louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02544516: Upside Down, Give me the Handle
Official title: Study on the Links Between Perception and Action in Schizophrenia, "Upside Down, Give me the Handle"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenic Disorders
Keywords: Schizophrenia
motor and sensory perceptions
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible (Fuchs, 2005). However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and actions potentially associated (Gibson (1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual motor neurons leads us to postulate that the affordance effect can be assisted by a visuomotor priming of a hand in a position to grasp. With Tucker \& Ellis sensory motor compatibility task, we study the capacity of affordance in schizophrenia, as well as the impact of perceptual motor priming on these affordance effects.

Detailed description: All participants will perform cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987). Controls will only have the first three tasks (cognitive spots Alert and laterality). Then all will perform all tasks in successive order (task 1 and task 2). For both tasks, photographs of 20 objects of everyday life typical grip with one hand are presented in 4 orientations. The instruction is to say if the object is presented upright or inverted; The second task differs from the first only by the introduction of a prime: presenting a hand in position "catching" before the picture of an object

Eligibility criteria: Inclusion Criteria:

For patients:

* a DSM-IV diagnosis of schizophrenia (men or women),
* no change in antipsychotic medication and clinical status within four weeks prior to the study

Exclusion Criteria:

* IQ \< 70

For patients and control group Inclusion criteria

- Age ≥ 18 years et ≤ 50 years

Exclusion Criteria:

* History of head trauma,
* neurological disease with cerebral repercussion or not stabilized serious physical illness;
* psychotropic medication,
* disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);

Primary outcomes:
measure: response time
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Catherine MASSOUBRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03160716: Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation
Official title: A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheek Augmentation
Midface Contour Deficiencies
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.


Eligibility criteria: Primary Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
* Mild to Substantial Midface Volume Loss

Primary Exclusion Criteria:

* Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
* Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents
* Undergone prior surgery to midface

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events [Safety]
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of Participants With Aesthetic Improvement
timeFrame: 16 weeks
measure: Number of Participants That Responded to Treatment
timeFrame: 16 weeks
measure: Subject Satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Facial Plastic and Cosmetic Surgery
state: California
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills
state: California
city: Palo Alto
country: United States
facility: Hessler Plastic Surgery
state: California
city: New York
country: United States
facility: Union Square Laser Dermatology
state: New York
Study officials:
References:
citation: Jones DH, Hessler J, Chapas A, Jonas B, Crider J, Chopra R. Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies. Dermatol Surg. 2020 Apr;46(4):465-472. doi: 10.1097/DSS.0000000000002105.
Clinical trial NCT02478216: The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
Official title: The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The patients were allocated randomly to receive remote preconditioning group (RIPC group, R) or not (Control group, C) using sealed envelopes with the options inside the sealed envelope of R and C before anaesthesia induction. The registered nurse who did not participate in patient care and was blind to the study performed the all randomization process. All medical staffs who involved the patient care were blind to the study. All data were collected by trained observers who were blind to the study and did not participate in patient care

Detailed description: RIPC was performed just after anesthesia induction and before the tourniquet application for the operation site. The tourniquet was applied at the opposite site of thigh in the both groups. The thigh was covered with blanket to conceal the tourniquet inflation and deflation. For R group, 3 cycles of tourniquet inflation for 5 minutes with 2 × systemic systolic arterial blood pressure of arrival at operation room and deflation were performed. For C group, the tourniquet was applied with same manner for R group except inflation pressure of 0 mmHg. The tourniquet pressure according to the randomization was set by the registered nurse who participated in the patients' allocation. The monitor of tourniquet pressure was sealed for blindness.

Eligibility criteria: Inclusion Criteria:

* patient who was planned to undergo total knee replacement surgery

Exclusion Criteria:

* emergency operation
* underlying cerebrovascular disease
* underlying peripheral vascular disease

Primary outcomes:
measure: Incidence of cerebral desaturation
timeFrame: during operation time (an expected average of 2 hours)
Secondary outcomes:
measure: Incidence of postoperative delirium
timeFrame: up to postoperative 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168116: Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
Official title: To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: nasopharynx
xerostomia
prevention
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2005-09-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.


Eligibility criteria: Inclusion Criteria:

* Patients with a histological diagnosis of squamous cell carcinoma
* Patients with unilateral or no neck involvement of the nasopharynx
* The submandibular transfer will be done on the uninvolved side of the neck.
* Karnofsky score greater than or equal to 70
* Expected survival greater than one year
* A signed informed consent

Exclusion Criteria:

* Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.

Primary outcomes:
measure: Quality of life
Secondary outcomes:
measure: Treatment interruptions
measure: Incidence of percutaneous endoscopic gastronomy (PEG)
measure: Incidence of oral candidiasis
measure: Overall survival
measure: Disease free survival
measure: Pattern of recurrence
measure: Complications
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Naresh Jha, MBBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753116: Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Official title: Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Failure, Chronic
Renal Dialysis
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.


Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure of 160 mmHg or greater
* On 3 or more antihypertensive medications
* On dialysis for more than 6 months

Exclusion Criteria:

* Renal artery abnormalities
* Known secondary hypertension attributable to a cause other than sleep apnea
* MI, angina, CVA within 6 months
* Others

Primary outcomes:
measure: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
timeFrame: Through 1 year
Secondary outcomes:
measure: Physiologic response to denervation (e.g., blood pressure reduction)
timeFrame: Through 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
Clinical trial NCT02142816: Fluid Requirement During Surgery PVI v Doppler
Official title: Non-invasive Assessment of Fluid Requirement During Surgery: a Comparison of Oesophageal Doppler and Pleth Variability Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Major Abdominal Surgery
Lead sponsor: York Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 38
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: Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications.

Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give.

The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery.

The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur


Eligibility criteria: Inclusion Criteria:

* Major abdominal surgery
* Anaerobic Threshold \>11 ml O2/kg/min
* VE/VCO2 \<34 OR
* Low risk according to Consultant anaesthetist

Exclusion Criteria:

* Patients age less than 18
* Patient refused consent
* Patient unable to give consent
* Patient has had \<24hrs to consider the Patient information Sheet
* Contraindication to Doppler Probe being inserted
* Emergency Procedure
* Patient has a ASA Grade 5
* Patient is receiving dialysis treatment
* Patient has a known hypersensitivity to hydroxyethyl starch or gelatin solutions
* Patients with renal failure with oliguria or anuria - not related to hypovolaemia
* Patients with a previously diagnosed dysrhythmia
* Patients who weight \>100kg

Primary outcomes:
measure: Difference between fluid volumes administered in the intra-operative period
timeFrame: End of operation
Secondary outcomes:
measure: Difference in 24 hour fluid balance
timeFrame: 24 hours
measure: Post-operative morbiditiy survey
timeFrame: 7 days
measure: Biochemical Markers of Tissue Perfusion
timeFrame: 24 hours
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: York Teaching Hospital
state: N Yorks
Study officials:
affiliation: York Teaching Hospital
name: David Yates, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01724216: Magnetic Resonance Imaging Using Innovative Pulse Sequences
Official title: Magnetic Resonance Imaging Using Innovative Pulse Sequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Indication for a Head MRI
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2012-11-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.

Detailed description: This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject must be willing and able to undergo verbal and written informed consent
* Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration

Exclusion Criteria:

* Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study.

  * Any contraindication to an MRI scan per the policy of Spectrum Health
  * Any contraindication to administration of an MRI contrast agent per the policy of Spectrum Health
  * Off-label utilization of contrast agents administered for the subject's clinical exam

Primary outcomes:
measure: Number of Head Images Successfully Collected
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Mark C DeLano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02948816: The Effects of Social Media on Food Intake and Behaviour
Official title: The Effects of Social Media on Food Intake and Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Hunger
Eating
Lead sponsor: University of Prince Edward Island
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will be exposed to 3 conditions, in random order:

1. A Facebook page where 70% of posts are related to food.
2. A Facebook page where only 20% of posts are related to food.
3. A control condition (colouring quietly).

During each of the above conditions participants will be provided with identical snacks. The snacks will be weighed before and after each condition, to determine whether there is a change in food intake across the 3 conditions.


Eligibility criteria: Inclusion Criteria:

* Age 18-25.

Exclusion Criteria:

* None

Primary outcomes:
measure: Ad libitum snack food intake
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottetown
country: Canada
facility: University of Prince Edward Island
state: Prince Edward Island
Study officials:
References:
Clinical trial NCT00408616: Efficacy and Safety of Grazax in Children
Official title: A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-12-07
Enrollment: 253
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season


Eligibility criteria: Inclusion Criteria:

* Boys and girls 5-16 years of age
* A clinical history of grass pollen induced hayfever
* Positive Skin Prick Test to Phleum pratense
* Positive specific IgE against Phleum pratense

Exclusion Criteria:

* History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
* History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
* History of severe asthma
* Current severe atopic dermatitis

Primary outcomes:
measure: Hayfever symptoms
timeFrame: Grass pollen season 2007
measure: Intake of hayfever symptom relieving medication
timeFrame: Grass pollen season 2007
Secondary outcomes:
measure: Combined hayfever symptom and medication scores
timeFrame: Grass pollen season 2007
measure: Asthma symptoms and medication
timeFrame: Grass pollen season 2007
measure: Global Evaluation of treatment efficacy
timeFrame: Grass pollen season 2007
measure: Adverse Events
timeFrame: 9 months
measure: Pharmacoeconomic Assessment
timeFrame: 9 months
measure: Immunological Assessment
timeFrame: 9 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Tangstedter Landstrasse 77
Study officials:
affiliation: Tangstedter Landstrasse 77, 22415 Hamburg, Germany
name: Friedrich Kaiser, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009 Jan;123(1):167-173.e7. doi: 10.1016/j.jaci.2008.10.044.
Clinical trial NCT00149916: Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107
Official title: Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant
Keywords: Renal Transplant, adults, immunosuppressants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.


Eligibility criteria: Inclusion Criteria:

* Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion Criteria:

* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To assess gastro-intestinal tolerability
Secondary outcomes:
measure: Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: