louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02253784: Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Pain, Postoperative
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-10-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect.


Eligibility criteria: Inclusion Criteria:

* Pre-surgical total knee arthroplasty patients

Exclusion Criteria:

* Skin infection near block site
* Allergy to local anesthetics
* Peripheral neuropathy
* Proven opioid dependency
* Coagulopathy
* Dementia

Primary outcomes:
measure: Efficacy Perineural DxaM
timeFrame: One day
Secondary outcomes:
measure: Efficacy of Systemic DxaM
timeFrame: One day
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Anatoly Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291184: Postoperative Residual Paralysis After Cardiac Surgery
Official title: Is Postoperative Residual Curarisation Still an Issue at the Moment of Weaning of the ICU Patient Following Cardiac Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Residual Curarization
Keywords: neuromuscular blockade
neuromuscular monitoring
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this study is to describe the incidence of postoperative residual paralysis (mean train-of-four \<90%) when weaning from the ventilator in patients admitted to the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will perform a measurement of the train-of-four at the thumb with a neuromuscular transmission monitor. Every value below 90% will be considered as residual paralysis and treated appropriately by means of a reversal agent.

Detailed description: Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is normothermic, hemodynamically stable, has normal blood gasses and absence of residual bleeding. The ICU nurse caring for the patient will start weaning the patient from the ventilator, following these departmental guidelines.

Eligibility criteria: Inclusion Criteria:

* patients admitted to the ICU after elective cardiac surgery

Exclusion Criteria:

* emergency cardiac surgery

Primary outcomes:
measure: postoperative residual curarisation
timeFrame: 6 hours after arrival in the ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
affiliation: Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium
name: GUY CAMMU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14.
citation: Videira RL, Vieira JE. What rules of thumb do clinicians use to decide whether to antagonize nondepolarizing neuromuscular blocking drugs? Anesth Analg. 2011 Nov;113(5):1192-6. doi: 10.1213/ANE.0b013e31822c986e. Epub 2011 Aug 24.
citation: Rudis MI, Guslits BG, Zarowitz BJ. Technical and interpretive problems of peripheral nerve stimulation in monitoring neuromuscular blockade in the intensive care unit. Ann Pharmacother. 1996 Feb;30(2):165-72. doi: 10.1177/106002809603000211.
Clinical trial NCT00537784: Platelet Concentrate in Achilles Tendon Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Soft Tissue Injury
Tendon Injury
Keywords: platelets tendon ligament
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2007-10-01
Enrollment: 30
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: People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.


Eligibility criteria: Inclusion Criteria:

* Achilles tendon rupture, age 18-65.

Exclusion Criteria:

* Any counterindication for surgical treatment.

Primary outcomes:
measure: Modulus of elasticity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Univ Hosp
Study officials:
affiliation: University of Linköping
name: per aspenberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schepull T, Kvist J, Norrman H, Trinks M, Berlin G, Aspenberg P. Autologous platelets have no effect on the healing of human achilles tendon ruptures: a randomized single-blind study. Am J Sports Med. 2011 Jan;39(1):38-47. doi: 10.1177/0363546510383515. Epub 2010 Nov 3.
Clinical trial NCT04158284: Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
Official title: KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Craniopharyngioma
Obesity
Keywords: Quality of life
Endocrinology
Oncology
Hypothalamus
Irradiation
Neurosurgery
Pediatric Brain tumors
Lead sponsor: Klinikum Oldenburg gGmbH
Sponsor class: OTHER
Collaborators: name: German Society for Pediatric Oncology and Hematology GPOH gGmbH
name: Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED)
name: Deutsche Gesellschaft für Endokrinologie (DGE)
name: Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
name: Deutschen Gesellschaft für Radioonkologie (DEGRO)
First posted: 2019-11-08
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed patients (≤ 18 years of age) with childhood-onset craniopharyngioma

Brief summary: KRANIOPHARYNGEOM Registry 2019 will prospectively collect and descriptively analyse data on diagnostics, treatment, and follow-up of patients with craniopharyngioma. In continuation of preceding studies also patients with xanthogranuloma, meningioma, pituitary adenoma, prolactinoma and cystic intracranial malformations will be registered.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with craniopharyngioma for the first time
2. Age at diagnosis 18 years or less of age
3. Agreement from patient's parents or legal guardian as well as the patient

Exclusion Criteria:

1. Age at diagnosis over 18 years of age
2. Diagnosis different from craniopharyngioma

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years follow-up
measure: Progression-free Survival (PFS)
timeFrame: 3 years follow-up
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: 3 years follow-up
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
state: Niedersachsen
Study officials:
References:
Clinical trial NCT03859284: Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions
Official title: Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Restoration Failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

Detailed description: flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.

Eligibility criteria: Inclusion Criteria:

* patients with anterior cervical carious lesions.
* Pulp asymptomatic vital carious anterior teeth.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Heavy smokers.

Primary outcomes:
measure: Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes
timeFrame: Change from the baseline at 6 months and12 months]
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
References:
Clinical trial NCT01549184: Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia
Official title: Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia Among 40 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenia
Systemic Lupus Erythematosus
Keywords: secondary ITP
hydroxychloroquine
Systemic Lupus Erythematosus
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 40
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: 40 patients with an immune thrombopenia with or without a definite SLE have been retrospectively studied. All the patients should have an ITP according to the ASH guidelines 2011 and have positive antinuclear antibodies (title \>1/160e on Hep2 cells).

Brief summary: Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).

Detailed description: Hydroxychloroquine (HCQ) is usually used in Patients with Systemic Lupus Erythematosus (SLE) in order to treat mainly arthralgia or skin manifestations of this disease. A few studies have previously shown that HCQ could also be useful for treating autoimmune cytopenia and particularly autoimmune thrombopenia associated with SLE. In this retrospective study, the investigators have selected patients followed in our center and who have received HCQ either for an authentic SLE or because they had positive antinuclear antibodies (\> 1/160e on HEP2 cells) without a definite SLE according to the American College of Rheumatology.

The main goal of this study is to compare the efficacy of HCQ in these two subgroups of patients.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011
* Positive antinuclear antibodies \> 1/160e on Hep2 cells

Exclusion Criteria:

* Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)

Primary outcomes:
measure: Number of patients achieving a response (Platelet count > 30x10^9/L and doubling of the baseline count) or a complete response (platelet count > 100x10^9/L for a t least 6 months)
timeFrame: one year
Secondary outcomes:
measure: Tolerance of Hydroxychloroquine
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
citation: Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.
Clinical trial NCT03961984: Long-term Follow-up of Anal Fistula Plug
Official title: Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Fistula
Keywords: anal fistula
fistula-in-ano
surgical plug
collagen plug
complex anal fistula
transsphincteric anal fistula
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 95
Sex: ALL
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 with anal fistulas not treatable with a simple fistulotomy offered to participate.

Brief summary: Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.

Detailed description: A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.

Eligibility criteria: Inclusion Criteria:

* complex transsphincteric anal fistula

Exclusion Criteria:

* ano/rectovaginal fistula

Primary outcomes:
measure: Fistula recurrence; Technical failure
timeFrame: Week 2
measure: Fistula recurrence; Infection
timeFrame: Week 2
measure: Fistula recurrence; Infection
timeFrame: Month 3
measure: Fistula recurrence; Infection
timeFrame: Month 6-12
measure: Fistula recurrence; Infection
timeFrame: Through study completion, an average of 8 years
measure: Fistula recurrence; New opening
timeFrame: Week 2
measure: Fistula recurrence; New opening
timeFrame: Month 3
measure: Fistula recurrence; New opening
timeFrame: Month 6-12
measure: Fistula recurrence; New opening
timeFrame: Through study completion, an average of 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Region Skane
name: Marianne Starck, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05525884: Mechanism of Serum PRL in the Development of MAFLD
Official title: Mechanism of Serum PRL in the Development of MAFLD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes
Fatty Liver, Nonalcoholic
Liver Fibrosis
Keywords: Type 2 Diabetes
Metabolic associated fatty liver disease,
Prolactin
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with T2DM who met the inclusion and criteria criteria were consecutively enrolled.

Brief summary: Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. The investigators aimed to explore the association between serum PRL and the risk of MAFLD in patients with type 2 diabetes (T2DM).


Eligibility criteria: Inclusion Criteria:

* aged 18\~65 years old,
* underwent the laboratory tests, hepatic ultrasonography, and valid transient elastography (FibroScan) examination

Exclusion Criteria:

* other known chronic liver diseases, such as chronic hepatitis B or C, autoimmune hepatitis, and haemochromatosis
* pre-existing active cancer, renal dysfunction, severe liver dysfunction, congestive heart failure or free abdominal fluid
* history of hyperthyroidism or hypothyroidism, pituitary diseases, and other types of diabetes
* significant alcohol consumption
* pregnancy
* receiving any therapeutic methods that could lead to liver steatosis or fibrosis, influence the glucolipid metabolism, or PRL levels, such as lipid-lowering, and PRL-lowering agents (bromocriptine) within 6 months prior to this study.

Primary outcomes:
measure: Diagnosis of MAFLD proposed by the international expert consensus statement in 2020
timeFrame: 2019-2024
measure: PRL
timeFrame: 2019-2024
measure: High PRL (HP)
timeFrame: 2019-2024
measure: Normal PRL (NP)
timeFrame: 2019-2024
measure: Diagnosis of hepatic steatosis
timeFrame: 2019-2024
measure: Diagnosis of significant hepatic fibrosis
timeFrame: 2019-2024
Secondary outcomes:
measure: Homeostasis model assessment of IR (HOMA-IR)
timeFrame: 2019-2024
measure: Hypertension
timeFrame: 2019-2024
measure: Dyslipidemia
timeFrame: 2019-2024
measure: Overweight or obesity
timeFrame: 2019-2024
measure: Abdominal obesity
timeFrame: 2019-2024
measure: T2DM
timeFrame: 2019-2024
measure: High CRP
timeFrame: 2019-2024
measure: High HOMA-IR
timeFrame: 2019-2024
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01823484: Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill
Official title: Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill
Acute Kidney Injury
Septic Shock
Keywords: hemofilter
coagulation
CRRT
critically ill
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 40
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: TREATMENT

Brief summary: Compared with AN69 hemofilter, AN69 ST hemofilter may prolong the time of hemofilter and decrease the quantity of heparin during continuous renal replacement therapy in critically ill.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years old
* admitted to ICU and need CRRT
* anticipated survival time \>72h

Exclusion Criteria:

* allergy to hemofilter or heparin
* heparin associated thrombocytopenia
* pregnancy or lactation
* using other anticoagulate drugs

Primary outcomes:
measure: The using time of hemofilters
timeFrame: 72h
Secondary outcomes:
measure: activated partial thromboplastin time
timeFrame: every 6h from the begining of continuous renal replacement therapy,up to 72h
Other outcomes:
measure: Number of participants with adverse events during continuous renal replacement therapy
timeFrame: 72h
Locations:
city: Nanjing
country: China
facility: Xiaohua Qiu
state: Jiangsu
Study officials:
References:
Clinical trial NCT04609384: Nudging Effect of Timer on Surgical Rub
Official title: The Effect on a Timer-device on the Time Spend on Surgical Rub
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Operation Wound; Infection
Bacterial Infections
Surgical Procedure, Unspecified
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All health care workers who perform alcohol rub.

Brief summary: To study whether a device has a nudging effect on the time spend on surgical rub.

Detailed description: The investigators observed the time spend on surgical rub prior to an operation. The investigators do not record names, age, sex or orther features about the health care workers who perform the surgical rub.

After 200 observations a device will be attach to the dispenser that might help increase the time spend on the surgical rub in the operathing theather. The investigatos will then make another 200 observations to see if the device cause an increase in the time spend on surgical rub.

Eligibility criteria: Inclusion Criteria:

• All professional health care workers, who perform surgical ru

Exclusion Criteria:

* Students and other persons at a hospital, who are not paid to be working at the hospital.

Primary outcomes:
measure: Time
timeFrame: Seconds used on surgical rub at least 300 seconds. Observation begin from start of surgical rub (defined as the time when the dispenser is activated) to the end of surgical rub (defined as the time when the surgeon pick up the surgical gown)
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Sygehus Lillebaelt
Study officials:
References: