louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01176721: Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Official title: Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenic disorders
psychosis
psychotic
dementia
delusional
delusions
hallucinations
residual-type schizophrenia
illusions
split mind
mental health disorder
schizoid
paranoid-type schizophrenia
disorganized-type schizophrenia
undifferentiated-type schizophrenia
catatonic-type schizophrenia
mental illness
tardive dyskinesia
neuroleptic malignant syndrome
NMS
antipsychotics
atypical antipsychotics
psychosocial treatments
rehabilitation
Lead sponsor: cerbomed GmbH
Sponsor class: INDUSTRY
Collaborators: name: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
First posted: 2010-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.

Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
* Appliance of the t-VNS® medical device according to the manual

Exclusion Criteria:

* Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
* Pregnancy
* Bronchial asthhma in medical history
* clinically relevant internistic, neurological or psychiatric diseases
* abuse of drugs or alcohol until 4 weeks to enrollment
* Traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (Gammma knife surgery))
* indication of structural impairment of the basal ganglia or the brain stem
* malformations of the pinna
* further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study

Primary outcomes:
measure: Safety and efficacy of t-VNS in schizophrenia
timeFrame: 24 weeks
Secondary outcomes:
measure: Recording of clinical performance of t-VNS in schizophrenia
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
state: Bavaria
city: Goettingen
country: Germany
facility: Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen
state: Niedersachsen
Study officials:
References:
Clinical trial NCT00078221: Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: Dry AMD
Age-related Macular Degeneration
Rheopheresis
Lead sponsor: OccuLogix
Sponsor class: INDUSTRY
First posted: 2004-03-01
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.


Eligibility criteria: * Age 50-85
* Diagnosis of Dry AMD
* BCVA between 20/32 and 20/125 in at least one eye
* Numerous large plaques (soft drusen)
* No history of HIV, Hepatitis B or C
* Elevation of certain blood factors, such as total cholesterol, fibrinogen, and IgA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates
state: California
city: Coral Gables
country: United States
facility: Aran Eye Associates
state: Florida
city: Ft. Myers
country: United States
facility: Retina Health Care
state: Florida
city: Chicago
country: United States
facility: UIC Eye Center
state: Illinois
city: New York
country: United States
facility: Macula Care
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Bala Cynwyd
country: United States
facility: Associated Retinal Consultants
state: Pennsylvania
city: Oakville,
country: Canada
facility: W. Bradley Kates, MD
state: Ontario
Study officials:
affiliation: OccuLogix
name: Irving Siegel, MD
role: STUDY_DIRECTOR
References:
citation: Pulido JS; Multicenter Investigation of Rheopheresis for AMD (MIRA-1) Study Group. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis. Trans Am Ophthalmol Soc. 2002;100:85-106; discussion 106-7.
Clinical trial NCT01630421: Genetic and Functional Analysis of Aplasia Cutis Congenital (ACC)
Official title: Identification of Mutations That Lead to Aplasia Cutis Congenita in Families and Isolated Cases and Studies of Cellular and Molecular Mechanisms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aplasia Cutis Congenita
Keywords: Aplasia cutis congenita
bone
osteoblast
osteoclast
skin
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with diagnosed ACC

Brief summary: The goal of this research study is to identify genes and regulatory elements on chromosomes that cause ACC. The investigators also study tissue samples from patients to learn about the processes that lead to this disorder.

Detailed description: Aplasia cutis congenita (ACC) or congenital scalp defect is a very rare disorder that affects bone and skin. The definition for ACC is the localized absence of (normal) skin at the time of birth (congenital). The skin appears thinner and the underlying structures are visible. We study mostly the isolated form of ACC with the lesion often being at the vertex of the skull (at or close to the top of the skull). The bone underlying the lesion is sometimes thinner as well.

For this study we will:

* Send out study participation kits and consent by phone
* Collect a saliva sample from eligible individuals
* Obtain information regarding ACC
* Document disorder with photos and doctor's letters
* If patients undergo surgery for ACC we ask to obtain some tissue that would otherwise be discarded
* Isolate DNA from the saliva sample
* Perform genetic analyses of the DNA with the most up-to-date methods available to identify genetic variations
* Study in the laboratory why the genetic variations cause the disorder

Eligibility criteria: Inclusion Criteria:

* ACC; unaffected individuals only if part of a participating ACC family

Exclusion Criteria:

* No ACC unaffected individuals only as part of a participating ACC family

Primary outcomes:
measure: Identification of genetic elements
timeFrame: at time of identification
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Ernst J Reichenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine SM, Reformat DD, Thorne CH. Cutis aplasia: perioperative management and case report. Am J Crit Care. 2012 May;21(3):212-5. doi: 10.4037/ajcc2012904.
Clinical trial NCT00372021: Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non Arthritic Anterior Ischemic Optic Neuropathy
Keywords: non arthritic ischemic optic neuropathy
anterior ischemic optic neuropathy
Optic nerve Neurotomy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-06
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual loss due to optic nerve involvement in patients above 50 years old. As this problem can be considered as a sclera out let syndrome an there is no effective and successful treatment for it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to achieve acceptable treating outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with non-arthritic anterior ischemic optic nerve

Exclusion Criteria:

* Visual acuity more than 20/200
* Other intra occular operations
* Passing more than 4 weeks of the problem
* Arthritic anterior ischemic optic nerve
* Age under 50 years
* Consumption of previous pharmaceutical treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Masoud Soheilian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01525121: Expiratory Rib Cage Compression in Mechanically Ventilated Patients
Official title: Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Infection
Keywords: mechanical ventilation
chest physiotherapy
critical care
pneumonia
Mechanically ventilated patients with pulmonary infection.
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage compression technique improves respiratory mechanics and is effective in secretion removal in mechanically ventilated patients.

Detailed description: Chest physiotherapy is an essential component of the multidisciplinary approach in critical care settings. In this context, a number of devices and manual techniques have been used to remove pulmonary secretions and re-expand collapsed areas. This study was designed to evaluate whether manual rib cage compression improves airway clearance and respiratory mechanics in mechanically ventilated patients. In a randomized crossover trial, 20 mechanically ventilated patients underwent thoracic manual compression and control intervention (normal ventilation) at the same day. The main outcomes were sputum production and the changes in respiratory mechanics.

Eligibility criteria: Inclusion Criteria:

* patients under mechanical ventilation
* diagnosis of pulmonary infection
* hypersecretive (defined as the interval between tracheal suctioning \< 2 hours)

Exclusion Criteria:

* haemodynamic instability (defined by heart rate \> 130 bpm and mean arterial pressure \< 60 mmHg)
* use of vasopressor drugs
* absence of respiratory drive
* acute bronchospasm
* acute respiratory distress syndrome
* atelectasis (identified by an independent radiologist that was not participating in the study)
* untreated pneumothorax
* lung haemorrhage.

Primary outcomes:
measure: Sputum Volume (mL)
timeFrame: Day 1
Secondary outcomes:
measure: Respiratory Mechanics
timeFrame: Day 1
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Centro Universitário Augusto Motta
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Fernando S Guimarães, PhD
role: STUDY_CHAIR
affiliation: Centro Universitário Augusto Motta
name: Sara LS Menezes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Universitário Augusto Motta
name: Agnaldo J Lopes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guimaraes FS, Lopes AJ, Constantino SS, Lima JC, Canuto P, de Menezes SL. Expiratory rib cage Compression in mechanically ventilated subjects: a randomized crossover trial [corrected]. Respir Care. 2014 May;59(5):678-85. doi: 10.4187/respcare.02587. Epub 2013 Oct 8.
Clinical trial NCT01856621: Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus
Official title: Pharmacokinetic Study Comparing Two Salmeterol Fluticasone Propionate Device-metered Dry Powder Inhalers, Salmeterol/Fluticasone Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; a Randomised, Doubleblind,Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 18-60 years
* Normal weight, at least 50 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease
* Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
* Known hypersensitivity to the active substance(s) or the excipient of the drug
* Pregnant or lactating females

Primary outcomes:
measure: Pharmacokinetic parameter Cmax of plasma salmeterol concentration
timeFrame: Within 34 h
measure: Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
timeFrame: Within 34 h
measure: Pharmacokinetic parameter AUCt of plasma salmeterol concentration
timeFrame: Within 34 h
measure: Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
timeFrame: Within 34 h
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma Clinical Pharmacology Unit
Study officials:
References:
Clinical trial NCT02199821: Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Narrow Transplantation
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 14
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Aims: Nutritional support is considered an integral part of the supportive care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare plasma cytokines levels in children after bone marrow transplantation using a lipid formula enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.

Methods: A randomized double blinded controlled study including 14 children with BMT and requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha (TNF-α).


Eligibility criteria: Inclusion Criteria:

Term infants. Children with a stable medical condition. Children in need of parenteral nutrition for at least 10 days, except for the cardiac group would be at least 5 days.

Exclusion Criteria:

Premature infants Children over 14 years Children with hypersensitivity to egg ingestion or soy protein Children with severe insufficiency of an organ, Children with inborn error of metabolism, and any condition that does not allow random use of lipid emulsion type.

Primary outcomes:
measure: average cytokines plasma levels between groups of children with the two different lipid formulas.
timeFrame: 21 days
Secondary outcomes:
measure: Anthropometric measurements such as: weight height
timeFrame: 21 days
measure: Incidence of adverse effects associated with formula consumption.
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01351402: Effects of Massage Versus Rest on Hormones
Official title: Investigating the Effects of Massage vs. Rest on Oxytocin, ACTH, and B-endorphins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Rest
Keywords: Massage
Rest
Lead sponsor: Claremont Graduate University
Sponsor class: OTHER
Collaborators: name: Gruter Institute
First posted: 2011-05-10
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the effects of 15 minutes of massage compared to 15 minutes of quiet rest on physiological variables. Specifically, the investigators will measure the effects on levels of the social hormone oxytocin, and on other physiological variables that interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin, and IL-1alpha). The investigators will also investigate whether, in the case of hormones changes, these influence social decision making.

Detailed description: Interested participants will have the experiment explained both verbally and in writing, and asked to give their informed consent in writing. After consent, the participants will be led to a private room for their first 30ml blood draw by a qualified phlebotomist. Participants will then have a second 30ml blood draw.

Eligibility criteria: Inclusion Criteria:

* Anyone English speaking and over the age of 18.

Exclusion Criteria:

* Minors and anyone who has used illicit drugs or alcohol in the last 24 hours.

Primary outcomes:
measure: Oxytocin
timeFrame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Secondary outcomes:
measure: Adrenocorticotrophic hormone (ACTH)
timeFrame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
measure: Beta-endorphin
timeFrame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
measure: Interleukin-1alpha (IL-1a)
timeFrame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cassel, UCLA
state: California
Study officials:
References:
Clinical trial NCT01654302: Efficacy and Safety of Synera in Osteoarthritis Pain
Official title: Efficacy and Safety of Synera in OA Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Nuvo Research Inc.
First posted: 2012-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

Detailed description: Subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (Synera patch or Inactive patch). Participants rated their pain on a NRS-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. Subjects were randomized to receive either Synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and Synera patch at the second visit.

Eligibility criteria: Inclusion Criteria:

1. Men and women, age 40 years and above
2. Meet American College of Rheumatology criteria for knee OA
3. Knee pain most days of the week for the past month
4. Knee pain \> 5/10 after exercise intervention
5. Capable of undertaking exercise intervention
6. Stable cardiovascular function
7. Able to return for all clinic visits
8. Able to read and understand the informed consent document

Exclusion Criteria:

1. Use of a walker to ambulate or inability to ambulate
2. Other forms of arthritis
3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
4. History of myocardial infarction
5. Blood Pressure \> 140 systolic/100 diastolic
6. Scheduled for and likely to need joint replacement surgery in the next 3 months
7. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
8. Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Primary outcomes:
measure: Index Knee Pain Scores on a Numeric Rating Scale (NRS)
timeFrame: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Thomas J Schnitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: