louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01256034: Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Official title: Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Cancer
Bile Duct Cancer
Keywords: immunonutrition
pancreaticoduodenectomy
Th1
Th2
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.

Detailed description: The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.

Eligibility criteria: Inclusion Criteria:

* patients underwent pancreaticoduodenectomy

Exclusion Criteria:

* age younger than 18 years
* ongoing infection
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological diseases
* preoperative evidence of widespread metastatic disease

Primary outcomes:
measure: Postoperative Infectious Complication
timeFrame: 30 days
Secondary outcomes:
measure: Plasma IL-6, CRP, Th1/Th2 Balance
timeFrame: 14 days
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University
Study officials:
affiliation: Chiba University
name: Katsunori Furukawa, MD
role: STUDY_DIRECTOR
References:
citation: Aida T, Furukawa K, Suzuki D, Shimizu H, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Preoperative immunonutrition decreases postoperative complications by modulating prostaglandin E2 production and T-cell differentiation in patients undergoing pancreatoduodenectomy. Surgery. 2014 Jan;155(1):124-33. doi: 10.1016/j.surg.2013.05.040. Epub 2013 Oct 25.
Clinical trial NCT05822934: Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer
Official title: Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urinary Bladder Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy

Detailed description: Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy. After finishing treatment, all patients should undergo follow up every 3 months for two years then six monthly thereafter .Follow up will include History, physical examination, full laboratory works (CBC, renal function testing and liver function testing). Imaging by CT or MRI abdomen and pelvis for all patients and cystoscopy in bladder preservation protocol

Eligibility criteria: Inclusion Criteria:All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are

* • Age above 18 years,

  * Pathologically proven urinary bladder cancer,
  * Patients with clinical stages T2-4a N0-3 M0,
  * Patients with good renal and liver functions
  * patients with no distant metastases,
  * no other malignancy (double malignancy).
  * Performance status 0-1 according to ECOG performance status scale.
  * Patients with no contraindications for radiotherapy.

Exclusion Criteria:

* • performance status 2-4 according to ECOG performance status scale.

  * patients refuse to receive chemotherapy,
  * patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia,
  * patients with M1 disease.

Primary outcomes:
measure: Clinical response rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
References:
Clinical trial NCT02150434: Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
Official title: Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Exercise
Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)
Keywords: Oxygen therapy
Hypoxemia
COPD
Closed-loop
Automated titration,
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: Canada Foundation for Innovation
First posted: 2014-05-29
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.


Eligibility criteria: Inclusion Criteria:

* Patients older than 40 years
* Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
* Who did not require long-term oxygen therapy were included in the study.
* Patients were also selected on the basis of known (end-exercise SpO2 \< 90% on a previous exercise test) or suspected (SpO2 \< 95% at rest) desaturation during exercise

Exclusion Criteria:

* Episode of exacerbation or hospitalisation within last four weeks
* Current medical condition that could influence exercise tolerance

Primary outcomes:
measure: Time within predefined SpO2 target
timeFrame: during exercise (Endurance shuttle walking test)
Secondary outcomes:
measure: Exercise tolerance
timeFrame: duration of ESWT
Other outcomes:
measure: Physiological parameters
timeFrame: during ESWT
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'IUCPQ
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
name: François Lellouche, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.
Clinical trial NCT01224834: Safety and Tolerability Study of Ragweed SLIT Tablets
Official title: Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinitis, Allergic, Seasonal
Ragweed Pollen Allergy
Keywords: Ragweed, allergy, sublingual immunotherapy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2010-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.


Eligibility criteria: Inclusion Criteria:

* written consent
* male or female subjects from 18 yo 60 years old and in general good health
* for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
* symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
* sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) \> 0.70 kU/l at screening
* FEV1 at least of 80% of predicted value at screening

Exclusion Criteria:

* past or current disease which, as judged by the investigator, may affect the outcome of this study
* history of life-threatening asthma
* asthma requiring daily treatment (whatever the pharmaceutical class)
* pregnant or lactating women
* subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
* symptoms during the treatment phase due to a sensitivity to a second allergen
* subjects treated with ongoing immunotherapy with another allergen

Primary outcomes:
measure: Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Immunological markers (IgE and IgG4)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Balatonfüred
country: Hungary
facility: DRC Drug Research Center
Study officials:
affiliation: DRC Drug Research Center, Balatonfüred - Hungary
name: Eva Péterfai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710834: Comparing Hemodiafiltration with and Without Hemoadsorption
Official title: Evaluating the Effectiveness of Combining Hemodiafiltration and Hemoadsorption in Comparison to Hemodiafiltration Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Hemodiafiltration
Hemoadsorption
Keywords: Adsorption
Convection
Hemodiafiltration
Efficacy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Goals: The aim of the study is to assess the efficacy and safety of the combination of HDF + HA compared to HDF. To do this, we will evaluate the elimination of a wide range of molecular weight molecules, including small protein-bound solutes.

Design: Prospective, single-center study. Each patient underwent two dialysis sessions with routine dialysis parameters in which HDF or HDF + HA treatment modality will be compared.

Study subjects: 20 patients, stable on a thrice-weekly hemodialysis program, will be included. Local Ethics Committee will approve the study and patients will give informed consent.

Interventions: Prospective collection of two dialysis sessions. The only difference among the sessions in each patient will be add or no sorbent cartridge. One session with FX60 Cordiax, helixone, Fresenius Medical Care in postdilution on-line hemodiafiltration and another session with the same dialyzer plus HA 130 cartridge. The order of these treatment sessions was randomly. Blood samples for analyses were taken for each patient in the same dialysis session of the week.


Eligibility criteria: Inclusion Criteria

* Adult patients (age \> 18 years)
* More than 6 months on a dialysis program
* Stable in a hemodialysis program
* AV fistula, prosthesis, or tunneled catheter as vascular access
* No residual diuresis (\< 200 ml/day)
* Not enrolled in a living donor transplant program
* No immunosuppressive treatment
* Provide written informed consent

Exclusion Criteria

* Chronic inflammatory diseases
* Neoplasms
* Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs
* Dysfunctional AV fistula or catheter
* Single-needle dialysis
* Kt/V less than 1.3 or PRU \< 70%
* Scheduled living donor kidney transplant

Primary outcomes:
measure: Uremic toxins reduction ratios (RR)
timeFrame: From enrollment to the end of treatment at 4-8 weeks.
Secondary outcomes:
measure: Uremic toxins reduction ratios
timeFrame: From enrollment to the end of treatment at 4-8 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
Study officials:
References:
Clinical trial NCT01860534: "Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"
Official title: "Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Light Sensitivity
Keywords: pain
mydriasis
light
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.

Detailed description: Pain management for Retinopathy of prematurity (ROP) screening focuses on pharmacological and non-pharmacological interventions during the actual eye examination. Management of pain related to increased light sensitivity during the post-mydriasis period has not been described.

This prospective, randomized study evaluated the impact of protecting the eyes from ambient light exposure post mydriasis. Vital signs and pain scales were recorded in infants randomized to either wear or not wear eye patches after mydriasis for their ROP exam. Infants less than 30 weeks gestational age or less than 1500 grams at birth were included. Standard statistical methods were used to compare vital signs and pain scores for each group at baseline, 1 and 3 hours after mydriasis.

Eligibility criteria: Inclusion Criteria:

* All infants with gestational age at birth of 30 weeks or less or with birth weight less than 1500g undergoing their first ROP exam in the Infant Special Care Unit (ISCU) at UTMB.

Exclusion Criteria:

* Infants were excluded if they had any congenital malformation or syndrome; a history of eye surgery or were receiving inotropics medications.

Primary outcomes:
measure: Heart Rate
timeFrame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
Secondary outcomes:
measure: Respiratory Rate
timeFrame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
measure: Oxygen Percent Saturation
timeFrame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
measure: Pain
timeFrame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: UTMB
name: Erika M. Espino-Torres, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338234: Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients
Official title: Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Intensive Care
Cardiac Surgery
Keywords: anemia
intensive care
cardiac surgery
iron metabolism
hepcidin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Société Française d'Anesthésie et de Réanimation
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-06-20
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * For the surgery :population 20 yers to 88 years old
* For the reanimation : population to the 41 years to 85 years old

Brief summary: Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

Detailed description: Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation. The latter is known to interfere with iron metabolism, inducing iron storage instead of using it for hemoglobin synthesis. The discover of a new regulatory hormone of iron metabolism, hepcidin, may help us to better understand the link between inflammation and iron functional deficit. The aim of our study is to observe the variation of usual iron metabolism biological markers and of hepcidin, in order to define the better marker of iron loss in these clinical situations.

Eligibility criteria: Inclusion Criteria:

* Anemia (haemoglobin \< 10 g/dL)
* Hospitalization in ICU for an expected duration of 7 days or more
* Or, day one post cardiac surgery

Exclusion Criteria:

* Chronic anemia (Hb \< 9 g/dL for more than one month before hospitalization)
* Iron metabolism disease

Primary outcomes:
measure: Functional iron deficiency
timeFrame: during the study
Secondary outcomes:
measure: fatigue assessed by the MFI20 score for cardiac surgery patients
timeFrame: at one day,at seven days and at 28 days
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP, hopital Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: sigismond lasocki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Carole Beaumont, PhD
role: STUDY_CHAIR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Isabelle Boutron, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00551434: Effect of Creatine and L-Arginine on Endothelial Function
Official title: Effect of Creatine and L-Arginine on Endothelial Function in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-10-31
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a double blind 2x2 factorial study. Patients with coronary disease will be randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary supplement. The function of the endothelium will be tested using ultrasound before and after each treatment. These studies will help us understand why the endothelium is abnormal in patients with coronary artery disease and how L-arginine is acting on endothelial function.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Pregnancy
* Creatine use within one month of study
* L-arginine use within one month of study
* Change in dose or initiation of lipid lowering therapy, aspirin therapy, or angiotensin converting enzyme therapy within one month of study

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: 5 days
Secondary outcomes:
measure: serum arginine, creatine, creatinine, homocysteine
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Joseph A Vita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05211934: Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery
Official title: Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery：A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Surgery
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.

Brief summary: Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing valvular surgery
* Age between 60 to 75

Exclusion Criteria:

* Have a history of cerebral infarction before operation
* Cardiac function was seriously impaired before surgery
* Neuropsychiatric disorders were present before surgery

Primary outcomes:
measure: heart function
timeFrame: up to 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Anzhen hospital, Beijing
state: Beijing
Study officials:
References: