louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05573399: Early Oral Feeding for Patients After Pancreaticoduodenectomy
Official title: Clinical Efficacy Analysis on Early Oral Feeding Versus Nasojejunal Early Enteral Nutrition for Patients After Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatoduodenectomy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent pancreaticoduodenectomy in Changhai Hospital.

Brief summary: This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is expected to revise the guidelines for early nutritional support after pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for clinical work.

Detailed description: Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%. Malnutrition is a relevant predictor of post-operative morbidity and mortality after pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications, including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic leak. The optimal nutritional support method after Pancreaticoduodenectomy is still uncertain, and the current nutritional support methods are diverse. The results of an international survey showed that there was very poor or no agreement on postoperative strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the investigators designed this retrospective study to evaluate which was safer and more feasible between early oral feeding and nasojejunal early enteral nutrition after Pancreaticoduodenectomy, using the method of propensity score weighting.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent pancreaticoduodenectomy by a certain surgeon in Changhai Hospital
* Patients who were treated with nasojejunal enteral nutrition or oral enteral nutrition after operation.

Exclusion Criteria:

* Patients who underwent pancreaticoduodenectomy by other surgeons during the same period;
* Patients who received other nutritional support rather than nasojejunal tube enteral nutrition or oral enteral nutrition after operation.

Primary outcomes:
measure: Perioperative complications
timeFrame: From Operation date to three months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital, Shanghai, China
name: Gang Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05243199: Sacubitril/Valsartan for CKD5 Stage Dialysis Patients
Official title: Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CKD5 Stage Dialysis
Heart Failure
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.


Eligibility criteria: Inclusion Criteria:

* CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
* NT-proBNP ≥2000pg/ml.
* hypertension
* Voluntary informed consent.

Exclusion Criteria:

* Unable to tolerate ACEI/ARB class antihypertensive drugs;
* History of symptomatic hypotension/systolic blood pressure \<100mmHg at screening;
* Potassium \>6.0mmol/L;
* History of angioedema;
* Abnormal liver function such as ALT and/or AST \>=3 times normal upper limit (ULN), total bilirubin \>= 2 times ULN;
* Moderate to severe anemia (hemoglobin \<80g/L);
* Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
* Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
* Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
* New and serious life-threatening infections;
* Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
* Persons suffering from mental disorders and taking psychotropic drugs;
* Patients with life expectancy less than 12 months;
* The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
* Patients who do not want to sign informed consent.

Primary outcomes:
measure: The effect of ARNI on blood pressure in patients with CKD who are on dialysis
timeFrame: 1 year
Secondary outcomes:
measure: The effect of ARNI on ambulatory blood pressure
timeFrame: 1 year
measure: The effect of ARNI on cardiac function in patients with CKD who are on dialysis
timeFrame: 1 year
measure: The safety of ARNI in patients with CKD who are on dialysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
References:
Clinical trial NCT03464799: Does Immunotherapy Have a Role in the Management of Endometriosis?
Official title: Does Immunotherapy Have a Role in the Management of Endometriosis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-14
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 operated for endometriosis

Brief summary: Pathological specimens of 40 women that had been operated for endometriosis will be included in this study. These tissues will be stained with a marker named as PDL-1 in pathological examination. "programmed cell death (PD-1)" is expressed on T cells. The immunotherapies in which antibodies against these PD-1 and its ligands (PDL-1) have been used are accepted as very effective in the treatment of many cancers. If these ligands can be shown in the endometriosis, it will be an important step for the treatment of endometriosis.

Detailed description: 40 women who had been operated for endometriosis between 2013 and 2014 will be included in this study. Pathological specimens will be stained with an immunohistochemical marker named as PDL-1. "programmed cell death (PD-1)" is a protein containing 288 aminoacids and expressed on T cells. It was shown on apoptotic cells in earlier times, but then it has been understood that its physiologic role is not cell death. The upregulation of PD-1 is a result of the activation of T cells and it is necessary for the termination of immune response. PD-L1 is a ligand for PD-1. The immunotherapies in which antibodies against these PD-1 and its ligands (especially PDL-1) provides significant improvements in many cancers such as melanoma. Evidence about the role of these ligands in endometriosis will be an important step in its management.

Eligibility criteria: Inclusion Criteria:

* patients operated for endometriosis between 2013 and 2014
* pathological examinations proving the diagnosis of endometriosis

Exclusion Criteria:

* patients operated for cysts other than endometriosis

Primary outcomes:
measure: immunohistochemical staining
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04433299: Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
Official title: Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Keywords: low back pain, phenotype
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2020-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 18 and 80 with low back pain

Brief summary: To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients

Detailed description: Low back pain patients will fill in a detailed questionnaire (incl. pain drawing) about their pain. Some of them will undergo a standardized quantitative sensory testing protocol and an fMRI procedure.

Eligibility criteria: Inclusion Criteria:

-primary complaint: low back pain clinically not attributable to red flags

Exclusion Criteria:

* any major medical or psychiatric condition that affects pain sensitivity
* contraindications to MRI

Primary outcomes:
measure: spatial pain extent
timeFrame: baseline
measure: measures for central sensitization
timeFrame: baseline
Secondary outcomes:
measure: changes in spatial pain extent
timeFrame: changes from baseline to 3 months
measure: changes in measures for central sensitization
timeFrame: changes from baseline to 3 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
state: Zurich
Study officials:
affiliation: Balgrist University Hospital
name: Petra Schweinhardt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007599: Wound Healing in Primary TKA
Official title: Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Total Knee Replacement
Wound Complication
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. The development of early wound complications can lead to increased length of hospital stay and more serious complications, including deep infection and major subsequent surgery. However, there are modifiable variables that could affect the risk of getting wound complications, such as the closure technique. This study aims to analyze the difference in rates of wound complications using two different closure techniques in primary TKA.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old that will undergo primary TKA with a midline approach

Exclusion Criteria:

* Previous knee arthroplasty surgeries or midline scars
* TKA secondary to oncologic or traumatic etiologies
* BMI ≥ 40
* uncontrolled diabetes (measured by a Hgb A1c above 8)
* reported allergy to skin adhesive
* immunodeficiencies
* bleeding disorders
* anticoagulation other than ASA

Primary outcomes:
measure: wound complications
timeFrame: 90 days
measure: Patient satisfaction
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03269799: Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients
Official title: The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2 With Hyperglycemia
Periodontitis
Keywords: uncontrolled type 2 diabetes mellitus
periodontitis
non surgical periodontal treatment
vitamin C
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at the end of week 4 and at the end of week 8.


Eligibility criteria: Inclusion Criteria:

* uncontrolled type 2 diabetes mellitus
* periodontitis

Exclusion Criteria:

* complications from diabetes mellitus, e.g., renal insufficiency
* receive insulin
* diseases that interfere with wound healing, e.g., HIV
* receive one of the followings: tetracycline, acetaminophen, NSAID, warfarin, aluminum-containing antacids, barbiturates, phenobarbital, pentobarbital, secobarbital, hormone replacement therapy, chemotherapeutic drug, protease inhibitor
* receive other vitamins or antibiotics within 6 months
* smoking
* pregnancy

Primary outcomes:
measure: sulcus bleeding index
timeFrame: baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Burapha University Hospital
Study officials:
affiliation: Faculty of Dentistry, Mahidol University
name: Nis Okuma, DDS, MD, M.Sc (Oral Medicine)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423799: Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
Official title: Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Cancer
Keywords: Quality of life
Cancer
Immunonutrition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically proven GI cancer.
* Age ≥ 18 years.
* Life expectancy more than 3 months.
* Female patients of child-bearing potential must be willing to employ effective contraception during the study period.
* Female patients of child-bearing potential must have a negative serum Beta Human Chorionic Gonadotrophin (βhCG) test at Visit 0.
* The patient is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
* The patient voluntarily gives written informed consent to participate in the study.

Exclusion Criteria:

* Severe concomitant clinical conditions other than the previously untreated digestive tract cancer that jeopardise the protocol follow-up.
* The patient is pregnant or is a lactating woman.
* Currently participating or having participated in another interventional clinical trial related to nutritional support during the 30 days prior to the beginning of the study product intake, except if this other interventional trial is testing new drug or surgical intervention. (Note: participation in a prior or concurrent clinical trial not related to nutritional support does not exclude the patient from participation.)
* Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
* Patients with more than 20% weight loss over a 6 months period.

Primary outcomes:
measure: Quality of Life (QOL), measured with the EORTC QLQ-C30
timeFrame: QOL will me measured 30 days post-surgery
Secondary outcomes:
measure: QOL assessed by the EORTC QLQ-OG 25
timeFrame: QOL will me measured 30 days post-surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
Study officials:
affiliation: University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
name: Christophe Mariette, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04122599: Melatonin for Prevention of Post Stroke Delirium
Official title: Melatonin for Prevention of Post Stroke Delirium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Post Stroke Delirium
Keywords: Melatonin
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Post stroke delirium is prevalent in 10-30% of all stroke patients. We aimed to investigate wether Melatonin 2mg may prevent post stroke delirium.


Eligibility criteria: Inclusion Criteria:

* all patients with stroke, TIA or ICH admitted to our stroke unit or intemdiate care unit
* Stroke / ICH /TIA onset \<= 48h

Exclusion Criteria:

* RASS \<=4
* severe dementia, psychosis or depression

Primary outcomes:
measure: Change of delir prevalence
timeFrame: 3months
Secondary outcomes:
measure: Change of hospital stay
timeFrame: 3months
measure: Change of antipsychotic drug administration
timeFrame: 3 months
measure: Changed stay on stroke unit and/or intermediate care
timeFrame: 3 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Klinik für Neurologie
state: BW
Study officials:
References:
Clinical trial NCT00890799: Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
Official title: Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Septal Defects
Keywords: transcatheter closure
ventricular septal defects
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.

Detailed description: Perimembranous Ventricular septal defect (VSD) is the most common congenital cardiac malformation and constitutes over 20% of all congenital cardiac disease. Though conventional surgery for VSD is a widely accepted procedure with minimal operative mortality, it carries a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. The newly appeared transcatheter device closure technique provides an alternative to surgical closure. However, the mid-to-long term effects of this technique using occluders is not clear. The aim of this study was to evaluate the safety and effectiveness of transcatheter closure of perimembranous ventricular septal defects using septal occluders.

Eligibility criteria: Inclusion Criteria:

* Patients with ventricular septal defects eligible for transcatheter closure.

Exclusion Criteria:

* Patients less than 2 years old. Patients not suitable for transcatheter closure. Patients comorbid with other diseases.

Primary outcomes:
measure: Major adverse events
timeFrame: till study end
Secondary outcomes:
measure: Minor adverse events
timeFrame: Till study end
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Cardiovascular Hospital
name: Jian Yang, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, Zuo J, Yu S, Yi D, Yang X, Zhu X, Li J, Yang L, Xiong L, Ge S, Ren J, Yang J. Effectiveness and Safety of Transcatheter Closure of Perimembranous Ventricular Septal Defects in Adults. Am J Cardiol. 2016 Mar 15;117(6):980-7. doi: 10.1016/j.amjcard.2015.12.036. Epub 2015 Dec 31.
citation: Yang J, Yang L, Yu S, Liu J, Zuo J, Chen W, Duan W, Zheng Q, Xu X, Li J, Zhang J, Xu J, Sun L, Yang X, Xiong L, Yi D, Wang L, Liu Q, Ge S, Ren J. Transcatheter versus surgical closure of perimembranous ventricular septal defects in children: a randomized controlled trial. J Am Coll Cardiol. 2014 Apr 1;63(12):1159-1168. doi: 10.1016/j.jacc.2014.01.008. Epub 2014 Feb 5.
citation: Yang J, Yang L, Wan Y, Zuo J, Zhang J, Chen W, Li J, Sun L, Yu S, Liu J, Chen T, Duan W, Xiong L, Yi D. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J. 2010 Sep;31(18):2238-45. doi: 10.1093/eurheartj/ehq240. Epub 2010 Aug 27.