louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02692989: The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly
Official title: The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly: A Retrospective Study in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 1270
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 who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications

Brief summary: Trauma for hip joint is common in old people. Anesthesia in these types of old patients carries more risk than the adult population.

In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications.

Detailed description: Trauma for hip joint is common in old people; usually trauma for the hip joint is treated surgically under anesthesia. Anesthesia in these types of old patients carries more risk than the adult population, since these type of patients have a lot of chronic diseases which affect their general health.

In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia between the years 2010 to 2015, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications like Deep Venous Thrombosis, Pulmonary complications, myocardial Infarction and others.

Eligibility criteria: Inclusion Criteria:

* patients who sustained hip fracture.
* patients who underwent surgical correction under Regional or general anesthesia.

Exclusion Criteria:

* Patients who sustained Hip fractures but treated conservatively.

Primary outcomes:
measure: Number of patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications
timeFrame: 30 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: Jordan University
name: Subhi M Alghanem, FFARCS
role: STUDY_CHAIR
References:
citation: Urwin SC, Parker MJ, Griffiths R. General versus regional anaesthesia for hip fracture surgery: a meta-analysis of randomized trials. Br J Anaesth. 2000 Apr;84(4):450-5. doi: 10.1093/oxfordjournals.bja.a013468.
Clinical trial NCT06214689: IDH1 and OCT4 in High Grade Astrocytoma
Official title: IDH1 and OCT4 Markers as a Prognostic Factor in Clinical Outcome of High Grade Astrocytic Glioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Grade Astrocytoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with high grade astrocytic glioma , more than 18 years old and fit for surgery that will be admitted in the department of neurosurgery in Assiut university hospital

Brief summary: observation of IDH1 and OCT4 markers level and high grade astrocytoma patients prognosis after excision.

Detailed description: explore the relationship between prognosis and IDH1 and OCT4 biomarkers after high grade astrocytoma excision , according to progression free survival and overall survival , in prospective and retrospective samples.

Eligibility criteria: Inclusion Criteria:

* patients of high grade astrocytic glioma patients fit for surgery

Exclusion Criteria:

* patients of low grade glioma patients unfit for surgery

Primary outcomes:
measure: IDH1 and OCT4 markers and their relation to postoperative prognosis of high grade astrocytoma patients
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine of Assiut University
Study officials:
References:
citation: PubMed
citation: Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.
citation: Perry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0.
citation: Sathornsumetee S, Rich JN, Reardon DA. Diagnosis and treatment of high-grade astrocytoma. Neurol Clin. 2007 Nov;25(4):1111-39, x. doi: 10.1016/j.ncl.2007.07.004.
Clinical trial NCT04198389: Retrospective Clinical and Functional Evaluation of Patients Undergoing Knee Replacement With Small Implants
Official title: Retrospective Clinical and Functional Evaluation of Patients Undergoing Knee Replacement With Small Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: KNEE REPLACEMENT
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retrospective evaluation of:

Functional results Clinical results Survivorship of knee replacement performed with small implants, isolated or combined

Detailed description: Retrospective evaluation of partial knee replacements (medial UNI, lateral UNI, patellofemoral replacement, combined UNI+ patellofemoral replacement, combined medial and lateral UNI) performed in the Joint Replacement Department of the IRCCS Istituto Ortopedico Galeazzi.

evaluation includes: clinical examination, functional results, survivorship at 1, 2, 5 , 10 and 15 years.

Eligibility criteria: inclusion criteria:

* patients receiving medial UNI or lateral UNI or patellofemoral replacement or combined UNI+ patellofemoral replacement or combined medial and lateral UNI
* age \> 18 years

exclusion criteria

* patients receiving total knee replacement
* patients having revision or a knee replacement

Primary outcomes:
measure: KNEE SOCIETY SCORE
timeFrame: 2 years
measure: KNEE SOCIETY SCORE
timeFrame: 5 years
measure: KNEE SOCIETY SCORE
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs Istituto Ortopedico Galeazzi
Study officials:
References:
citation: Romagnoli S, Vitale JA, Marullo M. Outcomes of lateral unicompartmental knee arthroplasty in post-traumatic osteoarthritis, a retrospective comparative study. Int Orthop. 2020 Nov;44(11):2321-2328. doi: 10.1007/s00264-020-04665-z. Epub 2020 Jun 20.
Clinical trial NCT02124889: Multivitamin Adherence Following Bariatric Surgery
Official title: Adherence to Multivitamin Use Following Bariatric Surgery for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
multivitamin
weight loss
adherence
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Celebrate Vitamins
First posted: 2014-04-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either receive the weekly survey or not.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Additional micronutrient supplementation is required due to the changes in the gastrointestinal anatomy and physiology following bariatric surgery along with decreased dietary intake and rapid weight loss. Good adherence to post-operative vitamins is essential to maintain healthy vitamin levels in the body following bariatric surgery. The hypothesis of this study is that patients receiving a weekly survey intervention will have better adherence to post-operative vitamins.


Eligibility criteria: Inclusion Criteria:

* Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health

Exclusion Criteria:

* Admission for a psychiatric event in the past year
* History of nausea and/or significant complaint of post-operative nausea
* History of stricture and/or significant complaint of post-operative stricture
* History of ulcer and/or significant complaint of post-operative ulcer
* History of major depression or psychiatric disorder

Primary outcomes:
measure: Adherence to Multivitamin
timeFrame: 50 days
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Adolfo Z Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01962389: First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis
Official title: First in Human Study of Winsor Laser Catheter
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Femoropopliteal In-Stent Restenosis
Keywords: ISR, Laser, SFA, PAD
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2013-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)


Eligibility criteria: Inclusion Criteria:

1. Patient age ≥ 18 years.
2. Rutherford Category 2-4.
3. Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form.
4. Documentation of significant ISR defined as \>50% stenosis and \>5 cm in length determined by diagnostic angiogram or duplex ultrasound.
5. A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter.
6. One or more patent tibial vessel(s) defined as \<50% stenosis thoughout the segment with outflow to the foot.
7. Successful treatment of any inflow lesion(s) defined as final residual stenosis \<30%.

Exclusion Criteria:

1. Patient is pregnant.
2. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
3. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
4. Crossing devices other than guidewire support catheters.
5. Type 4 or 5 stent fracture as assessed by angiography.
6. Target lesion is located within a covered stent.
7. Acute limb ischemia

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: up to 48 hours
Secondary outcomes:
measure: Efficacy
timeFrame: During Interventional Procedure
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Centro Cardiovascular Colombiano
Study officials:
affiliation: Yale University
name: Carlos Mena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05152589: Maternal Diabetes in Newborns With Hearing Loss
Official title: Newborn Hearing Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes
Pregestational Diabetes
Hearing Loss
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NEWBORNS WHO CANNOT PASS THE HEARING TEST APPLIED AS ROUTINE SCREENING

Brief summary: This study aims to investigate the presence and characteristics of maternal diabetes as a risk factor in newborns with hearing loss.

Hearing loss is one of the most common congenital anomalies among newborns. The newborn hearing screening program is important for early diagnosis in newborns with hearing loss.Gestational diabetes, on the other hand, is a metabolic disease that occurs during pregnancy and can cause complications as in other diabetes mellitus patients.

Despite our knowledge of major complications, the effect of the hyperglycemic intrauterine environment on hearing outcomes has not been adequately studied. The inner ear does not store energy, so it has a particularly high sensitivity to altered blood sugar and insulin. Altered inner ear metabolism leads to auditory and balance disorders.

There is no study in the literature comparing uncomplicated gestational diabetes and pregestational diabetes as a prenatal complication that poses a risk of hearing loss.


Eligibility criteria: Inclusion Criteria:

* POSTNATAL AGE BETWEEN 0-28 DAYS
* BIRTH WEIGHT ≥2000GR
* TO HAVE TESTED ON THE NEWBORN HEARING SCREENING UNIT AT ANKARA CITY HOSPITAL

Exclusion Criteria:

* PRETERMS
* CRANIOFACIAL ANOMALIES
* INTRAUTERINE INFECTIONS
* BIRTH WEIGHT \<2000 GR

Primary outcomes:
measure: Hearing Loss
timeFrame: 6 months
Secondary outcomes:
measure: diabetic mother
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Fuat Emre Canpolat
state: [Select]
Study officials:
References:
Clinical trial NCT00126789: Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
Official title: An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Cancer Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Cancer
Keywords: Pain Cancer
Chronic Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of cancer pain.

Detailed description: This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe cancer pain currently taking an around-the-clock opioid. Patients will discontinue their current opioid regimen and begin using ZR-02-01 as soon as possible under the direction of the physician investigator upon entry into the study. Patient's dose of ZR-02-01 will be determined by the investigator using sponsor-provided conversion. Pain therapy will be under the supervision of the physician investigator.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 and no older than 75 years of age at the time of screening
* Patient has a diagnosis of cancer
* Patient has moderate to severe pain that is related to cancer or its treatment and is expected to last indefinitely and is currently taking an around-the-clock opioid to treat his/her pain
* Patient is already receiving opioid therapy, has demonstrated opioid tolerance
* A responsible adult caregiver is available in the event of an emergency at home

Exclusion Criteria:

* Patient has uncontrolled or rapidly escalating pain as determined by the investigator
* Patient has a history of substance abuse or has a substance abuse disorder

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 12 weeks
measure: Global Satisfaction satisfied)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Center for Pain Management
state: California
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
Study officials:
affiliation: The Center for Clinical Research
name: Richard Rauck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782089: Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer
Official title: A Phase II, Open, Single-center Study of PD-1 Antibody and PARP Inhibitor as Consolidation Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Not Progressed After First-line Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Cell Lung Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment


Eligibility criteria: Inclusion Criteria:

1. All subjects were required to sign the informed consent before starting the study;
2. Histologically documented Extensive stage small cell lung cancer；
3. ECOG PS 0\~1 ；
4. 18-75 years；
5. According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
6. .Life expectancy ≥ 3 months；

Exclusion Criteria:

1. Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
2. Active infection including tuberculosis, HIV, hepatitis B and C；
3. Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
4. Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
5. Symptomatic brain metastasis and cancerous meningitis;

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01158989: Clinical Evaluation Gastrointestinal Motility With PillCam
Official title: Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Motility
Keywords: Critical care
Endoscopy, Video Capsule
Nutrition, Enteral
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients (i.e., all were intubated, mechanically ventilated and sedated) and healthy patients scheduled for an outpatient procedure.

Brief summary: The purpose of this study is to evaluate the clinical usefulness of a video camera pill (PillCam) in assessing intestinal function in the small intestines of patients. It is believed that the condition of the subjects digestive system can have a large impact on their overall physical health. Therefore, the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery. The same device will be used in healthy subjects scheduled for elective ambulatory surgery.


Eligibility criteria: Inclusion Criteria:

* mild-to-moderate brain injury patients who suffered from traumatic or non-traumatic intracranial hemorrhage
* admitted to an intensive care unit (ICU)
* needed an enteral tube placed for feeding
* control (ambulatory) group consisted of outpatients with no history of major abdominal surgery

Exclusion Criteria:

* younger than 18 years
* suffered multiple injuries (especially abdominal trauma or inflammatory bowel disease)
* had a history of complicated or unknown abdominal surgery
* presented with clinical evidence of ileus or suspected obstruction
* Patients with a pacemaker

Primary outcomes:
measure: small bowel transit times
timeFrame: 8 hours
Secondary outcomes:
measure: visualization
timeFrame: 8 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Stefan Rauch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03856489: Patients' Sleep at the Intensive Care Unit
Official title: Patients' Sleep at the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Quality of ICU Patients
Keywords: sleep
intensive care unit
patient
nurse
inter-rater reliability
Richards-Campbell sleeping questionnaire
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at intensive care units at the University Hospital Ostrava, Czech Republic fulfiling the inclusion criteria.

Brief summary: The primary objective of this study is to evaluate patient-nurse reliability and agreement of the Richards-Campbell sleep questionnaire (RCSQ) in a population of medical intensive care unit patients.

Detailed description: The main instrument of this research is the Richards Campbell Sleeping Questionnaire (RCSQ) regarding patients' overnight sleep quality. This questionnaire is given to complete to eligible patients between 7 am and 10 am. The same questionnaire is given to the night-shift nurse between 7 am and 7:30 am, who was taking care of that particular patient overnight. This RCQS assessment is based solely on each nurse´s perception of the patient´s sleep quality last night. Neither the nurse nor the patient know each other´s RCSQ response.

Eligibility criteria: Inclusion Criteria:

* ICU patients
* Age 18 years and older
* Glasgow coma scale 15

Exclusion Criteria:

* Age \< 18 years
* Glasgow coma scale \< 15

Primary outcomes:
measure: Patient-nurse inter-rater reliability
timeFrame: 30 weeks
Secondary outcomes:
measure: Patient sleep quality
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Kateřina Tejkalová, Mgr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
citation: Frisk U, Nordstrom G. Patients' sleep in an intensive care unit--patients' and nurses' perception. Intensive Crit Care Nurs. 2003 Dec;19(6):342-9. doi: 10.1016/s0964-3397(03)00076-4.