louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06288074: Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration
Official title: Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Community-acquired Pneumonia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective cohort including 100 patients with severe and 100 patients with non-severe community-acquired pneumonia and 100 healthy people was selected.

Brief summary: Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia.


Eligibility criteria: Inclusion Criteria:

Age\> 18 years old

Clinical diagnosis of community-acquired pneumonia

Exclusion Criteria:

Pregnancy, perinatal and lactating women

Combined immunosuppressive diseases: such as HIV, solid organ transplantation, solid organ/hematologic malignant tumor chemotherapy, rheumatic diseases or glomerular diseases need to take hormone/immunosuppressant therapy

Combined blood system diseases: such as leukemia reactions, aplastic anemia, neutropenia or deficiency of granulocytes, previous bone marrow/stem cell transplantation

Primary outcomes:
measure: Hospital mortality
timeFrame: during hospitalization (up to day 14)
Secondary outcomes:
measure: Cause of death
timeFrame: during hospitalization (up to day 14)
measure: Length of stay
timeFrame: during hospitalization (up to day 14)
measure: Length of ICU stay
timeFrame: during hospitalization (up to day 14)
measure: Expense during hospitalization
timeFrame: during hospitalization (up to day 14)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine
state: Beijing
Study officials:
References:
Clinical trial NCT05365074: Intrathecal Chloroprocaine for Lower Limb Arthroplasty
Official title: Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia
Keywords: chloroprocaine
total hip arthroplasty
total knee arthroplasty
unicompartmental knee arthroplasty
spinal anesthesia
Lead sponsor: Hôpital de la Croix-Rousse
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2022-05-09
Enrollment: 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients operated for total knee, unicompartment knee or anterior access hip arthroplasty under chloroprocaine spinal anesthesia in the period of years 2020 - 2021

Brief summary: This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia.

Detailed description: This study evaluates the failure rate of spinal anesthesia, the duration of surgical anesthesia, the needs for complementary intraoperative analgesia, the time for recovery, the incidence of urinary retention, postoperative nausea and vomiting, and length of stay in the recovery room in patients operated for knee or hip arthroplasty under spinal anesthesia with chloroprocaine 50 mg.

Eligibility criteria: Inclusion Criteria:

* adult patients
* with spinal anesthesia using 50 mg of chloroprocaine
* operated for total knee, unicompartment knee or anterior access hip arthroplasty
* in the period of years 2020 - 2021

Exclusion Criteria:

* expressed disagreement to to participate after receiving information notice

Primary outcomes:
measure: Spinal anesthesia failure
timeFrame: Day 0
Secondary outcomes:
measure: Hemodynamic instability
timeFrame: Day 0
measure: Need for sedation
timeFrame: Day 0
measure: Surgical block duration
timeFrame: Day 0
measure: PACU analgesia requirement
timeFrame: Day 0
measure: Urinary retention
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
measure: Length of stay in recovery room
timeFrame: Day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix Rousse - Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT06191874: Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation
Official title: Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Deep Brain Stimulation
Keywords: DBS
Parkinson's Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease scheduled for Deep Brain Stimulation Surgery

Brief summary: The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS).

This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard.

The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions.


Eligibility criteria: Electronic medical records (EMR) from all patients undergoing preoperative DBS evaluation will be reviewed and their data will be used for this study's purposes if they fit the inclusion and exclusion criteria.

Inclusion criteria:

* age 18 years and over
* meeting qualification for deep brain stimulation for Parkinson's disease with one or more of medication refractory tremor, motor fluctuations despite medication optimization, or levodopa responsiveness but limited by medication induced adverse effects (nausea, dystonia, dyskinesia for example).

Exclusion criteria:

* consideration of alternate diagnosis to Parkinson disease
* high risk medical comorbidities which would make the patient not a candidate for surgery.

Primary outcomes:
measure: Difference between the actual post-operative location of the DBS electrode and the planned location.
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Number of physicians who reply 'yes' to the question, 'Was the additional data available in the HoloDBS application valuable in defining your theoretical optimal electrode position?'
timeFrame: 6 months and 1 year after study starts
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT01166074: Retrospective Chart Review of Subcutaneous IgG Use in Infants
Official title: Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Deficiency
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 27
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 2 years of age

Brief summary: This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.


Eligibility criteria: Inclusion Criteria:

* Infants who received more than one dose of IgG by the subcutaneous route before the age of two years.
* Consent of parent/guardian if required by institution/IRB.

Exclusion Criteria:

* Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy.
* Concomitant treatment with plasma, other blood products or IGIV while on SCIG.
* Lack of consent by parent/guardian (if required by Institution/IRB).
* Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.

Primary outcomes:
measure: SCIG use
timeFrame: 1 year
Secondary outcomes:
measure: Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Plymouth
country: United States
facility: Midwest Immunology Clinic
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Memphis
country: United States
facility: St. Judes Children's Research Hospital
state: Tennessee
Study officials:
affiliation: CSL Behring
name: Melvin Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05925582: Vestibular-Based Exercises vs. Calisthenic Exercises for Cognitive Functions
Official title: Comparison of the Effects of Vestibular-based and Callisthenic-based Exercises on Cognitive Function and Dual Task in Ambulatory Older Adults Living in Nursing Homes: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Interventional (study) group and Control group
Primary purpose: TREATMENT

Brief summary: This study was planned to determine the effects of vestibular-based exercises (VBE) and calisthenic-based exercises (CBE) on the cognitive functions of the older individuals. A total of 30 people (21 male, 9 female; range: 65 - 85) will participate in the study. In this randomized controlled study, 30 participants will be divided into two groups: VBE Group (n: 15) and CBE Group (n: 15). Standardized Mini Mental State Test (SMMT) and 3 dual task (motor + cognitive: Dual Task 1, 2, 3) tests will be used to evaluate the cognitive functions of the participants.

Detailed description: All the evaluations will be done before and after the 8-week exercise program (three times a week). Each group participants will be divided into 3 groups (each group consists of 5 persons) and involved in an 8-week (3 days a week) exercise program (warm-up, VBE or CBE, cool-down).

Eligibility criteria: Inclusion Criteria:

Male and female individuals aged 65-85 years living in a nursing home.

* Individuals who are self-sufficient (independent) in daily life (including those who use a cane or canadian).
* Volunteer to participate in the study.

Exclusion Criteria:

* Having an orthopedic, neurological or psychiatric disorder that would prevent the evaluation and exercise program in the study.

Primary outcomes:
measure: Standardized Mini Mental State Test (SMMT)
timeFrame: 15 min.
measure: Dual task 1 (Motor + Cognitive) Test
timeFrame: 10 min.
measure: Dual task 2 (Motor + Cognitive) Test
timeFrame: 5 min.
measure: Dual task 3 (Motor + Cognitive) Test
timeFrame: 10 min.
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Faculty of Health Sciences in Biruni University
state: Zeytinburnu
Study officials:
affiliation: Biruni University
name: UGUR CAVLAK, Prof.
role: STUDY_DIRECTOR
References:
citation: Li L, Liu M, Zeng H, Pan L. Multi-component exercise training improves the physical and cognitive function of the elderly with mild cognitive impairment: a six-month randomized controlled trial. Ann Palliat Med. 2021 Aug;10(8):8919-8929. doi: 10.21037/apm-21-1809.
citation: Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
Clinical trial NCT02488382: Lonquek for Autologous Stem Cell Mobilization
Official title: Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Multiple Myeloma
Keywords: lymphoma
multiple myeloma
stem cell mobilization
autologous stem cell transplantation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed multiple myeloma or Hodgkins or non Hodgkin lymphoma at need of autologous stem cell transplantation.
* Disease must be chemosensitive or stable status to prior therapy before transplant.
* Age between 18 and 65 years inclusive.
* ECOG performance status 0, 1 or 2.
* Written informed consent.
* Adequate birth control in fertile patients.

Exclusion Criteria:

* Lymphoma patients that did not fulfill the inclusion criteria.
* Patients with factors predicting poor mobilization including \>3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like Melphalan, Fludarabine, \>2 courses of Revlimid, age \>65 years, platelets counts \<100x109/L, WBC\<2.5x109/L or WBC \> 35x109/L.
* Previous autologous stem cell transplantation.
* Inability to tolerate peripheral blood stem cell harvest.
* Peripheral venous access not possible.

Primary outcomes:
measure: Mobilisation success rate
timeFrame: 4 weeks
Secondary outcomes:
measure: engraftment after transplantation
timeFrame: 100 days
measure: Safety
timeFrame: 100 days
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Arnon Nagler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danylesko I, Sareli R, Varda-Bloom N, Yerushalmi R, Shem-Tov N, Magen H, Shimoni A, Nagler A. Long-acting granulocyte colony-stimulating factor pegfilgrastim (lipegfilgrastim) for stem cell mobilization in multiple myeloma patients undergoing autologous stem cell transplantation. Int J Hematol. 2021 Sep;114(3):363-372. doi: 10.1007/s12185-021-03177-9. Epub 2021 Jul 2.
Clinical trial NCT02805582: Ultrasound Guided Intercostobrachial Nerve Block
Official title: Area of Sensory Loss, Onset Time and Duration of Two Different Ultrasound Guided Intercostobrachial Nerve Blocks for Vascular Access Surgery of the Upper Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Keywords: Peripheral Nerve Block
Lead sponsor: Marienhospital Stuttgart
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound guided block of the intercostobrachial nerve is not yet known. The investigators compare a proximal and a more distal approach to the nerve referred to onset time, sensory blocked area and duration.

Detailed description: The participants will be randomized into two groups:

Group one receives a modified PECS 2 (thoracic wall) block above the second intercostal space with injection between the Musculus serratus anterior and Musculus pectoralis minor.

Group 2 receives a subpectoral block under the pectoralis major muscle at the medial boarder of the axillary triangle.

Eligibility criteria: Inclusion Criteria:

* patients planned for vascular access surgery of the upper arm
* surgery planned under regional anaesthesia

Exclusion Criteria:

* patients refusal
* age under 18
* allergy against local anaesthetics
* polyneuropathies

Primary outcomes:
measure: Blocked area in squared cm
timeFrame: Assessment 30 minutes after intervention
Secondary outcomes:
measure: Block onset time in minutes
timeFrame: Complete timeframe of 45 minutes with testing every 5 minutes
measure: Block duration in minutes
timeFrame: Assessment every 30 minutes for 8 hours after nerve block
measure: The pain numeric rating scale (NRS) during surgical manipulation in the axilla
timeFrame: From beginning to end of surgery. Estimated mean duration of 90 minutes.
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart, Dpt. of Anaesthesiology
state: Baden Württemberg
Study officials:
References:
Clinical trial NCT00654082: A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
Official title: A Placebo-Controlled, Randomized, Two-Way Cross-Over, Double-Blind, Flexible Dose, Multicenter Study to Evaluate the Efficacy and Safety of Viagra in Male Patients With Traumatic Spinal Cord Injury and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Erectile Dysfunction
Spinal Cord Trauma
Injuries, Spinal Cord
Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 88
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.


Eligibility criteria: Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

-N/A

Primary outcomes:
measure: The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections
timeFrame: Weeks 6 and 14
Secondary outcomes:
measure: Responses to the International Index of Erectile Function (IIEF)
timeFrame: Weeks 0, 6, 8, and 14
measure: Responses to the Global Efficacy Assessment (GEA) Question
timeFrame: Weeks 0, 6, 8, and 14
measure: Responses to questions on the Quality of Life (QoL) Questionnaire
timeFrame: Weeks 0, 6, 8, and 14
measure: Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions
timeFrame: Weeks 0, 6, 8, and 14
measure: Intercourse success rate derived from patient event log
timeFrame: Weeks 0, 6, 8, and 14
Other outcomes:
Locations:
city: Bahcelievler
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Balcova
country: Turkey
facility: Pfizer Investigational Site
state: Izmir
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Bursa
country: Turkey
facility: Pfizer Investigational Site
city: Konya
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: