louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03241758: Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy
Official title: Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Erectile Dysfunction Following Radical Prostatectomy
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

Brief summary: A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.


Eligibility criteria: Inclusion Criteria:

* Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

Exclusion Criteria:

* Patients who were not interested in their sexual function and refused to perform this study
* Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.

Primary outcomes:
measure: Left and right Cavernous artery diameter
timeFrame: 1 year
measure: Left and right Systolic velocity cavernous artery
timeFrame: 1 year
measure: Left and right Diastolyc velocity cavernous artery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Corporació Sanitaria Parc Tauli
name: Jesus Muñoz-Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01126658: Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure
Official title: Evaluation of the Intracranial Volume Pressure Relationship in Increased Intracranial Pressure Patients by a Mathematic Manner
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injury
Intracranial Hypertension
Keywords: pressure-volume curve
intracranial pressure
volume pressure response
pressure-volume relationship
mathematical model
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: over 30 patients with severe brain injury and underwent bilateral external ventricular drainage in situ.

Brief summary: The purpose of this study is to discover a mathematic equation to express the intracranial pressure-volume (P-V) curve and a single indicator to reflect the status of the curve.

Detailed description: Monitoring of intracranial pressure (ICP) has been used in the management of patients with increased ICP, or in whom increased ICP was suspected. ICP depends on the relative constancy of total volume inside the skull, comprising cerebrospinal fluid (CSF), blood, and brain tissue. The changes of CSF volume affect the ventricular fluid pressure and defined it as volume pressure response (VPR). The shape or curve of the intracranial volume-pressure (V-P) relationship is well known in daily neurosurgical practice. If the P-V curve can be expressed by mathematic manner, then there should be an indicator to reflect the status of the curve. This study is conducted in order to understand the difference of each P-V curve in patients with increased intracranial pressure. The individual VPR values have been tested with three mathematical models (linear, parabolic and exponential regression equation).

Eligibility criteria: Inclusion Criteria:

* Patients with severe brain damage
* Underwent bilateral external ventricular drainage (EVD)

Exclusion Criteria:

-

Primary outcomes:
measure: intracranial pressure
timeFrame: one minute.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Neurosurgery,Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Neurosurgery,Chang Gung Memorial Hospital
name: Shih-Tseng Lee, MD
role: STUDY_CHAIR
affiliation: Department of Neurosurgery,Chang Gung Memorial Hospital
name: Hung-Yi Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai HY, Lee CY, Hsu HH, Lee ST. The intracranial volume pressure response in increased intracranial pressure patients: Part 1. Calculation of the volume pressure indicator. Acta Neurochir (Wien). 2012 Dec;154(12):2271-5; discussion 2275. doi: 10.1007/s00701-010-0765-8. Epub 2010 Aug 18.
Clinical trial NCT00004358: Phase II Study of Calcitonin for Tumoral Calcinosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Calcinosis
Keywords: arthritis & connective tissue diseases
rare disease
tumoral calcinosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 1999-10-19
Enrollment: 9
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis.

II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus.

IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.

Detailed description: PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. Ondansetron premedication and intravenous hydration are also administered.

Patients are followed for disease progression and tumor recurrence.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital, Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Craig B. Langman
role: STUDY_CHAIR
References:
Clinical trial NCT00327158: A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs
Official title: Using Transesophageal Echocardiography To Assess Fat Emboli As A Result Of Reaming In A Prospective Randomized Control Trial To Determine The Effectiveness Of Reaming In Diminishing Fat Emboli To The Lungs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphyseal Femur Fracture
Keywords: Reaming
fracture
emboli
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if there is a difference in the amount of fat droplets reaching the heart during surgery between the standard reamer currently used and a new reamer system which is expected to reduce the fat going into the blood, via an intraoperative echocardiography done through the food pipe.

Detailed description: Reamed intramedullary nailing of diaphyseal femur fractures remains the standard of care for treatment of these fractures. Pressurization of the femoral canal during reaming leads to extra vasations of fat emboli into the systemic circulation, resulting in deposition of fat droplets in the pulmonary vasculature. This phenomenon has been well documented by use of Transesophageal Echocardiography. A novel reaming system has recently become available that may limit this phenomenon. The new reamer system incorporates irrigation and aspiration during reaming, theoretically minimizing pressurization and fat emboli. Additionally, this reamer system allows for one pass reaming as compared to the current system which requires multiple reaming passes.

The objective of this study is to determine effectiveness of reaming in diminishing fat emboli to the lungs as evidenced by decreased numbers of large fat droplets entering the right heart as measured by transesophageal echocardiography during the reaming process. This will determine if there is a benefit to aspiration during reaming as would be expected.

During the reaming process a transesophageal echo cardiogram will be performed to analyze the presence or absence of emboli and the mean regarding the total time that each of the embolic grades is present during each of the intervals across the patient groups

Eligibility criteria: Inclusion Criteria:

* diaphyseal femur fractures undergoing reamed intramedullary nailing
* male or female
* 18 years of age or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Presence of Emboli
timeFrame: Immediately following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky, Department of Orthopaedic Surgery
name: William Rosenblum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky Department of Orthopaedic Surgery
name: Jeffrey Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598658: Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
Official title: Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Ischemic Conditioning
Keywords: Remote Ischemic Conditioning
Intravenous Thrombolysis
Cerebral Hemodynamics
Cerebral Autoregulation
Cerebral Blood Flow Velocity
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 100
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: TREATMENT

Brief summary: The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis

Detailed description: In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 and \< 80 years, both sexes;
2. a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
3. pre-onset modified Rankin Scale (mRS) score ≤1;
4. baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
5. Glasgow Coma Scale score ≥8.

Exclusion Criteria:

1. having received bridging therapy (IVT plus mechanical thrombectomy);
2. previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
3. contraindications to RIC treatment or previous RIC treatment or similar treatment;
4. pregnancy or breastfeeding;
5. life expectancy of ≤3 months or inability to complete the study for other reasons;
6. unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
7. had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.

Primary outcomes:
measure: Cerebral autoregulation parameter
timeFrame: 1-10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT03365258: The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
Official title: The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Malnutrition is very common in critically ill patients. It is quite important to evaluate nutritional status precisely. Heyland et al firstly reported NUTRIC score including age, APACHE II score, SOFA score, number of commorbidities, days from hospital to ICU admission and IL-6. Because the IL-6 is not routinely checked at ICU. A modified NUTRIC score without IL-6 is more practical. Previous studies showed lower in-hospital mortality in higher nutritional risk patients with higher caloric intake compared with lower caloric intake. However, there is still controversial regarding the in-hospital mortality between full caloric feeding and permissive underfeeding in critically ill patients. Herein the investigators conduct a study to investigate what kinds of nutritional supplements will decrease in-hospital mortality in different nutritional risk patients.


Eligibility criteria: Inclusion Criteria:

* 1. Medical intensive care unit patients 2. age elder than 20 years old 3. Intubated with ventilator support patients 4. Predicted ICU stay longer than 72 hours

Exclusion Criteria:

* 1. NPO patients 2. Contraindication for enteral feeding 3. TPN use 4. Upper or lower GI bleeding patients 5. Feeding with gastrostomy or Jejunostomy patients 6. Metoclopramide related EPS or Torsades de pointes history

Primary outcomes:
measure: In-hospital mortality
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: 王振宇
state: 台中市
Study officials:
References:
Clinical trial NCT04011358: Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Official title: Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Retinal Vein Occlusion
Obstructive Sleep Apnea
Keywords: Retinal Vein Occlusion
central retinal vein occlusion
branch retinal vein occlusion
obstructive sleep apnea
sleep apnea
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case-control comparison study
Primary purpose: PREVENTION

Brief summary: This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

Detailed description: There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation.

The compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age.

They will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.

Eligibility criteria: Inclusion Criteria:

* All patients with an Retinal Vein Occlusion for one group (patients)
* All patients with no Retinal Vein Occlusion for the other group (control)

Non-inclusion Criteria:

* minor
* Severe Insomnia
* Neuromuscular Disease with respiratory muscle impairment
* Chronic opioid medication
* Pregnancy women.
* Patient under guardianship

Primary outcomes:
measure: Apnea Hypopnea index >5/hour
timeFrame: Hour 12
Secondary outcomes:
measure: Berlin Questionnaire sleep test
timeFrame: Hour 12
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR Orléans
name: Pierre BONICEL, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glacet-Bernard A, Leroux les Jardins G, Lasry S, Coscas G, Soubrane G, Souied E, Housset B. Obstructive sleep apnea among patients with retinal vein occlusion. Arch Ophthalmol. 2010 Dec;128(12):1533-8. doi: 10.1001/archophthalmol.2010.272.
citation: Chou KT, Huang CC, Tsai DC, Chen YM, Perng DW, Shiao GM, Lee YC, Leu HB. Sleep apnea and risk of retinal vein occlusion: a nationwide population-based study of Taiwanese. Am J Ophthalmol. 2012 Jul;154(1):200-205.e1. doi: 10.1016/j.ajo.2012.01.011. Epub 2012 Mar 30.
citation: Kwon HJ, Kang EC, Lee J, Han J, Song WK. Obstructive Sleep Apnea in Patients with Branch Retinal Vein Occlusion: A Preliminary Study. Korean J Ophthalmol. 2016 Apr;30(2):121-6. doi: 10.3341/kjo.2016.30.2.121. Epub 2016 Mar 25.
citation: Agard E, El Chehab H, Vie AL, Voirin N, Coste O, Dot C. Retinal vein occlusion and obstructive sleep apnea: a series of 114 patients. Acta Ophthalmol. 2018 Dec;96(8):e919-e925. doi: 10.1111/aos.13798. Epub 2018 Sep 6.
Clinical trial NCT02698358: Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iliac Artery Disease
Keywords: Peripheral artery disease, Iliac artery, nitinol stent, restenosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Iliac artery disease

Brief summary: * Prospective, single-arm, multi-center registry study
* A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included.
* Patients will be followed clinically for 12 months after the procedure.
* Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
* Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
* Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)


Eligibility criteria: Inclusion Criteria:

1. Age 19 years of older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4)
3. Iliac artery lesions with stenosis \> 50%
4. ABI \<0.9
5. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 5 or 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion revascularization rate
timeFrame: 12 months
measure: Stent fracture rate
timeFrame: 12 months
measure: Quality of life by standardized questionnaires
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT05177458: Exercise and Therapeutic Exposure
Official title: The Effects of Acute Aerobic Exercise on Therapeutic Safety Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Trauma
Exercise
Mental Health
Aerobic
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed project seeks to demonstrate that a brief bout of aerobic exercise can improve a particular type of therapeutic learning among victimins of interpersonal violence with or without posttraumatic stress disorder (PTSD).

Detailed description: The proposed study has one aim:

Specific Aim: To examine the effects of acute exercise on the consolidation of therapeutic safety learning. It is hypothesized that participants who engage in 30-min of moderate-intensity aerobic exercise following the first session of imaginal exposure will show larger between-session (visit 2 to 3) reductions in heart rate and anxiety during imaginal exposure to trauma narratives compared to participants who engage in light-intensity exercise.

Eligibility criteria: Inclusion Criteria:

* Experience of interpersonal violence
* English speaking
* Medically healthy

Exclusion Criteria:

* Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
* Major medical disorders (such as cancer, AIDS)
* Psychotic disorders
* Intellectual disabilities
* Developmental disorders
* Active substance use disorders
* Pregnancy or probably pregnancy
* Body mass index greater than or equal to 35
* Daily cannabis use
* History of any cardiac disease
* Inability to provide informed consent
* Physical disabilities that prohibit task performance (such as deafness or blindness)
* Self-reported history of loss of consciousness (greater than 30 minutes)

Primary outcomes:
measure: Change in participant heart rate
timeFrame: 24 hours (visit 2), 48 hours (visit 3)
measure: Change in participant subjective emotional ratings
timeFrame: 24 hours (visit 2), 48 hours (visit 3)
measure: Change in participant electrodermal response
timeFrame: 24 hours (visit 2), 48 hours (visit 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Thomas G Adams Jr, PhD
role: PRINCIPAL_INVESTIGATOR
References: