louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02545374: Medico-economic Evaluation of a Project of Wounds by a Remote Network
Official title: Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resident of Languedoc-roussillon
Carrying a Chronic Wound
Keywords: chronic wound
tablet
telemedicine
wounds consultation
Smartphone
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).


Eligibility criteria: Inclusion Criteria:

* Being adult
* Taken up residence on the Languedoc-Roussillon
* Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
* Informed consent signed,
* Patient member of the Security Social
* Patient having a visiting nurse.

Exclusion Criteria:

* Patient in vital or functional emergency situation during the first call or during the consultation
* Tumoral wound
* dialysis patient
* Arteritis of stage 4 and not revascularizable
* Absence of regular doctor and visiting nurse
* patient refusal
* Refusal of one of the health professionals participating in the pathology care
* Anybody incapable to communicate and to answer the questions
* Pregnant or nursing woman
* Subject deprived of freedom by court or administrative order
* Major subject protected by the law
* For the patients in telemedicine: refusal of the collaboration agreement

Primary outcomes:
measure: Rate of healed chronic wounds during a telemedicine care
timeFrame: Six months after inclusion
measure: Rate of healed chronic wounds during a usual medical care
timeFrame: Six months after inclusion
Secondary outcomes:
measure: Result to the questionnaire on the quality of life: EQ-5D
timeFrame: Six months after inclusion
measure: A measure of the costs of the management of the disease
timeFrame: Seven months after the inclusion of the last patient
measure: A measure of the costs of the intervention assessed
timeFrame: Seven months after the inclusion of the last patient
measure: The total healing time
timeFrame: Six months after inclusion
measure: The decrease in centimeters of the wound surface to 6 months
timeFrame: Six months after inclusion
measure: The response time between making an appointment and support
timeFrame: Six months after inclusion
measure: The mortality rate within 6 months
timeFrame: Six months after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Wound healing Department
Study officials:
References:
Clinical trial NCT01730274: Cerebellum - Cognitive Outcome and Functional Connectivity
Official title: Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cerebellar Tumor
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 31
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: young adolescent operated on a cerebellar tumor as a child

Brief summary: Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional connectivity level in higher order cognition networks known to interact with the cerebellum. Furthermore, to correlate the connectivity level of these networks with the neuropsychological performance and functional outcome of the patients.

The investigator's hypothesis is that the functional connectivity of various cognition networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging can be impaired after cerebellar tumor surgery and can be correlated with the neuropsychological performance. The effect of surgery on the cognition networks and the neuropsychological performance is dependent on the tumor location within the cerebellum. Such a correlation seems feasible as functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders. Furthermore, investigators were able to depict the maturation of the functional connectivity networks in parallel to the neurocognitive development in childhood


Eligibility criteria: Inclusion Criteria:

* • Male or female patients aged \> 15 yrs

  * Age at surgery between 1 yrs - 12 yrs
  * Compliance (the patients have to be able to lay motionless in a 3 Tesla MR scanner and to cooperate with the examiner during the examination)
  * Signed informed consent from the patient and/or the parents

Exclusion Criteria:

* • Patients with Neurofibromatosis 1

  * Severe visual or auditory impairment
  * Cerebrospinal fluid shunt device
  * Prior radiotherapy or chemotherapy
  * Contraindications to MRI

Primary outcomes:
measure: neuropsychological assessment
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: MUV, Department of Neurosurgery
Study officials:
affiliation: MUV, Department of Neurosurgery
name: Christian Dorfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06696274: Kinesiophobia, Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
Official title: Investigation of the Relationship Between Kinesiophobia and Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemodialysis
End Stage Renal Disease (ESRD)
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage renal disease receiving hemodialysis will be enrolled in the study.

Brief summary: The aim of our study was to investigate the relationship between kinesiophobia and pain, balance, physical performance, quality of life and mental status in patients receiving hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Patients with end stage renal disease receiving hemodialysis
* Receiving hemodialysis for more than 3 months
* Being clinically stable
* Volunteering to participate in this stud

Exclusion Criteria:

-Having musculoskeletal disorders that may affect physical performance

Primary outcomes:
measure: Kinesiophobia
timeFrame: Day 1
measure: Pain
timeFrame: Day 1
measure: Balance
timeFrame: Day 1
measure: Physical performance
timeFrame: Day 1
Secondary outcomes:
measure: Quality of life
timeFrame: Day 1
measure: Mental health
timeFrame: Day 1
measure: Comorbidity level
timeFrame: Day 1
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Yusuf Topal
role: STUDY_CHAIR
affiliation: Kirsehir Ahi Evran University
name: Aydin Guclu
role: STUDY_CHAIR
References:
Clinical trial NCT01530074: Quantitative Sensory Testing of the Lower Lip After Inferior Alveolar Nerve Block, and Evaluation of the Role of the Contra-lateral Inferior Alveolar Nerve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Mandibular nerve
Mental nerve
Mandibular incisive nerve
Local anesthesia
None, only healthy subjects will be enrolled in this study
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the contribution of the innervation of the contra-lateral mandibular nerve for the innervation of the lower lip area.

The investigators hypothesis is that the sensation of the lower lip is contributed by both mandibular nerves (from both sides of the jaw).


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with no systemic diseases, chronic medication, past nerve injury, or sensory complaint.

Exclusion Criteria:

* Hypersensitivity/allergy to local anesthetic materials
* Systemic diseases, Chronic medication
* Past nerve injury
* Congenital or acquired deformity in the lower jaw
* Past fractures/neoplasm of the lower jaw
* Past surgery to the lower lip

Primary outcomes:
measure: Quantitative sensory test
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03411174: Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
Official title: Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
hypofractionated partial breast irradiation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 220
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Detailed description: A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Eligibility criteria: Inclusion Criteria:

* Female
* Age≥ 50 years
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Negative surgical margins
* Pathologically confirmed invasive breast cancer
* A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
* Tumor bed is labeled with Titanium clips
* Received adjuvant hormonal treatment
* No adjuvant chemotherapy
* ECOG:0-1
* Written informed consent.

Exclusion Criteria:

* Age\<50 years
* KPS\<70
* Treated with neoadjuvant chemotherapy
* Treated or being treated with chemotherapy
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing

Primary outcomes:
measure: The change of breast cosmetic outcome
timeFrame: Baseline, and three years after the completion of radiation therapy
Secondary outcomes:
measure: Acute radiation-induced toxicity assessed by CTCAE v4.0
timeFrame: 3weeks, 5weeks,1 and 3 months after treatment beginning
measure: Late complications
timeFrame: 3 years
measure: Ipsilateral breast tumor recurrence rate
timeFrame: 5 years
measure: Local-regional recurrence
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jinli Ma, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815074: Military Women's Health and Illness Behaviors in Deployed Settings
Official title: Military Women's Health and Illness Behaviors in Deployed Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genitourinary Symptoms
Keywords: Military Women
Women's Health
Genitourinary Symptoms
Illness Behaviors
To determine how women manage genitourinary symptoms while deployed.
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2008-12-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 50 military women.

Brief summary: The purpose of this study is to gain better understanding of how recently deployed military women managed urinary and vaginal symptoms while deployed. Participants in this study will be asked to take part in a 45-60 minute interview.


Eligibility criteria: Inclusion Criteria:

* Deployment within the last 12 months
* Managed genitourinary symptoms while deployed (does not have to be diagnosed by a medical provider)

Exclusion Criteria:

* Women who are assigned to a medical group/hospital

Primary outcomes:
measure: Description of deployed experience using qualitative methods
timeFrame: 2008 to 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: CR Darnall Army Medical Center
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
References:
citation: Wilson C, Corrigan R, Braun L. Deployed women's illness behaviors while managing genitourinary symptoms: An exploratory theoretical synthesis of two qualitative studies. Nurs Outlook. 2017 Sep-Oct;65(5S):S17-S25. doi: 10.1016/j.outlook.2017.07.009. Epub 2017 Jul 15.
citation: Wilson C, Nelson JP. Exploring the patterns, practices, and experiences of military women who managed genitourinary symptoms in deployed settings. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):293-302. doi: 10.1111/j.1552-6909.2012.01347.x.
Clinical trial NCT01744574: Sex Differences, Hormones & Smoking Cessation
Official title: Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Cessation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-12-06
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.

Detailed description: Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).

Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Male 18 to 60 years old
* Female 18 to 50 years old
* Self-report regular smoking
* Motivated to quit smoking
* In stable physical/mental health
* Self report of regular menstrual cycles (female only)
* English fluency
* Understand the study procedures and able to provide informed consent
* Ability to participate fully in research elements for the duration of the trial.

Exclusion Criteria:

* Current or recent (\< 3 months) breastfeeding (females only)
* Current or planned pregnancy within the next three months (females only)
* Conditions contraindicated to progesterone treatment.

Primary outcomes:
measure: Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12
timeFrame: Weeks 8 and 12
measure: Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Number of Participants With Continuous Abstinence From Smoking at Week 12
timeFrame: Week 12
measure: Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Average Number of Days to Relapse
timeFrame: Days 1 through 84
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Delaware Clinical Research Unit, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Sharon S. Allen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06185374: Text Messaging to Improve Adherence To Repeat Colonoscopy In a Veterans Affairs (VA) Hospital
Official title: Text Messaging to Improve Adherence To Repeat Colonoscopy In The VA: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Colorectal cancer is a common but preventable condition, and increasing colorectal cancer screening is one of the most impactful public health contributions in the field of gastroenterology. Text messaging is a simple, cheap, and rapid method to reach patients that may improve adherence to colonoscopy appointments as well as simplify the process of bowel preparation. The purpose of the study is to evaluate the feasibility of a pilot bidirectional text messaging intervention on attendance for screening/surveillance colonoscopy and bowel preparation quality at an urban VA hospital. The goal is to improve adherence to colonoscopy among patients who are due for a repeat colonoscopy.


Eligibility criteria: Inclusion Criteria:

• Has previously undergone a colonoscopy and is currently due for a repeat screening or surveillance colonoscopy at the VA.

Exclusion Criteria:

* Patients not due for screening or surveillance colonoscopy. This will be based on 2020 guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer.
* Patients with personal history of colorectal cancer (CRC)/inflammatory bowel disease/ hereditary colon cancer syndrome or family history of hereditary colon cancer syndrome. These criteria will be determined based on ICD9/10 codes or the medical record.

Primary outcomes:
measure: National Annie Colonoscopy Survey Score
timeFrame: Day 21 (Up to 7 Days Post-Procedure)
Secondary outcomes:
measure: Percentage of Participants who Attend Scheduled Colonoscopy Appointment
timeFrame: Up to Day 14
measure: Percentage of Participants who Had Adequate Bowel Preparation at Colonoscopy Appointment
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Harbor Health Care System - Department of Veterans Affairs
state: New York
Study officials:
affiliation: NYU Langone Health
name: Peter Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05029674: Understanding Performance: Enhancing Recovery as Surgeons
Official title: Use of Biometric Data to Understand Surgeon Performance, Strain, and Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Professional
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 66
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: Surgical trainees and attendings at Stanford Health Care

Brief summary: Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors can maximize recovery and performance.

Detailed description: Participants will be asked to wear a biometric sensor for six months. The biometric sensor, namely, 'The Whoop strap' collects heart rate and heart rate variability data.

Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, exercise and mindfulness, and surgical performance as well as video and audio recordings during a simulated surgical task.

Surveys will be individually numbered and a master list of subject number and video, audio, and sensor ID will be kept in a separate location. This practice will enable us to better understand survey feedback by reviewing relevant videos, images, and sensor recordings. Images and data associated with a subject will be labeled with the subject number only.

Eligibility criteria: Inclusion Criteria:

* Study participants will include trainee and attending surgeons

Exclusion Criteria:

* Exclusion criteria will be anyone who is not full-time clinically active as a surgical trainee or attending

Primary outcomes:
measure: Surgeon Recovery
timeFrame: 6-12 months
Secondary outcomes:
measure: Clinical Strain
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References: