louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03765827: Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass
Official title: Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 140
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: Patients will be randomized into 2 groups:

* Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses
* Control group: Vitamin E will not be applied

Postoperative pain will be assessed 24 hours after surgery.

Detailed description: Patients will be randomized into 2 groups:

* Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.
* Control group: Vitamin E will not be applied

Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).

Eligibility criteria: Inclusion Criteria:

* BMI \>40 Kg/m2 or \>35 Kg/m2 associated to obesity-related comorbidities
* Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
* Patients accepting to participate in the study and signing and Informed Consent form

Exclusion Criteria:

* Patients undergoing other bariatric techniques
* Patients undergoing Roux-en-Y gastric bypass as revisional procedure

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: General Hospital Elche
state: Alicante
Study officials:
affiliation: Hospital Rey Juan Carlos
name: Damian Garcia, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ruiz-Tovar J, Garcia A, Ferrigni C, Duran M. Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants. Obes Surg. 2020 Aug;30(8):2988-2993. doi: 10.1007/s11695-020-04635-9.
Clinical trial NCT02224027: Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway
Official title: Comparison of Proceal Laryngeal Mask Airway and I-gel to Machintoch Laryngoscope by Novice Operators in Simulated Difficult Airway - a Manikin Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Obstruction
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of laryngeal mask airway or i-gel to manage airway may improve success rates, especially in difficult situations more than tracheal intubation.

Detailed description: This study compares the insertion success rate and insertion time among the proceal laryngeal mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult laryngoscopy scenarios.

Eligibility criteria: Inclusion Criteria:

* medical student
* nurse
* no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway

Exclusion Criteria:

* experience of insertion using tracheal tube, i-gel, and laryngeal mask airway

Primary outcomes:
measure: the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
name: Sangjin Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06134427: Body Fat Percentage Prediction Model After Basic Combat Training on Army Candidate in Indonesia
Official title: Body Fat Percentage Prediction Model of the Basic Combat Training Effect on Army Candidate' Body Composition in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Activity
Keywords: Anthropometry
body composition
basic combat training
predictive model formula
military cadets
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 258
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-Experimental Model One-Group Pretest-Posttest Design
Primary purpose: SCREENING

Brief summary: This research is a quantitative study using the Pre-Experimental Model One-Group Pretest-Posttest Design with total sampling from the Republic of Indonesia Defense University batch 4 cadets that fullfiled criteria. The intervention is 12 weeks basic combat training (only one group), a compulsory program for cadets.

Detailed description: the purpose of this study is know the effect of basic combat training on the anthropometry and body fat percentage prediction model of army cadets after basic combat training in Indonesia

Eligibility criteria: Inclusion Criteria:

* Students as fourth batch in bachelor program in Indonesia Defense University
* Aged 16-18 years

Exclusion Criteria:

* Drop out or resign from Indonesia Defense University during research
* Having emergency condition during examination

Primary outcomes:
measure: Anthropometry after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Anthropometry after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Anthropometry after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Anthropometry after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Body composition after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Body Fat Percentage Prediction Model of the Basic Combat Training (BCT) Effect on Army Candidate'
timeFrame: 12 weeks
measure: Sleep quality after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Macronutrient intake before and after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
measure: Physical activity before and after basic combat training in cadets of Indonesia
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bogor
country: Indonesia
facility: Indonesia Defense University
state: West Java
Study officials:
References:
Clinical trial NCT03875027: Outcome of Proximal Femur Replacement at a Tertiary Care Hospital
Official title: Outcome of Proximal Femur Replacement at a Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome, Fatal
Keywords: proximal femur
functional outcome
fracture
failed hip surgery
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient underwent proximal femur replacement

Brief summary: This is a retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement

Detailed description: retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement will be conducted All patients that fall in the selection criteria from 2009 to 2018 will be included as part of this study will be selected Patients are identified using medical record numbers. A questionnaire containing questions on demographics of the patients which includes their age, sex and co morbids. Furthermore, the cause of fracture, time from the fracture to presentation in the emergency room, time from the presentation to ER to the time patient was in the operating room would be noted. Duration of the surgery.

The weight bearing status in the ward and follow-up would be noted. Functionality of the patient; which is that how much patients are able to carry their normal daily routine work would also be noted from the medical records.

Collected data will be analysed using Statistical Package for Social Sciences (SPSS, Inc, Chicago, IL, USA). Results will be recorded as frequencies, means, Standard Deviation (SD) and p-values while statistical tests will be applied for comparative reasons. For all purposes a p-value of 0.05 will be considered as the level of significance.

Eligibility criteria: Inclusion Criteria:

* All patients, regardless of race, gender, age and co-morbids, who were treated with proximal femur fracture with any of the following variables:

Poor bone quality Bone loss Severe communition Multiple comorbids Failed hip surgery Pathological fractures

Exclusion Criteria:

* The patient who weren't treated with proximal femoral replacemnt, those lost to follow up, those with missing record.

Primary outcomes:
measure: functional outcome
timeFrame: 2009 till 2018
Secondary outcomes:
measure: mortality
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03243994: Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale
Official title: Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Cor Pulmonale
Keywords: Cor pulmonale
COPD
Malabsorption
D-xylose
Zinc
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without
Primary purpose: DIAGNOSTIC

Brief summary: Aim: To investigate whether patients with pulmonary hypertension have reduced absorption capacity compared to COPD patients without cor pulmonale potentially due to venous obstruction in the portal vein system.

The presence of cor pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.

Detailed description: Background: Cor pulmonale is a common complication to Chronic Obstructive Pulmonary Disease (COPD), and may result in increased pressure in the inferior caval vein and stasis of the liver. The chronic pulmonary hypertension may lead to stasis in the veins from the small intestine and thereby compromise absorption of nutrients.

Aim: To investigate whether patients with pulmonary hypertension have reduced absorption capacity compared to COPD patients without cor pulmonale.

Methods: Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose, was tested in 14 COPD patients, seven with and seven without cor pulmonale. The presence of cor pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of COPD
* Clinically stable = Unchanged medication for COPD for at least 6 months

Exclusion Criteria:

* Unable to understand Danish
* Other clinically important heart-disease than chronic right heart changes presumably due to lung disease
* Clinically significant gastro-intestinal or kidney disease
* Diabetes
* Treatment with corticosteroids for at least 6 months.

Primary outcomes:
measure: Absorption fraction of D-xylose
timeFrame: 3 hours
Secondary outcomes:
measure: Absorption of zinc
timeFrame: 3 hours
measure: Absorption fraction of D-xylose
timeFrame: 5 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, MD, MPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271294: Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse
Official title: Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
Exair
Transvaginal mesh
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2017-09-05
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done for uterine prolapse in this study. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of large uterine prolapses precluding the need for a hysterectomy.


Eligibility criteria: Inclusion Criteria:

* subjects desiring surgery for stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q) and symptoms specific to pelvic organ prolapse mainly bothersome perception of a vaginal bulge

Exclusion Criteria:

* any physical or mental limitation that precluded their participation or inability to give informed consent

Primary outcomes:
measure: Exair transvaginal mesh procedure success in anatomy and function at 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03115060: Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluid During Renal Transplantation
Official title: Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acid-Base Balance Disorder
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-04-14
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective living donor renal transplant

Exclusion Criteria:

-

Primary outcomes:
measure: acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient
timeFrame: during the surgery
Secondary outcomes:
measure: serum creatinine on day 1, 2 and 7 of surgery
timeFrame: day 1, 2 and 7
measure: intraoperative hemodynamics in all patients
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References:
Clinical trial NCT03944694: White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke.
Official title: White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. DELirium in Acute Ischemic Stroke [DELIAS]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Ischemic Stroke
Keywords: delirium
stroke
neutrophil-to-lymphocyte ratio
NLR
mortality
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients (age \>18 years) with acute ischemic stroke, admitted to a neurology department of a busy district general hospital in Poland between 30.06.2015 and 31.03.2018. Patients with AIS were admitted to the neurology department within 48 hours of symptom development.

Brief summary: The aim of this study was to investigate the role of Neutrophil-to-Lymphocyte Ratio (NLR) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (AIS).

Detailed description: Delirium is an acute brain disorder, potentially reversible, commonly occurring in patients with acute ischemic stroke. The pathomechanism of delirium is related to neuroinflammatory process and oxidative stress. Search for readily available diagnostic marker that will aid clinicians in early identification of delirium is an on-going process. The aim of this study was to investigate the role of Neutrophil-to-Lymphocyte Ratio (NLR) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (AIS).

Eligibility criteria: Inclusion Criteria:

* age \>18 years)
* acute ischemic stroke

Exclusion Criteria:

* hematology disorders
* incomplete laboratory testing
* no data regarding follow-up

Primary outcomes:
measure: Early-onset-delirium.
timeFrame: 24 hours
Secondary outcomes:
measure: Mortality at 30 days.
timeFrame: 30 days
measure: Mortality at 1 year.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Pomeranian Medical University Szczecin
name: Iwona Rotter, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00533494: The Effect of Patients' Participation in Improving Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-09-21
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Despite the advent of efficacious medicines, there is a gap between ideal and actual care in the achievement of recommended outcomes among diabetic patients. The study enrolled 429 diabetic patients attending four HMO clinics in Israel, two in the northern region and two in the southern region. All clinics were randomly selected from all clinics affiliated with the Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to compare the effects of a multi-component physician-patient intervention to physician feedback alone on a combined outcome of diabetes, blood pressure and serum lipids control. We hypothesized that in medical practices where physicians have received feedback on quality of care indicators, patients who received a letter encouraging them to discuss a list of important diabetes-related issues with their doctors, would experience better outcomes compared to patients who did no received such a letter.


Eligibility criteria: Inclusion Criteria:

* Known diabetic patients enrolled in the four primary care clinics
* Age 30 years and older.

Exclusion Criteria:

* Below age 30 years
* Type 1 diabetes
* Spoke neither Hebrew nor Russian
* Bedridden or confined to home.

Primary outcomes:
measure: HbA1c, LDL, systolic blood pressure
timeFrame: Baseline and 1 year after 1-year intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beersheva, Afula, Migdal Haemek
country: Israel
facility: Clalit Health Services
Study officials:
affiliation: Department of Epidemiology- Faculty of Health Sciences-Ben Gurion University
name: Shimon Weitzman, MD, MPH
role: STUDY_CHAIR
affiliation: Department of Family Medicine, Afula - Clalit Health Services
name: Hava Tabenkin, MD, LLB
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, School of Medicine,UCI
name: Sheldon Greenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, School of Medicine,ICI
name: Sherrie H Kaplan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664494: An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer
Official title: A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer, Colorectal Cancer, Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer receiving Xeloda

Brief summary: This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label

Exclusion Criteria:

* Contraindications according to label and off-label use

Primary outcomes:
measure: Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
timeFrame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Secondary outcomes:
measure: Median Dose of Capecitabine
timeFrame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Other outcomes:
Locations:
city: Wien
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: