louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02896374: Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia
Official title: Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Case-control comparison of clinical population, interventional and single-center research.

Detailed description: The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.

Eligibility criteria: Inclusion Criteria:

Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group

Exclusion Criteria:

Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device

Primary outcomes:
measure: Event related electric amplitudes
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
Study officials:
affiliation: Versailles Hospital
name: Eric Brunet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02147665: Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Official title: Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hookah Smoking
Keywords: Hookah
waterpipe
smoking
sympathetic
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. Here the investigators will directly measure the acute effects of Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.


Eligibility criteria: Inclusion Criteria:

* 18 to 39 years of age
* Habitual Hookah smoker defined as having smoked Hookah \>=12 times in the past 12 months
* Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

* Exhaled carbon monoxide level greater than 10 ppm\* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
* History of cardiopulmonary disease
* Use of any prescription medication with exception of oral contraceptive pills
* History of psychiatric illness
* History of neurologic disease
* BMI ≥ 35
* Evidence of any of the above by physical examination, ECG or echocardiogram
* Smoked cigarette in the past 12 months
* History of illicit drug use
* Pregnant
* Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

Primary outcomes:
measure: Sympathetic nerve activity
timeFrame: At the initial study visit
Secondary outcomes:
measure: Myocardial contrast echocardiography
timeFrame: At the initial study visit
Other outcomes:
measure: Venous Occlusion Plethysmography
timeFrame: At the initial study visit
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald G Victor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767765: A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy
Official title: Pilot Study for Evaluating the Efficacy and Tolerability of Induction Therapy With Recombinant Human Erythropoietin Beta (rHuEPO) NeoRecormon® - at High Dose in Anemic Cancer Patients Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 61
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: This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed cancer
* Participants who are treated with at least first line chemotherapy
* Hemoglobin less than (\<) 11 grams per deciliter (g/dL)
* Participants able to receive iron supplement, if necessary

Exclusion Criteria:

* History of hypersensitivity to active or inactive excipients of r-HuEPO
* Insufficient controllable hypertension
* Thalassemic syndromes
* Anemia caused by hematic loss
* Women who are pregnant or lactating

Primary outcomes:
measure: Percentage of Participants With Response to Treatment
timeFrame: Week 4
Secondary outcomes:
measure: Time to Response
timeFrame: Baseline up to Week 4
measure: Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment
timeFrame: Week 2
measure: Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment
timeFrame: Week 4
measure: Percentage of Participants Who Required Transfusion
timeFrame: Baseline, Week 2, Week 4
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Bari
country: Italy
city: Benevento
country: Italy
city: Cagliari
country: Italy
city: Campobasso
country: Italy
city: Napoli
country: Italy
city: Palermo
country: Italy
city: Palermo
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT04059965: AntiCoagulation Tracking InterVention and Evaluation
Official title: AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anticoagulation
Atrial Fibrillation
Atrial Flutter
Pulmonary Embolus/Emboli
Deep Vein Thrombosis
Stroke
Hypercoagulability
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anticoagulants are a leading cause of acute injury from adverse drug events, leading to \~20,000 serious injuries reported to the Food and Drug Administration per year and more than 220,000 emergency department visits annually. Therefore, we propose to implement a health information technology (HIT) population management tool at two distinct anticoagulation clinics that will allow the care team to assign and track tasks essential for timely patient monitoring. We will examine its effect on anticoagulation management outcomes through a randomized trial, hypothesizing that such interventions can be effective as well as cost-effective strategies to improve patient safety in the context of anticoagulation management services.


Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years)
* those prescribed an anticoagulation medication at Zuckerberg San Francisco General Hospital or University of California, San Francisco Health

Exclusion Criteria:

* Minors (age\<18)
* those not prescribed anticoagulation medication at ZSFG or UCSF Health

Primary outcomes:
measure: Time in Therapeutic Range
timeFrame: 6 months
Secondary outcomes:
measure: Proportion Time in Range
timeFrame: 6 months
measure: Time from initiation to therapeutic INR (TWTR)
timeFrame: Study Period (average of 2 years)
measure: Adverse events
timeFrame: Study Period (average of 2 years)
Other outcomes:
measure: Time from out-of-range to patient contact (T2C)
timeFrame: Study Period (average of 2 years)
measure: Adherence to monitoring guidelines
timeFrame: Study Period (average of 2 years)
measure: Attendance/ no-show rate
timeFrame: Study Period (average of 2 years)
measure: Timely discontinuation of treatment
timeFrame: Study Period (average of 2 years)
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Urmimala Sarkar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398565: Pregnancy Subsequent to Ventral Hernia Repair
Official title: Pregnancy Subsequent to Ventral Hernia Repair: a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Ventral
Pregnancy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-03-25
Enrollment: 7612
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide study population of patients registered with a ventral hernia repair in The Danish Hernia Database between January 1 2007 and December 31 2014

Brief summary: We will examine the outcome of ventral hernia repair with subsequent pregnancy


Eligibility criteria: Inclusion Criteria:

* History of ventral hernia repair with subsequent pregnancy
* Born between January 1 1955 and January 1 1995

Exclusion Criteria:

* Registered in the Danish Hernia Database with a non-valid ID-number, i.e. non-Danish resident.

Primary outcomes:
measure: Recurrence of ventral hernia
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Digestive Disease Center, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Lars N Jorgensen
role: STUDY_CHAIR
References:
Clinical trial NCT03789565: Hepcidin Levels in Periodontal Health and Disease
Official title: Gingival Crevicular Fluid and Serum Levels of Hepcidin, IL-6 and IL-10 in Periodontal Health and Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: periodontal diseases
hepcidin
elisa
interleukin 6
interleukin 10
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 90
Sex: ALL
Minimum age (years): 32
Maximum age (years): 52
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study included a total of 60 individuals between 32 and 52 years of age, with a total number of teeth \> 20, who underwent consultation for periodontal treatment

Brief summary: Periodontal disease refers to inflammatory disease of the periodontium caused by the host and/or pathogenic microorganisms. Anti-inflammatory and pro-inflammatory cytokines play a role in the periodontal inflammation process. The aim of this study was to evaluate the levels of hepcidin, interleukin (IL)-6, and IL-10 levels in gingival crevicular fluid (GCF) and in serum samples obtained from individuals with periodontal inflammation.

Detailed description: The study included 90 individuals, who were divided into three groups: periodontally healthy (PH) (n=30); gingivitis (G) (n=30); and chronic periodontitis (CP) (n=30). GCF and serum samples were obtained from each individual, and samples were evaluated using ELISA. Statistical evaluation of the data was performed using the SPSS packet data program.

Eligibility criteria: Inclusion Criteria:

* Systematically healthy patients. Patients who did not receive any medication or periodontal treatment within the previous 6 months

Exclusion Criteria:

* Individuals who smoked and women who were pregnant and/or lactating were excluded from the study

Primary outcomes:
measure: Hepcidin levels
timeFrame: 1 year
Secondary outcomes:
measure: IL-6 levels
timeFrame: 1 year
measure: IL-10 levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Çiğdem Coşkun Türer
Study officials:
References:
Clinical trial NCT06199765: Risk Perception of Needlestick Injury
Official title: Predictors of Perception on Risk of Needlestick Injury and Effectiveness of The Needlestick Prevention Module Among House Officers in Kelantan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Needlestick Injuries
Lead sponsor: Hospital Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All house officers who were eligible and consented, who participated in cross sectional study were included into intervention group until the required sample size was achieved. The same numbers of officers, eligible and consented were included into control group. For intervention, only educational intervention will be given which consist of lecture, demonstration, and role play. After that, data collection will be given right after the intervention completion and 4 weeks after that using self administered questionnaire. The same will be applied to the control group which data collection will be done right masking and 4 weeks later.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effectiveness of needlestick injury prevention module

Detailed description: After being informed about the study and the potential risk, participants were given written informed consent to be filled out and signed. Agreed participants will receive a 1-week duration of educational intervention. The intervention only involved education and was less likely to cause injury or damage to the body.

Eligibility criteria: Inclusion Criteria:

1. All house officer in government hospitals with house officer training programme
2. House officers must be among those who join housemanship program for minimum of 1 month duration

Exclusion Criteria:

1. House officer who undergo attachment outside the training hospital
2. House officer that are not available during the data collection period or on long leave

Primary outcomes:
measure: Needlestick injury Risk Perception Score
timeFrame: right after intervention and 4 weeks after
Secondary outcomes:
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
Study officials:
References:
Clinical trial NCT04706065: SHMT1 Polymorphism in Parkinson's Disease,
Official title: Genetic Polymorphisms of Serine Hydroxylmethyl Transferase 1 (SHMT1) in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Study the Role of SHMT1 Polymorphism in Parkinson Disease
Keywords: SHMT1 polymorphism
Parkinson disease
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Aswan University Hospital
First posted: 2021-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with parkinson diisease

Brief summary: Parkinson Disease (PD) is the most common movement disorder and represents the second most common degenerative disease of the central nervous system . SHMT has been shown to be associated with various diseases.

Detailed description: This case -control observational prospective study will conducted on 40 patients with PD.

Eligibility criteria: Inclusion Criteria:

* Patients age ≥ 50 years.
* Patients with PD diagnosed according to the United Kingdom Parkinson's Disease Society Brain Bank (UK PDS Brain Bank diagnostic criteria)

Exclusion Criteria:

* Patients with parkinsonian plus syndrome

  * Patients with secondary parkinsonism
  * Patients with other chronic comorbidities (renal, hepatic, and endocrinal disturbances and chronic chest disease.)
  * Past and /or present history of epilepsy.
  * Patients with disturbed conscious level.

Primary outcomes:
measure: polymorphism of SHMT1gene
timeFrame: one year
Secondary outcomes:
measure: the role of SHMT1plymorphism in pathogenesis PD
timeFrame: one year
measure: Study the relationship of Shmt1 polymorphism to the severity of Parkinson disease
timeFrame: One year
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Effat abdelhady tony
Study officials:
affiliation: Assistant professor
name: Abeer a tony, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03451565: Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning
Official title: Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning : an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Keywords: Hypotension
Systemic blood pressure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 200
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: The population studied will include patients operated at the University Hospitals of Strasbourg in a sitting position.

Brief summary: This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study.

The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm.

The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,


Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Patient operated in a sitting position at Hopitaux Universitaires de Strasbourg
* Patient willing to participate in the study

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Blood pressure
timeFrame: 10 min after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Anesthesiologie - Reanimation Chirurgicale
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Eric Noll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811265: Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Official title: Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: ExAblate MRgFUS
Focused ultrasound
Magnetic resonance imaging
Prostate cancer
Radical prostatectomy candidate
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 10
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.

Detailed description: The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.

Eligibility criteria: Inclusion Criteria:

* Age of patients: up to 75 years.
* Men scheduled for radical prostatectomy due to prostate cancer.
* Patients who are able and willing to give consent and able to attend all study visits.

Exclusion Criteria:

* Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
* Severely abnormal coagulation (INR\>1.5)
* Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP \> 100 on medication), and patients with cardiac pacemakers
* Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
* Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)
* Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc...)
* Any spinal pathology that prohibits maintaining supine position for more then an hour
* Any previous radiation to the pelvis.

Primary outcomes:
measure: Device-related adverse events
timeFrame: Throughout study period
Secondary outcomes:
measure: Device compatibility with human anatomy
timeFrame: During simulated device use
measure: MR Imaging Quality
timeFrame: During simulated device use
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References: