louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06707350: Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
Official title: Protective Effect of Remote Ischemic Preconditioning (RIPC) Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiopulmonary Bypass
Cardiovascular Diseases
Inflammatory Response During Cardiac Surgery
Keywords: inflammation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2024-11-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote ischaemic pre-conditioning (RIPC) has been recognized as a low-cost, non-invasive intervention method by applying brief ischaemia and reperfusion on an arm or a leg. Previous studies have mainly focused on the organoprotective effects of RIPC in patients undergoing cardiac surgery. However, whether it has an organ-protecting effect is still highly debated. We aimed to determine whether intensive RIPC can prevent from negative inflammatory response and organ dysfunction as well as postoperative complications in patients undergoing cardiovascular surgery.


Eligibility criteria: Inclusion Criteria:

* patients at high risk for organ dysfunctions who underwent elective cardiovascular surgery requiring cardiopulmonary bypass (CPB);
* age of 18 -80 years old, regardless of gender;
* subjects voluntarily participate in the trialand sign the informed consent;

Exclusion Criteria:

* 1) Arm fracture, skin injury or infection;
* 2) There is limb nerve injury;
* 3) Limb placement PICC, arteriovenous fistula and other devices that affect armband placement;
* 4) There are basic vascular lesions and poor blood supply at the extremities;
* 5) Limb thrombosis.

Primary outcomes:
measure: ∆SOFA
timeFrame: within the prior 7 days after cardiac surgery.
Secondary outcomes:
measure: Plasma interleukin-1 levels
timeFrame: within the prior 7 days after cardiac surgery.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yong-feng Shao, MD
role: STUDY_DIRECTOR
References:
citation: Jia P, Ji Q, Zou Z, Zeng Q, Ren T, Chen W, Yan Z, Shen D, Li Y, Peng F, Su Y, Xu J, Shen B, Luo Z, Wang C, Ding X. Effect of Delayed Remote Ischemic Preconditioning on Acute Kidney Injury and Outcomes in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial. Circulation. 2024 Oct 22;150(17):1366-1376. doi: 10.1161/CIRCULATIONAHA.124.071408. Epub 2024 Sep 25.
Clinical trial NCT01574950: Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Official title: The Impact of Impaired Cerebral Autoregulation on the Development of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 99
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is male and female subjects age 70 years and older that are having spine surgery.

Brief summary: Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Detailed description: Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. We hypothesize that impaired cerebral autoregulation may be a possible mechanism for postoperative delirium. We will measure intraoperative cerebral autoregulation and assess the relationship with postoperative dleirium. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Eligibility criteria: Inclusion Criteria:

1. ≥ 70 years old,
2. Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery \> 2 levels

Exclusion Criteria:

1. MMSE \< 15
2. Delirium at baseline
3. Inability to speak and understand English
4. Severe hearing impairment, resulting in inability to converse.
5. Planned use of intraoperative ketamine
6. Planned use of intraoperative remifentanil, except for airway management pre-incision.
7. Arterial catheter not planned to be inserted

Primary outcomes:
measure: Incidence of post-operative delirium in elderly patients undergoing spine surgery at Johns Hopkins Hospital
timeFrame: 24 months
Secondary outcomes:
measure: Severity of postoperative delirium, using Delirium Rating Scale-Revised-1998, in elderly patients undergoing spine surgery.
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: The Johns Hopkins University
name: Charles Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02663050: The Effect of Kinesio Taping Application for Dysmenorrhea
Official title: The Effect of Kinesio Taping Application for Dysmenorrhea: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
kinesio tape
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment strategies are being held. But invasive and pharmacological therapies have good outcome with systemic side effects. Kinesio taping is being widely used in different pain conditions. Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which can be used in outpatient practice without systemic side effects.

Detailed description: Dysmenorrhea is a kind of visceral pain that result of peritoneal irritation. It is so common in gynecological outpatient practice. Most of treatment is based pharmacological treatments as NSAIDs, oral contraceptives with many side effects. Kinesio taping is widely used for musculoskeletal parenchymal pain like sports related injuries. As in other complementary treatment methods like acupuncture and acupressure; pain carrying unmyelinated thin pain fibers are blocked by touch sensation carrying myelinated thick fibers which is stimulated by acupressure(gate control theory by Melzack), kinesio taping blocks the pain fibers that comes from same spinal level. So it can be used easily and instantly for dismenore

Eligibility criteria: Inclusion Criteria:

* Dysmenorrhea

Exclusion Criteria:

* pregnancy
* surgical abdominal emergency
* metabolic or inflammatory illnesses or cardiovascular diseases,
* endocrine disorders such as diabetes, thyroid disorders, androgen excess (hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumor),
* smokers
* using pharmaceutical agents such as anti-inflammatory agents that could possibly impact on endocrine and liver enzymes
* musculoskeletal pain
* inguinal hernia

Primary outcomes:
measure: Visual analog scale
timeFrame: 0- 4th day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Etimesgut Military Hospital
name: Mustafa Öztürk, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06230250: Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer
Official title: Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap in Patients With a History of Total Mastectomy for Breast Cancer Single-centre Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patient Satisfaction
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent unilateral secondary total breast reconstruction using a TDAP or MSLD flap.

Brief summary: The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer. However, little data exists regarding patient satisfaction after this surgery. The main objective of this study was to evaluate patient satisfaction after unilateral total secondary breast reconstruction using a TDAP or MSLD flap.


Eligibility criteria: Inclusion Criteria:

* Breast reconstruction using a TDAP or MSLD flap between January 1, 2018 and December 31, 2022
* Major
* Non opposition
* Women with social security number

Exclusion Criteria:

* Bilateral reconstruction
* Partial reconstruction
* Immediate reconstruction
* Prophylactic reconstruction
* Women who did'nt have a breast cancer
* Women who don't finish their reconstruction
* Women who don't want participate

Primary outcomes:
measure: Patient satisfaction
timeFrame: 5 years
Secondary outcomes:
measure: Patient characteristics
timeFrame: 5 years
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT03651050: Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
Official title: Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed project is to develop a Pediatric-Mental Health Digital Toolkit (P-MHDT) Toolkit to support innovative child mental health preventive interventions in FBO settings. This project focuses on developing a P-MHDT and carrying out a pilot feasibility evaluation in real world settings. A group of Mental Health Professionals (MHPs)/ Community Healthcare Workers (CHWs) will be trained and the P-MHDT Toolkit intervention will be tested in 6 Faith Based Organizations (FBOs) in Uganda.

Detailed description: The specific aims of this proposed study include:

Aim 1. To develop a P-MHDT (by employing qualitative focus-group interviews and user-centered design to enhance usability).

Aim 2. To train mental health professionals and community health workers (CHWs) for the P-MHDT approach of child mental health promotion in Uganda (including monitoring impacts of training on CHWs' program implementation competency).

Aim 3 (11-24 month). To estimate impacts of the P-MHDT on FBOs and families (i.e., caregivers' mental health literacy, practices, and children's mental health) when implemented in the real world FBO settings.

Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years of age. Participating parents must be caregivers of age 1-7 years old children.
* Children are not the subjects of this study, and will not participate in research activities.

Exclusion Criteria:

* Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
* Minors (age \<18) will also be excluded.

Primary outcomes:
measure: Aggression measured by parent report
timeFrame: 24 Months
measure: Anxiety measured by parent report
timeFrame: 24 Months
measure: Depression measured by parent report
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Keng-Yen Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03774550: Atrial Fibrillation Ablation: Radiofrequency or Cryoablation?
Official title: A Comparison of Radiofrequency Catheter Ablation With or Without Contact-force and Cryoablation for Paroxysmal Atrial Fibrillation Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Catheter ablation
Radiofrequency
Contact-force
Cryoablation
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 206
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 had an atrial fibrillation for symptomatic paroxysmal atrial fibrillation, refractory to antiarrhythmic drugs, between 01/01/2014 and 30/09/2017 in CHR Metz-Thionville

Brief summary: The study aims to compare 3 techniques routinely used for paroxysmal atrial fibrillation ablation: radiofrequency catheter ablation without contact-force, radiofrequency catheter ablation with contact-force and cryoablation. The hypothesis is the non-inferiority between the 3 techniques in terms of free-from atrial fibrillation survival (primary criteria). It will also compare lenght of procedure, radioscopy time and immediate complications (secondary criteria).


Eligibility criteria: Inclusion Criteria:

* Patients who had an atrial fibrillation for symptomatic paroxysmal atrial fibrillation, refractory to antiarrhythmic drugs, between 01/01/2014 and 30/09/2017 in CHR Metz-Thionville

Exclusion Criteria:

* Patients not willing to participate via using their medical files

Primary outcomes:
measure: Atrial Fibrillation survival
timeFrame: Day 1
Secondary outcomes:
measure: Immediate complications
timeFrame: Day 1
measure: Radioscopy duration
timeFrame: Day 1
measure: Lenght of procedure
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References:
Clinical trial NCT06199050: The Effect of 360° Virtual Reality Movies on Fear and Anxiety
Official title: The Effect of 360° Virtual Reality Movies on Fear and Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fear
Anxiety
Breast Cancer
Lung Cancer
Prostate Cancer
Head and Neck Cancer
Brain Tumor
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.

Detailed description: In ENGAGE, a KWF Samenloop Voor Hoop subsidized project, we have developed VR movies to reduce fear and anxiety for patients who are going to be treated at Maastro. These movies are based on where most fear and anxiety are experienced and have been developed after extensive discussion with different disciplines in patient care and with agreement of the Director Patient Care. The movies include: 1) Mouldroom, 2) VMDIBH mamma photons, 3) Head and Neck photons, 4) Lung photons, 5) CT-scan, 6) Prostate photons, and 7) Head and Neck/ Neuro protons. Currently, the web-based 360° movies are implemented in clinical practice and the VR glasses with the 360° movies will be used as soon as social work has decided on where to integrate the use in the care pathway.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with breast- (only VMDIP), lung-, prostate-, head and neck cancer, a brain tumor.
* Age 18+
* Being able to speak, read and write in Dutch
* General interview between radiation oncologist and patient (= Intake)
* Ability to give written informed consent before the start of the study
* Decision talk about start of treatment must have taken place

Exclusion Criteria:

* Patients who are already receiving radiotherapy treatment
* Pre-operative consultation for breast cancer patients
* Patients who have seen the VR-videos already

Primary outcomes:
measure: Subjective fear, anxiety and stress (QSC-R23)
timeFrame: 1 month
measure: Subjective fear, anxiety and stress (PROMS)
timeFrame: 1 month
measure: Subjective fear, anxiety and stress (HADS)
timeFrame: 1 month
measure: Subjective fear, anxiety and stress (SPIRIT)
timeFrame: 1 month
measure: Relationship with demographics
timeFrame: 1 month
measure: Relationship between fear, anxiety, stress experience, and answers given in the standard PROMS questionnaire
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology
Study officials:
affiliation: Maastricht University
name: Cheryl Roumen
role: STUDY_DIRECTOR
affiliation: Maastro
name: Maria Jacobs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235650: Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
Official title: Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal fusion patients

Brief summary: This is a retrospective chart review of patients undergoing spinal fusion surgery to see the prevalence of hyperventilation.

Detailed description: Retrospective review of the operative schedules to identify patients who have undergone spinal fusion with placement of an arterial cannula for intermittent arterial blood gas analysis. The intraoperative records will be retrospectively reviewed. The following demographic data will be recorded: age, weight, gender, and co-morbid medical conditions. Ventilatory parameters at the time of ABG analysis will include (respiratory rate and tidal volume). ABG data will be collected.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of inadvertent hyperventilation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00848055: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion (1 Mcg/kg, 5 Mcg/kg, 25 Mcg/kg, 125 Mcg/kg, 625 Mcg/kg, 3 mg/kg, or 10 mg/kg) or Subcutaneous Injection (625 Mcg/kg) to Patients With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis


Eligibility criteria: Inclusion criteria:

Patients with chronic plaque psoriasis covering at least 3% of body surface area. Female subjects must be postmenopausal or surgically sterilized.

Exclusion criteria:

Recent use of biologic agents, oral psoriasis medications or phototherapy

Primary outcomes:
measure: Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events
timeFrame: Baseline, on treatment,and at end of study
Secondary outcomes:
measure: Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy
timeFrame: Baseline and on treatment
Other outcomes:
Locations:
city: Boise
country: United States
facility: 1240.1.05 Boehringer Ingelheim Investigational Site
state: Idaho
city: Evansville
country: United States
facility: 1240.1.06 Boehringer Ingelheim Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: 1240.1.04 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 1240.1.02 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: New York
country: United States
facility: 1240.1.01 Boehringer Ingelheim Investigational Site
state: New York
city: Dallas
country: United States
facility: 1240.1.03 Boehringer Ingelheim Investigational Site
state: Texas
city: Berlin
country: Germany
facility: 1240.1.7 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: