louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03630523: Response of Immune System to Flu Vaccination in PHTS
Official title: Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTEN Hamartoma Tumor Syndrome
Keywords: PHTS
PTEN
Vaccination
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.


Eligibility criteria: Inclusion Criteria:

* Must be diagnosed with PHTS based on genetic testing
* Must be a Radboudumc patient
* Must be 18 years or older
* Must be mentally competent
* Must have provided written informed consent to participate in the study
* Must be able to adhere to visit schedule and available to complete the study

Exclusion Criteria:

* • Known history of significant medical disorder, which in the investigator's judgment might confound the results of the study or pose additional risk to the subject by participation in the study

  * Known hypersensitivity to previous influenza vaccinations (Anaphylaxis)
  * Must not be allergic to chicken eggwhite
  * Pregnancy at start of study
  * Immunocompromised patients and those receiving concomitant immunosuppressive therapy or other immune modulating drugs including chronic steroid treatment.
  * Bleeding disorders including haemophilia and thrombocytopenia or treatment with anticoagulants(Due to risk of intramuscular hematoma after injection)
  * Must not have received vaccination with attenuated pathogens in the 4 weeks leading up to study. (Measles, mumps, rubella, yellow fever, rotavirus, BCG, typhoid)

Primary outcomes:
measure: Hemagglutination inhibition assay titre
timeFrame: 7 days
Secondary outcomes:
measure: Proliferation assay
timeFrame: 21 days
measure: interleukin profile
timeFrame: 21 days, 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05815823: Effect of Robotic Therapy on Upper Extremity With Stroke
Official title: The Effect of Virtual Reality Assisted Upper Extremity Robotic Therapy on Pain, Daily Living Activities and Functional Status in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Effect of Virtual Reality on Stroke Rehabilitation
Keywords: stroke
upper extremity
robot-assisted therapy
armeo
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.After conventional and robotic therapy Each patient was evaluated The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

Detailed description: The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.

Materials and Methods: The study included 40 stroke patients. Two groups of patients were created. Group I also underwent 20 sessions of upper extremity robot-assisted therapy for 4 weeks, 5 days a week, for 30 minutes per session, in addition to receiving conventional therapy (5 days a week for 4 weeks, 1 hour each day). Group II only got traditional therapy. Each patient was assessed both before and after the procedure.

The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

Eligibility criteria: Inclusion Criteria:

- Ischemic or hemorhagic hemiplegia

* Brunnstrom upper extremity motor stage ≥3
* At least 3 months have passed
* Modified Ashworth Score ≤2
* 18-85 year old patients with diagnosis of stroke

Exclusion Criteria:

* Aphasia
* Cognitive impairment
* mini mental test \<24
* deformity and / or contracture in the upper extremity
* Patients diagnosed with KBAS

Primary outcomes:
measure: FMA-UE scale
timeFrame: baseline
measure: FMA-UE scale
timeFrame: after treatment (1 month)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00355823: Bioelectric Field Imaging Near Human Skin Wounds
Official title: Phase I Study of the Electric Field Near Human Skin Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: electric field
wound current
wound healing
bioelectric field
chronic ulcer
diabetic
Diabetes
aging
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2006-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two age groups will be studied: 1. Young adults 18-19 years old; and 2. older adults 65-80 years old.

Brief summary: The investigators have developed a new non-invasive medical device called the Bioelectric Field Imager. They plan to use this device to measure the electric field near small lancet wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for wound healing and the magnitude of this field will vary with wound healing capability. The investigators will compare the electric fields near arm and leg wounds in males and females in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in diabetics and near chronic ulcers.

Detailed description: We will first characterize the lateral electric field near reproducible skin wounds in healthy male and female subjects 18-30 years of age. A standard superficial, dermal wound 0.5 mm long will be inflicted using the Ascensia Microlet Vaculance by Bayer Health Care with a 21 gauge lancet on its deepest setting. This setting will penetrate the epidermis and stop within the dermis. We will first determine variability within the same individual by measuring the electric field near two wounds close to each other on the volar forearm. We will then determine the variability between different body regions by comparing the wound field near a lancet wound in the volar forearm and one in the leg. If hair is present it will be removed by shaving the wound site prior to wounding. By collecting these data from 10 males and 10 females in both age groups we can determine if there is a gender or age dependence to the field strength. Finally we will determine the lateral electric field near lancet wounds in diabetics and near chronic skin wounds. If these fields are smaller than fields found near acute wounds, it would provide a rationale for future studies imposing electric fields to enhance wound healing.

Eligibility criteria: Inclusion Criteria:

* Aged 18-30 years or 65-80 years
* Chronic leg ulcer present
* Diabetic

Exclusion Criteria:

* Hemophilia
* Fever

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Antoinette F. Hood, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002923: Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Official title: Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different treatment strategies, PVI only versus PVI plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after follow-up of at least 1 years with the use of an implanted monitoring device (IMD).


Eligibility criteria: Inclusion Criteria:

* Persistent and paroxysmal AF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm

Primary outcomes:
measure: Freedom of AF or other atrial arrhythmias
timeFrame: 1 year
Secondary outcomes:
measure: serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT04775823: Hybrid Ceramic on Worn Dentition Patients
Official title: Evaluation of Hybrid Composite-nanoceramic on Material Characteristic and Clinical Use Over Tooth Wear Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Wear
Keywords: Dentistry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Hospital
First posted: 2021-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.

Detailed description: Composite resin is often used to restore patient's dental defficiency, and also the material to cover and protect weak tooth structure. In tooth wear patients, multiple factors attributing to destruct their teeth. The durability and strength of the resotrative material must be reinforced. Nanoceramic infiltrated in composite resin may enhance its mechanical characteristics. Therefore, hybrid composite-nanoceramic material may be effective for tooth wear patients.

Eligibility criteria: 1. Tooth erosion/attrition/abrasion/abfraction patients
2. Age above 20 years old
3. Return at certain period during the trial
4. Full understanding of written and spoken language
5. Agree with the questionnaire

Primary outcomes:
measure: Evaluation the change of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.
timeFrame: 3months, 6months, 12months, 24months, 36months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: Associate Professor
name: Yang Tsung-Chieh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
citation: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
Clinical trial NCT00933023: Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children
Official title: A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Phimosis
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 0
Sex: MALE
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Topical steroids are used as treatment for non-retractile foreskin in children for decades, but, there are disagreement among physicians about the optimum potency of the agent used. This study is designed to determine any difference in the beneficial effects of mild versus potent topical corticosteroids in treatment of non-retractile foreskin in children.


Eligibility criteria: Inclusion Criteria:

* Children 2-16 with non-retractile foreskin

Exclusion Criteria:

* Balanitis xerotica obliterans, balanitis, \<2yrs

Primary outcomes:
measure: Achievement of fully retractile foreskin with full exposure of glans at the end of therapy
timeFrame: 16 weeks
Secondary outcomes:
measure: Complications of topical corticosteroids
timeFrame: 16 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Research Fellow in Paediatric Surgery
name: Anindya Niyogi, MBBS, MRCSEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04153123: Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine
Official title: Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmic Artery
Peribulbar Block
Keywords: ocular flow
cataract surgery
peribulbar block
ocular Doppler
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000.

Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.
Primary purpose: PREVENTION

Brief summary: Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

Detailed description: There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected. Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and 1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 min after the peribulbar block.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I, II or III physical status classification
* Cataract surgery

Exclusion Criteria:

* glaucoma
* diabetic retinopathy
* previous eye surgery in the same eye
* ocular trauma
* allergic to any protocol medication
* uncooperative patients or cognitive difficulties
* axial eye diameter of less than 21.0 mm or greater than 25.5 mm.

Primary outcomes:
measure: Artery resistance index of ophthalmic artery
timeFrame: Change on resistance index 10 minutes after peribulbar anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.
state: Minas Gerais
Study officials:
References:
Clinical trial NCT02040623: Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
Official title: Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Graft-versus-host Disease
Keywords: Chronic Graft versus Host Disease
Keratoconjunctivitis Sicca
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
* To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.


Eligibility criteria: Inclusion Criteria:

* Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.
* Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
* Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
* Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
* Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.

Exclusion Criteria:

* Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality
* Used topical ophthalmic cyclosporine within 45 days.
* Used any topical ophthalmic steroid within 2 weeks.
* Used autologous serum eye drops within 2 weeks.

Primary outcomes:
measure: Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
timeFrame: Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Plantation
country: United States
facility: U. Miami - Bascom Palmer Eye Institute
state: Florida
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Rigel Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02184923: Verticality Perception in Stroke Patients
Official title: Verticality Perception in Patients With Acute Lateralized Lesions Along the Central Graviceptive Pathways- Acute Assessment on the Ward and the Stroke Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Verticality Perception in Stroke
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright.The strategy of this research is to quantify changes in verticality perception after unilateral lesions along the central graviceptive pathways and to assess the frequency and pattern of abnormal verticality perception in patients with acute stroke (ischemic or hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality perception by use of a mobile device assessing the subjective visual vertical (SVV) during the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those patients with defects. Early detection of deficits in verticality perception may help to initiate balance physiotherapy early.


Eligibility criteria: Inclusion Criteria:

1. ages 18-90 years
2. informed consent
3. for group 1: acute (i.e. symptom onset \<3 days ago) lateralized ischemia or hemorrhage as confirmed by clinical examination and / or brain imaging (CT or MRI).
4. absence of exclusion criteria

Exclusion Criteria:

1. history of a peripheral-vestibular deficit
2. disturbed consciousness
3. severe sensory or motor aphasia
4. visual field deficits
5. other neurological or systemic disorder which can cause dementia or cognitive dysfunction
6. intake of antidepressants, sedatives, or neuroleptics

Primary outcomes:
measure: Accuracy of verticality perception
timeFrame: during the measurement period (10 minutes)
Secondary outcomes:
measure: Test-re-test reliability of verticality perception
timeFrame: from session 1 (day 0) to session 2 (day 1)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neurology
name: Dominik Straumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zwergal A, Rettinger N, Frenzel C, Dieterich M, Brandt T, Strupp M. A bucket of static vestibular function. Neurology. 2009 May 12;72(19):1689-92. doi: 10.1212/WNL.0b013e3181a55ecf.