louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04430868: Lifestyle Redesign For Schizophrenia
Official title: The Impact of Lifestyle Redesign Program in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Rehabilitation
Lead sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effects of lifestyle redesign program plus treatment as usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and occupational engagement for schizophrenia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
* age from 20 to 65
* attending day care center regularly for at least 1 month and taking stable dose of medication

Exclusion Criteria:

* comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)
* comorbid mental retardation
* lacking the reading and writing skills

Primary outcomes:
measure: Change scores of Brief Psychiatric Symptom Rating Scale (BSRS)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
measure: Change scores of Occupational Self Assessment (OSA)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
measure: Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03282968: Balance Training After Stroke With REWIRE
Official title: Balance Training With the Rehabilitative Wayout In Responsive Home Environments (REWIRE) System in Patients After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: exergaming
physiotherapy
balance
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
Collaborators: name: Jozef Stefan Institute
First posted: 2017-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study will include 20 patients after stroke, randomly assigned to the experimental and control group (10 each). In both groups, the program with last for five days; walking and balance will be assessed before and after the program. Both groups will receive regular neurophysiotherapy; in addition, the experimental group will exercise each day by playing REWIRE games, while the control group will perform standing balance exercises.

Detailed description: Detailed inclusion and exclusion criteria are specified in the appropriate section. Both groups will perform the additional exercises for 15 minutes daily. In addition to the outcome measurement, informal feedback will be obtained from the patients and the therapists on the feasibility of the REWIRE system.

Eligibility criteria: Inclusion Criteria:

* first stroke
* first admission to inpatient rehabilitation

Exclusion Criteria:

* less than 25 points scored on the Mini-Mental State Examination
* inability to walk independently

Primary outcomes:
measure: Change in walking speed
timeFrame: Assessment one day before and one day after the program
measure: Change in dynamic balance
timeFrame: Assessment one day before and one day after the program
Secondary outcomes:
measure: Change in mobility
timeFrame: Assessment one day before and one day after the program
measure: Change in static standing balance
timeFrame: Assessment one day before and one day after the program
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Rehabilitation of Slovenia
name: Imre Cikajlo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cikajlo I, Rudolf M, Mainetti R, Borghese NA. Multi-Exergames to Set Targets and Supplement the Intensified Conventional Balance Training in Patients With Stroke: A Randomized Pilot Trial. Front Psychol. 2020 Apr 2;11:572. doi: 10.3389/fpsyg.2020.00572. eCollection 2020.
Clinical trial NCT02003768: The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Optic Nerve Sheath
Keywords: pneumoperitoneum
optic nerve sheath diameter
laparoscopy
Patients
general anesthesia
diameter
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia

Exclusion Criteria:

* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery

Primary outcomes:
measure: the ultrasonographic measurement of optic nerve sheath diameter
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
Clinical trial NCT04519268: Adherence Degree of Kasr-Alaini Hospital Pre-anesthetic Tests to the NICE-UK Guidelines
Official title: The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-UK Guidelines, and Its Effect on Decision Making & Patient Outcome: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Surgery
Exanimation
Keywords: Pre-anesthetic tests
NICE-UK guidlines
Kasr Alaini hospital
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 185
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: Adult patients that will be scheduled for an elective surgical operation at Kasr Alaini hospital during the study period.

Brief summary: Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Also unneeded tests may harm the patient due to overtreatment for borderline / false positive results. Therefore, the routine use of such examinations remains controversial.

The National Institute of Health and Clinical Excellence (NICE-UK) guidelines for preoperative examination are the assessment standard developed by NICE in collaboration with the National Collaboration Center for Acute Care in the UK; in order to reduce unnecessary tests by recommending which tests should be offered to people before minor and major operations.

The aim of this study is to assess the degree of adherence of the current preoperative tests at Kasr Alaini hospital to the NICE guidelines, to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in the hospital and to also evaluate the cause of delay \& its effect to predict postoperative complications.


Eligibility criteria: Inclusion Criteria:

* All adult patients scheduled for elective surgical operations.

Exclusion Criteria:

* Patients operated upon an emergency basis.
* Pregnant females.
* Patients scheduled for cardio-thoracic and neurosurgical procedures.

Primary outcomes:
measure: Degree of Adherence to NICE-UK Guidelines
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Beshoy A Naguib, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Nazmy S Michael, MD
role: STUDY_DIRECTOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Manar M Elkholy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01739868: Screening and Understanding of the Pre-diabetes: DECODIAB
Official title: Screening and Understanding of the Pre-diabetes: DECODIAB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Keywords: Pre-diabetes
Type 2 diabetes
Biomarkers
Diabetes risk score
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years)
* Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \< 1 .26 g/L
* And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and \< 1 .26 g/L ; or blood glucose ≥ 1g/l and \< 1,1 g/L WITH HbA1C ≥ 6,5%
* Signed informed consent
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Fasting glycemia ≥ 1.26 g/l
* Fasting glycemia ≤ 1.10 g/l AND HbA1C \< 6,5%
* Fasting glycemia \< 1 g/l
* Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
* Subjects previously treated with insulin, except gestational diabetes
* Severe coagulation disorders
* Thrombocytopenia \< 100 000/mm 3
* Severe psychiatric disorders
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe hepatic insufficiency
* Alcohol abuse (\> 30g/j)
* Contra-indication in the realization of the local anesthetic
* Subject unable to follow the study during the 5 years of follow-up
* Subject exclusion period in a previous study

Primary outcomes:
measure: To identify new biomarkers
timeFrame: 5 years
Secondary outcomes:
measure: To identify new therapeutic targets
timeFrame: 5 years
measure: To connect identified biomarkers with the degree of insulinoresistance
timeFrame: 5 years
measure: Number of patients with high Diabetes Risk Score and pre-diabetes
timeFrame: 5 years
measure: Number of patients with others cardiovascular risk factors
timeFrame: 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Bertrand CARIOU, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03845868: Tongji-Ezhou Study
Official title: Tongji-Ezhou Prospectively Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Cardiovascular Diseases
Obesity
Metabolic Syndrome
Nutritional and Metabolic Diseases
Environmental Exposure
Risk Factor, Cardiovascular
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples were collected at two medical centrals (retired employees at Egang hospital and working employees at Ezhou CDC). The Retirement Office of Egang hospital and Health checkup center of CDC provided a list of the individuals and invited them to participant in our study.

Brief summary: Tongji-Ezhou study (TJEZ) is a prospective cohort study launched at 2013 in EZhou city, Hubei province, with the goal of recruiting and assessing 10,000 individuals and then following them for at least 2 decades. In addition, blood samples would be collected every 3-5 years among 6000 of them to investigate the nutritional biomarkers and potential determinants of chronic diseases such as obesity, type 2 diabetes, metabolic syndrome, and cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* (i) permanent residence in Ezhou district (minimum of 9 months); (ii) written informed consent; (iii) age ≥ 20 years old at the time of enrolling in the study.

Exclusion Criteria:

* (i) with chemotherapy or radiotherapy for cancer and other severe diseases.

Primary outcomes:
measure: Incidence of diabetes
timeFrame: 5 years
measure: Incidence of metabolic syndrome
timeFrame: 5 years
measure: Diabetic complications
timeFrame: mean follow up of 10 years
measure: Incidence of cardiovascular diseases
timeFrame: mean follow up of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
citation: Sun T, Deng Y, Geng X, Fang Q, Li X, Chen L, Zhan M, Li D, Zhu K, Li H, Liu L. Plasma Alkylresorcinol Metabolite, a Biomarker for Whole-Grain Intake, Is Inversely Associated with Risk of Nonalcoholic Fatty Liver Disease in a Case-Control Study of Chinese Adults. J Nutr. 2022 Apr 1;152(4):1052-1058. doi: 10.1093/jn/nxab404.
Clinical trial NCT01898468: Post-Thoracotomy Closure Study
Official title: Post-Thoracotomy Pain Syndrome: A Randomized, Double Blind, Study Comparing Closure Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Thoracotomy Pain Syndrome
Keywords: Neuropathic pain symptoms
Intracostal Closure Technique
Pericostal Suture Closure Technique
Post surgical pain
Post thoracotomy pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 90
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: Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the compression of the intercostal nerves during routine closure. Closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at 3, 6, and 12 months after surgery between groups.


Eligibility criteria: Inclusion Criteria:

* Patients 18-88 years age
* Patients undergoing surgery with an open thoracotomy incision

Exclusion Criteria:

* Patient refusal
* Inability to give informed consent
* Concurrent drug addiction or methadone use
* Present chronic pain syndrome
* Significant psychiatric illness excluding depression
* Cannot understand English, read or write in English independently

Primary outcomes:
measure: Incidence and severity of post-thoracotomy pain
timeFrame: 3 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Hance Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068768: Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
Official title: A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Keywords: fusion
lateral interbody fusion system
lumbar spine
degenerative disc disease
Lead sponsor: LDR Spine USA
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be drawn from the patient populations of the physicians participating in the study. The principal investigators include community physicians in private practice as well as physicians affiliated with academic institutions.

Brief summary: The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.


Eligibility criteria: Inclusion Criteria:

* Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
* Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
* Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
* The placement of the Avenue L device must be a primary surgery
* Subject must be willing to sign the consent form and be able to return for all follow up visits.

Exclusion Criteria:

* Subject must not have had prior surgery at the operative level(s)
* Subject is known to have substance or alcohol addictions
* Subject has lateral curvature of the spine (scoliosis, all types)
* Subject is a prisoner
* Subject is pregnant
* Subject has an active infection or sepsis at the time of surgery
* Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations

Primary outcomes:
measure: Fusion Rate
timeFrame: 12 months after device implantation
Secondary outcomes:
measure: Mean Oswestry Disability Index (ODI)
timeFrame: preop, 3 mo, 6 mo, 12 mo post op
measure: Visual Analog Scale (VAS) of Back Pain
timeFrame: preop, 3 mo, 6 mo, 12 mo
Other outcomes:
Locations:
city: Thornton
country: United States
facility: Center for Spine and Orthopedics
state: Colorado
city: Atlanta
country: United States
facility: Orthopedic Surgery
state: Georgia
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Johnson City
country: United States
facility: Southern New York Neurosurgical Group
state: New York
Study officials:
References:
Clinical trial NCT01455168: Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome
Official title: Prospective Study to Examine the Efficacy of a Capsular Tension Ring (CTR) in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome (XFS) With no Zonular Weakness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract With Exfoliation Syndrome
Keywords: anterior capsule shrinkage
capsular tension ring
exfoliation syndrome
phacoemulsification and aspiration
Lead sponsor: University of Occupational and Environmental Health
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with cataract and exfoliation syndrome

Brief summary: The purpose of this study is to examine the efficacy of a capsular tension ring (CTR) in preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (XFS) with no zonular weakness. The eyes with XFS undergo phacoemulsification and aspiration (PEA) with an intraocular lens (IOL) implantation. All operations are performed by a single surgeon. No eyes with either ectopia lentis or phacodonesis are included. There are three groups; CTR is not used in group A, CTR is simply implanted in group B, and CTR is implanted and closed by tying both eyelets in group C. The areas of continuous curvilinear capsulorhexis (CCC) are calculated, and both the time-course change and the comparison among the 3 groups are tested.


Eligibility criteria: Inclusion Criteria:

* Eyes with exfoliation syndrome are included.

Exclusion Criteria:

* Eyes with either ectopia lentis or phacodonesis are excluded.

Primary outcomes:
measure: Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome
timeFrame: 3 years
measure: Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health
state: Fukuoka
Study officials:
References: