain syndrome
* Unwilling to complete follow up pain scores (visual analog score)

Primary outcomes:
measure: Incidence of a Flare Reaction
timeFrame: Post-injection day 1 through 7
Secondary outcomes:
Other outcomes:
Locations:
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: Tyler Brolin, MD
role: PRINCIPAL_INVESTIGATOR
References: