louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04498923: Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants
Official title: Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Peripheral Neuropathy
Fractures of the Upper Limb
Fracture of the Lower Limb (Except Hip), Initial Encounter
Intraoperative Hypotension
Intraoperative Hypertension
Pain Syndrome
Anesthesia
Anesthesia, Local
Local Anesthetic Systemic Toxicity
Keywords: Regional anesthesia
Pain management
Local anesthetic
Electromyography
Lead sponsor: Lviv National Medical University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing orthopedic surgery on the upper and lower extremities in the Regional Center of Orthopedics, Traumatology and Vertebrology of Rivne Oblast State Hospital

Brief summary: The main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.

Detailed description: Peripheral nerve plexuses blocks are performing as a component of analgesia in patients undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12, 24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic anesthetic used in the postoperative period is also recorded. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing upper or lower extremity orthopedic surgery

Exclusion Criteria:

* diabetes mellitus;
* diseases of the peripheral nerv system

Primary outcomes:
measure: The duration of blockade
timeFrame: 6th, 12th, 24th and 36th hours after blockade
Secondary outcomes:
measure: The amount of narcotic anesthetic used in the postoperative period
timeFrame: 48 hour after surgery
Other outcomes:
Locations:
city: Rivne
country: Ukraine
facility: Rivne Oblast State Hospital
state: Rivne Region
Study officials:
affiliation: Сlinical resident
name: Maksym Barsa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470623: Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy
Official title: Randomized, Prospective Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus
Keywords: hallux valgus
chevron osteotomy
bioabsorbable screw
steel screw
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hallux valgus is the most common deformity of forefoot and the patients would suffer pain and disable of walking and wearing normal shoes. Chevron osteotomy of the first metatarsal is widely used for the treatment of mild or medium hallux valgus. It is a "V" sharp osteotomy that can decrease the intermetatarsal degree of first-second metatarsal by pushing the distal side of osteotomy laterally.A 2.5mm or 3.0mm steel cannulated screw is usually used for the fixation of the osteotomy side to provide stability.However,there are some shortcomings of steel screws such as rejection of internal fixation or the financial cost of the second surgery of fixation taken-out. To obviate these shortcomings of steel screws, bioabsorbable screw fixation may be an alternative method for chevron osteotomy.

This trial is a randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of bioabsorbable screw versus steel screw for the treatment of hallux valgus with chevron osteotomy. The patients will be randomized to two groups, one treated with bioabsorbable screws while the other treated with steel screws.Data collection for the outcomes measures will occur pre-op,immediate post-op and then 6 weeks, 12 weeks, and at 1 years post operation.

The clinical outcomes measure are the VAS (visual analogue scale) score and AOFAS (American orthopedic foot and ankle society) forefoot score.The radiographic outcomes measures are the IMA (intermetatarsal angle) and the HVA (hallux valgus angle)


Eligibility criteria: Inclusion Criteria:

1. hallux valgus treated with distal chevron osteotomy
2. age between 18-70

Exclusion Criteria:

1. hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc)
2. age \<18 or age \>70
3. rheumatoid
4. osteoporosis -

Primary outcomes:
measure: American orthopedic foot and ankle society forefoot score change
timeFrame: pre-op,6 weeks,12 weeks and 1 year after operation
Secondary outcomes:
measure: Radiographic outcomes parameters
timeFrame: pre-op,6 weeks,12 weeks and 1 year after operation
measure: VAS score
timeFrame: pre-op,6 weeks,12 weeks and 1 year after operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00719823: Maraviroc Compassionate Use
Official title: Maraviroc Compassionate Use
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Human Immunodeficiency Virus Type 1
Keywords: Maraviroc Compassionate Use
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

Detailed description: This study was cancelled prior to enrollment.

Eligibility criteria: Inclusion Criteria:

* Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.
* Have only CCR5-tropic HIV-1 virus
* CD4+ cell count \< 200 cells/mm3

Exclusion Criteria:

* CXCR4- or dual/mixed-tropic HIV-1 virus
* Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness
* Patients who are pregnant or breast feeding an infant or planning to become pregnant.

Primary outcomes:
measure: Safety analysis will include all subjects who receive at least one dose of study drug
timeFrame: Two Years
Secondary outcomes:
measure: Safety analysis will include all subjects who receive at least one dose of study drug
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02463123: Energy Expenditure Estimation in Cardiac Surgery
Official title: Resting Energy Expenditure in Cardiac Patients Operated Under Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Surgical Procedures
Intensive Care
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-06-04
Enrollment: 240
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 after cardiothoracic interventions using cardiopulmonary bypass

Brief summary: Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Different predictive equations have been developed, but not evaluated in cardiac population and have low accuracy in compare to the indirect calorimetry. The aim of present study is to develop cardio-specific equation for resting energy expenditure estimation.


Eligibility criteria: Inclusion Criteria:

* Patient of cardiothoracic ICU

Exclusion Criteria:

* Shock
* patients on ECMO
* Hypoxemia \<60 mmHg
* Active bleeding
* Ventilation with FiO2 \>0.6

Primary outcomes:
measure: Resting energy expenditure measured in kcal/day using indirect calorimetry
timeFrame: participants will be followed for the duration intensive care unit stay, an expected average 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
citation: Efremov SM, Talaban VO, Ponomarev DN, Vedernikov PE, Chechenin MG, Artemieva VV, Lomivorotov VV. Development and Validation of a New Cardio-Specific Resting Energy Expenditure Equation for Adults. JPEN J Parenter Enteral Nutr. 2018 May;42(4):702-708. doi: 10.1177/0148607117711648. Epub 2017 Dec 19.
Clinical trial NCT04435223: Lipid Metabolism in COVID-19 Severe Pneumonia Compared With Severe Pneumonia Caused by Other Pathogen
Official title: Lipid Metabolism in COVID-19 Severe Pneumonia Compared With Severe Pneumonia Caused by Other Pathogen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Severe Pneumonia
Severe Pneumonia Due to Other Pathogene
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with pneumopathy

Brief summary: SARS-COV 2 infection might be responsible for sever pneumonia. Obesity seems to be a risk factor for severe SARS-COV 2 pneumonia. Lipid metabolism alteration are described with both obesity and sepsis. The aim of the present study was to describe association between lipid metabolism, obesity, sepsis inflammation and clinical outcome in COVID-19 patient with severe pneumonia compared with severe pneumonia caused by other pathogenes.


Eligibility criteria: Inclusion Criteria:

* 2 of the following criteria: Cough/ Dyspnea/ Spitting/ Thoracic pain/ Hyperthermia (\>=38 °C) Hypothermia (\< 35°C) AND new radiologic pulmonary infiltrate
* At admission or within 48 hours following hospital admission
* With 2 qSOFA criteria: MAP =\< 100 mmHg, Respiratory Rate \>= 22, Glasgow score \< 15 OR on mechanical ventilation OR under vasopressor
* Age \> 18
* affiliated to social security

Exclusion Criteria:

* Pregnancy
* immunodepression
* Pathology known to cause severe lymphopenia
* hospitalisation within 3 month before inclusion AND sepsis

Primary outcomes:
measure: Cholesterol concentration
timeFrame: Within 48 hours following hospital admission
Secondary outcomes:
measure: LDL cholesterol / HDL cholesterol/ Lipoprotein size and composition/ Non esterified Fatty acid/ Triglyceridemia/ CETP and PLTP activity/ apolipoprotein canceration/ lipid peroxidation/ Pro and anti inflammatory profile.
timeFrame: Within 48 hours following hospital admission
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
citation: Nguyen M, Bourredjem A, Piroth L, Bouhemad B, Jalil A, Pallot G, Le Guern N, Thomas C, Pilot T, Bergas V, Choubley H, Quenot JP, Charles PE, Lagrost L, Deckert V, de Barros JP, Guinot PG, Masson D, Binquet C, Gautier T, Blot M; Lymphonie study group. High plasma concentration of non-esterified polyunsaturated fatty acids is a specific feature of severe COVID-19 pneumonia. Sci Rep. 2021 May 24;11(1):10824. doi: 10.1038/s41598-021-90362-9.
Clinical trial NCT03663023: Band Adhesions in Relation to Previous Abdominal Surgery
Official title: Band Adhesions in Relation to Previous Abdominal Surgery - a Retrospective Analysis of Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Adhesions
Intestinal Obstruction
Surgery Induced Tissue Adhesions
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the protocol, 213 surgical procedures were identified. 17 procedures were excluded due to no bowel obstruction at surgery. Intestinal obstruction was evident in 196 procedures. These procedures were included in this study.

Brief summary: This study investigates the prevalence of previous abdominal surgery in a cohort of patients operated for bowel obstruction and analyzes the causes of obstruction discovered at surgery.

Detailed description: Postoperative intra-abdominal adhesions are a common cause of small bowel obstruction. The extent of adhesions has been assigned to the magnitude of previous surgery. In a county hospital, with a catchment population of 120 000 inhabitants, records of operations performed for bowel obstruction over a period of 70 months were retrieved. Codes for bowel obstruction according to an International Classification of Diseases (ICD-10) will include: Intestinal adhesion with obstruction, Other and unspecified intestinal obstruction, Intestinal obstruction and Peritoneal adhesions. Amount of adhesions will be calculated in relation to previous surgery.

Eligibility criteria: Inclusion Criteria:

Subjects operated for bowel obstruction -from January 1st 2006 to October 31st 2011

Surgical codes for bowel obstruction:

* Intestinal adhesion with obstruction
* Other and unspecified intestinal obstruction
* Intestinal obstruction
* Unspecified and Peritoneal adhesions

Surgical procedures identified for bowel obstruction:

* Division of band adhesion
* Adhesiolysis
* Other separation of adhesion during bowel obstruction
* Laparotomy and reposition or detorsion of intestine.

Exclusion Criterias:

-Extra-peritoneal surgery such as inguinal or ventral hernia repair was excluded.

Primary outcomes:
measure: Cause of bowel obstruction
timeFrame: 70 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01113723: Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device
Official title: A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laminectomy
Keywords: C-MAC
Fiberoptic bronchoscope
Laryngoscopy
Cervical spine injury
Glottic view
Tracheal intubation
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2010-04-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.


Eligibility criteria: Inclusion Criteria:

* Patients with an unstable Cervical-spine as a result of C-spine injury.
* Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
* Willingness and ability to sign an informed consent document.
* 18-80 years of age.
* ASA Class I - III adults of either sex

Exclusion Criteria:

* Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
* Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
* Emergency surgeries.
* Any other conditions which may interfere with the conduct of the study.

Primary outcomes:
measure: Intubation Time (Seconds)
timeFrame: 3 minutes
measure: Time to Confirm the Placement of the Tracheal Tube
timeFrame: up tp 3 minutes
Secondary outcomes:
measure: Time to Obtain Glottis Visualization (Seconds)
timeFrame: 1 minute
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920023: Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
Official title: Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Cancer
Keywords: SPIO MRI
Feridex
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.

Detailed description: * On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI.
* All MRI scans will be done at Massachusetts General Hospital.

Eligibility criteria: Inclusion Criteria:

* Locally resectable pancreatic mass present on one or more pre-operative imaging modalities
* Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan
* Deemed eligible for resection with curative intent by a treating surgeon who is listed as an investigator on this study
* 18 years of age or older
* No uncontrolled serious medical or psychiatric illness
* Women of childbearing potential must not be pregnant or lactating

Exclusion Criteria:

* Known allergy to iron or dextran
* Pregnant or lactating
* Counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device
* Sickle cell disease or hemoglobinopathy

Primary outcomes:
measure: To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
timeFrame: 3 years
measure: To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachussetts General Hospital
name: Ralph Weissleder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931423: The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Haemorrhage
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2013-08-29
Enrollment: 485
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.


Eligibility criteria: Inclusion Criteria:

1. greater than 37 gestational weeks
2. single pregnancy
3. vaginal delivery
4. estimated fetal weight 2500-4500 gr.

Exclusion Criteria:

1. PPROM
2. 37 or lower gestational week
3. multiple pregnancy
4. grand multiparıty (greater than 5)
5. coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)
6. a history of any bleeding during pregnancy
7. caesarean delivery or any uterine scar
8. a history of postpartum haemorrhage
9. hydramnios
10. known uterine anomalies
11. suspected abnormal placentation (accreta, increta, or percreta)
12. prepartum hemoglobin concentration less than 8 g/dL
13. history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours

Primary outcomes:
measure: postpartum blood loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Osman Aşıcıoğlu
state: ŞiŞLİ
Study officials:
affiliation: T.C.S.B. Şişli Etfal Research Hospital
name: Osman Aşıcıoğlu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: