louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01575132: Deep Brain Stimulation Follow-up After 10 Years
Official title: STN-DBS Retrospective/Prospective Study With a Follow-up Time of Minimum 10 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Stimulation, Deep Brain
Study, Follow-Up
Adverse Effects
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 15
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: All Parkinson-patients treated with Deep Brain Stimulation at Aarhus University Hospital in the years 1998-2002.

Brief summary: The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. We wish to examine the effect of stimulation on motor symptoms as well as make a follow-up on complications and side-effects related to treatment. We also wish to follow-up on the quality of life-studies made in the years 2003-2008.

Detailed description: Parkinson's Disease (PD) is caused by a progressive loss of dopamine-producing cells in substantia nigra in mesencephalon.

PD is characterized by the symptoms resting tremor, rigidity and bradykinesia. Later in the course of the disease, patients develop gait- and balance symptoms. In the first years of the disease, the patients' symptoms are treated well with levodopa. As the disease develops and the loss of dopamine-producing cells grows, the physiological buffer-capacity for levodopa is lost and patients develop motor fluctuations in the shape of on-off symptoms and dyskinesias. Patients with these symptoms may benefit from implantation of electrodes in the subthalamic nucleus, which is stimulated by an pulse generator on the chest.

A number of studies have found a long-term effect of DBS, but most of these studies have a follow-up time of no more than five years. Overall, these studies show a beneficial effect of DBS after five years: The patients need less medication, the number of off-periods is decreased and they score lower on the Unified Parkinson Disease Rating Scale, part three. However, the axial symptoms and the bradykinesia progress.

As of yet, few studies examine the effect of Deep Brain Stimulation after 10 years. In our study we wish to examine the effect of DBS for all patients operated at Aarhus University Hospital in the years 1998-2002, which gives us a follow-up time of 10-14 years.

Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's Disease treated with DBS at Aarhus University Hospital in the years 1998-2002.

Exclusion Criteria:

* Dementia, i.e. MMSE\<24
* DBS removed
* Deceased

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Neurology
Study officials:
affiliation: Aarhus University Hospital
name: Karen Ostergaard, DMSci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06270537: Post-market Clinical Trial of the Dominus® Stent-Graft
Official title: Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Aortic Dissection
Keywords: Aneurysm
Acute Aortic Syndrome
Aortic Dissection
Aortic Diseases
Cardiovascular Diseases
Lead sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 100
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: Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.

Brief summary: Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use

Detailed description: The multicenter study aims to collect post-market clinical data on the Dominus® Stent-Graft in the treatment of thoracic aortic diseases. With the goal of assessing safety and efficacy, the prospective follow-up study will include 100 patients undergoing Endovascular Treatment of Thoracic Aortic Diseases, following the product's Instructions for Use

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older;
2. Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use;
3. Patient available for appropriate follow-up times for the study duration;
4. Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.

Exclusion Criteria:

1. Patient currently participating in another clinical study of drug or medical device;
2. Life expectancy less than 12 months.

Primary outcomes:
measure: Early occurrence of adverse events (Safety Outcome)
timeFrame: 1 month post index procedure
Secondary outcomes:
measure: Device Success
timeFrame: Intraoperative
measure: Absence of endoprosthesis fracture
timeFrame: 1 month and 1 year
measure: Endoleak
timeFrame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
measure: Reintervention-free
timeFrame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
measure: Adverse Events
timeFrame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Other outcomes:
Locations:
city: Vila Velha
country: Brazil
facility: Hospital Evangélico de Vila Velha
state: Espirito Santo
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
name: Edwaldo Joviliano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04954937: Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.
Official title: Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Anti-SARS-CoV-2 antibodies
COVID-19
Convalescent plasma
Lead sponsor: NHS Blood and Transplant
Sponsor class: OTHER_GOV
First posted: 2021-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.

Detailed description: This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff).

Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains.

The results of this study will:

1. Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration.
2. Understand if antibody levels rebound to a concentration suitable for CCP and PFM.
3. Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners).
4. Assist in development of recording vaccination status on NHSBT databases of donors.

Eligibility criteria: Inclusion Criteria:

* Individuals who have had a previous SARS-CoV-2 infection
* Individuals who have previously donated COVID-19 convalescent plasma (CCP)
* Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine)

Exclusion Criteria:

* Not received a SARS-CoV-2 vaccine

Primary outcomes:
measure: Increase in antibody levels post-vaccination assessed via Euroimmun assay
timeFrame: at least 28 days following vaccination
measure: Increase in antibody levels post-vaccination assessed via Roche IgG assay
timeFrame: at least 28 days following vaccination
measure: Increase in antibody levels post-vaccination assessed vial live virus neutralization
timeFrame: at least 28 days following vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: NHSBT - Birmingham Donation Centre
Study officials:
affiliation: NHS Blood and Transplant
name: Lise Estcourt, MB BChir, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06784037: Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax
Official title: Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Robotic Thoracic Surgery
Mechanical Ventilation
Positive End Expiratory Pressure (PEEP)
Keywords: robotic lung surgery
PEEP
capnothorax
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 60
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: Patients receiving uniportal robotic assisted lung resection with no capnothorax

Brief summary: The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.

Detailed description: Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP without capnothorax. PEEP requirement and lung mechanics without capnothorax will be compared with a historical cohort population of robotic surgery with capnothorax.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing uniportal robotic lung resection under no capnothorax

Exclusion Criteria:

* Refusal to participate
* Contraindications to recruitment maneuvers

Primary outcomes:
measure: Respiratory airway pressures
timeFrame: During intra-operative mechanical ventilation (4 hours)
measure: Respiratory rate
timeFrame: During intra-operative mechanical ventilation (4 hours)
measure: Respiratory system compliance
timeFrame: During intra-operative mechanical ventilation (4 hours)
Secondary outcomes:
measure: Arterial blood gas parameters: pO2
timeFrame: During intra-operative mechanical ventilation (4 hours)
measure: Arterial blood gas parameters: pCO2
timeFrame: During intra-operative mechanical ventilation (4 hours)
measure: Arterial blood gas parameters: pH
timeFrame: During intra-operative mechanical ventilation (4 hours)
measure: Arterial blood gas parameters: sodium bicarbonate
timeFrame: During intra-operative mechanical ventilation (4 hours)
measure: Arterial blood gas parameters: base excess
timeFrame: During intra-operative mechanical ventilation (4 hours)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
state: Catalunya
Study officials:
References:
Clinical trial NCT01424137: Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)
Official title: Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 227
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler® (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children, adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Written informed consent (IC) obtained
* Documented diagnosis of asthma and/or COPD
* Age: 4 years and above

Exclusion Criteria:

* Any severe chronic respiratory disease other than asthma or COPD
* Acute respiratory infection
* Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study

Primary outcomes:
measure: Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
timeFrame: 1 day
Secondary outcomes:
measure: The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Lasnamäe Medicum
city: Tartu
country: Estonia
facility: Children's Clinic of Tartu, Allergy Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital, Lung Clinic
city: Espoo
country: Finland
facility: Jorvi Hospital HUS
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Kati Kaijasilta
role: STUDY_DIRECTOR
References:
Clinical trial NCT02001337: Examination of the Pancreas in New-onset Diabetes
Official title: Examination of the Pancreas in New-onset Diabetes (EXPAND Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: pancreatic cancer
new-onset diabetic
diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 79
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Suspected or definite new-onset diabetes

Brief summary: The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

Detailed description: Compared to the general population, subjects \>50 years of age with new-onset diabetes (DM) are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset DM is further increased in those who have weight loss or elevated CA19-9. In this study patients with newly diagnosed diabetes will be prospectively identified. Those with weight loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All subjects will be followed up to 24 months. If successful in identifying surgically removable PaC, this study will fundamentally change our practice and will be a major breakthrough in PaC treatment and research.

Eligibility criteria: Patient Characteristics:

--Suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin A1c values

* No acute illness or steroid therapy
* No prior pancreas surgery

Primary outcomes:
measure: To create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and identify pancreatic cancer in this cohort.
timeFrame: Follow subjects for 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gloria Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05512637: Screening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers
Official title: Screening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Siblings
Neurodevelopmental Disorders
Keywords: Siblings
Screening
Autism Spectrum Disorder
Neurodevelopmental Disorders
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2022-08-23
Enrollment: 384
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The expected number of children is 384 children (142 with NDD and 242 without NDD).

Brief summary: In this study, a selective and multi-stages screening for neurodevelopmental disorders (NDD) in siblings of children with a confirmed ASD is done. The main aims are to estimate the prevalence of NDD among siblings and to evaluate the feasibility and acceptability of a standardized screening procedure.

Detailed description: Although NDD are frequent among siblings of children with ASD, their developmental screening is not yet sufficiently organized in routine practice. The needs and the characteristics of these siblings have yet to be better understood in order to define their developmental surveillance.

Eligibility criteria: Inclusion Criteria:

* Step 1: Brothers or sisters (including stepsisters and brothers); aged between 2 and 16 years; living in Occitanie; informed and express consent of parents ; affiliated to social security.
* Step 2: step 1 positive screening or parental concerns for child's development ; parental signed informed consent.

Exclusion Criteria:

* Parents (or child) refusal to participate; adopted brother or sister. Do not speak French

Primary outcomes:
measure: Percentage of family participation
timeFrame: 12 months
Secondary outcomes:
measure: Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure
timeFrame: 12 months
measure: Percentage of satisfied parents
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Véronique GONNIER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01374737: ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children
Official title: ED50 of Dexmedetomidine for Reduction of Emergence Agitation Incidence Undergoing Tonsillectomy or Adenoidectomy in Desflurane Anesthesia Following Sevoflurane Induction in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Agitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-06-16
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

Detailed description: To investigate ED50, Dixon's up and down method will be used.

Eligibility criteria: Inclusion Criteria:

* tonsillectomy or adenoidectomy

Exclusion Criteria:

* recent URI

Primary outcomes:
measure: agitation
timeFrame: 30 minutes
Secondary outcomes:
measure: pain
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, M.D, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03965637: Intravenous Ascorbic Acid Administration in Hysterectomy
Official title: Effect of Ascorbic Acid Administration on Intraoperative Blood Loss and Wound Healing in Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Hysterectomy
Keywords: vitamin c
Hysterectomy
bleeding
wound healing
abdominal surgeries
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: vitamin C or ascorbic acid has known role in tissue repair. due to it's properties(water_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets.

Detailed description: In this randomized clinical trial, 1000 mg vitamin C will administrate intravenously a day before surgery and during surgery in patients who undergo abdominal hysterectomy.

Eligibility criteria: Inclusion Criteria:

* To be 18 years and older
* No smoking
* No history of bleeding disorder
* No history of favism
* No history of uterus, ovary, cervical cancer

Exclusion Criteria:

* Need to injection of vasopressor drugs
* Surgeon disagreement

Primary outcomes:
measure: volume of hemorrhage
timeFrame: During surgery
Secondary outcomes:
measure: Hemoglobin value
timeFrame: 6 and 24 hours after surgery
measure: wound healing
timeFrame: during 2 weeks post surgery
measure: duration of stay in hospital
timeFrame: up to 2 weeks post surgery
measure: Infection
timeFrame: up to 2 weeks post surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: Associatec professor
name: zahra vahdat shariatpanahi, MD,PhD
role: STUDY_CHAIR
References:
citation: Farahani-Jam S, Yaghmaei M, Vahdat Shariatpanahi Z. Effect of intravenous ascorbic acid administration on hemorrhage and wound complications in total abdominal hysterectomy: A prospective randomized clinical trial. Clin Nutr ESPEN. 2022 Jun;49:74-78. doi: 10.1016/j.clnesp.2022.03.024. Epub 2022 Mar 26.