louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02659176: Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
Official title: Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectocele
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

Detailed description: Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients with anterior rectocele

Exclusion Criteria:

* Pregnant females
* Rectocele with pelvic organ prolapse
* Any patient with previous anorectal surgery
* Pudendal nerve neuropathy
* Anal fistula and sepsis
* Patients with sphincter defect proved by endo-anal sonography
* Patients proved to have colonic inertia either by colon transit time and/or history
* Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
* Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.

Primary outcomes:
measure: Incidence of recurrence
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura Univesity
name: Mohamed Youssef, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04013776: The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People
Official title: The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Aging
Nutrient; Excess
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, cross-over design
Primary purpose: OTHER

Brief summary: Phosphate is present in many of the foods that the investigators eat and is required by many cellular processes. The kidneys are the only organ that excrete the extra phosphate from the diet that the body does not require. Phosphate is linked to vascular calcification and cardiovascular disease. Measures of serum phosphate do not reflect the burden of phosphate and are not sensitive to early changes in the way the kidneys eliminate phosphate. This study will determine whether the kidneys handle an oral phosphate load differently after 5 days of a low phosphate diet compared to 5 days of a high phosphate diet.

Detailed description: In this study, participants will follow a low-phosphorus diet (750 mg) with a 500 mg calcium supplement for 5 days keeping a detailed diary of the foods eaten during this period. On the 5th day, the participant will undergo a 24 hour urine collection. Participants will present after an overnight fast for baseline blood and urine measurements. Then they will consume water containing 500 mg of phosphorus. Urine and blood will be collected every hour for 3 hours for measurement of phosphate and calcium and for measurement of hormones known to regulate phosphate and calcium including fibroblast growth factor-23, parathyroid hormone and vitamin D. One week later, participants will follow the same diet but will also receive a 1250 mg phosphorus supplement for 5 days. On the 5th day, urine will be collected for 24 hours. Participants will present again after an overnight fast and undergo the identical testing.

Eligibility criteria: Inclusion Criteria:

* healthy
* between ages of 20 and 40

Exclusion Criteria:

* known heart disease
* known diabetes
* pregnant
* breast-feeding

Primary outcomes:
measure: Urinary phosphate excretion
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
References:
Clinical trial NCT01430676: Risk Factors for Morbidity After Incisional Hernia Repairs
Official title: Risk Factors for Morbidity After Incisional Hernia Repairs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: Incisional hernia
recurrence
longterm
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 3460
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: All incisional hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Brief summary: The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after incisional hernia repair.

Detailed description: All principal incisional hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility criteria: Inclusion Criteria:

* Incisional hernia repair

Primary outcomes:
measure: Recurrence repair
timeFrame: up to 4 years
measure: Readmission
timeFrame: 30 days after operation
measure: Reoperation
timeFrame: 30 days
measure: Death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge Hospital
Study officials:
affiliation: dept. surgery, Køge sygehus, Denmark
name: Frederik Helgstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02319876: Expression of TIM-3 on Lymphocytes in Sepsis
Official title: Expression and the Clinical Significance of TIM-3 on Lymphocytes During Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Immunosuppression
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in ICU at Changhai Hospital

Brief summary: The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

Detailed description: Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.

Eligibility criteria: Inclusion Criteria:

* patients with severe sepsis
* patients undergo invasive spine surgery
* healthy volunteers

Exclusion Criteria:

* patients with immunodeficient diseases
* patients who accept glucocorticoid or immunosuppressant
* patients with an age older than 18 years
* patients providing the informed consent

Primary outcomes:
measure: TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes
timeFrame: within 24h after recruitment
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days after diagnosis of sepsis
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anesthesiology and Intensive Care, Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Xiaoming Deng, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01014676: Probiotics and Infections in Children Attending Day Care Centres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Tract Infections
Gastrointestinal Diseases
Keywords: Costs and Cost Analysis
Lead sponsor: Valio Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
First posted: 2009-11-17
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD

Brief summary: The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.


Eligibility criteria: Inclusion Criteria:

* Age 2 to 6 years in the beginning of the intervention
* Attendance at a day care centre participating in the study (5 days a week)

Exclusion Criteria:

* Milk allergy or lactose intolerance
* Congenital heart diseases that requires regular medication
* Malign diseases
* Cytostatic treatment
* Use of biological rheumatic medication
* Continuous microbial medication
* Regular use of oral corticosteroids (inhalable accepted)
* Diabetes
* Simultaneous participation in other clinical trials

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kajaani and Oulu
country: Finland
facility: Clinical Life Sciences Inc.
state: Province of Oulu
Study officials:
affiliation: Helsinki University Central Hospital
name: Anne Pitkäranta, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korpela K, Salonen A, Virta LJ, Kumpu M, Kekkonen RA, de Vos WM. Lactobacillus rhamnosus GG Intake Modifies Preschool Children's Intestinal Microbiota, Alleviates Penicillin-Associated Changes, and Reduces Antibiotic Use. PLoS One. 2016 Apr 25;11(4):e0154012. doi: 10.1371/journal.pone.0154012. eCollection 2016.
Clinical trial NCT04694976: Vitamin D Status in Children With Sickle Cell Disease Living in Lyon, France
Official title: Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Sickle Cell Disease
Keywords: Vitamin D deficiency prevalence rate
Vitamin D level
Children with sickle cell disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 130
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will focus on minor patients (0-17 years) with sickle cell disease, currently monitored in the active queue of the Lyon sickle cell reference centre of IHOPe, consulting their referring physician or paediatric emergencies of HFME, and having a blood test independently of the study.

Brief summary: Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.


Eligibility criteria: Inclusion Criteria:

* Children: under 18 years old
* Sickle cell any genetic type homozygous or composite heterozygous
* To receive an assessment independently of the study, during a presentation to the emergency ward and/or a follow-up consultation by the hematologist
* no parental opposition signed by at least one parent/legal representative and no child opposition
* social security beneficiary

Exclusion Criteria:

* History of hematologic grafting

Primary outcomes:
measure: Determination of 25-OH Vitamin D level
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère enfant - Urgences pédiatriques
Study officials:
affiliation: Urgences pédiatriques de l'Hôpital Femme Mère Enfant - Hospices Civils de Lyon
name: Valérie LAUNAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04479176: Comparison of Two Methods of Transnasal Sphenopalatine Ganglion Block
Official title: Comparison of Temperature and Pain Changes Between the Drip and Topical Methods of Administering the Transnasal Sphenopalatine Ganglion Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sphenopalatine Ganglion Block
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who visited pain clinic of Ajou university hospital, and a total of 74 patients who be performed transnasal sphenopalatine ganglion block

Brief summary: The transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.

Detailed description: The objective of this study was to compare facial temperatures and visual analogue scale (VAS) between drip method and topical method of transnasal sphenopalatine ganglion block (SPGB).

The transnasal SPGB is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.

Medical records of 74 patients who visited the pain clinic and underwent transnasal SPGB were retrospectively reviewed. A total of 156 transnasal SPGB were performed. The patients were divided into the drip-method and topical-method groups. Facial temperatures were measured in six areas of the right and left forehead, maxilla, and mandible before and 30 min after completion of the transnasal SPGB. Temperatures were compared before and 30 min after SPGB in each group and between the two groups. VAS scores were compared at same times of SPGB in each group and between the two groups.

Eligibility criteria: Inclusion Criteria:

(1) age over 20 years ; (2) head and neck pain; (3) pain score \> 4 on the VAS in the head and neck; and (4) having undergone a transnasal SPGB and having had facial temperatures measured.

Exclusion Criteria:

(1) patients with a history of head and neck surgery, (2) treatment with a vasodilator or vasoconstrictor, (3) contraindication to treatment using a transnasal approach, (4) clinically significant systemic disease or any reduced organ failure, and (5) missing data.

Primary outcomes:
measure: Facial temperatures
timeFrame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
measure: Visual analogue scale(VAS)
timeFrame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyunggi
Study officials:
affiliation: Ajou University School of Medicine
name: Kim
role: STUDY_CHAIR
References:
Clinical trial NCT01231776: Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass
Official title: Study of Acupuncture of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Diseases
Cardiopulmonary Bypass
Keywords: cardiopulmonary bypass
sleep
acupuncture
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 60
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: PREVENTION

Brief summary: Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients with heart operations.

Detailed description: 60 patients are divided into three groups. control group: no any intervention; experiment group 1: acupuncture are used in patients before cardiac operation; experiment group 2: acupuncture are used through all the course in hospital.

before operation, before discharge, one month after operation, two month after operation, the quality of sleep are evaluated. and comparisons will be made in three groups.

Eligibility criteria: Inclusion Criteria:

* aging:18yr--65yr
* cardiopulmonary bypass
* NYHA ≤II and EF≥50%
* not illiterate person

Exclusion Criteria:

* neurological disease,mentality disorder
* abuse of alcohol
* long history of smoking
* sleep disorder before admitting to hospital

Primary outcomes:
measure: multiple monitoring for sleeping
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Zhang Jinzhou
state: Shaanxi
city: Xi'an
country: China
facility: Zhang Jinzhou
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: zhang jinzhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02178176: Participatory Design of Patient-centered Depression and Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Type 2 Diabetes Mellitus
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.


Eligibility criteria: Inclusion Criteria:

1. 18 years and older
2. a current diagnosis of Type 2 DM
3. HbA1c 7%
4. current prescription for an oral hypoglycemic agent
5. able to communicate in English
6. willing to give informed consent

Exclusion Criteria:

1. acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately)
2. significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21)
3. markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)

Primary outcomes:
measure: Depression: nine-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 14 weeks
measure: Glycemic control: hemoglobin A1c
timeFrame: Baseline and 14 weeks
measure: Adherence to oral hypoglycemic agents: Medication Event Monitoring System
timeFrame: Over 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02085876: Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy
Official title: Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight
Type 2 Diabetes
Obesity
Keywords: patients
present
undergo bariatric surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 30
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Overweight patients or patients with type 2 diabetes or obese patients (who present a liver anomaly and should undergo bariatric surgery)

Brief summary: This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

* The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2\*. The other data will be extracted from usual sequences.
* Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
* Usual blood samples will be completed by samples for the serum library


Eligibility criteria: Inclusion Criteria:

* Patients who have been informed about the research
* Patients with national health insurance cover
* Patients who are overweight (BMI \> 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT \< 8 times normal values and ALAT \> twice normal values) after a complete hepatopathy assessment
* Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT \< 8 times normal values and ALAT \> twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.

Exclusion Criteria:

* Non-corrected coagulation disorder.
* Patients aged over 80 years
* Patients aged less than 18 years
* Patients without legal protection
* Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight\>150kg)
* Patients without national health insurance cover

Primary outcomes:
measure: To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.
timeFrame: Baselines
Secondary outcomes:
measure: To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.
timeFrame: Baselines
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References: