louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03882658: Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury
Official title: Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury: a Retrospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 37610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult non-cardiac, non-obsteric, non- kidney elective surgery patients

Brief summary: Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.


Eligibility criteria: Inclusion Criteria:

adult non-cardiac, non-obsteric, non- kidney elective surgery patients

Exclusion Criteria:

patients aged \<18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP \<100 mmHg

Primary outcomes:
measure: incidence and odds ratio of postoperative acute kidney injury
timeFrame: 30 days postoperatively in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First hospital Peking University
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yan Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02183558: Screening for GDM in Women With PCOS and Controls
Official title: Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Gestational Diabetes Mellitus
Keywords: PCOS
GDM
OGTT
Glucose metabolism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Municipality of Odense
name: University of Southern Denmark
First posted: 2014-07-08
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy, insulin sensitivity decreases. The investigators examine glucose metabolism during oral glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective cohort of pregnant women with PCOS and controls.


Eligibility criteria: Inclusion Criteria:

* Pregnancy achieved during 2010-2012
* Residents of the municipality of Odense

Exclusion Criteria:

* Moving from Odense during pregnancy

Primary outcomes:
measure: Gestational diabetes mellitus
timeFrame: 2 years
measure: Gestational Diabetes Mellitus
timeFrame: Gestational week 28
Secondary outcomes:
measure: Anthropometric measures in offspring
timeFrame: At birth
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: OdenseUH
Study officials:
affiliation: Odense University Hospital
name: Marianne Andersen, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03566758: Muscle Mass and Nutritional Risk in Older Adults
Official title: The Association Between Muscle Mass and Nutritional Risk by COAST in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 136
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults

Brief summary: This study aims to compare the COAST (comprehensive older adult screening tool) to muscle mass as determined by BIA (bioelectric impedance analysis) and thus, determine if the COAST is a valid predictor of muscle loss in older adults. This study follows a comparison of COAST to MNA and will further test the validity of the COAST nutrition screening tool.

Detailed description: The association between muscle mass, as determined by BIA (bioelectric impedance analysis), and the recently developed COAST (Comprehensive Older Adult Screening Tool) has not been studied. Therefore, the main objective of this study is to test the correlations between muscle mass, measured by BIA, and COAST. The population to be studied will be older adults (n=150). Participants will be included if they are 60 years or older, willing to have weight, height, handgrip and body composition measured, willing to provided demographic information and answer questions related to their nutritional and health status. Individuals will be excluded if they have had recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device. Participants will be recruited from community groups in Florida. Participants muscle mass will be measured using BIA. Also, their handgrip strength will be tested using a dynamometer. Weight and height will be measured and demographic information will be collected. In addition, the participants will be given COAST (5 questions related to their nutritional and health status). The associations among BIA, handgrip strength and the COAST will be analyzed.

Eligibility criteria: Inclusion Criteria:

* 60 -100 years of age
* willing to weight, height, handgrip and body composition measured, willing to provide demographic information and answer questions related to their nutritional and health status

Exclusion Criteria:

* recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device.

Primary outcomes:
measure: COAST (Comprehensive Older Adult Screening Tool) score
timeFrame: baseline only
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and Human Nutrition Department
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03107858: The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function
Official title: The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Renal Transplant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Renal transplantation is now recognized as a treatment of choice for patients with chronic renal failure with end-stage renal disease. Renal transplantations are associated with better quality of life, better cost/benefit ratio, and possibly longer survival. Significant changes in blood pressure are common throughout the surgical procedure for kidney transplantation. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a living donor kidney transplantation

Exclusion Criteria:

* Patients (less than 18 years old)
* Patients' refusal of consenting for enrolment in the study

Primary outcomes:
measure: serum creatinine
timeFrame: four hours postoperatively
Secondary outcomes:
measure: blood urea
timeFrame: four hours postoperatively
measure: urine output
timeFrame: over 24 hours
measure: renal artery diameter
timeFrame: four hours postoperatively
measure: renal artery blood flow
timeFrame: four hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT01751958: Radiation Exposure in Spine Intervention Under Angiography
Official title: Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI

Detailed description: The purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators (experienced staff and trainee) and among different method for ESI.

Eligibility criteria: Inclusion Criteria:

* Suspected of having radiculopathic low back pain

Exclusion Criteria:

* Angiography is contraindicated

Primary outcomes:
measure: Radiation dose
timeFrame: Treatment on the day
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si,
country: Korea, Republic of
facility: Joon-woo Lee
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Joon-woo Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086158: Effect of Reverse Nordic Exercise on Vertical Jump in Youth Soccer Players
Official title: Effect of Reverse Nordic Exercise on Vertical Jump in Youth Soccer Players: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength
Keywords: Soccer
Eccentric Force
Quadriceps
Reverse Nordic Hamstring Exercise
Vertical Jump
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 19
Sex: MALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: BASIC_SCIENCE

Brief summary: BACKGROUNDː The reverse nordic hamstring exercise is developed for the eccentric work of the rectus femoris. After performing Nordic exercise protocol (its original), the relationship between increased eccentric hamstring strength, improvements in sprint capacity and reduced incidence of injuries can be confirmed. The review of evidence, led us propose the relationship and the possible benefits that could exist in the performance of four weeks of reverse nordic exercise protocol and the vertical jump, measured with countermovement jump test (CMJ) on a platform of jump.

METHODSː An open randomized controlled trial was conducted, with an intervention and control group, to which they were randomly assigned. The sample was made of 19 players from the San Antonio de Murcia Catholic University Team in the youth A category, aged between 16 and 18 years old. The experimental group (n=10) performed the reverse nordic hamstring exercise protocol for four weeks, in addition to the usual training that they shared with the control group (n=9). Data collection for the CMJ test was done before starting the protocol and immediately after finishing it for all participants. Statistical analysis was carried out with the SPSS program.


Eligibility criteria: Inclusion Criteria:

* Between 16 and 18 years old
* Soccer Players

Exclusion Criteria:

* Pathologies or Musculoskeletal Injuries in the last 6 months
* Surgical Interventions in the lower extremities in the last 6 months

Primary outcomes:
measure: Flight Time
timeFrame: It was performed 3 days after completing the 4-week reverse Nordic exercise protocol.
measure: Jump Height
timeFrame: It was performed 3 days after completing the 4-week reverse Nordic exercise protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Torre del Mar
country: Spain
facility: Lara Sánchez Torres
state: Málaga
Study officials:
References:
Clinical trial NCT04520958: Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
Official title: Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Pain, Joint
Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.


Eligibility criteria: Inclusion Criteria:

* English-speaking males or females.
* 18 years old or older
* Patients within the University of Utah Hospital system
* Patients attending Joint Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Primary outcomes:
measure: Change in Preoperative Pain Intensity
timeFrame: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
measure: Change in Postoperative Pain Intensity
timeFrame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Secondary outcomes:
measure: Change in Postoperative Pain Unpleasantness
timeFrame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
measure: Change in Postoperative Opioid Use
timeFrame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Other outcomes:
measure: Change in Self-Transcendent State
timeFrame: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
measure: Patient Confidence
timeFrame: Completed immediately after the preoperative intervention
measure: Patient Intent
timeFrame: Completed immediately after the preoperative intervention
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.
Clinical trial NCT05601258: Lipase Levels and Coronavirus Disease 2019
Official title: Association Between Pancreatic Lipase Levels and Coronavirus Disease 2019
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Lipase Increased
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 4000
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eighteen years of age or older, whose lipase level is measured in the course of COVID 19, will be included in the study.

Brief summary: Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.

In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury and acute pancreatitis in the course of COVID 19 disease.


Eligibility criteria: Inclusion Criteria:

* Patients with lipase levels measured during COVID-19

Exclusion Criteria:

Patients with age \<18 years Patients with pregnancy Patients whose lipase levels were not measured in the course of COVID-19 Patients with known solid organ malignacy Patients with known hematologic malignacy

Primary outcomes:
measure: The frequency of lipase enzyme elevation will be compared
timeFrame: From 31th March 2020 until 9th July 2021
measure: The mortaliy rate will be compared
timeFrame: From 31th March 2020 until 9th July 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Cevdet Duran
Study officials:
References:
Clinical trial NCT03543358: A Long-Term Study of Rovalpituzumab Tesirine
Official title: A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: rovalpituzumab tesirine
rollover study
cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.


Eligibility criteria: Inclusion Criteria:

* Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.
* Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.

For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:

* Tolerated their initial 2 doses of rovalpituzumab tesirine.
* Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.
* Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.
* Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, kidney, and liver function, per protocol.
* In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.

Exclusion Criteria:

* Subjects not previously enrolled in a rovalpituzumab tesirine study.

Primary outcomes:
measure: Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center /ID# 204885
state: California
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Med Ctr /ID# 204763
state: Pennsylvania
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04692363: Plasmapheresis Before Rituximab in Cryoglobulinemia
Official title: Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cryoglobulinemic Vasculitis
Keywords: Cryoglobulinemic vasculitis requiring rituximab therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 120
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: Adult patient with cryoglobulinemic vasculitis requiring rituximab treatment

Brief summary: Initial worsening following initiation of rituximab therapy in patients with cryoglobulinemic vasculitis was described in 3.6% of cases. This worsening is often a serious condition, with high levels of mortality.

The objective of our study is to evaluate the efficacy of preventive plasmapheresis prior to the introduction of rituximab performed in Montpellier France since 2013 by assessing the frequency and severity of this flare effect in these patients compared to those reported in the literature.


Eligibility criteria: Inclusion criteria:

* cryoglobulinemic vasculitis requiring rituximab treatment
* Patient ≥18 years old

Exclusion Criteria:

* Patient who reject the study protocol
* Patient \< 18 years old

Primary outcomes:
measure: comparison of frequency of occurrence of flare effects
timeFrame: 1 day
Secondary outcomes:
measure: evaluation of the severity of the flare effect
timeFrame: 1 day
measure: impact of known risk factors
timeFrame: 1 day
measure: evaluation of the safety of plasmapheresis in this indication
timeFrame: 1 day
measure: evaluation of the efficacy of plasmapheresis on biological parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Charles HERBAUX, assistant Professor
role: STUDY_DIRECTOR
References: