louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02250469: A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
Official title: A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.


Eligibility criteria: Inclusion Criteria:

1. Subject is appropriate for SCS implantation according to standard criteria
2. Subject is \>18 to \<75 years old
3. Subject is able and willing to comply with the follow-up schedule and protocol
4. Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Subject has no other exclusion criteria for SCS implantation according to standard criteria
2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
4. Subject has participated in another clinical study within 30 days
5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy

Primary outcomes:
measure: Specificity of Stimulation Induced Paresthesia
timeFrame: 3 Months post implantation
measure: Stability of Stimulation Induced Paresthesia
timeFrame: 3 Months post implantation
measure: Patient Interactions with System
timeFrame: 3 Months post implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
affiliation: AIDS Malignancy Consortium
name: M W Hollmann, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02349269: Postoperative Atrial Fibrillation and Long-term Survival
Official title: Postoperative Atrial Fibrillation After Cardiac Surgery is Not an Independent Risk Factor for Long-term Cardiovascular Morbidity and Mortality in Anticoagulated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Stroke
Myocardial Infarction
Keywords: Atrial fibrillation
CABG
Stroke
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2015-01-28
Enrollment: 519
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously

Brief summary: The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.

Detailed description: The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances.

Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.

Eligibility criteria: Inclusion Criteria:

* previously cardiac operation, CABG or AVR

Exclusion Criteria:

* Previous Atrial fibrillation

Primary outcomes:
measure: cardiovascular and all-cause death
timeFrame: 1-105 month
measure: stroke
timeFrame: 1-105 month
measure: late atrial fibrillation
timeFrame: 1-105 month
measure: myocardial infarction
timeFrame: 1-105 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01879969: Computer Assisted Orthognathic Surgery. Facial Asymmetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Asymmetry
Keywords: computer-assisted orthognathic surgery; facial asymmetry
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.

Detailed description: The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).

Eligibility criteria: Inclusion Criteria:

* facial asymmetry or mandibular deviation (cant of the occlusal plane \> 3° and/or midline discrepancies \> 2.5 mm)
* presence of all central incisors,
* pre- and postoperative radiographs and plaster casts (group 1)
* cranial CBCT images (group 2)
* pre- and postoperative digital photographs.

Exclusion Criteria:

* previous trauma involving the hard or soft facial tissues
* functional deviation of the mandible
* incomplete records (CBCT, radiographs, casts or digital photographs).

Primary outcomes:
measure: Change in linear measures
timeFrame: Preoperative (baseline)-Postoperative (up to 1 month)
measure: Change in angular measures
timeFrame: Preoperative (baseline)- Postoperative (up to one month)
Secondary outcomes:
measure: age of patients
timeFrame: Preoperative (baseline)
measure: Type of surgery needed
timeFrame: Preoperative (baseline)
measure: sample size
timeFrame: Preoperative (baseline)
measure: gender
timeFrame: Preoperative (baseline)
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Maxillofacial Unit, University of Sassari
state: SS
Study officials:
References:
Clinical trial NCT04299269: "Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
Official title: "Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this project is to identify a variable that discerns patients who are interested in their disease (atrial fibrillation/atrial flutter) from patients who show no interest and furthermore test this theory in a questionnaire survey.

This should help distinguish between patients who are interested in shared decision making and patients who are not (further projects planned).


Eligibility criteria: Inclusion Criteria:

* Current atrial fibrillation/flutter
* \>18 years of age
* sufficient knowledge of the german language to fill out the questionnaire

Exclusion Criteria:

* \< 18 years of age
* insufficient knowledge of the german language to fill out the questionnaire
* Hemodynamic instability

Primary outcomes:
measure: Preferences for autonomy measured with questionnaire
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH Wien
Study officials:
References:
Clinical trial NCT01821469: Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study
Official title: Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions Influencing Health Status
Bipolar Disorders
Keywords: bipolar disorders
euthymic
psychotherapy
Functional magnetic resonance imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of bipolar disorders
* euthymic (Montgomery and Asberg depression rating scale \< 10, Young Mania rating scale \< 10)

Exclusion Criteria:

* other concomitant psychiatric disorders

Primary outcomes:
measure: fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])
timeFrame: measurements were performed at T1 and T2 (up to 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Ums Irmage
Study officials:
affiliation: CHU grenoble pôle psychiatrie et neurologie
name: Thierry Bougerol, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.
Clinical trial NCT01055769: Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Official title: An Open Label, Single Dose, 2-Way, Randomized Cross-Over Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Bio-equivalence
Linezolid OS
Linezolid tablet
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.

Detailed description: To support Linezolid NDA in China.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers.
* 18-40 years old, male.
* BMI 19-24kg/m2.

Exclusion Criteria:

* Alcohol, drug, smoke user.
* Sensitive to oxazolidinones antibiotics class drug or heparin.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12-ECG abnormal.
* Treatment with study drug; clinically significant.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
measure: Terminal Half-Life (t1/2)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01831869: Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
Official title: The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Keywords: Subclinical hypothyroidism
L-thyroxine
Lipid
endothelial function
inflammatory factor
adipocytokine
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2013-04-15
Enrollment: 400
Sex: ALL
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: Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.


Eligibility criteria: Inclusion Criteria:

* Male and female aged of 18 to 60 years old;
* Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
* untreated.

Exclusion Criteria:

* Pregnancy or lactation women;
* Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
* Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
* Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
* Obviously poor compliance.

Primary outcomes:
measure: change in lipid profile
timeFrame: measured at baseline; 6 month; 12 months and 24 months.
measure: change in thickness of blood vessel wall
timeFrame: measured at baseline; 6 months; 12 months and 24 months.
Secondary outcomes:
measure: change in endothelial function
timeFrame: measured at baseline; 6 months; 12 months and 24 months.
measure: change of adipocytokines
timeFrame: measured at baseline; 6 months; 12 months and 24 months.
measure: Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
timeFrame: measured at baseline; 6 months; 12 months and 24 months.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Jiajun Zhao
role: STUDY_CHAIR
References:
Clinical trial NCT06011369: Study of Usefulness of Fluorescence in Thiroid Surgery
Official title: A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Surgery
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PROSPECTIVE, CONTROLLED, RANDOMIZED
Primary purpose: TREATMENT

Brief summary: In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.

For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.


Eligibility criteria: Inclusion Criteria:

* Total thyroidectomy with/without lymph node dissection
* Signature of informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Hemithyroidectomy
* Reintervention of thyroid surgery

Primary outcomes:
measure: Type of surgery performed
timeFrame: Up to 12 months.
measure: Number of parathyroid glands identified before the use of AF (Autofluorescence)
timeFrame: Up to 12 months.
measure: Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
timeFrame: Up to 12 months.
measure: Quantification of each parathyroid gland with AF(Autofluorescence)
timeFrame: Up to 12 months.
measure: Number of glands accidentally removed.
timeFrame: Up to 12 months.
measure: Number of autotransplanted glands.
timeFrame: Up to 12 months.
measure: Surgical time.
timeFrame: Up to 12 months.
measure: Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
timeFrame: Up to 12 months.
measure: Concentration of PTH and calcium corrected by albumin and/or ionic
timeFrame: 4, 24 Hours
measure: Concentration of PTH and calcium corrected by albumin and/or ionic
timeFrame: 6,12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: HCUVA
name: Beatriz Febrero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852669: Adjunct Inversion for Lower Pole Stone
Official title: A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Lam Wah Ee Hospital
First posted: 2013-05-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.


Eligibility criteria: Inclusion Criteria:

1. Solitary lower pole caliceal stone which is \> 5 mm and \< 20mm
2. Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
3. Patient able to comply strictly with visits/medications
4. Patient willing and agrees to enter study

Exclusion Criteria:

1. Impaired function of the affected kidney
2. Gross hydronephrosis of the affected kidney
3. Associated distal obstruction
4. Multiple stones
5. Stone more than 2 cm in size
6. Diverticular stone
7. Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
8. Patients who are unable to tolerate the procedure
9. Significant cardiac condition that does not allow the administration of force hydration or inversion.
10. Uncontrolled hypertension

Primary outcomes:
measure: Number of Participants Who Are Stone Free at 3 Months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lam Wah Ee Hospital
name: Liong Men Long, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14.