louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02884739: Mental Healthcare in Older Adults With Schizophrenia
Official title: The Mortality and Its Associated Factors in Schizophrenia Patients Older Than 60 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Chronic Psychiatric Disorder
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 685
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia and patients with chronic psychiatric disorder other than schizophrenia were included

Brief summary: As in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. But this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. This excessive early mortality is explained by an overrepresentation of suicide deaths, but also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only very few epidemiological data on the mortality of patients with schizophrenia, including those aged over 60 years. What are the sociodemographic and clinical characteristics (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a somatic follow-up adequate and systematic? What are their levels of social independence and of quality of life? the answers these questions and the description of the offer of geriatric care and of psychiatric care currently provided by different sectors of psychiatry in France is an indispensable prerequisite for any project to improve the quality of life, state of health and mortality of older patients with schizophrenia.

Detailed description: Evaluate prospectively over 5 years, the rates and causes of mortality in a cohort of schizophrenic patients older than 60 years, followed by adult psychiatry sectors, compared to those patients matched for sex and age and monitored by the same sectors for a chronic psychiatric disorder other than schizophrenia

Eligibility criteria: Inclusion Criteria:

* Men or women aged than 60 years with a diagnosis of schizophrenia, according to the DSM-IV criteria
* Men or women aged than 60 years with chronic psychiatric disorder other than schizophrenia
* Patients consenting to participate to the study
* Patients enrolled in the national healthcare insurance program

Exclusion Criteria:

-Disease affecting the central nervous system

Primary outcomes:
measure: Death
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: Raucher-Chene D, Hoertel N, Bera-Potelle C, Terrien S, Barriere S, Da Rin D, Tran E, Cuervo-Lombard C, Portefaix C, Limosin F. Mental healthcare in older adults with schizophrenia: results from 118 French public psychiatric departments. Int Psychogeriatr. 2015 Oct;27(10):1749-50. doi: 10.1017/S1041610215001064. Epub 2015 Jul 6. No abstract available.
Clinical trial NCT02168439: Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
Official title: Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laceration
Anxiety
Keywords: Dexmedetomidine
Midazolam
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Clinical and Translational Science Institute (CTSI)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2014-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.


Eligibility criteria: Inclusion Criteria:

* Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
* Laceration \<5 cm in total length
* Require simple suture laceration repair

Exclusion Criteria:

* Allergies/intolerance/contraindication to the study drugs
* Lacerations requiring complex (multilayer) repair or total laceration length\>5cm

Primary outcomes:
measure: mYPAS Score as Completed by Researchers to Assess Anxiety
timeFrame: Day 1
Secondary outcomes:
measure: mYPAS Scores at Other Time Points
timeFrame: Day 1
measure: VAS for Anxiety as Completed by Caregiver and Observer
timeFrame: Day 1
Other outcomes:
measure: Procedure Completion
timeFrame: Day 1
measure: Need for Procedural Sedation
timeFrame: Day 1
measure: Anxiolysis Satisfaction
timeFrame: Day 1
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
name: Desiree Neville, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04070339: Cerebral Blood Flow Using Transfontanelle Ultrasound
Official title: A Study on Cerebral Blood Flow Velocity Reference Values Considering Age, Blood Pressure and Carbon Dioxide Partial Pressure i n Small Children: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Blood Flow
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatrics including preterm neonates undergoing general anesthesia

Brief summary: We planned to evaluate cerebral blood flow and its association with age, blood pressure, and end tidal carbon dioxide in small pediatric using transfontanelle ultrasound during general anesthesia.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing general anesthesia

Exclusion Criteria:

* patients with hydrocephalus, brain tumor

Primary outcomes:
measure: cerebral blood flow
timeFrame: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT06108739: ATG Plus Low-dose PT-Cy for GVHD Prevention
Official title: Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hematologic Malignancy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 66
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.


Eligibility criteria: Inclusion Criteria:

1. Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
2. Male or female , aged 12-55 years;
3. Haploidentical donor transplantation;
4. ECOG score ≤3; The basic organ function tests met the following standards;

1) Cardiac ejection index \>55% 2) Creatinine ≤1.5 times the highest normal value (ULN)

Exclusion Criteria:

1. Severe brain, heart, kidney or liver dysfunction;
2. Refractory malignant state;
3. Patients with other malignant tumors requiring treatment;
4. Clinically uncontrolled severe active infection;
5. The expected survival time was less than 3 months.
6. A history of severe anaphylaxis.
7. Pregnant or lactating women;
8. Any condition considered by the investigators to be unsuitable for enrollment.

Primary outcomes:
measure: The incidence of acute graft versus host disease.
timeFrame: 100 days post HSCT.
Secondary outcomes:
measure: Engraftment
timeFrame: 30 days post HSCT.
measure: The incidence of chronic GvHD
timeFrame: 1 year post HSCT.
measure: The incidence of non-relapse mortality
timeFrame: 1 year post HSCT.
measure: The incidence of infection
timeFrame: 1 year post HSCT.
measure: The incidence of relapse
timeFrame: 1 year post HSCT.
measure: Overall survival
timeFrame: 1 year post HSCT.
measure: Disease free survival
timeFrame: 1 year post HSCT.
measure: GvHD relapse free survival
timeFrame: 1 year post HSCT.
measure: Immune reconstitution
timeFrame: 1 year post HSCT.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
Clinical trial NCT03295539: Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System
Official title: MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Ischemia
Lead sponsor: Lancashire Care NHS Foundation Trust
Sponsor class: NETWORK
Collaborators: name: St. Franziskus Hospital
First posted: 2017-09-28
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.

Detailed description: A detailed registry has been designed and approved to be used world wide in vascular and trauma centres, already providing endovascular service for the management of critical limb ischaemia (CLI).

Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of patients to avoid amputation rates. During this time many devises have been used and available on the market. The 'Indigo' system by Penumbra was originally designed from the acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system. This is currently being used in many centres to manage acute clot causing lower limb ischaemia, however no official registry or international clinical trial has been done to show its significance in managing this disease.

The investigator groups, have created this to come up with enough data to evaluate the Indigo system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed with the Penumbra/Indigo System (study device), and gather greater data and information than the PRISM trial in 2013-2014 which obtained only 79 patients.

Eligibility criteria: Inclusion Criteria:

* Acute lower limb Ischaemia with acute soft clot.

Exclusion Criteria:

* Calcified plaques/ chronic disease causing critical limb Ischaemia

Primary outcomes:
measure: Technical success using the Indigo system.
timeFrame: Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.
Secondary outcomes:
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Interventional Radiology
state: Lancashire
Study officials:
affiliation: Lancashire NHS
name: Bella Huasen, MD
role: STUDY_CHAIR
References:
citation: Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.
Clinical trial NCT00153439: Purdue University Parenting Program Attrition
Official title: Purdue University Parenting Program Attrition and Compliance Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Child Abuse
Keywords: parenting
motivation
child maltreatment
program attrition
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Purdue University
First posted: 2005-09-12
Enrollment: 560
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the efficacy of techniques to enhance participation in parenting programs.

Detailed description: This project addresses the problem of involving parents in interventions that promote parenting effectiveness and child coping-competence in preschoolers as a means of reducing risk of child maltreatment (and related adverse developmental outcomes). Purdue University will examine the impact of partnership (organizational involvement in recruitment and retention), cash incentives, and a motivational goal setting component on participation and engagement in the Parenting Our Children to Excellence program, a group intervention for parents and caregivers of preschool children.

Eligibility criteria: Inclusion Criteria:

* Parents with children 3-5 years old who attend centers in which interventions are offered

Exclusion Criteria:

* See above. No other exclusion criteria will be used.

Primary outcomes:
measure: Engagement and participation in an 8-week parenting program
Secondary outcomes:
measure: Measures of parenting behavior and attitudes, incidents of child maltreatment, measures of child adjustment and functioning
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Jean E Dumas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046239: Suture vs Staples for Skin Closure After Liver Resection
Official title: A Randomised Controlled Trial to Compare Subcuticular Suture vs Staples for Skin Closure After Liver Resection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closure of the Skin After Liver Resection
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 200
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: Closure of the skin after liver resection (surgery to remove part of the liver) may be achieved by one of several methods. The standard method at our institution is to use stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous absorbable suture may be used to "sew" the skin together.

The ideal method of closure should be safe, effective, associated with minimal patient discomfort and have a good cosmetic result. At present, there is no scientific evidence to describe which method is most suitable following liver resection.

The primary aims of this study is to investigate which method (subcuticular sutures vs staples) offers the best result in postoperative rate of (1) skin infection, (2) skin dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we are interested in which method is best for patient satisfaction and cosmetic appearance and which method is most cost effective.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing liver resection surgery for benign or malignant aetiology
* All patients undergoing surgery as a living liver donor.

Exclusion Criteria:

* Any patient with an active wound infection
* Any patient with an active incisional wound hernia from previous surgery
* Synchronous bowel/liver surgery
* History of keloid formation

Primary outcomes:
measure: Post-operative infection time
timeFrame: 1 year
Secondary outcomes:
measure: Time taken for skin closure
timeFrame: 12 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
Study officials:
References:
Clinical trial NCT00635739: Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
Official title: Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: Whey protein
Resistance exercise
Physical activity
Mobility disability
Physical function
Muscle mass
Muscle strength
Older Adults
Mobility-Limited
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Dairy Council
First posted: 2008-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.


Eligibility criteria: Inclusion Criteria:

* Male and Females 70-85 yrs
* Community dwelling
* Short Physical Performance Battery score \< 10
* BMI = 21-32.5

Exclusion Criteria:

* Acute or terminal illness
* Mini Mental State Exam \< 23
* Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure
* Upper or lower extremity fracture in previous 6 months
* Uncontrolled hypertension (\>150/90 mm Hg).
* Neuromuscular diseases and drugs which affect neuromuscular function.
* Hormone replacement therapy
* eGFR \<30 mL/min/1.73m2
* Types I and II Diabetes Mellitus
* Dietary protein intake \< 0.8 g.kg-1.day-1
* Disorders of nutrient absorption
* Milk, or whey allergy
* Sulfa drugs and allergy to PABA-containing sunscreens

Primary outcomes:
measure: 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
timeFrame: Baseline and follow up (6 months)
Secondary outcomes:
measure: Lean Mass
timeFrame: Baseline and follow up (6 months)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging
state: Massachusetts
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging
name: Roger A Fielding, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chale A, Cloutier GJ, Hau C, Phillips EM, Dallal GE, Fielding RA. Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):682-90. doi: 10.1093/gerona/gls221. Epub 2012 Oct 31.
Clinical trial NCT03451539: OUT OF THE ICU SHIFTING
Official title: SHIFTING OF ANESTHESIS PHYSICIANS OUT OF THE INTENSIVE CARE UNIT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospital Rapid Response Team Activation
Keywords: Anaesthetist
ICU
Intensif care unit
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All physician anesthetist of Intensive Care Unit of new civil hospital in Strasbourg

Brief summary: Numerous studies dealt with the hospital doctors' work but little is known about the work of ICU doctors, especially concerning the medical time spent outside the Intensive Care Unit (ICU) which is a significant workload that has never been evaluated to date. The main objective of our study was to evaluate the time spent by ICU doctors outside the unit, for the management of their patients during the IHT and for the care of patients in other departments. Secondary objectives were to describe the organization and distribution of medical time outside the intensive care unit.

In this observational study, which took place during 5 years, from January 2012 to December 2016 in the medical ICU of the "Nouvel Hôpital Civil" at the University Hospitals of Strasbourg, every day after the morning medical staff, the anonymized information were collected in a register.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Physician anesthetist of Intensive Care Unit of new civil hospital in Strasbourg
* Physician anesthetist who has agreed to participate in the study

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: daily time spent by physicians outside their service
timeFrame: The period from 2012 to 2017 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Reanimation Medicale
Study officials:
References:
Clinical trial NCT06977139: Interventional Structural Registry - LuEbeck
Official title: Interventional Structural Registry - LuEbeck
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Structural Heart Disease
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients for who the indication for a catheter-based heart valve replacement or closure system was set due to a structural heart disease can be included.

Brief summary: The aim of the registry is to investigate the effect of catheter-assisted procedures in the context of structural heart disease on clinical morbidity and mortality. Furthermore, the long-term prognosis of patients after a catheter-based procedure is to be evaluated.

In particular, the following parameters will be documented and the following questions discussed:

* Underlying and concomitant diseases of these patients
* Evaluation of the methods in relation to the respective disease
* Safety - acute and long-term
* Effectiveness - periprocedural, hospital and long-term course
* Concomitant therapies


Eligibility criteria: Inclusion Criteria:

* Structural heart disease

Exclusion Criteria:

* Patients without consent/information
* Age ≤ 18 years

Primary outcomes:
measure: Combined endpoint
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
References: