louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04001530: Half-normal Saline in Atrial Flutter Ablation
Official title: Verification of Half Normal Saline as a Superior Irrigant in the Catheter Radiofrequency Ablation of Typical Cavotricuspid Isthmus Dependent Atrial Flutter: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.

Detailed description: It is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. Given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. The efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age at the time of enrollment
* Patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation
* Fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities

Exclusion Criteria:

* The presence of thrombus within the left atrial appendage
* Prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter
* The inability to provide consent or comply with study requirements
* A predicted life expectancy of \< 12 months

Primary outcomes:
measure: Time taken to produce bidirectional block
timeFrame: intraprocedural
measure: Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
timeFrame: intraprocedural
measure: Freedom from atrial flutter recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Time taken for termination of atrial flutter
timeFrame: intraprocedural
measure: Total radiofrequency ablation time and procedural time
timeFrame: intraprocedural
Other outcomes:
measure: Incidence of procedure-related complications
timeFrame: at the time of the procedure and up to 1 month
measure: Incidence of steam pops
timeFrame: periprocedural
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02087930: Microbiota as Potential Target for Food Allergy
Official title: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cow Milk Allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.


Eligibility criteria: Inclusion Criteria:

* children with cow's milk allergy
* age 6-12 months

Exclusion Criteria:

* concomitant chronic systemic diseases
* congenital cardiac defects
* active tuberculosis
* autoimmune diseases
* immunodeficiency
* chronic inflammatory bowel diseases
* celiac disease, cystic fibrosis
* metabolic diseases
* malignancy
* chronic pulmonary diseases
* malformations of the gastrointestinal tract
* suspected eosinophilic esophagitis or eosinophilic enterocolitis
* suspected food-protein-induced enterocolitis syndrome.

Primary outcomes:
measure: Composition and function gut microbiota in children with cow milk allergy and healthy children
timeFrame: Change from baseline at 6 and 12 months
Secondary outcomes:
measure: Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries
timeFrame: Change from baseline at 6 and 12 months
measure: Composition and function gut microbiota comparing healthy Italian and healthy children of other countries
timeFrame: Change from baseline at 6 and 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT02522130: Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?
Official title: Different Analgesics Prior to IUD Insertion: Is There Any Evidence?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUD Insertion Complication
Lead sponsor: Al Hayat National Hospital
Sponsor class: OTHER
Collaborators: name: Menoufia University
First posted: 2015-08-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role

Detailed description: A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.

Eligibility criteria: Inclusion Criteria:

Patients are considered eligible if:

1. they are alert oriented and co-operative to response to the visual analogue scale (VAS).
2. They will sign the informed consent to participate in the clinical trial before entering the study.
3. Willingness to be randomized and complete study questionnaires.

Exclusion Criteria:

Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:

1. A lidocaine allergy
2. Copper allergy
3. Current cervicitis
4. Pelvic inflammatory disease (PID) within 3 months
5. Uterine anomalies
6. Pain medication within 6 hours before insertion
7. Misoprostol administration within 24 hour before insertion
8. History of cervical surgery and contraindication to study medications.

Primary outcomes:
measure: current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shebin Elkom
country: Egypt
facility: Menoufia University
city: Abha
country: Saudi Arabia
facility: Alhayah national hospital
Study officials:
References:
Clinical trial NCT03415230: Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer
Official title: Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Anxiety
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: Cyprus Anticancer Society
First posted: 2018-01-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.

Detailed description: The period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. This can often trigger increased anxiety levels and sleep disturbances. This trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.

Eligibility criteria: Inclusion Criteria:

* Women that completed their treatment
* women experiencing insomnia
* women experiencing anxiety
* women that speak and understand Greek

Exclusion Criteria:

* allergy to essential oils
* use of anticoagulants
* presence of edema
* presence of Varicose veins

Primary outcomes:
measure: Sleep Disturbances (insomnia)
timeFrame: Change from baseline total score at 4 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: Change from baseline total score at 4 weeks
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Oncology Centre
Study officials:
affiliation: Cyprus University of Technology
name: Andreas Charalambous, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108730: Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism
Official title: Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-focal Congenital Hyperinsulinism
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 13 children and one adult (30 years)

Brief summary: Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

Detailed description: In non-focal congenital hyperinsulinism (CHI) the current doctrine warrants subtotal pancreatic resection in all children who do not respond to medication. However, the rate of diabetes after these extensive resections is very high. In this study investigators show that a less aggressive approach may suffice to wean many children from all medication or to get them manageable medically.

Eligibility criteria: Inclusion Criteria:

* patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

* patients with focal congenital hyperinsulinism

Primary outcomes:
measure: necessity of medication after restrictive surgery in congenital hyperinsulinism
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Pediatric Surgery
Study officials:
affiliation: University Medicine Greifswald
name: Winfried Barthlen, Professor of Pediatric Surgery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643030: Hypercapnia During Shoulder Arthroscopy
Official title: The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Ischemia
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

Detailed description: The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective shoulder arthroscopic surgery

Exclusion Criteria:

* a history of age \> 65 years, morbidly obesity (BMI \> 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.

Primary outcomes:
measure: Regional cerebral oxygen saturation
timeFrame: Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center
name: Kyung Cheon Lee, MD
role: STUDY_CHAIR
References:
citation: Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.
Clinical trial NCT04400825: Dry Needling Versus Stretching for Muscle Extensibility
Official title: Comparing Dry Needling and Stretching for the Management of Muscle Extensibility in Patients With Hip Osteoarthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: physiotherapy
stretching
dry needling
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently several authors have shown the presence of active myofascial trigger points (MTrP) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.

Despite of the beneficial effects that have shown may conservative non-pharmacological treatments, there is a lack of studies evaluating the effects of the conservative treatments on muscle extensibility.

According to the new paradigm about the presence of MTrPs, the investigators decided to conduct a randomized clinical trial to compare the effects of DN intervention and stretching protocol on muscle extensibility in patients with hip OA.


Eligibility criteria: Inclusion Criteria:

* unilateral hip OA diagnosed medically with a X-Ray tess and following the American College of Rheumatology Criteria

Exclusion Criteria:

* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
* Vascular or neurological disease.
* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
* DN contraindications or fear of needles

Primary outcomes:
measure: muscle extensibility
timeFrame: Baseline
measure: muscle extensibility
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Stiffness
timeFrame: Baseline
measure: Stiffness
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Luis Ceballos Laita
Study officials:
References:
Clinical trial NCT01588925: Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Official title: Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hearing Loss
Keywords: Cochlear implantation
Dexamethasone
Acid, Hyaluronic
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Detailed description: Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.

In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.

Eligibility criteria: Inclusion Criteria:

* Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation.
* Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies

Exclusion Criteria:

* Malformation or cochlear ossification
* Developmental Disabilities

Primary outcomes:
measure: Hearing thresholds
timeFrame: within the first 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital
Study officials:
affiliation: University of São Paulo General Hospital
name: Bernardo F Ramos
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo General Hospital
name: Rubens V Brito Neto
role: STUDY_DIRECTOR
References:
Clinical trial NCT01328925: Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Official title: Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rotavirus Infection
Viral Gastroenteritis Due to Rotavirus
Keywords: Rotavirus
Viral gastroenteritis
Gastroenteritis
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 100
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.


Eligibility criteria: Inclusion Criteria:

* Age \< 6 years.
* Patients with diarrhea (defined as 3 or more liquid stools per day).
* Stool positive for rotavirus by ELISA.

Exclusion Criteria:

* Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
* Serious systemic disorders incompatible with the study.

Primary outcomes:
measure: Time from first dose to resolution of symptoms.
timeFrame: Up to 14 days
Secondary outcomes:
measure: Time from first dose to virologic response
timeFrame: Up to 14 days
measure: Time from first dose to hospital discharge
timeFrame: Up to 14 days
measure: Volume of oral rehydration solutions consumed
timeFrame: Up to 14 days
measure: Frequency of intravenous rehydration required
timeFrame: Up to 14 days
measure: Stool weight
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Children's Hospital
Study officials:
affiliation: Cairo University Children's Hospital
name: Mona Abu-Zekry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05200325: Clinical Utility Evidence for TissueCypher®
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for TissueCypher®: A CPV® Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Disorder
Barrett Esophagus
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.


Eligibility criteria: Inclusion Criteria:

* Board-certified gastroenterologist or GI surgeon for at least two years
* Averages at least 20 hours per week of clinical and patient care duties over the last six months
* performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
* practicing in the US
* english speaking
* access to the internet
* informed and voluntarily consented to be in the study

Exclusion Criteria:

* non-English speaking
* unable to access the internet
* not practicing in the US
* not averaging at least 20 hours per week of clinical or patient care duties over the last six months
* does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
* does not voluntarily consent to be in the study

Primary outcomes:
measure: Clinical Performance and Value (CPV)-measured change in physician behavior
timeFrame: 4 months
measure: CPV-measured evidence based management decisions
timeFrame: 4 months
measure: CPV-measured cost savings
timeFrame: 1 month
Secondary outcomes:
measure: CPV-measured baseline levels of variation
timeFrame: 4 months
measure: CPV-measured use case analysis
timeFrame: 4 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
References:
Clinical trial NCT00321425: Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Surgery
Brachial Plexus Block
Lead sponsor: Rikshospitalet University Hospital
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In an observer-blinded study ultrasound guidance and electrical nerve stimulation will be compared for lateral sagital infraclavicular blocks (LSIB). Block effectiveness, time consumption and patient acceptance will be registered in 80 patients. Ultrasound guidance may cause less discomfort and could be less time consuming than electrical nerve stimulation.


Eligibility criteria: Inclusion Criteria:

* Infraclavicular brachial plexus block
* Hand surgery

Exclusion Criteria:

* ASA \> 2
* Block assessment impossible
* Allergy to local anesthetic

Primary outcomes:
measure: Block effectiveness, time consumption; patient acceptance, discomfort
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Anaesthesiology, Rikshospitalet University Hospital
Study officials:
affiliation: Department of Anaesthesiology, Rikshospitalet University Hospital
name: Axel R Sauter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, Rikshospitalet University Hospital
name: Øivind Klaastad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, Rikshospitalet University Hospital
name: Audun Stubhaug, MD
role: STUDY_CHAIR
References: