louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00462410: Effect of Advertisements on Treatment Compliance in Women With Breast Cancer
Official title: Socio-anthropological Study Evaluating the Impact of Observance or Treatment in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-04-19
Enrollment: 65
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in women with breast cancer.

Detailed description: OBJECTIVES:

Primary

* Evaluate the consequences of advertisement on treatment compliance in women with breast cancer.

Secondary

* Determine the factors favoring or not favoring adherence to the medical recommendations.

OUTLINE: Patients and their medical and nonmedical caregivers are interviewed by a sociologist or anthropologist twice over 1 year. The first interview is at the consultation visit and the second interview is at the patient's home. The impact of advertisement on treatment compliance is measured.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Treatment compliance
Secondary outcomes:
measure: Factors affecting adherence to the medical plan
Other outcomes:
Locations:
Study officials:
affiliation: Institut Bergonié
name: Marc Debled, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03261310: Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
Official title: Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: acetaminophen
pain
laminectomy
craniotomy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-08-25
Enrollment: 55
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: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Detailed description: The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Eligibility criteria: Inclusion Criteria:

* 18-90 years old
* undergoing non-emergent craniotomy or single level lumbar laminectomy
* must be able to rate pain on a 0-10 scale post-operatively

Exclusion Criteria:

* history of liver disease
* allergy to acetaminophen
* age less than 18 years
* renal failure with creatinine clearance less than 30
* pregnancy
* altered mentation with inability to report pain score
* patients who have received acetaminophen within 6 hours of surgery
* patients in which a neuraxial technique has been performed for surgery
* prisoners

Primary outcomes:
measure: Pain Scores
timeFrame: 1hour -6 hours
Secondary outcomes:
measure: Opioid administration
timeFrame: 1 hour-6 hours
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: BAMC
name: Dimitar Dentchev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BAMC
name: Betsy Murray, MD
role: STUDY_CHAIR
affiliation: BAMC
name: Robert Vietor, MD
role: STUDY_CHAIR
affiliation: BAMC
name: Jonathan Deeth, MD
role: STUDY_CHAIR
affiliation: BAMC
name: Daniel Stypula, DO
role: STUDY_CHAIR
References:
Clinical trial NCT05724212: Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
Official title: Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tuberculosis
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: San Raffaele Hospital wards

Brief summary: Evaluate the possibility of using an IGRA (Interferon-γ Release Assay) test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma (IFN-γ) response to the QFT-Plus test in the two tubes containing antigens and the gold standard for monitoring TB therapy (culture conversion) in patients with slide positive/culture positive and slide negative/culture positive PTB.

Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis. To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts.


Eligibility criteria: Inclusion Criteria:

1. Clinical symptoms consistent with a high probability of having PULMONARY TB disease (probable case), such that they are receiving or are likely to receive ther-apy for active PTB (therapy must not have been initiated for more than 72 hours before recruitment into the study).
2. Positive sputum smear for AAR
3. Positive culture for mycobacterium tuberculosis (confirmed PTB case).
4. Positive nucleic acid amplification (NAA) test for mycobacterium tuberculosis.

Exclusion Criteria:

1. Taken therapy for active tuberculosis or latent TB infection for more than 72 hours.
2. Culture confirmation of M. tuberculosis not obtained.
3. Age less than 18 years.
4. Immunosuppression: HIV-infection, solid organ transplantation, stem cell transplantation, rheumatoid arthritis.

Primary outcomes:
measure: Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment
timeFrame: 1. At time of diagnosis (t0) 2. 30+ 4 days after anti-TB treatment initiation (t1) 3. 2 months after anti-TB treatment initiation (t2) 4. At the end of the anti-TB therapy (6 to 9 months) (t3)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute Via Olgettina 60 20132 Milan Italy
name: Daniela M Cirillo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06488612: Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting
Official title: Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting: A Prospective Half-side Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts
Keywords: Split- thickness Skin grafting
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration.

There is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity.

Small portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance

Detailed description: The aim of this study is to compare the duration of wound healing, scar quality and cosmetic results of donor sites after split-thickness skin grafting with and without the use of residual graft pieces as minced skin grafts.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing split-thickness skin grafting, between 12 - 60 years of age.

Exclusion Criteria:

* Patients under the age of 12 years or above 60 years.
* Patients with a known tendency for hypertrophic scarring/keloids
* Pregnancy
* Co-morbid factors such as uncontrolled diabetes, ischemic heart disease, renal failure or Collagen vascular disease.

Primary outcomes:
measure: Scar quality
timeFrame: Follow up at 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Plastic surgery department, Faculty of medicine, Sohag university
Study officials:
References:
Clinical trial NCT03921112: Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients
Official title: Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients :Prospective , Randomized Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care (ICU)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to demonstrate the role of lung ultrasound in weaning from mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest X-ray , ABG, rapid shallow breathing index, ventilator parameters.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients
* ASAI ,ASAII, ASAIII

Exclusion Criteria:

* Patients or gurdians refuse
* Patients with pneumthorax
* Patients with pleural effusion
* Patients with surgical emphysema
* Glasco coma score more than 8
* Patients on high inotropic support
* patients with diaphragmatic paralysis

Primary outcomes:
measure: success of weaning
timeFrame: success of weaning for 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
affiliation: Ain Shams University
name: Amin m Alansary
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05204212: Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Official title: Prospective, Randomized, Controlled, Unblinded, International, Multicentre, Parallel Two Group Trial of Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 430
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: In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and/or Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.

Detailed description: The purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) and end-stage renal failure.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Ability to give informed consent
* Documented NVAF (paroxysmal, persistent, or permanent)
* CHA2DS2VASc risk score ≥2
* Chronic kidney disease KDOQI stage 5 (eGFR \<15 ml/min/1.73m2) with or without hemodialysis

Exclusion Criteria:

* Absolute contraindication to aspirin and/or clopidogrel
* Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
* Present LAA thrombus
* Mobile aortic atheroma
* Age ≤18 years
* Patients presenting with pregnancy
* Patients without informed consent
* Participation in another trial
* Expected life expectancy \<2 years

Primary outcomes:
measure: "Net clinical benefit"
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universität zu Lübeck
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT02914912: Investigation of Chronic Intestinal Ischemia
Official title: Investigation of Chronic Intestinal Ischemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Mesenteric Ischemia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome and confirmed with CTA, duplex ultrasound, and clinical examination shall be included in the study. The included patients are referred to the Department of Vascular Surgery for investigation and treatment of the CMI and MALS.

Brief summary: Patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser Doppler flowmeter and visible light spectroscopy.

Detailed description: Patients with suspected chronic mesenteric ischemia (included median arcuate ligament syndrome/truncus coeliacus compression syndrome) referred to the vascular surgery department for investigation of splanchnic and mesenteric circulation shall be included in this study.

In addition to CT angiography, patients shall be investigated

1. with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS) before and after the surgical or endovascular treatment
2. Endoscopic ultrasound before and after the surgical or endovascular treatment
3. Transserosal laser Doppler flowmetry and light spectroscopy during the surgical treatment
4. Plasma Ischemia bio-markers, before and after the surgical or endovascular treatment
5. Health related quality of life assessed with EQ5D and SF36 before and after the treatment
6. clinical outcomes of the treatment (early and late results).

Eligibility criteria: Inclusion Criteria:

Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome

Exclusion Criteria:

Patients unable to go through gastroscopy

Primary outcomes:
measure: Transmucosal Oxygen concentration of the stomach and duodenum
timeFrame: Baseline, 3 months and 12 months
Secondary outcomes:
measure: Ischemia biomarkers
timeFrame: 10 years
measure: Health-related quality of life in the patients with chronic mesenteric ischemia
timeFrame: 10 years
measure: Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia
timeFrame: 10 years
measure: Transserosal microcirculation assessment
timeFrame: 10 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Department of vascular surgery, Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Syed Sajid Hussain Kazmi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380912: Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
Official title: Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
mastectomy
methylprednisoloneacetate
seroma
numbers of punctures
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2011-06-27
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated for primary breast cancer with mastectomy and eihter axillary dissection or Sentinel Node operation

Brief summary: A randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.

Detailed description: After mastectomy, up to 90 % of patients develops seroma in the cavity. The treatment is puncture, which is a small operation, but many patients have to come several times, and there is a risk of infection. In some cases further treatment can be postponed.

Preventing seroma to develop would be an improvement in the treatment of breast cancer patients operated with mastectomy.

An earlier study found that the seroma production was significant lower in the group who had Prednison injected directly into the cavity.

In this study the patient are divided into two groups: patients who have mastectomy and axillary dissection and patients who have mastectomy and Sentinel Node operation. Each group are examined separately.

Using Prednison in patients after operation could be a potential risk, but correct injection into the cavity will seldom give systemic side effects.

Eligibility criteria: Inclusion Criteria:

* women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either Sentinel Node or Axillary dissection, signed consent form

Exclusion Criteria:

* dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if the patient don't speak danish, allergy towards steroid, other medical conditions which the investigator find contradict participating

Primary outcomes:
measure: number of punctures
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Chemistry Laboratorium, Copenhagen University Hospital at Gentofte
city: Herlev
country: Denmark
facility: Department of Breast Surgery, Copenhagen University Hospital at Herlev
Study officials:
name: Gro M Qvamme, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03541512: Remote Mindfulness Education PLV
Official title: Remote Mindfulness-Education Intervention for Women with Provoked Localized Vulvodynia: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Provoked Localized Vulvodynia
Keywords: Mindfulness therapy
Vulvodynia
Vulvar pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study designed to learn more about the use of an online remote education and mindfulness practice program for the pain and anxiety associated with provoked localized vulvodynia.

Detailed description: The purpose of study is to evaluate the effectiveness of a remotely delivered mindfulness intervention combined with education for the treatment of the pain and distress associated with Provoked Localized Vulvodynia (PLV). Women with PLV will be randomized to either an app- based mindfulness program (Headspace®) with online education or online education only. Pain and sexual distress with be evaluated through a number of measures. The primary outcome of the study will be the change in distress relating to sexual activity over the 8-week intervention period, which will be measured by a change (reduction) in the Female Sexual Distress Scale (FSDS). Participants will additionally perform a weekly Tampon Test and fill out a weekly survey regarding their perceived pain as well as the frequency of use and completion of the weekly education materials

Eligibility criteria: Inclusion Criteria:

* Reported dyspareunia for at least 3 months in non-pregnant, healthy women over aged 18 years old and estrogen replete with confirmed diagnosis of provoked localized vulvodynia (PVL) or positive Q-tip test, meeting Friedrich's criteria for PLV.
* Ability to insert a regular Tampax® tampon
* Phone access
* Cellular phone with ability to download applications
* Reliable Internet Access

Exclusion Criteria:

* Pregnancy
* Active sexual counseling or mindfulness training (within 6 months of study)
* Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc).
* Unable or unwilling to complete baseline assessments or agree to be randomized.
* Non-English speaking, as Headspace® is not validated in other languages
* Actively engaged in a meditative practice

Primary outcomes:
measure: Change in Female Sexual Distress Scale (FSDS) at 8 weeks
timeFrame: Baseline & 8 weeks
Secondary outcomes:
measure: Change in Tampon Test Pain Scores at 8 weeks
timeFrame: Baseline & 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Catherine Leclair, MD
role: PRINCIPAL_INVESTIGATOR
References: