louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01105442: Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice
Official title: Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Diseases
Post-operative Pain
Local Anesthesia
Keywords: Post-operative pain treatment
Fast-track colonic surgery patients
Surgery
Lead sponsor: Martini Hospital Groningen
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Martini Hospital Groningen

Brief summary: The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with morphine on demand. The expectation is that the use of levobupivacaine leads to less side effects.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo fast-track colonic surgery and with post operative epidural pain treatment

Exclusion Criteria:

* Patients who are admitted to an other ward
* Patients with a spinal catheter

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Martini Hospital ward 4b
Study officials:
affiliation: Martini Hospital
name: Marinus van Hulst, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02691806: New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
Official title: New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Fatigue
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Sometimes, during strenuous aerobic activity, activity ceases only when the discomfort that follows lack of oxygen would be intolerable. Reaching this fatigue condition can cause organ damage, muscular damage and / or in different tissues of the body. In this study, investigators aim at developing new indexes, based on hemodynamics measurements from the peripheral micro - circulation system, for the benefit of early detection of fatigue during accelerated physical activity.

Detailed description: 14 healthy volunteers, 7 males and 7 females, aged 18-30 will participate in this study.The study includes 2 stages: In the first stage, aerobic capacity of the subjects will be measured by measuring maximum oxygen consumption (VO2max test). This phase will be conducted to determine physical measurements that could indicate different stages in muscle fatigue (anaerobic threshold, maximum oxygen consumption, heart rate and breathing indices).

In the second phase, the subjects will perform the same physical effort protocol that carried out at the first stage. Non- invasive measurements of leg muscles activity during aerobic exercise and at rest (before and after activity), will be carried out using a wireless EMG. Additionally, hemodynamic measurements of oxygen levels in the skin and skin perfusion monitoring before and after strenuous activity will be performed using two optic sensors.

Eligibility criteria: Inclusion Criteria:

* Aged 18-30 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Any metabolic disorder.
* Any muscles or skeleton condition.
* Any neurological condition.
* the physician decision.

Primary outcomes:
measure: electric activity of leg muscles
timeFrame: 1 day
Secondary outcomes:
measure: oxygen levels in the skin
timeFrame: 1 day
measure: anaerobic threshold
timeFrame: 1 day
measure: maximum oxygen consumption
timeFrame: 1 day
measure: heart rate
timeFrame: 2 days
measure: skin perfusion
timeFrame: 1 day
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Haggai Schermann, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02694406: MRI Perfusion in Adnexal Masses
Official title: Added Value of MRI Perfusion in Evaluation of Complex Adnexal Masses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Adnexal Masses
Keywords: Diagnosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with adenxal masses

Brief summary: As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide number of immature microvessels. These vessels are characterized by a lack of coverage by pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio pathogenic characteristics have been demonstrated to be in line with variations of MR perfusion parameters.

Unlike many lesions that occur in other parts of the body, biopsy should not be performed in adnexal masses that demonstrate no evidence of peritoneal disease because it may cause spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have been a malignant tumor that was limited.


Eligibility criteria: Inclusion Criteria:

* complex adnexal mass
* patient fit for surgery

Exclusion Criteria:

* any general contraindication to MRI
* severely ill patients
* those with claustrophobia.

Primary outcomes:
measure: detect the number of malignant adnexal masses
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
city: Assiut
country: Egypt
facility: Ahmed Abbas
Study officials:
References:
Clinical trial NCT00787306: Cardiovascular Health And Risk Modification in Family Health Teams
Official title: Multidisciplinary Cardiovascular Health And Risk Modification in Family Health Teams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Risk Factors
Hypertension
Hyperlipidemia
Diabetes
Keywords: chronic disease management
decision aids
cardiovascular risk factors
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2008-11-07
Enrollment: 229
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular diseases remain the main cause of mortality in Canada. While effective interventions are available for reducing the risk of cardiovascular disease,there continue to be gaps between the potential reduction in risk that could be achieved by effectively managing these risk factors and levels of risk factor control currently in clinical practice. This study will evaluate the ability of a different model of risk factor care using other health providers assisting family doctors, along with information aids for patients and health professionals,to achieve better levels of cardiovascular risk factor control in adults.


Eligibility criteria: Inclusion Criteria:

* adults 50 to 80 years of age
* having attending a family medicine clinic for more than one year

Exclusion Criteria:

* not able to participate for one year
* not able to read English
* requires house calls
* nursing home resident
* cognitive impairment
* current chest pain or symptoms of active coronary heart disease

Primary outcomes:
measure: mean systolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of adults with 3 cardiovascular risk factors under optimal control
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Granovsky Gluskin Family Medicine Cwntre
state: Ontario
Study officials:
affiliation: Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital
name: Warren J McIsaac, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03315806: Pregnancy, Nitrate, Endothelial Function and Tissue Oxygen Saturation
Official title: Effect of Beetroot Juice Consumption on Endothelial Function and Tissue Oxygen Saturation in Pregnant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Dietary nitrate
Nitrate
Flow-mediated dilation
Tissue oxygen saturation
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Adequate macro and microvascular endothelial function during pregnancy is essential for the normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins this parameters in no-pregnant individuals, however the beneficial effect did not avaliated in pregnant. The present study evaluated effects of BJ on macro and microvascular endothelial function in pregnant. Twelve pregnant were submitted to BJ and nitrate-depleted juice (PLA) interventions. Brachial flow-mediated dilation (FMD) and muscle oxygenation were measured 120 min after interventions. Urinary nitrate, nitrite were measured at baseline and 120 min after interventions.


Eligibility criteria: Inclusion Criteria:

* gestation between 20 and 35 weeks;
* over 18 years

Exclusion Criteria:

* diabetes mellitus and gestational diabetes;
* hypertensive syndromes;
* HIV positive;
* liver or kidney disease;
* beetroot allergy;
* use of antioxidants and medicament that alter endothelial function;
* use of antibiotics up to 2 weeks before the visits and using.

Primary outcomes:
measure: Macro endothelial function
timeFrame: Evaluated 120 minutes after the nutritional intervention
measure: Micro endothelial function
timeFrame: Evaluated 140 minutes after the nutritional intervention
measure: Nitrate urinary
timeFrame: Evaluated 150 minutes after the nutritional intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05651906: The Role of Endothelial Glycocalyx in Kidney Transplantation
Official title: The Role of Endothelial Glycocalyx in Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation
Keywords: Endothelial
Glycocalyx
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: Donors after brain death, Donors after circulatory death Group 2: Patients with end-stage renal disease who are eligible for kidney transplantation

Brief summary: The goal of this observational study is detailed examination of endothelial glycocalyx in kidney transplantation. Researchers will evaluate markers of degradation of EG in blood and urine; and also perform direct visualisation of EG with sidestream dark field imaging (SDF) in both donors and recipients of kidney transplantation.

The aim is to summarize the current knowledge and to point out the importance of EG in kidney transplantation.

Detailed description: The endothelial glycocalyx (EG) is a thin layer on the surface of the endothelium that plays an important role for microcirculation and tissue metabolism. The role of EG is diverse - it acts as a protection of the endothelium against shear stress which is mediated on the intracellular structures of endothelial cells, allows the interaction of blood elements and endothelium, prevents the formation of uncontrolled thrombosis and excessive oxidative stress by free radicals. EG dysfunction can occur with partial or complete loss of its components, resulting in impaired vascular regulation and increased vascular permeability. Disruption or dysfunction of EG has been associated with disease states such as diabetes, chronic kidney disease, inflammatory conditions, sepsis, hypernatraemia, hypervolaemia and ischaemia/reperfusion injury. Enzymes such as hyaluronidase and metalloproteinases can degrade the components of EG. Damage to EG leads to the release of breakdown products into the bloodstream which can be detected. There are also direct methods of visualization of EG. Thanks to advances in the study of EG in kidney transplantation a comprehensive relationship in this field and specific clinical aspects can be assessed. In the future exploring potential therapeutic options to protect EG may have implications for better graft function and survival.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing kidney transplantation

Exclusion Criteria:

* Patients who don't sign the informed consent

Primary outcomes:
measure: Examination of Endothelial Glycocalyx in Donors
timeFrame: 1 year
measure: Examination of Endothelial Glycocalyx in Recipients
timeFrame: 1 year
Secondary outcomes:
measure: Endothelial Glycocalyx under different settings
timeFrame: 1 year
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Czech Republic
Study officials:
References:
Clinical trial NCT00227006: Promoting Long-term Behavior Change to Reduce CVD Risk
Official title: Promoting Long-term Dietary Change to Reduce CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Unrestricted research gift from Nutrilite Health Institute
First posted: 2005-09-27
Enrollment: 163
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI).

Detailed description: Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI). Participants were randomized to Taste-Based Choices (taste-based goal setting + a standard 6-month behavioral weight-loss intervention), Smart Consumers (a standard 6-month intervention alone) or Community Access (access to commercial/community-based behavioral weight-loss programs) and followed over 18 months. To test our hypotheses, we examined a set of orthogonal contrasts (TBC and SC vs. CA; TBC vs. SC) on reductions in saturated fat (Block FFQ) and clinic-measured BMI.

Eligibility criteria: Inclusion Criteria:- Body mass index between 27-37

* Physically inactive
* Able to participate in physical activity
* Percentage of daily calories from total fat 30% or more
* Free of diagnosed heart disease
* Stable on medications for 3 months or more Exclusion Criteria:- Diabetic
* Dysphoric (Beck Depression Inventory score greater than 18)
* Binge eating or bulimic (Eating Disorder Diagnostic Scale)

Primary outcomes:
measure: Percentage of saturated fat in diet
timeFrame: 18 months
Secondary outcomes:
measure: Body weight
timeFrame: 18 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Michaela Kiernan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldberg JH, Kiernan M. Innovative techniques to address retention in a behavioral weight-loss trial. Health Educ Res. 2005 Aug;20(4):439-47. doi: 10.1093/her/cyg139. Epub 2004 Dec 14.
citation: Kraemer HC, Kiernan M, Essex M, Kupfer DJ. How and why criteria defining moderators and mediators differ between the Baron & Kenny and MacArthur approaches. Health Psychol. 2008 Mar;27(2S):S101-8. doi: 10.1037/0278-6133.27.2(Suppl.).S101.
Clinical trial NCT03620006: Subclavian Artery Plug Embolization (SAPE)
Official title: Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subclavian Artery Plug Embolization
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients aged ≥ 18 years, candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug

Brief summary: This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December 2018. Target study population size is 150 patients between two groups analyzed.

Endovascular occlusion of the prevertebral subclavian artery was first used in the Vascular Surgery Department at San Raffaele Hospital in August 2009. During the initial experience (2009-2014) this technique was used with low frequency. Since 2015, the volume of cases receiving this treatment, has increased and the investigators expect to reach the study population target, by the end of 2018.

The objective of this study is describe the casuistry of endovascular occlusion of the subclavian artery by means of the Amplatzer Vascular plug in the Vascular Surgery Department at San Raffaele Hospital, and to evaluate the efficacy of such procedure.

Moreover, the investigators will evaluate the patency and success rate of the carotid-subclavian bypasses performed at the same time of the analyzed procedure.


Eligibility criteria: Inclusion Criteria:

* adult patients aged ≥ 18 years,
* patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug

Exclusion Criteria:

• none

Primary outcomes:
measure: Technical success rate
timeFrame: within 30-day
measure: Major adverse event rate
timeFrame: within 30-day
Secondary outcomes:
measure: Access site complications requiring secondary adjunctive procedures
timeFrame: within 30-day
measure: Supra-aortic vessels patency rate
timeFrame: within 5-years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
citation: Bertoglio L, Salvati S, Fittipaldi A, Melloni A, Kahlberg A, Cambiaghi T, Melissano G, Chiesa R. Carotid to subclavian bypass and Amplatzer vascular plug subclavian endovascular occlusion before thoracic open or endovascular repair. J Vasc Surg. 2020 May;71(5):1480-1488.e1. doi: 10.1016/j.jvs.2019.08.237. Epub 2019 Oct 17.
Clinical trial NCT05430906: AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
Official title: Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile.

AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.


Eligibility criteria: Key Inclusion Criteria:

- 1. Woman ≥ 18 and ≤ 75 years old on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended.

4. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function.

Key Exclusion Criteria:

* 1. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary.

  2. Patients with other active malignancies within 5 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

  5. Presence of other uncontrolled serious medical conditions.

Primary outcomes:
measure: Complete(R0) resection rate
timeFrame: Average 4 months after the start of drugs
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
measure: Disease control rate (DCR)
timeFrame: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
measure: Pathological Complete Response (pCR) Rate
timeFrame: One week after the surgery
measure: Progression-free survival (PFS)
timeFrame: From the date of the start of drugs to date event, assessed up to 1 years
measure: Number of participants with adverse events (AEs)
timeFrame: From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment
measure: Number of participants with surgical complications
timeFrame: Intraoperatively, within 30 days after surgery
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Jie Tang
role: STUDY_CHAIR
References: