louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00746889: Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Official title: Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
knee
corticosteroids
ultrasound
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.


Eligibility criteria: Inclusion Criteria:

* knee pain
* diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

* intraarticular corticosteroids in affected knee within past three months
* primary inflammatory connective tissue disease (ie rheumatoid arthritis)
* currently taking oral corticosteroids

Primary outcomes:
measure: Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
timeFrame: baseline to 4 weeks
Secondary outcomes:
Other outcomes:
measure: Change in WOMAC Pain Subscale
timeFrame: baseline to 12 weeks
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: La Jolla
country: United States
facility: San Diego VA Hospital
state: California
Study officials:
affiliation: University of California, San Diego
name: Kenneth Kalunian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego VA Hospital
name: Anna Quan, MD
role: STUDY_CHAIR
affiliation: San Diego VA Hospital
name: Michal Kalli Hose, MD
role: STUDY_DIRECTOR
affiliation: University of California, San Diego
name: Jeannie Chao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00195689: Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
Official title: A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis


Eligibility criteria: Inclusion Criteria:

* Subject completed study M02-518 or M02-570

Exclusion Criteria:

* Subject prematurely discontinued study M02-518 or M02-570

  * Female subject who is pregnant or breast-feeding or considering becoming pregnant
  * Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Primary outcomes:
measure: Safety parameters
measure: ACR 20/50/70
measure: PsARC
measure: HAQ
measure: SF-36
measure: FACTIT Fatigue Scale
measure: Disease progression measurements
Secondary outcomes:
measure: Patient reported outcomes
measure: Clinical response indicators
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Global Medical Information-Abbott Laboratories
state: Illinois
Study officials:
affiliation: Abbott
name: Beverly Paperiello
role: STUDY_DIRECTOR
References:
citation: Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.
citation: Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, Birbara C, Thomson GT, Perdok RJ, Medich J, Wong RL, Gladman DD. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009 May;68(5):702-9. doi: 10.1136/ard.2008.092767. Epub 2008 Aug 6.
Clinical trial NCT02512289: Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation
Official title: Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: University Hospital of Mont-Godinne
First posted: 2015-07-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

Detailed description: tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.

Eligibility criteria: Inclusion Criteria:

* stroke with at least slight deficit in upper limb

Exclusion Criteria:

* epilepsy
* contraindication to tDCS
* presence of metal in the head
* inability to understand/complete behavioural tasks
* chronic intake of alcohol or recreative drugs
* major health condition (e.g. terminal renal failure, instable heart failure etc ...)
* pregnancy

Primary outcomes:
measure: Upper Limb Kinematics
timeFrame: kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Secondary outcomes:
measure: Box and Block test
timeFrame: Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
measure: Purdue Pegboard Test
timeFrame: Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Mont Godinne
country: Belgium
facility: CHU Dinant-Godinne UCL
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Thierry Lejeune, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02733289: Standard Follow-up Program Cervix Cancer (SFP CERVIX)
Official title: Standard Follow-up Program Cervix Cancer (SFP CERVIX)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer Radiation Complications
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient who receives curative radiotherapy for cervical cancer at the department of Radiotherapy at the UMCG.

Brief summary: Standard evaluation and follow-up data regarding complications of curative radiation treatment for cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Every cervical cancer patient with curative intent for radiotherapy, treated at our department

Exclusion Criteria:

* Non-curative treatment
* Part of the treatment is given in another hospital

Primary outcomes:
measure: Complications
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Principal Investigator
name: Jannet Beukema
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00446589: The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Papageorgiou General Hospital
Sponsor class: OTHER
First posted: 2007-03-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hemodialysis patients with low bone density (total hip T-score \<-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).

Follow-up period: one year. A second bone biopsy at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Bone mineral density (T-score\<-2.5)
* Adynamic bone disease for the teriparatide group
* Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
* Calcium greater than 8.1 mg/dl

Exclusion Criteria:

* Suspected carcinoma
* Unstable clinical setting

Primary outcomes:
measure: Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
timeFrame: one year
Secondary outcomes:
measure: Effects of ibandronate and teriparatide on other bone disease markers
timeFrame: one year
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
affiliation: Papageorgiou General Hospital, Thessaloniki, Greece
name: Efstathios Mitsopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06070389: Polysomnography Validation of the Sansa Device
Official title: Polysomnography Validation of the Sansa Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Lead sponsor: Huxley Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* able to read, understand, and sign informed consent documentation
* willing to sleep with the Sansa device and PSG simultaneously in the sleep clinic
* suspected or known to have sleep disordered breathing

Exclusion Criteria:

* exhibit deformities of the chest that would interfere with sensor placement
* have broken or injured skin that would interfere with sensor placement
* known to experience adverse reactions to medical-grade adhesive
* diagnosed with hypoventilation
* diagnosed with severe chronic obstructive pulmonary disease
* exhibit symptoms of significant non-respiratory sleep disorders
* diagnosed with a neuromuscular disorder leading to muscle weakness
* chronically use supplemental oxygen at night or during the day
* pregnant
* scheduled to undergo titration of a hypoglossal nerve stimulation device
* undergo permanent pacing with an implanted pacemaker
* diagnosed with congestive heart failure with an ejection fraction less than 45%

Primary outcomes:
measure: Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Pulmonary & Sleep Specialists
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cathy Goldstein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02773589: Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
Official title: Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagus Achalasia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique allowing to cure this pathology. In this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy). This technique does not require any cutaneous incision.

Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context, the introduction of the POEM technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.


Eligibility criteria: Inclusion Criteria:

* Esophagus achalasia
* Confirmed by esophageal manometry
* Requiring surgical care
* No contraindication to general anesthesia
* BMI under 40 kg/m²
* Ability to give an informed consent
* Candidate to elective Heller's myotomy
* Affiliation to a social security system
* Signed and informed consent

Exclusion Criteria:

* Advanced esophageal dilatation (sigmoid megaesophagus)
* Previous mediastinal or esophageal surgery
* Contraindication to esophagogastroduodenoscopy (EGD)
* Contraindication to general anesthesia
* BMI above 40 kg/m²
* Infectious esophagitis (e.g. candidiasis)
* Psychiatric context unsuitable with an experimental protocol
* Allergy to beta-lactam
* Contraindication to endoscopy (esophageal stenosis, suspicion of digestive perforation, state of shock, severe anemia, cardiorespiratory failure or severe metabolic disorders)
* Contraindication to monitored pneumoperitoneum (cardiorespiratory failure or severe metabolic disorders)
* Inability to give an informed consent (emergency situations, misunderstanding...)
* Patient in custody
* Patient under guardianship
* Pregnancy or breastfeeding

Primary outcomes:
measure: The safety assessment will be based on the reading of all surgical intraoperative complications
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Silvana PERRETTA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00034489: A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
Official title: A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: metastatic breast cancer
combination therapy
Alimta
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-04-30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.

Detailed description: Gemcitabine is given by vein over 30 minutes on days 1 \& 8 of each 21-day cycle. LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12 is administered approximately every 9 weeks after the first injection. Appropriate antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to prevent or lessen the possibility of a rash.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of breast cancer
* measurable disease
* received prior anthracycline and taxane
* life expectancy \> 3 months
* acceptable lab results

Exclusion Criteria:

* \>3 prior regimens
* prior treatment with protocol drugs
* prior (pelvic) radiation
* active CNS metastasis
* inability to take oral vitamins

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT01747889: Objective and Subjective Outcomes of an Electronic Chest Drainage System
Official title: Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: chest tube
lung resection
patient satisfaction
mobility
Lead sponsor: Ospedali Riuniti Ancona
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: The University of Hong Kong
name: Yale University
First posted: 2012-12-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to compare the Thopaz chest tube drainage system to the traditional collection chamber system. The Thopaz system is already in clinical use in the United States and throughout the world. As such, this study is not evaluating safety or efficacy of this system both of which have already been demonstrated. This study's primary aim is to determine whether the use of a digital chest drainage system compared with a traditional system affects duration of chest drainage and length of hospital stay.

Furthermore, we aim to determine whether the use of a digital chest drainage system compared with a traditional system increases the total distance of ambulation in the first 48 hours after thoracic surgery and affects overall patient satisfaction in the peri-operative period.

Finally, we want to determine whether the aforementioned outcomes relative to the chest tube drainage systems differ in different parts of the world.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to read, understand, and provide written Informed Consent
2. Age range of 18-90 years
3. Patients undergoing a segmentectomy, lobectomy, or bilobectomy. Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable.

Exclusion Criteria:

1. Patients unstable enough to require ICU care upon completion of the resection
2. Redo thoracotomies

Primary outcomes:
measure: Duration of chest tubes
timeFrame: date of chest tube removal
Secondary outcomes:
measure: total distance of ambulation in the first 48 postoperative hours
timeFrame: 48 hours after surgery
Other outcomes:
measure: overall patient satisfaction with chest drainage system.
timeFrame: 48 hours after surgery
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti Ancona
Study officials:
affiliation: Ospedali Riuniti Ancona, Italy
name: Cecilia Pompili, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
Clinical trial NCT06856889: Systematic Ultrasound in the Initial Assessment of Ankle Sprain
Official title: Evaluation of the Value of Systematic Ultrasound in the Initial Assessment of Ankle Sprain on Functional Prognosis At 3 Months in the General Population: Pilot Observational Study (PFEEC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Sprain
Keywords: ultrasound scan
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ankle sprain

Brief summary: Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Optimal initial management is essential for a successful return to previous condition, with the aim of preventing chronic ankle instability, chronic pain, stiffness or recurrence. One of the 13 physicians at our facility routinely performs an ultrasound routinely scan during the second consultation to assess the severity of the sprain. We would therefore like to evaluate whether the performance of this examination at the time of clinical reassessment is associated with a better prognosis at 3 months post-trauma.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ankle sprain made during a preliminary prior consultation
* Patients undergoing re-evaluation of sprain severity, between D3 and D6 of trauma

Exclusion Criteria:

* Medial sprain
* Sprain recurrence \<6 months
* Age \< 15 years
* Radiographic fracture confirmed on an X-ray performed between initial diagnosis and re-evaluation visit
* History of hyperlaxity syndrome

Primary outcomes:
measure: Value of systematic ultrasound in the initial assessment of ankle sprains on patients' quality of life and sporting activities at 3 months post-injury trauma.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bletterans
country: France
facility: Maison Médicale des Bords de Seille
Study officials:
References: