louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01441739: Intestinal Failure in Necrotising Enterocolitis
Official title: Intestinal Failure in Necrotising Enterocolitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Enterocolitis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with abdominal signs suspected of NEC All neonates admitted to the NICU of the Maastricht University Medical Center between July 2007 and July 2008

Brief summary: Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis.

The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.


Eligibility criteria: Inclusion Criteria:

* Neonates with abdominal signs suspected of NEC
* All neonates admitted to the NICU of the Maastricht University Medical Center between July 2007 and July 2008

Exclusion Criteria:

* No written informed consent of both parents

Primary outcomes:
measure: Urinary I-FABP
timeFrame: Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
Clinical trial NCT02865239: Feasibility Study of Breast MRI in Decubitus Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Imaging, Three-Dimensional
Magnetic Resonance Imaging/methods*
Breast Neoplasms/diagnosis*
Prone Position
Prospective Studies
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 15
Sex: FEMALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position.

Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.


Eligibility criteria: Inclusion Criteria:

* Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma
* Assessment on 3.0 Tesla in Magnetic Resonance Imaging
* Age \>18 years old
* ECOG performance status ≤ 3
* Ability to provide written informed consent form

Exclusion Criteria:

* Age \< 18 years old
* Claustrophobia
* Contraindication to the injection of contrast medium Gadoline
* Contraindication to MRI
* Persons deprived of liberty or under supervision

Primary outcomes:
measure: Percentage of lesions where the topography is discordant between the positions (prone and supine).
timeFrame: 1 day
Secondary outcomes:
measure: Comfort patient in supine position compared to the prone position using a self-administered questionnaire
timeFrame: 1 day
measure: distance from the anterior border of the lesion to the nipple in supine position compared to the prone position
timeFrame: 1 day
measure: distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position
timeFrame: 1 day
measure: distance from lesion to pectoralis major muscle in supine position compared to the prone position
timeFrame: 1 day
measure: Quandrant of the lesions and positions on a clock in supine position compared to the prone position
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: OLDRINI GUILLAUME, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552639: Evaluation of Compulsive Exercise Group Therapy for Eating Disorders
Official title: A Randomized Control Trial Study Evaluating a Compulsive Exercise Group for Adolescent Inpatients With Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders in Adolescence
Lead sponsor: Newbridge House
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial.


Eligibility criteria: Inclusion Criteria:

* Inpatients at Newbridge House
* Aged 11-18
* Primary diagnosis of any form of eating disorder
* Females

Exclusion Criteria:

* Previously received NEAT group at Newbridge House
* Aged under 10 years
* Severe learning disability
* Inpatients without compulsive exercise behaviours
* Day patients
* Co-morbid psychosis
* Males

Primary outcomes:
measure: Change in Compulsive Exercise Test
timeFrame: Week 1 and week 7
Secondary outcomes:
measure: Change in Eating Disorder Examination Questionnaire
timeFrame: Week 1 and week 7
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Newbridge House
Study officials:
References:
Clinical trial NCT06488339: Food Replacement on Weight Control in Overweight Volunteers
Official title: Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Weight Gain
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Mae Fah Luang University
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* Body mass index more than 23 kg/m2
* No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
* Wiling to attend the study

Exclusion Criteria:

* Allergic to protein, grains, guar gum
* Take medicine, supplement, herbal substance for weight control within 1 month
* During intermittent fasting
* Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs
* Cushing syndrome's
* Pregnancy and lactation

Primary outcomes:
measure: Weight
timeFrame: 8 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: 8 weeks
measure: Percentage of body fat
timeFrame: 8 weeks
measure: Percentage of visceral fat
timeFrame: 8 weeks
measure: Percentage of subcutaneous fat
timeFrame: 8 weeks
measure: Percentage of muscle
timeFrame: 8 weeks
measure: Waist Circumference
timeFrame: 8 weeks
measure: Hip Circumference
timeFrame: 8 weeks
measure: Skin fold thickness
timeFrame: 8 weeks
measure: Total cholesterol
timeFrame: 8 weeks
measure: Low density lipoprotein
timeFrame: 8 weeks
measure: High density lipoprotein
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: Fasting blood sugar
timeFrame: 8 weeks
measure: Hemoglobin A1C
timeFrame: 8 weeks
measure: Total protein
timeFrame: 8 weeks
measure: Hemoglobin
timeFrame: 8 weeks
measure: SIRT1 (NAD-dependent deacetylase sirtuin-1)
timeFrame: 8 weeks
measure: 8-hydroxy-2-deoxyguanosine
timeFrame: 8 weeks
measure: Blood urea nitrogen
timeFrame: 8 weeks
measure: Creatinine
timeFrame: 8 weeks
measure: Aspartate transaminase
timeFrame: 8 weeks
measure: Alanine aminotransferase
timeFrame: 8 weeks
measure: Alkaline phosphatase
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03742739: Predictive Value of Intraoperative Ventilatory Leak Flow in Prolonged Alveolar Air Leak After Lung Resection Surgery
Official title: Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pronlongated Alveolar Air Leak (PAAL)
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 300
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: All consecutive patients scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy (including pulmonary wedge resection, segmentectomy, lobectomy, bilobectomy, pneumonectomy).

Brief summary: After lung resection surgery, patients usually receive a postoperative pleural drain. Prolongated alveolar air leak (PAAL) is a frequent complication after lung surgery (6 to 26% of patients), defined by the European Society of Thoracic Surgeons (ESTS) as a duration of drainage greater than or equal to five days. PAAL is most often due to prolongated bubbling of the drain. Prolonged drainage is a leading cause of prolongated hospital stay, increasing care costs.

The risk of prolongated drainage can not be predicted with sufficient accuracy. Existing risk scores for PAAL do not take into account the intraoperative ventilatory leakage (IVL). IVL is a parameter displayed on the ventilator (anaesthetic machine that make the patient breathing during surgical procedure). There is new evidences suggesting that IVL could predict the risk of PAAL after lung resection surgery, but these data have to be supplemented by a well conducted prospective study.


Eligibility criteria: Inclusion criteria:

* To be 18 years old or older
* To be of French nationality or native from an European country affiliated to the French health care system
* To be scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy in the center of the study

Exclusion criteria:

* Patient minor, or major under legal protection, or enable to give consent
* Refusal or consent withdrawal
* No pulmonary resection or no pleural drain at the end of the surgical procedure (decided by the surgical team)
* Postoperative pleural fistula

Primary outcomes:
measure: PAAL after pulmonary resection surgery
timeFrame: 5 days after operation
Secondary outcomes:
measure: clinical features
timeFrame: up to 28 days after the pulmonary resection surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesie Reanimation
Study officials:
affiliation: University Hospital, Montpellier
name: Pierre SENTENAC, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493839: A Reverification of the Berlin Definition Plateau Criteria in Golmud
Official title: A Reverification of the Berlin Definition Plateau Criteria in Golmud
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ards
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg \< PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg \< PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg).

Brief summary: This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg \< PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg \< PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time observed respectively.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria of ARDS

Exclusion Criteria:

* length of stay in hospital less than 48h Data missing younger than 18 years or older than 80 years

Primary outcomes:
measure: ICU mortality
timeFrame: up to 24 weeks
measure: 28-days mortality rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Ventilator Free time
timeFrame: up to 24 weeks
measure: Ventilator time
timeFrame: up to 24 weeks
measure: Hospital length of stay
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01526239: Reminding Patients of the Important of Colorectal Cancer Screening Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
Official title: Patient-Reminder Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Colorectal cancer screening
colon cancer screening
colonoscopy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 274
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Colorectal cancer is the third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been dropping as a result of screening and early detection of cancer. In 2007, ACS reported that early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could be prevented each year if eligible patients received screening when necessary. However, despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible US patients are currently being screened.

Specific Aims

The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening. The following three areas will be investigated during this research:

1. To determine whether a communication tool provided to patients will initiate a conversation with their primary care physicians about CRC screening, especially via colonoscopy.
2. To determine whether this tool will impact referral patterns for screening, especially, although not primarily, among poor and underserved populations.
3. To determine whether differences exist in regard to patient-physician communication patterns about screening among residents and faculties in the fields of internal medicine and family practice clinics.

At the close of the investigators study, the investigators wish to organize quantifiable data demonstrating how patient-initiated prompting of primary care physicians for CRC screening increases early detection and decreases potential mortality from colorectal cancer. This data will inform a second, larger study to pursue the questions surrounding patient-initiated prompting in


Eligibility criteria: Inclusion Criteria:

* All patient age older than 50, exception for African American age 45 and older

Primary outcomes:
measure: Communication with primary care physicians about CRC screening
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma city
country: United States
facility: OUHSC HSC, GI department
state: Oklahoma
Study officials:
References:
Clinical trial NCT04440839: Implementation of Telemedicine for Patient With Lower Extremity Wounds
Official title: Implementation of Telemedicine for Patient With Lower Extremity Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Artery Disease
Peripheral Vascular Diseases
Diabetic Foot
Diabetic Foot Ulcer
Diabetic Foot Infection
Diabetic Peripheral Neuropathy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients identified as having a lower extremity wound with peripheral artery disease or diabetes mellitus are offered a telemedicine consult. Patients are then followed for time to consultation, time to revascularization if needed, and time to wound healing.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.

Detailed description: This is a clustered trial where patients identified as having lower extremity ulcers with peripheral artery disease and diabetes are given the option to be seen by specialty care providers through telemedicine vs. normal standard in person referral. The study is being conducted in rural areas where there are no in person vascular surgery providers. The aim of the study is to determine if patient activation affects likelihood to use telemedicine and if use of telemedicine can expedite speciality care.

Eligibility criteria: Inclusion Criteria:

* Patient with the diagnosis of a lower extremity ulcer that has been present for longer than 2 weeks
* Must be willing to complete the patient activation survey
* Must be willing to have the study personnel call them to check in on their status

Exclusion Criteria:

* Patients that do not have a telephone

Primary outcomes:
measure: Specialty Consultation
timeFrame: up to 365 days
Secondary outcomes:
measure: Revascularization
timeFrame: up to 365 days
measure: Hospitalizations
timeFrame: up to 365 days
measure: Emergency room visits
timeFrame: up to 365 days
measure: Wound healing
timeFrame: up to 365 days
measure: Amputation
timeFrame: up to 365 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Misty D. Humphries
state: California
Study officials:
affiliation: University of California, Davis
name: Misty D Humphries
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04040439: Precedex Special Investigation (in Pediatric Patients)
Official title: Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation
Keywords: Precedex;
Dexmedetomidine Hydrochloride;
Sedation;
intensive care;
pediatric
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Maruishi Pharmaceutical
First posted: 2019-07-31
Enrollment: 111
Sex: ALL
Minimum age (years): 45
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting"

Brief summary: Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

Detailed description: To assess the data, including safety profile, of Precedex Intravenous Solution administered for "sedation during and after mechanical ventilation in the intensive care setting" in pediatric patients under actual medical practice in Japan.

Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting.

Exclusion Criteria:

* No exclusion criteria is set out in this study.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest).
Secondary outcomes:
measure: Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
timeFrame: At the end of administration of Precedex (up to Month 33, at the longest)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Japan Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: