louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02715869: Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Official title: Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Keywords: Myocardial Preconditioning, inotropic score
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).

Detailed description: Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)

Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)

Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury

Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality

Aim of the work:

Is to validate the impact of Sevoflurane versus ischemic \& Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* American Society of Anesthesiologists physical status II and III
* Patients scheduled for open heart surgery

Exclusion Criteria:

* Emergency surgery
* Clinically significant kidney or liver disease
* Patients allergic to local anesthetic
* Patients with prolonged cardiopulmonary bypass time (\>120 min)
* Patients required intra-aortic balloon pump
* Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration

Primary outcomes:
measure: Highest inotropic score
timeFrame: first 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
affiliation: Department of Anesthesia, faculty of Medicine, Assiut University
name: Emad Zarief Kamel Said, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04957069: Comparison of Surgical Outcomes Between Avulsion Fracture of the AT and Conventional ATR--a Retrospective Study
Official title: Comparison of Surgical Outcomes Between Avulsion Fracture of the Achilles Tendon and Conventional Achilles Tendon Rupture--a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avulsion Fracture of the Achilles Tendon
Achilles Tendon Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From 2013 to 2017, patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture that underwent surgical treatment in our institute.

Brief summary: To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively.

Detailed description: Include 30 patients with avulsion fracture of the Achilles tendon and 30 patients with Achilles tendon rupture underwent surgical treatment in our institute. Collect and evaluate MRI, VAS, AOFAS, and FFI score preoperatively and postoperatively. Finally explore the surgical outcomes between avulsion fracture of the AT and conventional ATR.

Eligibility criteria: Inclusion Criteria:

* patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture

Exclusion Criteria:

* neuromuscular related diseases
* other injuries of ankle joint

Primary outcomes:
measure: MOCART
timeFrame: one year after sugery
Secondary outcomes:
measure: VAS
timeFrame: pre-surgery, one year after sugery
measure: AOFAS
timeFrame: pre-surgery, one year after sugery
measure: FFI
timeFrame: pre-surgery, one year after sugery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Qinwei Guo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01493869: Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
Official title: A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Hepatic Impairment
Keywords: Normal healthy adult subjects
Adult subjects with hepatic impairment
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight must be ≥50 kg and \<130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).
* Must use acceptable forms of birth control during the course of the study and for 3 months following the single dose of study drug.
* Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
* Must have adequate vital sign reads at screening and check-in.
* Must be able to comply with dietary and fluid restrictions required for the study

Primary outcomes:
measure: AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity
timeFrame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22
Secondary outcomes:
measure: Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 75 mg dose in hepatic impaired adult subjects and healthy adult subjects
timeFrame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22
Other outcomes:
Locations:
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
Study officials:
References:
Clinical trial NCT01850069: The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
Official title: The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hypertension
Keywords: Intracranial hypertension
intracranial elastance
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor

Brief summary: The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy

Detailed description: The management of intracranial hypertension requires the presence of an intracranial pressure monitor. We are investigating whether the waveforms obtained from a near infrared spectroscopy device can predict what the intracranial pressure is non-invasively.

* Patients with intracranial hypertension who are intubated and ventilated in the ICU will be recruited
* we will record there intracranial pressure and systemic arterial pressure
* recordings from the near infrared device will be recorded and analysed off-line
* we will correlate the waveform tracings from near infrared spectroscopy and the arterial tracing

Eligibility criteria: Inclusion Criteria:

Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU

Exclusion Criteria:

Less than 18 years

Primary outcomes:
measure: Intracranial elastance
timeFrame: Participants will be followed while an arterial line and intracranial pressure monitor is present duing the ICU admission. This is expected to be an average of 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bhiken Naik, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Carney NA. Guidelines for the management of severe traumatic brain injury. Methods. J Neurotrauma. 2007;24 Suppl 1:S3-6. doi: 10.1089/neu.2007.9996. No abstract available.
citation: Rosenberg JB, Shiloh AL, Savel RH, Eisen LA. Non-invasive methods of estimating intracranial pressure. Neurocrit Care. 2011 Dec;15(3):599-608. doi: 10.1007/s12028-011-9545-4.
citation: Lee JK, Kibler KK, Benni PB, Easley RB, Czosnyka M, Smielewski P, Koehler RC, Shaffner DH, Brady KM. Cerebrovascular reactivity measured by near-infrared spectroscopy. Stroke. 2009 May;40(5):1820-6. doi: 10.1161/STROKEAHA.108.536094. Epub 2009 Mar 12.
Clinical trial NCT01781169: Vitamin D Supplementation to Obese Chinese Males
Official title: Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Vitamin D,
Oral supplementation,
Obese males
Lead sponsor: Shenzhen Center for Chronic Disease Control
Sponsor class: OTHER
Collaborators: name: Danone Institute China Diet Nutrition Research and Communication
First posted: 2013-01-31
Enrollment: 43
Sex: MALE
Minimum age (years): 23
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males.

Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI \< 24 (kg/m2)
* non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for \> 2 y
* fasting serum glucose \< 7.0 mmol/L
* serum glucose of 2 hr after 75 g oral glucose loading \< 11.1 mmol/L
* normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid

Exclusion Criteria:

* not match the above inclusion criteria
* diagnosed as having any organic diseases were excluded

Primary outcomes:
measure: Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)
timeFrame: Endpoint and baseline of the 8 weeks' trial
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Center for Chronic Disease Control
state: Guangdong
Study officials:
affiliation: Shenzhen Center for Chronic Disease Control
name: Ji-Chang Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
citation: Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
citation: Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Clinical trial NCT03250169: Neurofilaments for NEDA Assessing in MS
Official title: Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsing-remitting MS

Brief summary: Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.

Detailed description: Primary

1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.

   Secondary
2. To assess prognosis at the end of the study based on neurofilament status.
3. To correlate neurofilament levels with clinical and MRI markers of disease activity.
4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
2. Age 18-55 years.
3. EDSS score between 0-5.5.
4. Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D

Exclusion Criteria:

1. A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
2. Those unable to comply with study requirement

Primary outcomes:
measure: Blood and CSF neurofilaments in Alemtuzumab patients over 24months
timeFrame: 2 years
Secondary outcomes:
measure: Overall clinical response based on neurofilament response
timeFrame: 2 years
measure: Neurofilament status and association with clinical and MRI markers of disease activity.
timeFrame: 2 years
measure: Longitudinal assessment of other biomarkers of inflammation & plasticity
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
state: England
Study officials:
References:
Clinical trial NCT02854969: Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device
Official title: Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaphylaxis
Lead sponsor: Adan Medical Innovation, SL
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or above
* Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed
* Patients with a smartphone
* Patients who signed the informed consent

Exclusion Criteria:

* Patients who have not signed the informed consent
* Patients with some limitations for understanding or following correctly the trial procedures
* Pregnant or nursing women

Primary outcomes:
measure: Patient satisfaction through a questionnaire in the use of the medical device
timeFrame: 3 months
Secondary outcomes:
measure: Medical device safety
timeFrame: 3 months
measure: Patient Adherence to the medical device through a questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
Clinical trial NCT02773069: The Church as a Bridge to Deliver Health Resources Via Telehealth
Official title: The Church as a Bridge to Deliver Health Resources Via Telehealth to Alleviate Obesity and Chronic Disease Disparities in Rural African Americans of Mississippi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diet, Food, and Nutrition
Church
Healthcare Disparities
Minority Health
Mobile Health
Telehealth
Community-based Participatory Research
Primary Health Care
Weight Loss Programs
Health Behavior
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
Collaborators: name: Southeast Mississippi Rural Health Initiative
name: MSU Extension- Stone County
First posted: 2016-05-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50 years of age) with families, the project will contribute to the long-term reduction of preventable chronic disease and related health care costs for the public.


Eligibility criteria: Inclusion Criteria:

* BMI \>/=30
* Must have elementary aged child (5-11 years) in household

Exclusion Criteria:

* Any health condition where weight loss is contraindicated
* Complicated disease states (ie., advanced renal disease or heart failure)

Primary outcomes:
measure: Change in weight at six months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01207869: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Official title: Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bronchopulmonary Dysplasia
Extremely Premature Infants
Severe BPD That Conventional Therapies Has Failed
No Severe Congenital Anomalies
no Severe IVH Neither Cystic PVL
Keywords: Bronchopulmonary dysplasia (BPD)
Extremely premature infant
Mesenchymal stem cells (MSCs)
umbilical cord
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.


Eligibility criteria: Inclusion Criteria:

* severe BPD, defined by the National Institute of Child Health and Human Development workshop, who conventional therapies (including furosemide and theophylline, and HFO ventilation) has failed

Exclusion Criteria:

* severe congenital anomalies
* severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.

Primary outcomes:
measure: The relations between the cytokine concentrations in the BAL fluid and PAP.
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: The severity score of BPD ranging from 0 to 6 on the serial chest radiographs
timeFrame: 6 months to 1 year
Other outcomes:
Locations:
city: Taichung,
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital,Taiwan
name: Bai-Horng Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391269: Review of the Pathological Results of Appendectomy Specimens
Official title: Histopathological Examination of Cases With Acute Appendicitis, A Retrospective Study at King Abdulaziz University Hospital, Jeddah, Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Pathology
Acute Appendicitis
Appendicitis (Diagnosis)
Keywords: Appendix
Pathology
Appendicitis diagnosis
Acute appendicitis
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 940
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: Patients underwent an appendectomy in king Abdulaziz university hospital in the period between 2010-2017

Brief summary: This is a retrospective review study to evaluate the histopathological findings post appendectomy

Detailed description: In this study, 940 cases will be reviewed. Patient demographics, accuracy of imaging modalities, and histopathological findings will be described.

Eligibility criteria: Inclusion Criteria:

* Patients underwent an appendectomy in king Abdulaziz university hospital in the period between 2010-2017

Exclusion Criteria:

* Any other patients will be excluded from the study

Primary outcomes:
measure: Description of histopathological findings post appendectomy
timeFrame: 2010-2017
Secondary outcomes:
measure: Relation between disease age, and gender
timeFrame: 2010-2017
measure: Assessment for accuracy of imagining modalities
timeFrame: 2010-2017
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
Study officials:
affiliation: King Abdulaziz University, Jeddah, Saudi Arabia
name: Mai S Kadi, MBBS
role: PRINCIPAL_INVESTIGATOR
References: