louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02222142: Volatile Versus Propofol Anesthesia in OPCAB
Official title: Comparison of Propofol and Isoflurane Anesthesia on Cardioprotection and Clinical Outcomes in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery : A Propensity-score Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Off Pump Coronary Artery Bypass Graft
Keywords: Ischemic heart disease
Off pump coronary artery bypass graft
Isoflurane
Propofol
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 1080
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent OPCAB from January, 2010 to December, 2012

Brief summary: Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode. The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB.

Detailed description: Several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB using propensity matching.

Eligibility criteria: Inclusion Criteria:

* OPCAB

Exclusion Criteria:

* On pump conversion

Primary outcomes:
measure: CK-MB, CRP
timeFrame: Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2
Secondary outcomes:
measure: Clinical adverse outcomes
timeFrame: until 1 year after OPCAB
Other outcomes:
measure: Cardioprotection and clinical adverse outcomes in diabetic patients
timeFrame: POD, POD 1, POD 2, one month, one year
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
Clinical trial NCT02510742: Physiological Changes With SPG Stimulation in Migraine Patients
Official title: Physiological Changes Induced With SPG Stimulation in Migraine Patients - Amendment to the Pathway M-1 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypothesis:

Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, concentration and cephalic vessel diameter.


Eligibility criteria: Inclusion Criteria:

* Chronic migraine patients

Exclusion Criteria:

-

Primary outcomes:
measure: Changes of mean blood velocity of middle cerebral artery (VMCA) using transcranial Doppler upon low frequency SPG stimulation
timeFrame: 0-90 min
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
Study officials:
References:
citation: Guo S, Falkenberg K, Schytz HW, Caparso A, Jensen RH, Ashina M. Low frequency activation of the sphenopalatine ganglion does not induce migraine-like attacks in migraine patients. Cephalalgia. 2020 Aug;40(9):966-977. doi: 10.1177/0333102420921156. Epub 2020 Apr 22.
Clinical trial NCT05876442: Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury
Official title: Efficacy of Extracorporeal Shock Wave Therapy Plus High-Intensity LaserTherapy on Carpal Tunnel Syndrome Post Burn Injury.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Injury
Keywords: Extracorporeal shock wave therapy
High Intensity Laser Therapy
Carpal Tunnel Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for moderate carpal-tunnel syndrome post-burn injuries.

Detailed description: To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for mild to moderate carpal tunnel syndrome post-burn injuries.

The effects of combining EPSW with High-intensity Laser Therapy for improving pain, Symptoms and function of motion, muscle strength, and quality of life in inpatients with carpal tunnel syndrome post-burn injuries

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with carpal tunnel syndrome after thermal burn injuries.
* Patients will be diagnosed with median nerve conduction study and Phalen sign and tinel test.
* Patients age: 20 to 60 years

Exclusion Criteria:

* Patients with severe (absent sensory or motor waves) and mild (sensory nerve latency \>3.5 ms at third digit) CTS according to EMG-NCV study.
* Conditions that could impact upon or impacted by outcome measures or laser intervention (e.g. hypothyroidism, cancer, active infection, pulmonary disease, acquired immunodeficiency syndrome, associated myopathy, myelopathy, history of neck and/or shoulder surgery, drugabuse, corticosteroids consumption, and pregnancy)
* Patients received continuous physical therapy or exercise during the previous two weeks or taking analgesic or anti-inflammatory drugs during the week prior to the baseline assessment

Primary outcomes:
measure: Pain Intensity.
timeFrame: 2 months
Secondary outcomes:
measure: Symptoms and Functions.
timeFrame: 2 months
measure: Median Nerve conduction Study
timeFrame: 2 months
measure: Muscle strength assessment
timeFrame: 2 Months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University, Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT00694642: Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
Official title: Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Refractory Angina
Keywords: Refractory angina
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2008-06-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.

Detailed description: The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.

Eligibility criteria: Inclusion Criteria:

* Functional class II- IV angina on maximal medical therapy
* Myocardial Ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques
* Patients should not be amenable to any type of revascularization procedure (percutaneous or surgical)
* Signed informed consent

Exclusion Criteria:

* Age \<18 years or \>75 years.
* Atrial fibrillation.
* LV thrombus
* Acute myocardial infarction in the last 3 months
* An LV wall thickness of \<8 mm at the target site for cell injection
* A history of malignancy in the last 5 years

Primary outcomes:
measure: major adverse cardiac and cerebrovascular event
timeFrame: 6, 12 and 24 months
Secondary outcomes:
measure: Efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hostpial Clinico San Carlos
name: Pilar Jimenez-Quevedo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01417442: BRAF V600E Mutations In Papillary Thyroid Carcinoma
Official title: Association Of Prognosis And BRAF V600E Mutations In Papillary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Papillary Thyroid Carcinoma
Keywords: papillary thyroid carcinoma
BRAF V600E
poor prognosis
aggressive
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

Detailed description: Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy and BRAF V600E mutation is the most common genetic alteration identified in PTC, ranging from 25 to 80%, with the average rate about 45%. Various studies demonstrated a relationship between BRAF V600E mutation and aggressive characteristics of the cancer, including the worse patient prognosis. But,there are no studies from Turkey regarding this topic. So the investigators will examine BRAF V600E mutation in our patients with PTC and try to assess the role of this mutation in prognosis and further management of the patients.

Eligibility criteria: Inclusion Criteria:

* Patients with papillary thyroid cancer

Exclusion Criteria:

* Patients who do not want to be a part of this study

Primary outcomes:
measure: BRAF V600E MUTATION
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeliz Emine Ersoy
Study officials:
References:
Clinical trial NCT05677542: Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
Official title: Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Psoriatic Arthritis
Keywords: Axial spondyloarthritis;
Psoriatic Arthritis;
electronic health records;
natural language processing;
artificial intelligence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 758
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs).

Brief summary: This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years.
* Diagnosed with axSpA or PsA.
* Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
* Had at least 3 months follow up from first bDMARD administration.
* Patients with EHRs.

Exclusion Criteria:

• Receiving bDMARD within a clinical trial from January 2018 to data collection.

Primary outcomes:
measure: Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment
timeFrame: month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02008942: Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
Official title: Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes


Eligibility criteria: Inclusion Criteria:

* Non-Insulin-Dependent Diabetes Mellitus
* Adults 21 to 79 years, inclusive
* Body mass index between 30 and 40 kg/m2, inclusive

Exclusion Criteria:

* Currently prescribed aspirin or anti-coagulants
* Contraindications to aspirin
* Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
* Patient requires insulin

Primary outcomes:
measure: Time to 99% Inhibition of Serum Thromboxane
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Lenexa
country: United States
facility: PRA Clinical Pharmacology Center
state: Kansas
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology
state: Ohio
Study officials:
References:
Clinical trial NCT02398942: Proximal Pole Fractures of the Scaphoid
Official title: A Prospective Study of Proximal Pole Fractures of the Scaphoid
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Proximal Pole Fractures of the Scaphoid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Medical Center Haaglanden, The Hague, The Netherlands
name: Skane University Hospital
name: Ghaem Hospital
First posted: 2015-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with proximal pole fracture of the scaphoid

Brief summary: Aim:

The aim of this study is to analyze the clinical and radiological outcomes of patients with a proximal pole fracture of the scaphoid

Primary null hypothesis:

There are no factors associated with nonunion of a proximal pole fracture of the scaphoid.

Secondary null hypothesis:

Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the Norway and 10.9 in the United States), 2 to 6 months after injury.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or greater
* Proximal pole fracture of the scaphoid on computed tomography scans made in the planes defined by the long axis of the scaphoid. The proximal pole will be defined as the proximal fifth of the scaphoid, excluding small scapholunate ligament avulsion fractures.
* Interval between injury and diagnosis of less than 2 weeks.
* English or Spanish fluency and literacy

Exclusion Criteria:

* Pregnant women
* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
* Patients with other fractures or injuries

Primary outcomes:
measure: Disability measured using QuickDASH
timeFrame: 6 months
measure: Nonunion of Fracture
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03292042: Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria
Official title: Impact of a Physical Health Promotion Program for People With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
lifestyle intervention
health promotion
mental health nurse
serious mental illness
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2017-09-25
Enrollment: 61
Sex: ALL
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 this study is to evaluate the effectiveness of a lifestyle intervention, to reduce the risk of metabolic syndrome in patients with serious mental illness who receive treatment with antipsychotic medications.

The hypothesis of the study is that: the application of a physical health promotion program in people with serious mental illness, who receive treatment with antipsychotic medications, carried out by a mental health nurse, will decrease the presence of metabolic syndrome and contribute to improve their quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnostic of serious mental illness.
* Treatment with antipsychotics.
* Met at least 3 of the 5 criteria of metabolic syndrome According to the NCEP ATP III definition.

Exclusion Criteria:

* Medical contraindications to exercise
* Admitted to hospital.
* intellectual disability

Primary outcomes:
measure: Decrease of at least 3 of the 5 criteria of metabolic syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Metabolic syndrome prevalence
timeFrame: 6 months
measure: use of antipsychotic
timeFrame: 6 months
measure: Toxic habits
timeFrame: 6 months
measure: Quality of life improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: university hospital Ramón y Cajal
Study officials:
References:
Clinical trial NCT05871242: Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
Official title: Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Issues
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Treviso Regional Hospital
First posted: 2023-05-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is aimed to explore the treatment effect from the intake of probiotic Lactobacillus crispatus M247 in the improvement of clinical and psychological aspects in women undergoing homologous level 2 ART procedures.

Detailed description: The use of assisted reproductive technology (ART) has increased dramatically worldwide due to the continuous rise in infertility rates; for these reasons an increasing number of couples undertake the path of ART, even though this is difficult journey, with uncertain outcomes and possible medical risks, both physical and psychological.

In this study the investigators aim to explore the hypothesis that recreating a favorable vaginotype through the intake of the probiotic Lactobacillus crispatus M247 can have a positive effect in achieving pregnancy in cryopreserved cycles as well as a positive relationship between vaginal, endometrial (still unknown), gut and oral microbiota.

Eligibility criteria: Inclusion Criteria:

* Women undergoing homologous level 2 assisted reproductive technology (ART) procedures
* Cryopreserved oocytes
* D3 embryos
* D5 blastulae
* Age 18-45

Exclusion Criteria:

* Presence of submucous uterine myomas.
* Uterine malformations.

Primary outcomes:
measure: Pregnancy
timeFrame: up to 12 months
Secondary outcomes:
measure: Effect on sex hormonal profile
timeFrame: up to 12 months
measure: Effect on sex hormonal profile
timeFrame: up to 12 months
measure: Effect on sex hormonal profile
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: ART center, Hospital of Conegliano
Study officials:
References: