louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02239328: A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer
Official title: A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Esophageal Cancer
Keywords: Lung cancer
esophageal cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Alliance for Clinical Trials in Oncology
name: Patient-Centered Outcomes Research Institute
First posted: 2014-09-12
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer Esophageal cancer

Brief summary: This survey study is looking to determine if patient reported outcomes(using the PROMIS survey) will vary according to the presence of recurrent or metastatic lung or esophageal cancer.

Detailed description: A patient-centered approach to lung cancer surveillance following resection needs to incorporate patient reported outcomes. The Patient Reported Outcomes Measurement Information System (PROMIS®) was designed to revolutionize the assessment of patient reported outcomes by establishing a national resource for the measurement of patient-reported symptoms and other health outcomes.

The PROMIS Assessment Center, the management tool within the larger PROMIS system, will be used to securely store de identified data, provide automated accrual reports and data export for this specific study. This study will have it's own study specific website.

Patients seen at the University of Virginia Cancer Center will be identified and invited to participate in an assessment of their reported outcomes over multiple domains available in PROMIS. Collecting this information on lung cancer survivors may provide a robust platform to design a patient-centered surveillance strategy following resection.

The study team hypothesizes that patient reported outcomes will vary according to the presence of recurrence or metastasis of lung or esophageal cancer. The study team also believes including patient reported outcomes into routine post-treatment surveillance will improve patient satisfaction and improve outcomes.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Suspected or Known diagnosis of lung or esophageal cancer
* Willing and able to complete questionnaires

Exclusion Criteria:

* Subjects unwilling to provide informed consent
* Subjects unwilling or unable to answer the questionnaires

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Scores.
timeFrame: Over a 3 year period
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Benjamin Kozower, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770328: The Effects of Pentoxifylline on PAI-1 in an Obese Population
Official title: The Effects of Pentoxifylline on PAI-1 in an Obese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Plasma PAI-1 level at 0, 4, 8 weeks
Plasma hsCRP level at 0, 4, 8 weeks
Plasma TNF-a level at 0, 4, 8 weeks
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects.

Detailed description: Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.

Eligibility criteria: Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems 4. PAI-1 level ≥ 10 ng/dl

Exclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE) Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for peptic ulcer

Primary outcomes:
measure: Change in PAI-1 Level
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in CRP Level
timeFrame: Baseline and 8 weeks
measure: Change in TNF-alpha Level
timeFrame: Baseline and 8 weeks
measure: Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: James A S Muldowney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03321461: TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Official title: Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.


Eligibility criteria: Inclusion Criteria:

* Suspicious of cervical disease required a colposcopy-directed biopsy.
* Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

* Breast-feeding or pregnant.
* Ongoing participation in another clinical trial with an investigational drug with 3 months.
* Own allergy towards ICG and/or alcohol.
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases.
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency.

Primary outcomes:
measure: Sensitivity
timeFrame: 1 day
Secondary outcomes:
measure: Specificity
timeFrame: 7 days
measure: Incidence of adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical Colledge, HUST
state: Hubei
Study officials:
References:
Clinical trial NCT05606861: Mindfulness Based Interventions in Pediatric Nurses
Official title: Effect of Mindfulness Based Stres Reduction Intervention on Psychological Resilience of Child Nurses: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Keywords: Pediatric Nurse
Psychological Resilience
Mindfulness
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction Intervention on increasing the psychological resilience of pediatric nurses.

Design: This is a single-center, single-blind, randomized controlled trial

Method:

In the study, the group in which the Mindfulness-Based Stress Reduction Initiative was applied was taken as the experimental (n: 15), the unstructured group (n: 14) in which the stressful life experiences were shared as the control group. Due to the limited number of the research population (N:56), 29 nurses who agreed to participate in the study and met the inclusion criteria were included in the study without using the sampling method. This research was conducted with pediatric nurses working in the inpatient units of a children's hospital affiliated to a university in Izmir. Stress reduction training based on mindfulness, including meditation and breathing techniques, was given to the experimental group for 5 weeks. No intervention was applied to the control group.

The primary outcomes of the study were measured using the Perceived Stress Scale, the Self-Compassion Scale, the Interpersonal Reactivity Index, and Psychological Resilience Scale for Adults.

This study is important because it is the first randomized controlled study on the effect of Mindfulness Based Stress Reduction (MBSR) on resilience in nurses in our country.

In addition, the results will contribute to preventing nurses from leaving the profession in the early period, providing more flexibility and therefore safe patient care to the nursing workforce, especially in today's health system where there is a heavy nursing shortage.


Eligibility criteria: Inclusion Criteria:

* Working for at least one year in the children's ward,
* Older than 18 years of age,
* The working program must be suitable for the experiment schedule.

Exclusion Criteria:

* Clinical diagnosis for a psychiatric disorder,
* Long experience of meditation or yoga.

Primary outcomes:
measure: Perceived Stress Level
timeFrame: For 9 weeks
measure: Psychological Resilience Level
timeFrame: For 9 weeks
measure: Empathy Level
timeFrame: For 9 weeks
measure: Self Compassion Level
timeFrame: For 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital
Study officials:
References:
Clinical trial NCT01242761: Ultrasound as a Diagnostic Tool for Rotator Cuff Tears
Official title: Ultrasound as a Diagnostic Tool for Rotator Cuff Tears: Accuracy of Results From the Community Versus Results From a Hospital-based Ultrasound Service and Surgical Findings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tear
Keywords: Accuracy of diagnostic ultrasound based in community or as part of a specialist hospital-based service
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-11-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic rotator cuff tears

Brief summary: After comparing ultrasound study of rotator cuff injuries that have been evaluated both in the community and in a hospital-based ultrasound service with actual surgical findings, it is expected that specialist performed imaging and evaluation will be most accurate and that those performed in the community will be not accurate enough.


Eligibility criteria: Inclusion Criteria:

* Symptomatic rotator cuff tears Indication for rotator cuff repair

Exclusion Criteria:

* Severe arm movement limitations

Primary outcomes:
measure: Rotator cuff tear surgical findings more accurately reflect hospital-based US imaging findings
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05652361: Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
Official title: Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectum Cancer
Keywords: Robotic Surgery
Total mesorectal excision
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2022-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.


Eligibility criteria: Inclusion Criteria:

* Patients with rectal cancer scheduled for robot-assisted rectal resection
* Intact preoperative urogenital/rectal function
* Full capability of consent

Exclusion Criteria:

* Previous/Second malignant disease \<5 years before diagnosis of rectal cancer
* Previous abdominal surgery, except for appendectomy, cholecystectomy or Cesarean section

Primary outcomes:
measure: Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
timeFrame: 72 hours after Surgery
Secondary outcomes:
measure: Operating time [min]
timeFrame: During Surgery
measure: Duration of postoperative hospital stay [days]
timeFrame: At day of discharge, assessed up to 90 days
measure: Duration of postoperative intermediate/intensive care unit stay [days]
timeFrame: At day of discharge, assessed up to 90 days
measure: Assessment of pelvic function before and after rectal resection
timeFrame: 24 months
measure: Rectal sphincter function before and after rectal resection
timeFrame: 24 months
measure: Frequency of peri-operative morbidity after resection
timeFrame: 24 months
measure: Kind of peri-operative morbidity after resection
timeFrame: 24 months
measure: Assessment of usability of guidance system
timeFrame: 48 hours after surgery
measure: Assessment of the difficulty of the preparation
timeFrame: 48 hours after surgery
measure: Assessment of oncological outcomes: Frequency of Overall survival (OS)
timeFrame: 24 months
measure: Assessment of oncological outcomes: Frequency of Progression Free survival (PFS)
timeFrame: 24 months
measure: Assessment of oncological outcomes: Frequency of Loco-Regional Tumor Free Survival (LRFS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
state: Saxony
Study officials:
affiliation: University Hospital Carl Gustav Carus Dresden
name: Marius Distler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800861: Glycemic Control in Diabetic Hospitalized Patients
Official title: Glycemic Control in Diabetic Hospitalized Patients: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus
Keywords: diabetes mellitus
hyperglycemia
glycemic control
inpatient
Lead sponsor: AlFayhaa General Hospital
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic patients admitted in the hospital

Brief summary: With the advanced management of diabetes and new innovative anti-hyperglycemic therapy hyperglycemia remains a culprit factor affecting the outcome of patients admitted to the hospital in general wards. Efforts from health care providers to assess and control blood sugar by a simplified method such as certified point of care hand-sized glucometers is the fruitful protocol if the results near the target that is endorsed by well-known diabetes societies. In non-critically patients the premeal blood sugar ≤140 mg /dl and ≤ 180 mg /dl after a meal. The unstable economy and political crises with the pandemic of Covid-19 making us use a glucometer to monitor and control the fluctuation of blood sugar in order to decrease the burden on the patients and health care providers in the form of a stay in the hospital and minimize wasting laboratory resources.


Eligibility criteria: Inclusion Criteria:

* admitted to the hospital

Exclusion Criteria:

* none

Primary outcomes:
measure: glycemic control
timeFrame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
Secondary outcomes:
measure: average blood glucose value per ward
timeFrame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
measure: average per patient
timeFrame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
Other outcomes:
Locations:
city: Basra
country: Iraq
facility: AlFayhaa Teaching hospital
Study officials:
affiliation: Al-Fayhaa teaching hospital
name: AbdulSattar J Yousif, MD
role: STUDY_CHAIR
affiliation: Al-Fayhaa teaching hospital
name: Ali Hussein A Alhamza, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02328261: A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma
Official title: Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.

Detailed description: This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced NPC
* Patients must be platinum-resistant defined as recurrence or progression of disease \<6 months since previous treatment with a platinum based treatment regimen.
* Measurable disease per RECIST
* Adequate organ and marrow function
* Capable of understanding and complying with the protocol, and written informed consent

Exclusion Criteria:

* Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR
* Patients must not be receiving any other investigational agents
* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
* Women who are pregnant or breast-feeding

Primary outcomes:
measure: Disease control rate(DCR)
timeFrame: At least 8 weeks
Secondary outcomes:
measure: Progression-free survival
timeFrame: At least 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The first affliated hospital of Guangxi medical university
name: Xiaohua Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00588861: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Official title: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Hip
Traumatic Arthritis of Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.

Detailed description: The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.

Eligibility criteria: Inclusion Criteria:

* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Exclusion Criteria:

* Infection, sepsis, and osteomyelitis

Primary outcomes:
measure: Harris Hip Score
timeFrame: 10 Years Post-Operative
Secondary outcomes:
measure: Harris Hip Score Pain
timeFrame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Biomet Orthopedics, LLC
state: Indiana
Study officials:
affiliation: Zimmer Biomet
name: Ken Beres, MD
role: STUDY_DIRECTOR
References: