louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03192605: The Effect of Wild Blueberry Consumption on Glucose Regulation in Healthy Adults
Official title: The Effect of Wild Blueberry Consumption on Diabetes: Evaluation of Glucose Regulation, Gastrointestinal Hormones and Satiety in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Prince Edward Island
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of the study is to determine how wild blueberry consumption affects glucose regulation, gastrointestinal hormones and satiety in healthy adults.

Detailed description: Healthy men and women (ages 21 - 65 years) were recruited to take part in a randomized, placebo controlled crossover design study. Subjects were screened to determine their health status (e.g. height, weight, body mass index, blood pressure and medical history). Subjects were randomly assigned to a sequence of two treatments with two study periods. The treatments are frozen wild blueberries and a placebo developed to match calories and fiber of the frozen wild blueberries. The subjects were asked to avoid high polyphenol foods in their typical diet for 7 days and consume one of the two treatments as a dietary intervention. After the seventh day subjects consumed a test meal along with either the wild blueberry or placebo. Blood was collected to determine glucose and satiety hormone levels.

Eligibility criteria: Inclusion Criteria:

* Male or female

Exclusion Criteria:

* BMI \< 20 and \> 30 kg/m²
* Pregnant women or women who plan on becoming pregnant during the study
* Postpartum women
* Lactating women
* Diabetes Mellitus
* Kidney disease
* Liver disease
* GI Disease
* Certain cancers
* Smokers
* Blueberry allergies

Primary outcomes:
measure: Glucose (mmol/L)
timeFrame: Change from baseline 0 hours and 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottetown
country: Canada
facility: University of Prince Edward Island, Health Sciences
state: Prince Edward Island
Study officials:
affiliation: University of Prince Edward Island
name: Katherine Gottschall-Pass, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108105: Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
Official title: Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy Stoma
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old
* Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
* Patient having a colostomy for at least 1 month
* Patient using a flat ostomy appliance
* Patient having a stoma protusion smaller than or equal to 1.5 cm
* Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
* Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* Patient agreeing to test the new appliance during the evaluation phase (14±3 days)
* Patient covered by social security

Exclusion Criteria:

* Patient experiencing repeated leakages with the usual pouching system
* Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
* Patient already participating in another clinical study or who have previously participated in this investigation
* Pregnant or breast-feeding woman

Primary outcomes:
measure: Description of efficacy in terms of stool collection and leakage prevention
timeFrame: At least 1 time per day during 14±3 days
measure: Description of efficacy in terms of stool collection and leakage prevention
timeFrame: At least 1 time per day during 14±3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: Elie CHOUILLARD
Study officials:
References:
Clinical trial NCT02272205: Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time
Official title: Evaluation of the Effect of a Conventional Antibiotic Prophylaxis on the Positivity of Intraoperative Bacteriological Samples During a Change of Hip or Knee Infected at a Time
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Hip Replacement
Keywords: Hip replacement
Knee replacement
Knee infection
Hip infection
Antibiotic prophylaxis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.

Brief summary: Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time.

Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. It must be conventionally administered before the surgical incision. In response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. This attitude, however, is not formally validated by the scientific literature. In contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. Our multidisciplinary team opted for a few months for this new strategy. We wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.


Eligibility criteria: Inclusion Criteria:

* patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.

Exclusion Criteria:

* patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.

Primary outcomes:
measure: concordance of pre-and intraoperative bacteriological documentation
timeFrame: preoperative; intraoperative
Secondary outcomes:
measure: rates to relapse of the initial infection or a new infection
timeFrame: preoperative; intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04432805: Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
Official title: Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnant Women Suspected of COVID-19
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cohort prospective study.

Objectives :

Primary objective:

To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19

Secondary objectives:

* To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions
* To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women
* To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19
* To describe the pregnancy issues of the study population

Course of the study:

* Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol
* Performing of lung ultrasound at bedside in labor ward or in COVID unit

Primary outcome:

Lung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Gestational age greater than or equal to 22 weeks of gestation
* Pregnant women suspected of COVID-19 :
* already having a nasopharyngeal RT-PCR for the SARS-CoV-2
* AND having a chest CT-scan or waiting for this exam
* Women giving a writing consent to participate

Exclusion Criteria:

* Women giving an opposition to participate
* Women not enough fluent in French to benefit from clear and intelligible information

Primary outcomes:
measure: Description of the lesions
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05591105: The Postoperative Lidocaine and Ketamine Effects on Morphine Requirement in Bariatric Surgery
Official title: Post-operative Morphine Consumption in Obese Patients Undergoing Laparoscopic Bariatric Surgery Following Ketamina and Lidocaine Perfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacological Action
Post Operative Pain
Opioid Use
Obesity, Morbid
Anesthesia Morbidity
Lead sponsor: Tiva Group
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patient schedule to laparoscopic bariatric surgery since january 2022 until diciembre 2022 at Hospital HM Delfos Barcelona España.

Brief summary: The goal of this observational study is to evaluate the quality of postoperative analgesia in a group of obese patients schedule to bariatric surgery under TIVA Opiod-free after to receive lidocaine and ketamine perfusion. The main question it aims to answer are: How lidocaine and ketamine perfusion during recovery period does impact over morphine consumption on the following 48 hours after surgery? All participants will receive total intravenous anesthesia and, at the end of the surgery, they will be divided in two groups, group A: placebo and, group B: with postoperative lidocaine and ketamine perfusion. Our hypothesis is ketamine and lidocaine are a good alternative to decrease the use of morphine in obese patients.

Detailed description: The obese patients have more risk for certain side effects and complications with elevated risk of perioperative mortality and morbidity. An effective postoperative pain management is important to prevent pulmonary complications and, it is not recommended continuous infusions of opioids in this kind of patients, because the opioid-induced upper airway obstruction and respiratory depression are more likely to be seen in obese patients with obstructive sleep apnea. We can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine, however, it is a little know the use and benefits of lidocaine and ketamine inmediately after surgery.

Eligibility criteria: Inclusion Criteria:

* All patients between 18 y 65 years old.
* IMC \> 30 kg/m2
* ASA II/III

Exclusion Criteria:

* Patients taking high doses of opioids before operation for chronic pain
* Patients with allergies to any study medication.
* Pregnancy or breastfeeding.
* Kidney or heptic failure.
* Surgical complication

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
measure: Kind of surgery
timeFrame: During surgery
Locations:
city: Barcelona
country: Spain
facility: Carolina
Study officials:
affiliation: Tivagrooup
name: Carolina Frederico
role: PRINCIPAL_INVESTIGATOR
affiliation: Tiva Group
name: Gregory Contreras-Pérez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03231605: Comparative Immunogenicity Study of Two Hepatitis A Vaccines
Official title: Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis A
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Shaanxi Provincial Center for Disease Control and Prevention
First posted: 2017-07-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.


Eligibility criteria: Inclusion Criteria:

* The healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol.
* No Hepatitis A disease and contraindication of vaccination
* No history of Hepatitis A Vaccine
* The subjects can follow the requirements of experiment project.
* Do not vaccinate other vaccine in one months.
* Axillary's temperature≤37℃

Exclusion Criteria:

* Having severe diseases.
* Allergy to the components in Vaccine
* Immune abnormalities
* The people who do not agree with the Inclusion Criteria
* Have a serious chronic disease
* Any conditions which researcher think will influence the results or the subjects.

Primary outcomes:
measure: To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
timeFrame: 35-42 days
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 month
Other outcomes:
Locations:
city: Yuncheng
country: China
facility: Shanxi Provincial Center for Disease Control and Prevention
state: Shanxi
Study officials:
References:
Clinical trial NCT01168505: Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
Official title: The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação Faculdade de Medicina
First posted: 2010-07-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.


Eligibility criteria: Inclusion Criteria:

1. Women older than 18 years
2. Patient with operated breast cancer with indication for (NEO)adjuvant therapy
3. They must have hemoglobin levels within the normal range (\> 12g/dL), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, AST, ALT.
4. Lack of folic acid deficiency and vitamin B12
5. Able to provide written informed consent.

Exclusion Criteria:

1. Use of any oral supplement containing iron;
2. Patients who have iron overload as defined by serum ferritin\> 800 microg / L or transferrin saturation\> 40%;
3. Patients who are pregnant or breastfeeding;
4. History of active infection or active bleeding except menstruation;
5. History of HIV or hepatitis B or C - clinically important; -

Primary outcomes:
measure: Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Do Cancer Do Estado de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hospital Sirio Libanes
Study officials:
affiliation: Instituto do Câncer do Estado de São Paulo
name: Paulo Hoff, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02664805: Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
Official title: A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid
* Physician's Global Assessment of disease severity graded as at least mild at Visit 1
* In overall good health including well controlled diseases

Exclusion Criteria:

* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
* PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization
* Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization
* Concurrent skin diseases on the hands
* Current diagnosis of exfoliative dermatitis
* Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment
* A marked abnormal ECG at baseline
* Known hepatic dysfunction or hepatic dysfunction tested at Screening
* Current participation in any other interventional clinical trial

Primary outcomes:
measure: Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment)
timeFrame: 56 days
Secondary outcomes:
measure: Hand Eczema Severity Index (HECSI) at visit 6
timeFrame: 56 days
measure: Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment)
timeFrame: 56 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
Study officials:
affiliation: Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
name: Margitta Worm, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03270605: Myomectomy During CS: A Retrospective Cohort Study
Official title: Myomectomy During Cesarean Section: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Uterine Fibroid
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with uterine fibroid during the index pregnancy

Brief summary: To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.


Eligibility criteria: Inclusion Criteria:

* Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery

Exclusion Criteria:

* Antepartum hemorrhage
* Blood diseases or bleeding tendencies.
* Medical conditions complicating pregnancy.
* Performed another surgical procedure at CS other than myomectomy.

Primary outcomes:
measure: Deficit in hemoglobin level
timeFrame: 24 hours
Secondary outcomes:
measure: Operative time
timeFrame: 3 hours
measure: Postoperative hospital stay period
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Port Said University
name: Waleed El-refaie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed Hassan, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, MD
role: STUDY_CHAIR
References: