louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05671952: Multi-center Study on Reducing Postoperative Pulmonary Complications in Elderly Patients
Official title: Multi-center Study on Reducing Postoperative Pulmonary Complications in Elderly Patients Based on Comprehensive Intervention System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pulmonary Complications
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Taihe Hospital
name: Wuhan Central Hospital
name: Shanxi Cardiovascular Hospital
name: Qinghai People's Hospital
First posted: 2023-01-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to carry out demonstrative comprehensive intervention for elderly patients in several hospitals to observe whether it can reduce the incidence and mortality of perioperative pulmonary complications in elderly patients and improve their perioperative prognosis.

Detailed description: This study investigated the incidence of postoperative pulmonary complications in various hospitals, and carried out demonstrative comprehensive intervention for elderly patients in several hospitals according to the comprehensive intervention system program of perioperative pulmonary complications, to observe whether the perioperative prognosis can be improved and the quality of life can be improved, thus verifying and optimizing the current evaluation system and intervention system, and providing evidence support for further extensive application.

Eligibility criteria: Inclusion Criteria:

1. age 65 years or older
2. receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

1. preoperative mechanical ventilation
2. procedures related to a previous surgical complication
3. a second operation after surgery
4. organ transplantation
5. discharged within 24 hours after surgery

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: within one week after surgery
Secondary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00830752: Neurobiological, Neuropsychological,Linguistic and Gestural Processes and Phenomena in Individuals With Alexithymia
Official title: Understanding Alexithymia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alexithymia
Keywords: alexithymia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 individuals between the ages of 18 and 60 years, both genders, who score high on an alexithymia questionaire (TAS-20) and who are otherwise emotionally and physically healthy. Individuals are sampled via newspaper and poster advertisements throughout the greater metropolitan area of Berlin, Germany

Brief summary: The syndrome of extremely restricted emotional competence, alexithymia, was originally conceptualized in psychoanalytic research and is now empirically and experimentally studied in clinical psychology and psychological medicine within the context of emotion regulation using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired ability to name or express feelings and to distinguish them from the physical consequences of an acute or chronic stress reaction. Modern "brain-body-interface" research suggests that alexithymia represents a complex deficiency in cognitive processing and emotional regulatory processes. The neurobiological basis is assumed to be a preconscious, automatic and involuntary information transfer to the amygdalae of acquired representations of emotional contents stored in ventromedial prefrontal cortical areas.

Alexithymia is not just "emotional coldness", i.e. a limited emotionality, but essentially the detachment of feelings from language. In alexithymia the link between affective phenomena and language, understood as media-supported sign practices, is insufficient or even absent.

The purpose of our observational study is to better understand the neurobiological and neuropsychological as well as linguistic and gestural processes and determinants of this phenomenon


Eligibility criteria: Inclusion Criteria:

* scoring high on the TAS-20

Exclusion Criteria:

* personal history of a mental disorder
* currently mentally ill

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite-Dept. of Psychiatry-Campus Benjamin Franklin
Study officials:
References:
Clinical trial NCT00380952: Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
Official title: MAST Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: IDC
DCIS
ILC
Lead sponsor: Dune Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.

Detailed description: Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.

Eligibility criteria: Inclusion criteria

1. Women diagnosed with carcinoma of the breast
2. Undergoing lumpectomy (local wide excision) procedure.
3. Over 18 years of age
4. Signed ICF

Exclusion criteria

1. Neoadjuvant systemic therapy
2. Previous radiation in the operated breast
3. Prior surgical procedure in the same quadrant
4. Implants in the operated breast
5. Pregnancy
6. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Mc
city: Haifa
country: Israel
facility: Rambam MC
city: Jerusalem
country: Israel
facility: Haddasah Medical Organization
city: Jerusalem
country: Israel
facility: Shaare Zedek
city: Kfar Saba
country: Israel
facility: Meir MC
city: Petah Tikva
country: Israel
facility: Rabin MC
city: Tel- Aviv
country: Israel
facility: Souraski MC
city: Tiberia
country: Israel
facility: Poria MC
city: Zefat
country: Israel
facility: Rivka Ziv MC
Study officials:
affiliation: Rambam MC
name: Dan Hershko, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin MC
name: Rona Spector, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin MC
name: Eran Sharon
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir MC
name: Zvi Kaufman, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bnei Zion Mc
name: Tal Kopelman, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: HaEmek MC
name: Yuri Berlin, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Mc
name: Moshe Papa, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Haddasah Medical Organization
name: Tanir Allweis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Souraski MC
name: Shlomo Schneebaum, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek MC
name: Moshe Carmon, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziv Mc
name: Amram Adari, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Poria MC
name: Moshe Zilberman, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277952: Deep Brain Stimulation for Traumatic Brain Injury
Official title: Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
DBS
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.

Detailed description: The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury. DBS has been proven safe and efficacious for remediation of multiple neurological conditions. It is the hope of the study team that the protocol will provide further insight into the potential of DBS to improve the quality of life and functioning of persons with severe disability due to TBI and at the same time can provide new clinical insights that will improve treatment for the entire spectrum of injury severity.

Eligibility criteria: Inclusion Criteria:

* 24 months post traumatic brain injury Scores in Severe range of the Glasgow Outcome Scale-Extended Evidence of impaired cognitive functioning Medically and neurologically stable

Exclusion Criteria:

* Medical contraindications for surgery Evidence of substance abuse in the last 12 months Current Diagnosis of major depressive disorder current participation in rehabilitation services Co-morbid conditions that would interfere with study activities

Primary outcomes:
measure: Improvement in Brain Functioning
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ali Rezai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968552: Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents
Official title: Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Keywords: Any Gastrointestinal problem that would require an endoscopically placed stent
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-08-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age 18 or older

Brief summary: The investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older.
2. Scheduled to undergo endoscopy with placement of self-expanding stent at the University of Florida, Gainesville, FL.
3. Subject must be able to give informed consent.

Exclusion Criteria:

1. Any contraindication to performing endoscopy.
2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
3. The subject is unable/unwilling to give informed consent.

Primary outcomes:
measure: The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.
timeFrame: at the time of stent placement
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands UF endoscopy Center
state: Florida
Study officials:
References:
citation: Wagh MS, Draganov PV. Per-oral endoscopic tunneling for restoration of the esophagus: a novel endoscopic submucosal dissection technique for therapy of complete esophageal obstruction. Gastrointest Endosc. 2017 Apr;85(4):722-727. doi: 10.1016/j.gie.2016.08.035. Epub 2016 Sep 7.
Clinical trial NCT01398852: Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia
Official title: Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Keratoconus and Ectasia
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.


Eligibility criteria: Inclusion Criteria:

* 12 years of age or older
* Diagnosis of Keratoconus or Ectasia
* Central or Inferior steepening on the Pentacam map
* Topography consistent with Keratoconus or Ectasia
* BSCVA 20/20 or worse
* Removal of contact lenses for required period of time
* Signed written informed consent
* Willingness and ability to comply with schedule for follow up visits

Exclusion Criteria

* For Keratoconus, a history of previous corneal surgery
* Corneal pachymentry equal to or greater and 400
* Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
* A history of chemical injury or delayed healing
* Pregnancy
* A known sensitivity to the study medications
* Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
* Presence or history of any other condition or finding that makes the patient unsuitable as a candidate

Primary outcomes:
measure: Changes in Corneal Curvature
timeFrame: 24 MO
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Boston
country: United States
facility: Massachusetts Eye And Ear Infirmary
state: Massachusetts
city: Bloomington
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: New York
country: United States
facility: Laser and Corneal Surgery Assoc. PC
state: New York
city: New York
country: United States
facility: Mt Sinai Hospital
state: New York
city: New York
country: United States
facility: Pamel Vision & Laser Group
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic-Cole Eye Institute
state: Ohio
city: Columbus
country: United States
facility: ReVision Advanced Laser Eye Center
state: Ohio
city: Columbus
country: United States
facility: OSU Department of Ophthalomogy
state: Ohio
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
city: Houston
country: United States
facility: Slade and Baker Vision Center
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
References:
Clinical trial NCT03703752: CT and Clinical Features of Internal Hernia
Official title: CT Images and Clinical Relevance of Internal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CT Images of Internal Hernia
Clinical Outcomes
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research

Brief summary: Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia.

Detailed description: 51 Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research. Medical records including MDCT images and intra-operative findings were collected retrospectively. The CT features of different subgroups were also evaluated.

Eligibility criteria: Inclusion Criteria:

* IH confirmed by surgical exploration

Exclusion Criteria:

* diaphragmatic hernia and traumatic IH

Primary outcomes:
measure: CT features
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT01474252: Comparison of Intubation Duration Between Rapid Sequence Intubation (RSI) Technique and Non-RSI Technique
Official title: Comparison of Intubation Duration Between Rapid Sequence Intubation Technique and Non- Rapid Sequence Intubation Technique in Siriraj Hospital by Emergency Medicine Residences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tracheal Intubation Morbidity
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate intubation duration between rapid sequence intubation technique (RSI) and non-rapid sequence intubation technique (non-RSI) performed by emergency medicine residents in Siriraj hospital.

Detailed description: A prospective cohort study was conducted in the non-traumatic emergency department (ED).

Eligibility criteria: Inclusion Criteria:

* patients required airway control by tracheal intubation

Exclusion Criteria:

* cardiac arrest

Primary outcomes:
measure: The overall intubation duration
timeFrame: Participants will be followed for the overall intubation duration until confirmation the endotracheal position, an expected average of 2 minutes
Secondary outcomes:
measure: the intubation duration
timeFrame: Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes
measure: Complication
timeFrame: Participants will be followed in the period of staying in the emergency room and hospital, an expected average of 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Mingkwan Wongyingsinn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844259: Functional Communicative Profile of Children With Down Syndrome
Official title: Functional Communicative Profile of Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Keywords: Down syndrome
Pragmatics
Language Development
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 children with Down syndrome aged from 5 to 8 years.

Brief summary: The aim of this study was to verify the use of communicative functions by children with DS in two interaction conditions: interaction with therapist and interaction with parent.

Detailed description: Parents and caregivers' engagement on therapeutic process of children with Down syndrome (DS) is important for language and communication development. The identification of the communicative skills presented by these children as well as the context influence in their performance as interlocutors, will contribute to the design of therapeutic interventions.

Pragmatics theories are helpful to language use studies, since it takes into account social and environmental aspects and considers adult-child interaction as a determinant factor for its occurrence.

Eligibility criteria: Inclusion Criteria:

* genetic diagnosis of Down syndrome
* good health conditions
* normal results on audiologic evaluation
* pediatric and ear, nose and throat periodic check ups.
* attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.

Exclusion Criteria:

* submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
* presence of visual or auditory important deficits

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Study officials:
affiliation: University of Sao Paulo
name: Suelly CO Limongi, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Eliza P Cunha, Ms student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01955759: Atrial Fibrillation and By-pass Surgery
Official title: Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Patients With Coronary Artery Disease Scheduled for by Pass Surgery
Lead sponsor: Heart Center BH Tuzla
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.


Eligibility criteria: Inclusion Criteria:

* significant coronary disease, sinus rhythm

Exclusion Criteria:

* valvular disease, former by-pass surgery

Primary outcomes:
measure: atrial fibrillation
timeFrame: 10 days on average during hospital stay after coronary by-pass surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Bosnia and Herzegovina
facility: Heart Center BH
state: TK
Study officials:
References: