louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01413802: Intra Operative Continuous Laryngeal Nerve Monitoring During Thyroid Surgery and Interpretation of the Post-operative Voice Quality in Relation to the Electromyography Data Obtained During Surgery
Official title: Intra Operative Continuous Laryngeal Nerve Monitoring During Thyroid Surgery and Interpretation of the Post-operative Voice Quality in Relation to the Electromyography Data Obtained During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Surgery
Keywords: Thyroid surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: During thyroid surgery the laryngeal recurrent nerves (and for this reason the voice quality) are at risk. Therefore intra operative continuous neuromonitoring could help to prevent harm to these nerves. Electromyographic data (EMG values) are collected during surgery (1). In the postoperative follow-up period detailed voice analysis is performed (2): subjective auditive perceptive evaluation and videostroboscopy. Analysis and comparison of (1) and (2) will be performed in order to find out if we can find a predictive correlation between the EMG data (1) and the voice quality (2).


Eligibility criteria: Inclusion Criteria:

* patients (men/women) requiring thyroid surgery

Exclusion Criteria:

* patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.

Primary outcomes:
measure: Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
timeFrame: 1 week after surgery
measure: Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
timeFrame: 3 weeks after surgery
measure: Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw clinic Aalst
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hubert Vermeersch, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538602: Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
cardiovascular disorders
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-02-24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers

Brief summary: Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.


Eligibility criteria: Inclusion Criteria:

* Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion Criteria:

* Pre-existing secondary endocrine disorders
* History of hypertension, diabetes mellitus or cardiovascular disorders
* Pharmacologic treatment in the last 6 months before entering the study.

Primary outcomes:
measure: Mean platelet volume
measure: Thromboxane A2
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Istituto di Patologia Ostetrica e Ginecologica
Study officials:
References:
Clinical trial NCT00861302: Evaluating a Chronic Pain Treatment Program
Official title: Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2009-03-13
Enrollment: 72
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: This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.


Eligibility criteria: Inclusion Criteria:

* Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program

Exclusion Criteria:

* Autoimmune diseases
* Cancer pain
* Illiterate
* Cognitively impaired
* Too medically ill

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: baseline, post-treatment, 3- and 6-month follow-ups
Secondary outcomes:
measure: Center for Epidemiologic Studies--Depression Scale
timeFrame: baseline, post-treatment, 3- and 6-month follow-ups
measure: Satisfaction with Life Scale
timeFrame: baseline, post-treatment, 3- and 6-month follow-ups
measure: McGill Pain Questionnaire
timeFrame: baseline, post-treatment, 3- and 6-month follow-ups
measure: Impact of Events Scale-Revised
timeFrame: baseline, post-treatment, 3- and 6-month follow-ups
measure: Positive Affect Negative Affect Scale-Expanded Version
timeFrame: baseline, post-treatment, 3- and 6-month follow-ups
Other outcomes:
Locations:
city: Southfield
country: United States
facility: St. John Providence Health System
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark A Lumley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burger AJ, Lumley MA, Carty JN, Latsch DV, Thakur ER, Hyde-Nolan ME, Hijazi AM, Schubiner H. The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial. J Psychosom Res. 2016 Feb;81:1-8. doi: 10.1016/j.jpsychores.2015.12.003. Epub 2015 Dec 11.
Clinical trial NCT01641302: The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

Brief summary: The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-90 years of age) scheduled for undergoing robot-assisted laparoscopic prostatectomy undergoing general anesthesia

Exclusion Criteria:

* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery

Primary outcomes:
measure: ultrasonographic measurement of optic nerve sheath diameter
timeFrame: before anesthesia induction, 10 minutes after anesthesia induction, 30 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position, CO2 desufflation.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Associate Professor Department of Anesthesiology and Pain Medicine,
Study officials:
References:
Clinical trial NCT00485602: Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Malocclusion
Keywords: malocclusion
aligner
crowding
expansion
orthodontic treatment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on "High-Tech" technology.

The appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-D screening technology of the patient's malocclusion. The aligner has a designed pathway "built-in" for the tooth to move, from the original position of the malocclusion to the "end point" - the correct position.

The force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner.

The study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.

Detailed description: The appliance include:

* silicone aligner (made specifically for the patient.
* simple air pump to blow air in the tiny balloons.

The patient is guided to wear the appliance 12-14 hours a day, after filling air in the balloons, under the doctor's instructions.

Clinical examination for follow-up will be done every 4 weeks.

Eligibility criteria: Inclusion Criteria:

* mild to moderate class I malocclusion
* good general health
* good oral hygiene

Exclusion Criteria:

* bad cooperation
* any mental or health problem
* severe class I malocclusion, class II or class III malocclusion

Primary outcomes:
measure: study models
timeFrame: every 2 appointments (8 weeks)
Secondary outcomes:
measure: occlusal photographs
timeFrame: every 3 appointments (12 weeks)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Meir Redlich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00108602: Sleep Apnea: Mechanism and Cerebrovascular Consequences
Official title: Sleep Apnea: Mechanism and Cerebrovascular Consequences
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Stroke
Keywords: sleep apnea
stroke
ventilatory control
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during CO2 administration. Following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs \[at bedtime\]) versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.

Detailed description: This study never enrolled patients. It was a component of a larger VA Merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.

Eligibility criteria: Inclusion Criteria:

* We will select non-obese patients (body mass index \[BMI\] \<30 kg/m2) with stroke diagnosed during the 3 previous months and obstructive sleep apnea on screening sleep study (apnea-hypopnea index \[AHI\] \>15 events/hr of study time).
* Patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (Rankin scale \< 3)

Exclusion Criteria:

* Hemorrhagic stroke,
* A history of chronic obstructive lung disease,
* Left ventricular ejection fraction (LVEF) \<55%
* Evidence of nasal or pharyngeal obstruction on physical examination.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wlliam S. Middleton Memorial Veterans Hospital, Madison
name: Steven Barczi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04893902: Digital VS. Conventional Ear Impression
Official title: An Innovative Approach for Auricular Rehabilitation Using Two Types Digital Impression Versus Conventional Techniques:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Loss His Ear and Need Auricular Prosthesis
Keywords: Ear impression -Ear scanning-intraoral scanner-scannin marker-ear prosthesis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-05-20
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control clinical rial
Primary purpose: TREATMENT

Brief summary: What is known:

Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort .

What this study adds:

Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort

Detailed description: Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects.

Purpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.

Eligibility criteria: Inclusion Criteria:

* any normal patient

Exclusion criteria:

* no exclusion criteria

Primary outcomes:
measure: total deviation between Conventional auricular impression and two types of digital impression
timeFrame: 1 day
Secondary outcomes:
measure: total deviation between two types of digital impression
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Mahmoud dohiem
Study officials:
References:
citation: Dohiem MM, Emam NS, Abdallah MF, Abdelaziz MS. Accuracy of digital auricular impression using intraoral scanner versus conventional impression technique for ear rehabilitation: A controlled clinical trial. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4254-4263. doi: 10.1016/j.bjps.2022.08.002. Epub 2022 Aug 5.
Clinical trial NCT00358202: Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
Official title: Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Keywords: intramuscular antibiotics
nursing home acquired pneumonia
nhap
pharmacoeconomics
cefepime
ceftriaxone
Lead sponsor: CPL Associates
Sponsor class: OTHER
Collaborators: name: Elan Pharmaceuticals
First posted: 2006-07-31
Enrollment: 69
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.

Detailed description: To compare the efficacy, safety, and pharmacoeconomics of cefepime versus ceftriaxone. Double-blind study of nursing home residents \>60 years of age with pneumonia. Patients were randomized to cefepime or ceftriaxone 1 gm q24h to be administered intramuscularly. After three days, responding patients could be switched to oral antibiotics. Main Outcome Measures: clinical success, adverse events, and cost-effectiveness ratios.

Eligibility criteria: Inclusion Criteria: Residents of a nursing home for \>=30 days who were at least 60 years of age and developed pneumonia not amenable to oral antibiotics while not requiring hospitalization, a new infiltrate on chest Xray, estimated Clcr \<=60 mL/min, presence of standard clinical criteria, signed informed consent.

Exclusion Criteria: Allergy to cephalosporins, receipt of \>24 hours of an antibiotic (unless no improvement was evident), an existing infection due to a pathogen known resistant to either study drug; expected mortality within 48 hours, immunosuppression, hypotension or respiratory distress requiring ventilatory support, prior limited treatment or supportive care only directives, suspected or known Pseudomonas aeruginosa or MRSA infections, primary lung cancer or another malignancy metastatic to the lungs, bronchial obstruction or a history of post-obstructive pneumonia, or patients receiving renal dialysis.

Primary outcomes:
measure: Total cost of all antibiotics.
timeFrame: 7-14 days
Secondary outcomes:
measure: Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: CPL Associates,LLC
state: New York
Study officials:
affiliation: CPL Associates, LLC
name: Joseph A Paladino, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06251102: Real-world Ruxolitinib Experience in PV
Official title: Real-world Ruxolitinib Experience in Polycythemia Vera: REVIEW Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Polycythemia Vera
Keywords: ruxolitinib
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Polycythemia vera according to WHO or ICC 2022 criteria who received treatment with ruxolitinib as second-line therapy for resistance / intolerance to hydroxyurea, according to the prescription criteria approved in Italy. Patients already on treatment (retrospective part) at the start date of the study and patients included after the start date for a period of 9 months may be included in the study

Brief summary: This is a multicentric, observational, retro-prospective study in adult PV patients - resistant or intolerant to hydroxyurea - who are going to receive or have already initiated treatment with ruxolitinib according to the approved local label. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

Detailed description: This is a multicentric, observational, retro-prospective study in adult population who have been diagnosed with polycythemia vera according to the 2022 (WHO or ICC) criteria, who are resistant or intolerant to hydroxyurea and who are going to be prescribed or have already initiated treatment with ruxolitinib according to the approved local label. Patients who started treatment with ruxolitinib - according to clinical practice - will be enrolled. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 18 years of age
2. Subjects must be diagnosed with PV according to the 2022 World Health Organization (WHO) or International Consensus Classification (ICC) criteria
3. Subjects must have a treatment history for PV that meets the definition of resistance or intolerance to hydroxyurea (HU) in accordance with the indications of the Italian Medicines Agency
4. Patients already on ruxolitinib treatment (retrospective cohort) at the start date of the study or patients who will start ruxolitinib (prospective cohort) during the study enrollment
5. Signed informed consent

Exclusion Criteria:

1. Different diagnosis from PV \[eg. other chronic myeloproliferative neoplasia such as essential thrombocythemia, myelofibrosis; or of congenital erythrocytosis or secondary erythrocytosis\]

Primary outcomes:
measure: effectiveness of ruxolitinib
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AOU Careggi, University of Florence
name: Paola Guglielmelli
role: PRINCIPAL_INVESTIGATOR
References: