louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06676085: A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation
Official title: A Novel Strategy Combined Regional Anticoagulation in Membrane Oxygenator and Low-intensity of Systemic Anticoagulation Applied in Management of Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ECMO
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.


Eligibility criteria: Inclusion Criteria:

* age older than 18 years old
* received ECMO because of severe respiratory failure

Exclusion Criteria:

* anticoagulant contraindications
* cerebral infarction or suspected patients
* severe hypertension
* women in gestational and lactational period
* hemophilia
* allergic to heparin or Nafamostat
* unwilling or unable to complete the study

Primary outcomes:
measure: incidence of ECMO related bleeding or thrombotic events
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bing Sun
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Bing Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720885: Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
Official title: Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta, Retained
Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage
Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage)
Pregnancy Related
Hysteroscopy / Methods
Retrospective Studies
Vacuum Curettage
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a placental remnant in medical history.

Brief summary: Collection of relevant data form patients who were treated in the Ghent University Hospital in the context of a placental remnant lager than 4 cm, performing statistical analyzes on the collected data, reviewing the literature on the subject and formulation of a recommendation for treatment of these large placental remnants.


Eligibility criteria: Inclusion Criteria:

* retained products of conception larger than 4 cm in largest dimension

Exclusion Criteria:

* retained products of conception 4 cm or smaller in largest dimension

Primary outcomes:
measure: Hysteroscopy
timeFrame: time of surgery
measure: Vacuum Curettage
timeFrame: time of curettage
measure: Polyp forceps
timeFrame: time of surgery
measure: Prostaglandines
timeFrame: time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Tjalina Hamerlynck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234385: Functional Outcome Following Surgical Treatment of Patients With Sternoclavicular Joint Infection
Official title: Functional Outcome Following Surgical Treatment of Patients With Sternoclavicular Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sternoclavicular Joint Infection
Keywords: QuickDASH questionnaire
extended SCJ resection
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 14
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 diagnosed with SCJ infection and surgical treatment of extended SCJ resection, treated at the Department of Thoracic Surgery at the University Hospital Basel between 31.05.2011 and 28.02.2022.

Brief summary: The Sternoclavicular joints (SCJ) represents an important factor in stability of shoulder joint. Its influence and its function is important for the functionality of the shoulder. SCJ infection is a rare condition and remains often mistreated and potentially life threatening.

This study is to assess the cases treated at the University Hospital Basel with a surgical approach of extended resection of the SCJ. One prospective follow-up visit inclusive one physical examination per patient will be performed to evaluate the long-term functional results of arm, shoulder, hand function with the QuickDASH questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patient assigned and treated at the Department of Thoracic Surgery, University Hospital Basel (USB)
* At hospital admission diagnosed with clinical characteristics of sternoclavicular joint infection
* Surgical treatment of extended SCJ resection received
* Signed written informed consent according to ICH-GCP regulations prior to initiation of any protocol-specific activities/procedure
* Patients who died will be included if a signed USB general research consent is available

Exclusion Criteria:

* Isolated sternal or clavicular infection
* Patients received other surgery than extended SCJ resection at USB thoracic surgery
* Inability to follow procedures or insufficient knowledge of language (German/French) or inability to give consent
* Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes

Primary outcomes:
measure: QuickDASH score
timeFrame: one time assessment at the prospective follow-up visit (timeframe of maximal 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Thoracic Surgery, University Hospital of Basel
Study officials:
affiliation: Department of Thoracic Surgery, University Hospital Basel
name: Didier Lardinois, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
citation: Vujic J, Hojski A, Dackam SVC, Bachmann H, Lardinois D. Functional Outcomes of Patients With Sternoclavicular Joint Infection After Extended Resection. Ann Thorac Surg Short Rep. 2024 Jan 19;2(2):193-196. doi: 10.1016/j.atssr.2023.12.015. eCollection 2024 Jun.
Clinical trial NCT04767685: The Bern Perioperative Biobank
Official title: The Bern Perioperative Biobank to Define Perioperative Changes of Molecular Markers of Perioperative Organo-dysfunctions, Inflammation, Adverse Events and Disease Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Surgical Procedure, Operative
Keywords: Genetic association study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for non-emergency surgery

Brief summary: The goal of the research is to define clinically relevant molecular markers for increased risk of peri-/ postoperative organo-dysfunctions, inflammation, adverse events and disease progression. To better understand the perioperative impact the investigators aim to determine perioperative levels of molecular markers over time in the available samples and clinical data of the Bern perioperative Biobank (BPBB) cohort to finally increase quality of perioperative care of patients by permitting preventive measures to be taken early in patients at risk.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Written informed consent
* Non-emergency surgery

Exclusion Criteria

* Transient incapacity to consent or insufficient time (\< 6h) to consider study participation
* No informed consent
* Cognitive impairment/Patients unable to consent
* Patients who retrospectively expressed their wish to be excluded

Primary outcomes:
measure: Assessing the change of the metabolic profile in the perioperative setting
timeFrame: Before induction of anesthesia as baseline
measure: Assessing the change of the metabolic profile in the perioperative setting
timeFrame: Ca. 2-5hours later upon finishing the surgery
measure: Assessing the change of the metabolic profile in the perioperative setting
timeFrame: On postoperative day 1 during the morning round between 07:30-9:00am
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Frank Stüber, Prof. MD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Markus M Lüdi, MD
role: STUDY_DIRECTOR
References:
citation: Heinisch PP, Mihalj M, Huber M, Schefold JC, Hartmann A, Walter M, Steinhagen-Thiessen E, Schmidli J, Stuber F, Raber L, Luedi MM. Impact of Lipoprotein(a) Levels on Perioperative Outcomes in Cardiac Surgery. Cells. 2021 Oct 21;10(11):2829. doi: 10.3390/cells10112829.
Clinical trial NCT06115785: Cognitive Stimulation Therapy and Olderly People With Mild Cognitive Impairment
Official title: Evaluation of the Effect of Cognitive Stimulation Therapy on Cognitive Status and Apathy in Olderly People With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognitive stimulation therapy
Mild Cognitive Impairment
Cognitive Status
Apathy
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of cognitive stimulation therapy on cognitive status and apathy in elderly individuals with mild cognitive impairment.

Detailed description: This randomized controlled experimental study is planned for 30 October - 25 December 2023, with a total of 60 people (30 in the control group and 30 in the intervention group) at the Elderly Care and Rehabilitation Center. The data of the research were collected from the Literature-Based Personal Information Form, Standardized Mini Mental Test (SMMT), Apathy Assessment Scale. Approval from the Clinical Research Ethics Committee and written permission from the participants were obtained to conduct the study. Individuals in the intervention group started with introduction and in the first week, pre-test administration and CST will be administered twice for 45 minutes.

For the next 7 weeks, it will be carried out for one week, with the introduction and pre-test application for individuals in the control group in the first week. They will continue their daily lives in two sessions for one week and two days. They will continue their lives in the following weeks.

Written informed consent form will be given to all individuals in the study. It will start after information about the measurement tools is given.

Eligibility criteria: Inclusion Criteria:

* Agree to participate in the study
* Being literate and speaking Turkish fluently
* Have communication and understanding skills
* Standardized Mini Mental Test result being between 18-23 points
* Having adequate vision and hearing functions for group participation

Exclusion Criteria:

* Presence of any sensory impairment
* Having a physical health problem that may impair group cohesion and integrity

Primary outcomes:
measure: Standardized Mini Mental Test (SMMT)
timeFrame: up to 9 weeks
Secondary outcomes:
measure: Apathy Rating Scale (ARS)
timeFrame: up to 9 weeks
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Türkiye
state: Korkut Ata University
Study officials:
affiliation: ejdanecoskun@osmaniye.edu.tr
name: Ejdane Coşkun, Lect.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517785: The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents
Official title: The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ADHD
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
Collaborators: name: Wingate Institute
First posted: 2022-08-26
Enrollment: 70
Sex: MALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 high school boys ages 15-18 years, diagnosed with ADHD and treated with stimulant medications

Brief summary: The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.

Detailed description: This study is designed as a single-center, crossover, randomized study. 70 high-school aged males aged between 15 and 18 years with a diagnosis of ADHD who are being treated pharmacologically using stimulants (such as Ritalin, Concerta, Vyvanse etc) will be recruited. The study will investigate motor performance using several motor function tests both with and without the influence of stimulant ADHD medications.

Participants will be assessed on two separate occasions, both sessions will occur during the morning in their regular school environment. During the sessions, participants will be randomized, 50% will be assessed one hour after taking their usual stimulant ADHD medication and the other 50% will be asked to postpone taking their usual stimulant ADHD medication until the session is finished. During the two separate sessions, all participants will be asked to perform the following motor tests: plank, single leg stance test, standing long jump test (broad jump), 4 x 10 agility tests and 20 m shuttle run tests (beeps).

Eligibility criteria: Inclusion Criteria:

* High school male students
* Diagnosis of ADHD
* Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).

Exclusion Criteria:

* Students with concomitant chronic disease (including asthma, cardiac, motor, neurological and gastrointestinal disturbances)
* History of acute illness in the previous two weeks
* Any injuries that would inhibit the ability to exercise or play sport
* Students unable to obtain parental/guardian consent
* Students unwilling to participate

Primary outcomes:
measure: Motor tests
timeFrame: 5 minutes
measure: Motor tests
timeFrame: 5 minutes
measure: Motor tests
timeFrame: 5 minutes
measure: Motor tests
timeFrame: 5 minutes
measure: Motor tests
timeFrame: 5 minutes
measure: AAC-Q questionnaire
timeFrame: 10 minutes
Secondary outcomes:
measure: Heart rate at rest
timeFrame: 5 minutes
measure: Blood pressure at rest
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Sharon Tsuk
Study officials:
References:
Clinical trial NCT03921385: Augmented Reality Enhanced Surgery: Use of Holographic Technology in Cranial and Spinal Surgery
Official title: Augmented Reality Enhanced Surgery: Proof-of-concept Study for the Use of Holographic Technology in Cranial and Spinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing an elective cranial or spinal procedure at the University of Pennsylvania, Department of Neurosurgery.

Brief summary: * To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field.
* To develop a systematic, efficient communication and registration process allowing holographic technology to be potentially utilized as a navigation tool in cranial and spinal neurosurgery. This entails developing software, optimizing connection parameters, and devising registration techniques incorporating line-of-sight fiducial markers to allow the holographic device to function as a navigation instrument.


Eligibility criteria: Inclusion Criteria:

* age \>= 18
* must be able to read and understand English, and sign the informed consent form

Exclusion Criteria:

* emergent/emergency procedures
* pediatric patients
* pregnant patients
* vulnerable populations

Primary outcomes:
measure: Assessment of holographic technology in the operating room using a feasibility scale ranging from 1-10
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01580085: Obstructive Sleep Apnea in Pulmonary Embolism
Official title: Obstructive Sleep Apnea is Prevalent in Patients With Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Thromboembolism
Obstructive Sleep Apnea
Keywords: Sleep disordered breathing
gender
hypercoagulability
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects admitted to Department of Pulmonary Medicine of Gaziantep University who were diagnosed to have PE were included in the study group. Control group consisted of age and sex matched subjects without a clinic consistent with PE referred to the Sleep Clinic. PE was diagnosed when one or more of the following was present: compatible physical examination findings and multislice CT angiography or presence of deep venous thrombus (DVT) in addition to high risk with Wells criteria \[5\]. Subjects with any restrictive/obstructive lung pathology or younger than 18 years old were excluded.

Brief summary: Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue. An increased tendency for coagulation has also been reported in OSA. Venous stasis, vascular endothelial activation and hypercoagulability are also known risk factors for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for the development of pulmonary embolism (PE) however there is limited data about role of thromboembolic events in OSA.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients diagnosed with pulmonary embolism

Exclusion Criteria:

* less than 18 years of age
* any restrictive or obstructive lung disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: University of Gaziantep Hospital
Study officials:
affiliation: University of Gaziantep
name: Meral Uyar, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567085: Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Official title: An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage V Chronic Kidney Disease
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.


Eligibility criteria: Inclusion Criteria:

1. Male or female participants ≥18 years old.
2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
3. History of prior exposure to HLA (human leukocyte antigen):

   * Prior solid organ or tissue allograft
   * Pregnancy
   * Blood transfusion
   * Prior exposure to specific donor's HLA

Exclusion Criteria:

1. Has received treatment with eculizumab at any time prior to enrolling in this study.
2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
3. History of severe cardiac disease.
4. Prior splenectomy.

Primary outcomes:
measure: Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation
timeFrame: Baseline, Week 9
Secondary outcomes:
Other outcomes:
measure: Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12
timeFrame: Baseline, Month 12
measure: Participants That Developed Severe ACR (Other AE Of Interest) At Month 12
timeFrame: Baseline, Month 12
Locations:
city: Adelaide
country: Australia
city: Camperdown
country: Australia
city: Parkville
country: Australia
city: Bordeaux
country: France
city: Paris
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Brescia
country: Italy
city: Padova
country: Italy
city: Barcelona
country: Spain
city: Gothenburg
country: Sweden
city: Uppsala
country: Sweden
city: Cambridge
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References: