louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05026424: Glycemic Response in Adults with Diabetes
Official title: Glucose and Insulin Response in Adults with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized crossover design with oral nutrition supplement interventions.

Detailed description: This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Eligibility criteria: Inclusion Criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg/dl
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Patients with anemia
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Patients with anemia
* Currently participating in another clinical trial

Primary outcomes:
measure: Post-prandial glycemic markers
timeFrame: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Secondary outcomes:
measure: Post-prandial insulin markers
timeFrame: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
measure: Insulinogenic index
timeFrame: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Nestle Health Science
name: Krysmaru Araujo Torres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02803424: Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia
Keywords: robot-assisted laparoscopic radical prostatectomy
Autoflow
trendelenburg position
pneumoperitoneum
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

1. Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

Exclusion Criteria:

1. chronic obstructive respiratory diseases
2. heart failure
3. body mass index (BMI \>30 kg/m2)

Primary outcomes:
measure: arterial oxygen tension (PaO2)
timeFrame: 30 minutes after steep trendelenburg position and pneumoperitoneum.
Secondary outcomes:
measure: The peak inspiratory pressure
timeFrame: 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Study officials:
References:
citation: Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.
Clinical trial NCT06037824: Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty
Official title: Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Cryotherapy Effect
Lead sponsor: Institut de Formation en Masso-Kinésithérapie Saint Michel
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the postoperative period of a total knee arthroplasty, subjects present limitations of articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is unanimously recommended, including the use of cryotherapy. However, there is no consensus regarding the methods of application of cryotherapy. Thus the objective of the study is to compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive cryotherapy and a so-called classic cryotherapy by cold pack.


Eligibility criteria: Inclusion Criteria:

* Volunteers
* First-line Total Knee Arthroplasty on an indication of knee osteoarthritis diagnosed by radio-clinical examination
* Between D3 and D10 postoperatively
* Age \< 90 years.

Exclusion Criteria:

* Intolerance to cryotherapy or compression,
* Occurrence of complications secondary to surgery,
* Withdrawal of consent,
* Non-compliance with the rehabilitation protocol (content and dosage of sessions).

Primary outcomes:
measure: knee range of motion
timeFrame: Day 1-Day 8-Day 15-Day 21
Secondary outcomes:
measure: Knee perimetry
timeFrame: Day 1-Day 8-Day 15-Day 21
measure: Swelling
timeFrame: Day 1-Day 8-Day 15-Day 21
measure: Pain at rest and on exertion
timeFrame: Day 1-Day 8-Day 15-Day 21
measure: 6min walking test
timeFrame: Day 1-Day 8-Day 15-Day 21
measure: KOOS score (Knee injury and Osteoarthritis Outcome Score)
timeFrame: Day 1-Day 8-Day 15-Day 21
Other outcomes:
Locations:
city: Versailles
country: France
facility: Hôpital de la Porte Verte
state: Yvelines
Study officials:
References:
Clinical trial NCT00430924: Inhibition of Aldosterone in Patients With Chronic Renal Disease
Official title: The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: Kidney Failure, Chronic
Proteinuria
Aldosterone
Renin-Angiotensin System
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2007-02-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.

Detailed description: Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this.

For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.

Eligibility criteria: Inclusion Criteria:

* Proteinuria \> 500 mg/24 hours
* Hypertension or anti-hypertensive treatment

Exclusion Criteria:

* Diabetic nephropathy
* GFR\< 20 ml/min
* P-potassium between 3,5 mmol/l and 5,0 mmol/l

Primary outcomes:
measure: Proteinuria reduction
timeFrame: bi-monthly
Secondary outcomes:
measure: Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.
timeFrame: weekly
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Blegdamsvej 9
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
name: Svend Strandgaard, DMSc
role: STUDY_DIRECTOR
affiliation: nonaffiliated
name: Anne-Lise Kamper, DMSc
role: STUDY_DIRECTOR
References:
citation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
citation: Boesby L, Elung-Jensen T, Klausen TW, Strandgaard S, Kamper AL. Moderate antiproteinuric effect of add-on aldosterone blockade with eplerenone in non-diabetic chronic kidney disease. A randomized cross-over study. PLoS One. 2011;6(11):e26904. doi: 10.1371/journal.pone.0026904. Epub 2011 Nov 4.
Clinical trial NCT04064424: Cancer Prevention & Online Technologies
Official title: Cancer Prevention & Online Technologies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-21
Enrollment: 720000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this research is to develop interventions that leverage online technology (e.g. ads, social media) to reduce individuals' skin-cancer-related risk behaviors and ultimately to reduce skin cancer incidence.

Detailed description: This research includes three phases:

1. To better understand the motivators and inhibitors of skin cancer risk behaviors in various populations including use of indoor tanning and outdoor sun exposure;
2. To develop content messages and images related to skin cancer risk that are resonant with various populations;
3. To test the relative effectiveness of these messages in reducing likelihood of or actual skin cancer risk behaviors in various populations.

Eligibility criteria: Inclusion Criteria:

* Facebook user between the age of 18 and 65
* Self-identifies as male
* Profile indicates interest in at least one of the following: LGBT community, LGBT culture, LGBT social movements, Rainbow flag, Gay pride, GAY-friendly, homosexuality

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: Measure intent to tan
timeFrame: 4 weeks
Secondary outcomes:
measure: Measure awareness of indoor tanning risk
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Eleni Linos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629524: Influence of Tumor Associated Immunity on the Number of Lymph Node Retrieved After Colorectal Cancer Surgery (Preliminary Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients diagnosed with clinically TNM I, II, or III stage

Brief summary: Hypothesis of this study is that increased immunity of primary tumor affects the increased number of lymph node retrieved. This study investigates whether immunity-related cytokine expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph node retrieved in colorectal cancer patients.


Eligibility criteria: Inclusion Criteria:

* 1. Histologically confirmed colorectal cancer 2. Non-metastatic cancer (cTNM I, II, or III) 3. Over 20 years of age 4. Curative resection (R0)

Exclusion Criteria:

* 1. Patient with distant metastasis 2. History of chemotherapy or radiation therapy for malignancy 3. Patient receiving immunosuppressive or anti-inflammatory treatment 4. Hereditory colorectal cancer 5. Preoperative chemoradiation therapy for colorectal cancer 6. Pregnancy 7. Emergency

Primary outcomes:
measure: Association between immune related cytokine and number of lymph nodes retrieved.
timeFrame: 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonji Christian Hospital
Study officials:
References:
citation: Kim YW, Kim SK, Kim CS, Kim IY, Cho MY, Kim NK. Association of serum and intratumoral cytokine profiles with tumor stage and neutrophil lymphocyte ratio in colorectal cancer. Anticancer Res. 2014 Jul;34(7):3481-7.
Clinical trial NCT03508024: Patients With Alzheimer's Disease or Related Youth Disease
Official title: Patients With Alzheimer's Disease or Related Youth Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease, Early Onset
Lewy Body Disease
Frontotemporal Lobar Degeneration
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Alzheimer disease, Lewy Bodies Dementia or FrontoTemporal Lobar Degeneration and their caregivers

Brief summary: This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.


Eligibility criteria: Inclusion Criteria:

As part of this study, patients will be considered:

* Residing in the departments of Nord (59) and Pas-de-Calais (62),
* whose diagnosis of Alzheimer's disease or related illness (DLFT, DCL) was made and announced,
* Whose diagnosis of illness was made after 2007
* whose first symptoms appeared before the age of 60 Patients included in the COMAJ cohort and those who completed the Pathways medical and social booklet will have to meet these criteria to be selected for this study.

As part of the survey, caregivers of patients meeting the above criteria and the following two will be recruited:

* Having consulted or being followed by liberal neurologists or in hospital memory consultations (excluding CMRR-CNR-MAJ Lille) of the departments of Nord and Pas-de-Calais,
* Not monitored at the CMRR-CNR-MAJ Lille (ad hoc notice possible). The caregiver is defined as a family member or friend who helps regularly by doing the necessary tasks so that the sick person can keep as much autonomy as possible.

Exclusion Criteria:

* aged under 18
* no social coverage
* refusal to sign informed consent form

Primary outcomes:
measure: the delay between the diagnosis and the first symptomsIdentification of factors related with diagnosis delay
timeFrame: 10 years
Secondary outcomes:
measure: Comparison of patient profiles followed at the CMRR-CNR-MAJ Lille and those who are not.
timeFrame: 10 years
measure: Comparison of patients characteristics followed at the CMRR-CNR-MAJ Lille and those who are not.Impact of the diagnosis on YOD
timeFrame: 10 years
measure: the percentage of patients who have had a lack of information about the disease and possible aids
timeFrame: 10 years
measure: the percentage of refusal or delay of treatment of certain medico-social aids by the competent authorities
timeFrame: 10 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Florence Pasquier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03348124: Prevention Among Young People With Intellectual Disability
Official title: Prevention of Unwanted Pregnancy and a Path to Informed Choice Among Young People With Intellectual Disability- a RCT, Intervention With Conversational Support and Real-Care-Baby Simulator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intellectual Disability
Adolescent Development
Young Adult
Keywords: Intellectual disability
Parenthood
Reproduction
Intervention
Adolescents
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala-Örebro Regional Research Council
First posted: 2017-11-20
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster randomized intervention study with waiting list control group.
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate an intervention using the Toolkit "Children - what does it involve?" and the "Real-Care-Baby" (RCB) simulator among students with intellectual disability (ID), using a cluster randomized trial design with waiting-list control group.

Detailed description: Background: There is limited knowledge about how young people with ID can be facilitated in their process of deciding about parenthood. A feasibility study showed that it is possible to evaluate an intervention using the chosen instruments among students with ID in order to provide them with further insights about parenthood. Methods: Randomization of eleven clusters/schools to intervention and eleven clusters to waiting-list control. Intervention includes thirteen educational lessons and a three-day and night caring-session with the RCB simulator. Intervention will be given 1-2 lessons/week during 8-14 weeks. Data will be collected with questionnaires and interviews before and after intervention. In control group: Before and after waiting-list time and after intervention.

Eligibility criteria: Inclusion Criteria:

* Students with mild or moderate ID with informed consent can be included
* Understand and respond to a questionnaire

Exclusion Criteria:

- Students with severe ID

Primary outcomes:
measure: Infant Simulator Attitude Scale (ISA)
timeFrame: Change from baseline after 13 weeks
Secondary outcomes:
measure: General Self-Efficacy Scale (S-GSE)
timeFrame: Change from baseline after 13 weeks
measure: Data extracted from Real Care Baby simulator
timeFrame: Change from baseline after three days and nights
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala Special school
Study officials:
affiliation: Uppsala University Sweden
name: Berit Höglund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02702024: The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Percreta
Keywords: efficacy
double incision technique
uterus preserving surgery
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-03-08
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT

Brief summary: Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. Fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. In this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.


Eligibility criteria: Inclusion Criteria:

* Intraoperatively and pathologically confirmed diagnosis of placenta percreta

Exclusion Criteria:

-

Primary outcomes:
measure: The success of segmental resection (Uterus preserving surgery)
timeFrame: Postoperative one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Polat I, Yucel B, Gedikbasi A, Aslan H, Fendal A. The effectiveness of double incision technique in uterus preserving surgery for placenta percreta. BMC Pregnancy Childbirth. 2017 Apr 27;17(1):129. doi: 10.1186/s12884-017-1262-3.