louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04265612: Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.
Official title: Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Infection, Surgical
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 253
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 objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical".

Detailed description: Negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed.

Negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy).

All these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs.

Today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy.
* Who signs Informed Consent after agreeing to participate in the microbiological study.

Exclusion Criteria:

* Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding.
* Patients with immunocompromised haematological diseases.
* Patients who are allergic or present some hypersensitivity to the dressing or excipient.
* Patients who are participating in another experimental study.
* Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.

Primary outcomes:
measure: Incidence of infection of the sternal surgical wound.
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Pilar Garrido Martín
Study officials:
affiliation: Hospital Universitario de Canarias
name: Rafael Martínez Sanz, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario de Canarias
name: Pilar Garrido Martín, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284712: Natural Killer Cells and Polycythemia Vera (Vaquez's Disease)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycythemia Vera
Keywords: treatment by bleedings
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: VAQUEZ'S DISEASE

Brief summary: Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective expression of HLA class I molecules and are complementary to specific cytotoxic T lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This defect is at least partially linked to a decreased or absent expression of some activating NK cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30, NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia vera). The investigators more particularly focused their attention on polycythemia vera (Vaquez's disease), a myeloproliferative disease characterized by the recently describet mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms leading to this cytotoxicity defect, the investigators also will evaluate the implication of V617F mutation on NK physiology, and will study the interactions between NK cells and hematopoietic progenitors.


Eligibility criteria: Inclusion Criteria:

* Polycythemia vera
* Treatment by therapeutic bleedings
* No cytotoxic treatment during the previous six months

Exclusion Criteria:

* No Polycythemia vera
* No treatment by therapeutic bleedings
* Cytotoxic treatment during the previous six months

Primary outcomes:
measure: To describe immunologic anomalies in polycythemia vera
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Regis Costello
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821912: TaxXel: Taxotere and Xeloda in Esophageal Cancer
Official title: A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cancer of the Esophagus
Gastric Cardia Carcinoma
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase.

The primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia.
* Inoperable metastatic disease
* Performance status (WHO) of 0-2
* Measurable disease.
* Adequate hematological, liver and renal function.
* Signed informed consent.

Exclusion Criteria:

* CNS metastases
* Symptomatic peripheral neuropathy equal to or greater than NCI grade 2.
* Other concomitant serious illness or medical condition.
* Past or current history of malignant neoplasm other than oesophageal carcinoma.
* \<18 years of age. Pregnant or lactating patients.

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: CT scan
timeFrame: Every 9 weeks
measure: Toxicity assessment
timeFrame: Every three weeks
measure: Quality of life
timeFrame: Every three weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland universitetssykehus
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Ullevål
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Malmö
country: Sweden
facility: Malmö General University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Dept of Oncology
city: Sundsvall
country: Sweden
facility: Sundsvall County Hospital
city: Uppsala
country: Sweden
facility: Uppsala Akademic Hospital
city: Västerås
country: Sweden
facility: Västerås Central Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Signe Friesland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772912: Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
Official title: Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthroplasty, Replacement, Knee
Keywords: Hemostatics
Coagulants
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2018-12-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing elective, unilateral total knee arthroplasty procedures that meet all eligibility criteria.

Brief summary: The purpose of this post-market observational registry is to collect additional data on the safety and effectiveness of the HEMOBLAST™ Bellows device in total knee arthroplasty procedures.

Detailed description: A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.

Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 10 months from the time of first subject enrollment to completion of the last subject follow up.

Eligibility criteria: Preoperative Inclusion Criteria:

* Patient is undergoing a unilateral total knee arthroplasty procedure; and
* Patient is willing and able to give written informed consent for registry participation.

Preoperative Exclusion Criteria:

* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and
* Patient has religious or other objections to porcine, bovine, or human components.

Intraoperative Inclusion Criteria

* Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
* The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indication for Use.

Primary outcomes:
measure: Achievement of Hemostasis at the Target Bleeding Site
timeFrame: Intraoperatively, expected within 3-10 minutes of application
Secondary outcomes:
measure: Incidence of Serious Adverse Device Effects (SADEs)
timeFrame: Through study completion, on average 1-2 days post-surgery
measure: Incidence of Unanticipated Serious Adverse Device Effects (UADEs)
timeFrame: Through study completion, on average 1-2 days post-surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01419912: Comparison of Soy-milk and Cow Milk Consumption on Inflammatory Factors, Cardiovascular Factors ,Renal Factors, Fibrinolytic Indice and Oxidative Stress Among Type-2 Diabetic Patients With Nephropathy Stage 1 and 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Oxidative Stress
Fibrinolytic Markers
Blood Pressure and Cardiorenal Risk Factors
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-08-18
Sex: ALL
Minimum age (years): 28
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Intervention model: CROSSOVER

Brief summary: Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with DN and there are few data about relationship of soy milk consumption and health effect in patients with DN . Therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* adults with (\>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min )

Exclusion Criteria:

* exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women
* changing dosage of oral hypoglycemic agents
* insulin therapy
* lipid-lowering medications
* use of hormone replacement therapy
* alcohol and cigarette consumption;allergy or intolerance to soybeans or milk
* presence of breast malignant and avoid of advisory diet

Primary outcomes:
measure: soy milk
Secondary outcomes:
measure: HbA1c
measure: creatinin
measure: total cholesterol
measure: insulin
measure: systolic blood pressure
measure: diastolic blood pressure
measure: Malondialdehyde
measure: fibrinogen
measure: Urine creatinine
measure: urine protein
measure: BUN
measure: TNF-α
measure: IL6
measure: FBS
measure: TG
measure: hs-CRP
measure: d-dimer
measure: HDL
measure: LDL
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
References:
citation: Miraghajani MS, Esmaillzadeh A, Najafabadi MM, Mirlohi M, Azadbakht L. Soy milk consumption, inflammation, coagulation, and oxidative stress among type 2 diabetic patients with nephropathy. Diabetes Care. 2012 Oct;35(10):1981-5. doi: 10.2337/dc12-0250. Epub 2012 Jul 11.
Clinical trial NCT00931112: Effects of Individualized Exercise Training in Patients With Peripheral Arterial Disease
Official title: Effects of Individualized Exercise Training on Arterial Function, Walking Ability and Quality of Life in Patients With Peripheral Arterial Disease Post Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Walking ability
Quality of life
Exercise training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to investigate individualized exercise training effects on arterial function, walking ability and quality of life in subjects with peripheral arterial disease post surgery.


Eligibility criteria: Inclusion Criteria:

* Peripheral arterial disease post surgery \> 1 month
* No discharge of surgical incision
* Intermittent claudication post invasive treatment

Exclusion Criteria:

* Necrosis
* Above/below knee amputee
* Other conditions might affect peripheral vascular elasticity

Primary outcomes:
measure: arterial function, walking ability and quality of life
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01249612: Knee Joint Icing and Knee-extension Strength
Official title: No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Arthroplasty
Keywords: Knee joint icing
knee-extension strength
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2010-11-30
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: With this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after TKA.

Detailed description: As knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after TKA.

Eligibility criteria: Inclusion Criteria:

* primary unilateral total knee arthroplasty

Exclusion Criteria:

* inability to speak and understand Danish
* inability to perform the measurements due to other diseases

Primary outcomes:
measure: Knee-extension strength
timeFrame: In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment
Secondary outcomes:
measure: Knee pain
timeFrame: In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Lundbeckcenter for fast-track hip and knee surgery
state: Hvidovre
Study officials:
affiliation: Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark
name: Bente Holm, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holm B, Husted H, Kehlet H, Bandholm T. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study. Clin Rehabil. 2012 Aug;26(8):716-23. doi: 10.1177/0269215511432017. Epub 2012 Jan 19.
Clinical trial NCT04519112: Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial
Official title: Department of Cardiology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Premature Ventricular Contraction
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 200
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: This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.


Eligibility criteria: Inclusion Criteria:

1. non-outflow tract PVCs
2. Holter\>10,000/24h or PVCs load\>10%
3. the first ablation procedure
4. failure of at least one AAD to treat PVCs before ablation

Exclusion Criteria:

1. PVC ablation history
2. HF with NYHA IV
3. 3 months prior to AMI or PCI
4. Cardiac thrombosi
5. Hyperthyroidism
6. Pregnancy

Primary outcomes:
measure: Freedom rate of PVC
timeFrame: one year
measure: Procedure-related Complications
timeFrame: one year
Secondary outcomes:
measure: fluoroscopic time
timeFrame: one day
measure: ablation time
timeFrame: one day
measure: procedure time
timeFrame: one day
Other outcomes:
Locations:
Study officials:
References:
citation: Noten AME, Hendriks AA, Yap SC, Mol D, Bhagwandien R, Wijchers S, Kardys I, Khan M, Szili-Torok T. Contact feedback improves 1-year outcomes of remote magnetic navigation-guided ischemic ventricular tachycardia ablation. Int J Cardiol. 2020 Sep 15;315:36-44. doi: 10.1016/j.ijcard.2020.05.028. Epub 2020 May 12.
citation: Qiu X, Zhang N, Luo Q, Liu A, Ji Y, Ye J, Lin C, Ling T, Chen K, Pan W, Zhao J, Jin Q, Wu L. Remote magnetic navigation facilitates the ablations of frequent ventricular premature complexes originating from the outflow tract and the valve annulus as compared to manual control navigation. Int J Cardiol. 2018 Sep 15;267:94-99. doi: 10.1016/j.ijcard.2018.03.105.
Clinical trial NCT00629512: Prevention of Gastric Ulcers
Official title: A Comparative Efficacy and Safety Study of Nexium (Esomeprazole Magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated With Daily NSAID Use in Patients at Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSAID Associated Gastric Ulcers
Keywords: NSAID, Nexium, esomeprazole, Gastric Ulcers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 504
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: Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.


Eligibility criteria: Inclusion Criteria:

1. No gastric or duodenal ulcer on baseline endoscopy.
2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
3. Other inclusion criteria, as defined in the protocol.

Exclusion Criteria:

1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other criteria, as defined in the protocol.

Primary outcomes:
measure: To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk
timeFrame: Assessments at Week 0, Week 4, Week 12, Week 26
Secondary outcomes:
measure: Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy.
timeFrame: Assessments at Week 0, Week 4, Week 12, Week 26
measure: Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy
timeFrame: Assessments at Week 0, Week 4, Week 12, Week 26
Other outcomes:
Locations:
Study officials:
affiliation: Queens Medical Centre
name: Professor Chris Hawkey
role: PRINCIPAL_INVESTIGATOR
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References: