louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04290260: Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
Official title: Randomized Controlled Trial of the Effectiveness of Bra Application in Women as a Device for Prevention of Surgical Wound Dehiscence in the Post-operative Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgical Procedures
Wound Healing
Keywords: Cardiovascular nursing
Bra
Dehiscence
Sternotomy
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fundació Institut Germans Trias i Pujol
First posted: 2020-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.

Detailed description: Background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. There is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound.

Aim: To assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.

Methods: Randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. Groups: application of post-surgical or non-surgical breast bra. Endpoint: incidence of dehiscence. Other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. Assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.

Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative
* Surgical intervention performed throughout medium sternotomy

Exclusion Criteria:

* More than 72 hours admitted in an intensive care unit after surgery
* Cognitive impairment or severe physical disability
* Mastectomy
* External wound occlusion with Opsite® fixative absorbent dressing
* Emergency surgery

Primary outcomes:
measure: Dehiscence
timeFrame: Baseline (admission) to 6 months after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol University Hospital
name: Violeta Díaz Herrera, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214460: Impact of Medical Emergency Team and EMS in Tampere University Hospital
Official title: Impact of Medical Emergency Team and EMS on ICU Readmissions and Sudden Cardiac Arrests in Tampere University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death, Sudden,Cardiac
Keywords: MET
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 10000
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: All adult EMS or in-hospital patients with deteriorating vital signs or patients in risk in Tampere University Hospital

Brief summary: Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes like cardiac arrest or transfer to intensive care unit. The aims of this study are to record and analyze the effects of EMS and department of emergency and both afferent and efferent limbs of MET activity in Finnish tertiary Hospital.


Eligibility criteria: Inclusion Criteria:

* 18 yrs or older

Exclusion Criteria:

* under 18 yrs

Primary outcomes:
measure: In-hospital mortality
timeFrame: patients are followed until death
Secondary outcomes:
measure: The rates of ICU readmissions
timeFrame: one month to six year
measure: The rates of DNAR orders
timeFrame: one month to six year
measure: The number of patients EMS or medical emergency team is called to treat
timeFrame: one month to six years
measure: Patient mortality after 6 mo of discharge
timeFrame: one month to six year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: Tampere University Hospital
name: Jari Kalliomäki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Sanna Hoppu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Joonas Tirkkonen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Timo Kontula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Eetu Loisa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03746860: N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France
Official title: Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis Due to House Dust Mite
Allergic Asthma Due to Dermatophagoides Farinae
Allergic Asthma Due to Dermatophagoides Pteronyssinus
Keywords: Allergy
Allergic Rhinitis
Allergic Asthma
House Dust Mite
Immunotherapy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: ITEC Services
First posted: 2018-11-20
Enrollment: 1508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults suffering of HDM allergic rhinitis or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis.

Patients are only included in the study after the decision for treatment with ACARIZAX® has already been made, and only with the objective of documenting data that reflects the treatment and its safety under 'real life' conditions. Accordingly, only examinations and inquiries conforming to routine practice are conducted and documented.

Brief summary: Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (\>18 years) with house dust mite allergy over a period of 12 months.

Detailed description: Condition:

* persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication
* HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment.

Eligibility criteria: Inclusion Criteria:

* At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent

Exclusion Criteria:

* Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).

Primary outcomes:
measure: Safety analysis: Number of patients with at least one Adverse Event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
Study officials:
affiliation: Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE
name: Pascal DEMOLY, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04506060: Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation
Official title: Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: BK Virus Nephropathy
Risk Factor
Kidney Transplantation
Keywords: BK Virus Nephropathy
risk factor
kidney transplantation
viral serology
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation

Brief summary: Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.


Eligibility criteria: Inclusion Criteria:

* adult kidney transplanted patients
* Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation.

Exclusion Criteria:

* Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)

Primary outcomes:
measure: Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00736060: Clinical and Laboratory Characteristics of Sickle Cell Anemia Patients Admitted With Fever
Official title: Study the Clinical and Laboratory Characteristics and the Outcome of Sickle Cell Anemia Patients Admitted to the Pediatric Ward Because of Fever as the Presenting Symptom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Anemia
Sickle Cell Thalassemia
Keywords: Fever
Blood cultures
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 patients treated at the Pediatric Hematology Unit in the Ha'Emek Medical Center suffering from sickle cell anemia or sickle cell thalassemia admitted with fever as the presenting symptom.

Brief summary: This study will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward.

Detailed description: The actual protocol for SCA patients admitted with fever is to obtain blood cultures and start empiric antibiotic treatment.

The study cohort included 60 SCA patients actually treated in the Pediatric Hematology Unit.

Eligibility criteria: Inclusion Criteria: All patients admitted with fever as the only presenting symptom.

Exclusion Criteria: Patients admitted with another causes related or unrelated to sickle cell disease and have also fever.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - Ha'Emek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
name: Carina Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
name: Ilena Arshinov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06396260: Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
Official title: Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Pseudobulbar Affect
Keywords: Diffusion Kurtosis Imaging
Magnetoencephalography
Connectivity
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2024-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal imaging study. Baseline acquisition of DKI and resting state MEG of ALS and matched healthy controls. Participants with ALS will be monitored for a period of 6 months for symptoms of PBA. If developed, or not developed after 6 months, follow-up DKI and MEG will be acquired.

An additional sub-study will be performed in patients with ALS and newly developed PBA, where resting state MEG will be acquired after at least 7 days of symptomatic treatment independent of the study.
Primary purpose: OTHER

Brief summary: The investigators aim to elucidate characteristics of structural and functional brain connectivity in patients with amyotrophic lateral sclerosis (ALS) and pseudobulbar affect (PBA) using diffusion kurtosis imaging (DKI) and magnetoencephalography (MEG).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ALS in the last 6 months according to Gold Coast Criteria

Exclusion Criteria:

* - Lack of ability to answer survey through own ability or through a surrogate, for example by hand controlled, eye-controlled computer and/or tablet, or through telephone interview.
* Lack of ability to cooperate.
* Pregnancy
* Drug addiction defined as the non-prescribed use of cannabis, opioids, or other narcotics.
* Alcohol addiction defined as over 21 units weekly.
* Lesional neurological diseases, such as stroke, tumor or multiple sclerosis
* Epilepsy
* Neurodegenerative diseases other than ALS
* Severe psychiatric disease such as major depression disorder, bipolar disease or schizophrenia
* Contraindication for MRI and MEG scan according to hospital guidelines
* Severe liver or kidney disease
* Dysregulated heart disease
* Ongoing treatment with any antidepressants or any antipsychotics at recruitment.
* Diagnosed with frontotemporal dementia.

Primary outcomes:
measure: Mean kurtosis
timeFrame: Baseline measurement and up to 6 month follow-up measurements
measure: Spectral connectivity
timeFrame: Baseline measurement and up to 6 month follow-up measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University hospital
state: Northern Jutland
Study officials:
References:
Clinical trial NCT00760760: n-3 Polyunsaturated Fatty Acids in Obesity
Official title: Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adipose Tissue Inflammation
Morbid Obesity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2008-09-26
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.


Eligibility criteria: Inclusion Criteria:

* Non-diabetic morbidly obese patients (BMI \> 40 kg/m2) supposed to undergo bariatric surgery
* Age 20-65 yrs

Exclusion Criteria:

* Acute illness within the last two week
* Known diabetes mellitus or current anti-diabetic medication
* Acquired immunodeficiency (HIV infection)
* Hepatitis or other significant liver disease
* Severe or untreated cardiovascular, renal, pulmonary disease
* Untreated or inadequately treated clinically significant thyroid disease
* Anemia
* Active malignant disease
* Inborn or acquired bleeding disorder including warfarin treatment
* Pregnancy or breast feeding
* Drug intolerability that prohibits the use of the study drug

Primary outcomes:
measure: Adipose tissue inflammation
timeFrame: Eight weeks of treatment
Secondary outcomes:
measure: Metabolic control
timeFrame: Eight weeks of treatment
measure: Dependence of effects on Pparg polymorphisms
timeFrame: Eight weeks of treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas M Stulnig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Itariu BK, Zeyda M, Leitner L, Marculescu R, Stulnig TM. Treatment with n-3 polyunsaturated fatty acids overcomes the inverse association of vitamin D deficiency with inflammation in severely obese patients: a randomized controlled trial. PLoS One. 2013;8(1):e54634. doi: 10.1371/journal.pone.0054634. Epub 2013 Jan 25.
citation: Itariu BK, Zeyda M, Hochbrugger EE, Neuhofer A, Prager G, Schindler K, Bohdjalian A, Mascher D, Vangala S, Schranz M, Krebs M, Bischof MG, Stulnig TM. Long-chain n-3 PUFAs reduce adipose tissue and systemic inflammation in severely obese nondiabetic patients: a randomized controlled trial. Am J Clin Nutr. 2012 Nov;96(5):1137-49. doi: 10.3945/ajcn.112.037432. Epub 2012 Oct 3.
Clinical trial NCT04218760: Multiomics After Headache Provocation of People Who Are Unable to Have Headache
Official title: Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Healthy
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case-control study.
Primary purpose: OTHER

Brief summary: Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.

The aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators will measure multiomic changes (transcriptomics and metabolomics) after headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.

The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.


Eligibility criteria: Inclusion Criteria:

* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
* Weight: 45 kg to 95 kg

Exclusion Criteria:

* Daily consumption of any medication.
* Consumption of any medication less than 12 hours prior to the study day.
* Headache on the study day or 48 hours prior to the study day.
* Amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).
* Any severe cardiovascular disease, including cerebrovascular illness.
* Amnestic or clinical signs of current mental illness.
* Amnestic or clinical signs of current substance or drug abuse.
* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.

Primary outcomes:
measure: Transcriptomic changes
timeFrame: 5 hours
measure: Metabolomic changes
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Region H
Study officials:
affiliation: Danish Headache Center
name: Jes Olesen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02718560: Handwriting Rehabilitation in Parkinson Disease
Official title: Effectiveness of Intensive Handwriting Rehabilitation in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Neurorehabilitation
Handwriting
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.

Detailed description: The investigators aimed to understand whether an intensive handwriting treatment with cognitive engagement is more effective than a treatment exploiting only the passive wrist joint mobilization in Parkinson's Disease.

Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease patients

Exclusion Criteria:

* Mini Mental State Examination (MMSE) score \< 24
* Left handed subjects
* Subjects with dyskinesias
* Subjects with Deep Brain Stimulation

Primary outcomes:
measure: letters size
timeFrame: 4 weeks
Secondary outcomes:
measure: writing speed (time spent to write every single letter and word, measured in milliseconds)
timeFrame: 4 weeks
measure: centimeters away from a straight line during writing
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale Generale di zona Moriggia Pelascini
state: Como
Study officials:
affiliation: Ospedale Generale Di Zona Moriggia-Pelascini
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References: