louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04470115: Blocks for Intertrochanteric Fracture Repair Surgery
Official title: Femoral Nerve Block Together With Lateral Femoral Cutaneous Nerve Block and Sedation as Anesthesia Among High Risk Patients With Intertrochanteric Fracture Repair Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intertrochanteric Fractures
Keywords: intratrochanteric fracture
general anesthesia
femoral nerve block
lateral femoral cutaneous nerve block
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 100
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: This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

Detailed description: This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

Patients are high risk individuals scheduled for intratrochanteric fracture repair, with contraindications to spinal anesthesia. One group will receive general endotracheal anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation.

Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and opioid consumption will be recorded.

Eligibility criteria: Inclusion Criteria:

* intratrochanteric fracture
* need for surgery
* contraindications for spinal anesthesia

Exclusion Criteria:

* allergy to local anesthetics

Primary outcomes:
measure: Percentage of patients surviving 30 days after the surgery.
timeFrame: 30 days from the day of the surgery.
measure: Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.
timeFrame: 30 days from the day of the surgery.
measure: Percentage of patients suffering from postoperative delirium during 7 days after the surgery.
timeFrame: 7 days after the surgery.
Secondary outcomes:
measure: Pain score after surgery
timeFrame: first 24 hours after surgery
measure: Opioid consumption
timeFrame: first 24 hours after surgery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
Study officials:
References:
Clinical trial NCT01012115: Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis
Official title: Temporal Behavior of Coagulation Factors,Cytokines and Tissue Injury Markers in Sepsis: Validation of Extracellular Histones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Histones
organ failure
sepsis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Medical Research Foundation
First posted: 2009-11-11
Enrollment: 500
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: Patients admitted to the ICU with suspected or proven sepsis.

Brief summary: In an effort to better understand the interaction between the different mediators, the investigators propose to examine the time course of mediators, the indexes of organ injury and the coagulation cascade.

Detailed description: All patients admitted to the ICU (Including VA Medical Center, University Hospital and Presbyterian hospital) will be screened for enrollment in the study. Patients who have the diagnosis of sepsis will be asked to volunteer. We will match sepsis patients with other ICU patients without the diagnosis of sepsis. The latter will also be asked to volunteer.

Patients will be stratified into three groups:

* Sepsis
* SIRS of non-septic origin
* Other ICU patients

Routine laboratory data and clinical data (see flow sheet) will be collected. The plasma or serum will be frozen separately until the target number of patients is met. Measurements of inflammatory mediators and other cytokines/injury markers will be carried out at that point.

Eligibility criteria: Inclusion Criteria:

* Admission to the ICU

Exclusion Criteria:

* No blood draws scheduled
* Hemoglobin level \< 6.5 gm/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veterans Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: OU Health Sciences Center
name: Gary T Kinasewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122315: Dry Needling in Post-operative Shoulder Pain
Official title: EFFECTIVENESS OF THE INCLUSION OF TRIGGER POINT DRY NEEDLING INTO A MULTIMODAL PHYSICAL THERAPY PROGRAM FOR POST-OPERATIVE SHOULDER PAIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humeral Fracture Fixated With PHILOS© Plate
Rotator Cuff Tear Surgical Repair
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 20
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: Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. The purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure for proximal humeral fixation or rotator cuff tear repair.


Eligibility criteria: Inclusion Criteria:

* proximal humeral fracture
* rotator cuff tear
* open reduction and internal fixation with PHILOS© plate (Synthes, Switzerland)
* rotator cuff tear repair
* post-operative shoulder pain
* active TrPs in the neck-shoulder muscles

Exclusion Criteria:

* no active TrPs
* multiple fracture
* previous surgery
* cervical radiculopathy or myelopathy
* diagnosis of fibromialgia
* having undergone any physical therapy intervention in the year before the surgery
* fear of needles
* any contraindication for dry needling

Primary outcomes:
measure: Changes in Constant-Murley score before and after the intervention
timeFrame: Baseline and one week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Jose Luis Arias Buría
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Cesar Fernández-de-las-Peñas, PhD
role: STUDY_CHAIR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT01853215: Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum
Official title: A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraosseous Vascular Access
Keywords: sternal intraosseous infusion study
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-14
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is being done to evaluate intraosseous vascular access through the sternum.

Detailed description: The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.

Eligibility criteria: Inclusion Criteria:

* 21 years of age or older;
* healthy adult subjects

Exclusion Criteria:

* Weight \< 45kg;
* BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
* Imprisoned subjects;
* pregnant subjects;
* prior sternotomy;
* cognitively impaired subjects;
* fracture in target bone, or significant trauma to the site;
* excessive tissue and/or absence of adequate anatomical landmarks in target bone;
* infection in target area;
* IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
* current use of anti-coagulants;
* previous adverse reaction to Lidocaine;
* current cardiac condition requiring pacemaker or anti-arrhythmic drugs
* previous adverse reaction to contrast dye
* Allergy to any food and drug
* History of impaired renal function
* History of impaired hepatic function
* History of cardiac disease
* History of pheochromocytoma

Primary outcomes:
measure: Occurrences of Extravasation During Infusion
timeFrame: during 12 minutes of infusion
Secondary outcomes:
measure: Stability of Locator
timeFrame: During insertion of the intraosseous needle set
measure: Stability of Catheter Hub
timeFrame: During insertion of the intraosseous needle set
measure: Adhesion Strips
timeFrame: During insertion of the intraosseous needle set
measure: Gravity Flow Rates
timeFrame: during the 12 minute infusion time frame
measure: 100mmHg Infusion Flow Rates
timeFrame: during the 12 minute infusion time frame
measure: 200mmHg Infusion Flow Rates
timeFrame: during the 12 minute infusion time frame
measure: 300mmHg Infusion Flow Rates
timeFrame: during the 12 minute infusion time frame
Other outcomes:
Locations:
city: Spring Branch
country: United States
facility: Bulverde-Spring Branch EMS
state: Texas
Study officials:
affiliation: Vidacare Corporation
name: Larry J Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434615: Medtronic South Asian Systolic Heart Failure Registry
Official title: SASHFR (South Asian Systolic Heart Failure Registry) : A Multi-center, Nonrandomized, Prospective Study to Collect Data Pertaining to the Demographic and Cardiovascular Profiles, Management Strategies and Clinical Outcomes of HF Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy
Moderate to advanced
patients
current consensus guidelines
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2011-09-15
Enrollment: 502
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to (a) characterize the current management of patients with systolic heart failure (HF) in South Asia following an educational intervention of current guidelines and delivery of disease management tools and (b) to characterize the effect of current therapy on clinical outcomes in patients managed by tertiary care centers across South Asia. Current therapy includes characterization of the post market performance of any market released Medtronic cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac resynchronization therapy (CRT).


Eligibility criteria: Inclusion Criteria:

* Patient has signed and dated study informed consent. Patients having moderate to severe heart failure (NYHA Class III or IV) EF \< 35% as measured by echo, MUGA, contrast ventriculogram or MRI. QRS duration \> 120 ms.

Exclusion Criteria:

Patient has life expectancy of less than 12 months due to medical conditions other than HF.

* Patient has experienced unstable angina, acute myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months.
* Patient is known to have chronic permanent atrial arrhythmias (i.e., cases of long-standing atrial fibrillation of greater than 1 year, including those in which cardioversion has not been indicated or attempted).
* Patient is enrolled in any concurrent study that would confound the results of this study.
* Patient is pregnant or breastfeeding.
* Patient has a CRT device implanted previously.
* Patient has had a heart transplant.

Primary outcomes:
measure: Clinical Composite score
timeFrame: 2 years
Secondary outcomes:
measure: Demographics
timeFrame: 2 years FU
measure: Profile of patients with positive response to CRT
timeFrame: 2 years
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Care Hospital
state: Andhra Pradesh
Study officials:
affiliation: Care Hospital, Hyderabd-India
name: C Narasimhan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03177915: Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome
Official title: Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Pain, Chronic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement

Detailed description: Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Eligibility criteria: Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal infection at the site of intervention
* local anesthetic allergy

Primary outcomes:
measure: pain alleviation
timeFrame: 6 months
Secondary outcomes:
measure: Changes in ultrasound imaging
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT05410015: Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Ovarian Cancer
Official title: Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Via Analysis of Immunoinflammation-related Protein Complexes in Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included normal ovarian controls, patients with benign ovarian disease, and patients with malignant epithelial ovarian cancer.

Brief summary: The relationship between immune inflammation-related protein complexes inblood and recurrence or metastasis of ovarian cancer will be studied

Detailed description: 100 cases in normal ovarian control group, 100 cases in benign ovarian disease group and 100 cases in malignant ovarian epithelial carcinoma group will be studied. Change regularity of ovarian cancer specific immune inflammation-related protein complexes in blood will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Female
* Normal ovary control
* Ovarian benign disease
* Ovarian malignant epithelial carcinoma

Exclusion Criteria:

* Male
* Age above 70
* Suffering from other malignant tumors
* Non-compliant patient

Primary outcomes:
measure: Immune Inflammation-Related Protein Pomplexes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00522015: Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy
Official title: Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Progressive Supranuclear Palsy
Dementia
Keywords: PSP
dementia
neuropsychology
treatment
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2007-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to show that

1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function
2. use of rivastigmine has a positive effect on apathy in PSP patients
3. therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST
4. changes in motor activity are associated with changes in language and overall results of the in MMST


Eligibility criteria: Inclusion Criteria:

* diagnosis of PSP
* willingness to participate in the study
* informed consent
* ability to speak
* no further CNS diseases
* written informed consent
* stable state of health
* ability to give informed consent, will checked by an independent physician

Exclusion Criteria:

* alcohol abuses
* acute psychosis
* pregnancy or lactation
* known previous drug reaction or hypersensitivity of rivastigmine or other carbamate derivatives
* liver failure
* known sick sinus syndrome or excitation disturbance
* known ulcus ventriculi or duodenal ulcer
* known asthma or COPD
* seizures
* renal failure

Primary outcomes:
measure: improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
timeFrame: 6 month
Secondary outcomes:
measure: changes in speech function and improvement of quality of life
timeFrame: 6 Month
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen
state: Baden Wuerttemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Daniela Berg, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06374615: Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy
Official title: Insights Into Tick-Borne Diseases: a Prospective Study From an Endemic Area of Northern Italy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tick-Borne Diseases
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 384
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a monocentric, experimental, non-pharmacological and non-device no profit study.

The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* all individuals aged \> 8 years presenting for tick removal.
* Individuals providing signed informed consent.

Exclusion Criteria:

* tick not available for analysis

Primary outcomes:
measure: Number of individuals diagnosed with Tick-Borne Diseases (TBD) over the total number of individuals who were bitten by a tick which carried an identified TBP.
timeFrame: baseline
Secondary outcomes:
measure: Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks
timeFrame: baseline
measure: Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period
timeFrame: 12 weeks
measure: Number of individuals who developed specific antibodies against a TBP after tick bite.
timeFrame: 12 weeks
measure: List of novel TBPs that were not previously found in the study areas.
timeFrame: baseline
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References:
Clinical trial NCT02781415: Acupuncture Versus Titrated Morphine in Patients With Renal Colic
Official title: Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Colic
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 200
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: The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score \>/= 70) taking for example acute renal colic.

Detailed description: acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score \>/= 70) taking for example acute renal colic.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* Presenting with acute non complicated renal colic
* Baseline VAS score \>/= 70

Exclusion Criteria:

* complicated renal colic
* VAS score \< 70
* Pain of traumatic origin
* Coagulation abnormalities
* Skin affections impairing the use of pre-specified insertion points
* Enable to use the VAS
* Patients who received analgesics less than 6 hours prior to enrollment
* Patients refusing or enable to give written informed consent
* Pregnant women

Primary outcomes:
measure: Pain score Change
timeFrame: at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: during the 1 hour protocol and up to 2 hours after
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
Study officials:
affiliation: University Hospital of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References: