louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05625958: Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery
Official title: Multicentre, Non-randomised Clinical Study Evaluating the Efficacy and Safety of Cilioscleral Interposition Device v2.2 in Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma, Narrow Angle
Lead sponsor: Ciliatech
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 35
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: The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

Detailed description: 35 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG Schafer 1 to 4
* Medicated IOP ≥ 21
* naive of any prior glaucoma surgery

Exclusion Criteria:

* Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Primary outcomes:
measure: Assess post-op IOP reduction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinica San Carlos
name: Julian GARCIA FEIJOO, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05914558: Comorbid Painful TMD Among Trigeminal Neuralgia
Official title: Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Trigeminal Neuralgia
Temporomandibular Disorder
Myofascial Pain
Trigeminal Neuropathy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2023-06-22
Enrollment: 5
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: Patients that visited three clinical centers in the study who sought care for their facial pain were diagnosed with trigeminal neuralgia, with active symptoms in the past 30 days.

Brief summary: An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.

Detailed description: This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.

Eligibility criteria: Inclusion Criteria:

* Patients visited the three clinical sites for facial pain
* Patients diagnosed with trigeminal neuralgia
* Has active pain symptoms in the past 30 days

Exclusion Criteria:

* Non-English speakers
* Patients with psychiatric disorders that might alter pain perception
* Adults lack the capacity to provide informed consent.
* Persons under the age of 18.
* All vulnerable populations.

Primary outcomes:
measure: Prevalence
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Neurosurgery
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Donald Nixdorf, DDS,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Qiman Gao, DDS,MS,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02815358: Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Pain
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
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 aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder ﬂexion/extension.


Eligibility criteria: Inclusion Criteria:

* women aged between 18 and 65 years old
* chronic lumbar pain (at least 3 months)
* average pain intensity of ≥3 on a 10-point scale

Exclusion Criteria:

* presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
* history of back surgery
* pregnancy
* less than 3 months of therapeutic treatment (physiotherapy) for low back pain

Primary outcomes:
measure: Anticipatory Postural Adjustment by means of Electromyography
timeFrame: change from pre to post-treatment (8 weeks)
Secondary outcomes:
measure: Disability level via the Oswestry Low Back Pain Questionnaire
timeFrame: change from pre to post-treatment (8 weeks)
measure: Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire
timeFrame: change from pre to post-treatment (8 weeks)
measure: Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool
timeFrame: change from pre to post-treatment (8 weeks)
measure: Pain level via visual analogue scale
timeFrame: change from pre to post-treatment (8 weeks)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT01593358: Venous Obstruction in Neurodegenerative Disorders Research Registry
Official title: Venous Obstruction in Neurodegenerative Disorders Research Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Cerebral Spinal Venous Insufficiency
Keywords: CCSVI
Lead sponsor: Synergy Health Concepts, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human subjects will be approached for participation in this registry that are receiving or seeking medical care at Synergy Health Concepts, Inc.No individuals shall be excluded from participation in the Research Registry based on race, ethnicity, or gender.

Brief summary: To establish if there are venous obstructions in patients with neurodegenerative disorders

Detailed description: This research registry will observe the venous obstruction in neurodegenerative disorders. This will provide data that will allow researchers to classify abnormal valve and venous morphology, distinguish vessels which are more responsive to treatment, determine groups who respond more favorably to treatment, and overall evaluate the outcomes of venous angioplasty in various neurodegenerative disorders that involve venous obstruction.

Eligibility criteria: Inclusion Criteria:

* Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
* Males or Females between the ages of 18 and 90 years of age
* Voluntary agreement to participate in the Venous Obstructions in Neurodegenerative Diseases Research Registry

Exclusion Criteria:

* Any implantable/metallic objects that prevent subject from having a magnetic resonance imaging ( MRI/MRV) study
* History of uncontrolled hypertension
* Previous venous angioplasty treatment for Chronic cerebral spinal venous insufficiency
* Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women,fetuses, and cognitively impaired individuals who are unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Synergy Health Concepts, Inc.
state: California
Study officials:
affiliation: Study Principal Investigator
name: John Joseph Hewett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806858: Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus
Official title: NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 526
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with Type 1 or Type 2 diabetes

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.
* A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations

Exclusion Criteria:

* Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
* Subjects with known or suspected allergy to any insulin or any of its excipients

Primary outcomes:
measure: The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire)
timeFrame: 3 months
Secondary outcomes:
measure: Subjects' device preference
timeFrame: 3 months
measure: Subjects' NovoPen® 4 evaluation
timeFrame: 3 months
measure: Number of clinical technical complaints
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02083458: An Infraclavicular Landmark-based Approach to the Axillary Vein
Official title: A New Infraclavicular Landmark-based Approach to the Axillary Vein as an Alternative Method of Central Venous Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: critical care
catheterization
axillary vein
Lead sponsor: Uniwersytecki Szpital Kliniczny w Opolu
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring.

The procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava.

There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique.

The primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in patients admitted to the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* patients admitted to the intensive care unit with indications for central venous catheterization

Exclusion Criteria:

* chest wall deformities at the cannulations side
* major hemostasis disorders
* infections at the catheterization site
* age less than 18 years
* lack of patients consent

Primary outcomes:
measure: Rate of successful catheterizations.
timeFrame: 24 hours
measure: Procedure success rate depending on physician experience.
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of early complications.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu
name: Ryszard Gawda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736658: AZD1386 Japanese Multiple Ascending Dosing Study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Japanese Young and Elderly Subjects After Oral Multiple Doses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Keywords: Japanese
MAD
Multiple ascending dose
Chronic pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese males or females young (≥20 to ≤45 years inclusive) or elderly (≥65 to ≤80 years inclusive). Female subjects must be surgically sterile or post-menopausal.
* Body Mass Index (BMI) of ≥19 to ≤ 27 kg/m2 and weight of ≥45 to ≤90 kg
* Clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria:

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
* A family history of short or long QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
* Subjects with orthostatic hypotension defined as a decrease of ≥ 25mmHg systolic blood pressure and/or a decrease of ≥15mmHg diastolic blood pressure within 5 minutes when going from a supine to standing position
* Clinically significant illness or clinically relevant trauma within 2 weeks prior to the administration of the investigational product as judged by the investigator

Primary outcomes:
measure: To investigate the safety and tolerability of AZD1386 after multiple dosing in young and elderly healthy Japanese subjects by assessment of adverse events, vital signs, ECG parameters, body temperature, clinical chemistry, haematology and urinalysis.
timeFrame: All assessments are made at each visit during the study.
Secondary outcomes:
measure: To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations.
timeFrame: Blood samples will be taken before and after study drug administration.
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
name: Rolf Karlsten
role: STUDY_DIRECTOR
affiliation: Kyusyu Clinical Phramacology Research Clinic
name: Shunji Matsuki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544658: Intervening Factors in Tooth Color Assessment
Official title: Intervening Factors in Tooth Color Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Color
Keywords: Tooth extrinsic stain
Tooth color
Dental prophylaxis
Visual shade guide
Dental spectrophotometer
Lead sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
Sponsor class: OTHER
Collaborators: name: University of Lisbon
First posted: 2018-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the influence of several factors (light, extrinsic stain removal and operator's experience) in tooth color assessment. Tooth color will be assessed by two different operators with visual shade guides under standardized light conditions and using a light correcting device (Smile Lite) or with a dental spectrophotometer in human subjects. Color measurement will be made before and 1 week after dental prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Capability to sign the informed consent
* Presence of upper teeth canines and central incisors, free of tooth decay, dental fillings, endodontic treatment or fixed rehabilitation
* Tooth color at least A3 in one of the included teeth
* Teeth should be possible to be subject to tooth color assessment with the predefined methods (color within the visual shade guides range)
* Absence of fixed orthodontic appliances or severe tooth structure anomalies

Exclusion Criteria:

* Pregnant patients
* Patients subjected to professional dental prophylaxis in less than 4 months

Primary outcomes:
measure: Tooth color change determined before and after professional dental prophylaxis, assessed with visual shade guide (VITA Classical)
timeFrame: 1 week (measurements before and 1 week after dental prophylaxis)
measure: Tooth color change measured before and after professional dental prophylaxis, assessed with visual shade guide (VITA Toothguide 3D-Master)
timeFrame: 1 week (measurements before and 1 week after dental prophylaxis)
measure: Tooth color change in CIELab system measured before and after professional dental prophylaxis
timeFrame: 1 week (measurements before and 1 week after dental prophylaxis)
Secondary outcomes:
measure: Agreement between operators in tooth color assessment with visual shade guides
timeFrame: Sequencial; repeated before and 1 week after intervention
measure: Influence of light conditions in tooth color assessment - change between determination with and without a light correcting device
timeFrame: Sequencial; repeated before and 1 week after intervention
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Faculdade de Medicina Dentária, Universidade de Lisboa
Study officials:
affiliation: Grupo de Investigação em Bioquímica e Biologia Oral
name: Duarte S Marques, PhD, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04786158: Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)
Official title: Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progressive Supranuclear Palsy
Corticobasal Degeneration
Keywords: pain
quality of life
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-03-08
Enrollment: 7
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: PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated

Brief summary: Treatment of tauopathies such as Progressive Supranuclear Palsy (PSP) and Cortico Basal Degeneration (CBD) remains a major challenge. These rare severe neurodegenerative extrapyramidal movement disorders share phenotypic overlap and are usually painful. Parkinson disease (PD) is a common extrapyramidal movement disorder and continuous subcutaneous apomorphine infusion (CSAI) is commonly used in advanced PD patients to alleviate motor and non-motor fluctuations. Effects of subcutaneous apomorphine were investigated especially on pain and, on quality of life in 7 patients with PSD or CBD.This is an observational "real life" surveillance-based study.The Verbal Rating Scale for Pain (VRS) was used to assess changes in pain level and the clinical global impression-improvement scale (CGI-I) was used to assess changes in patient's illness before and during six months of treatment. Detailed report of the symptoms and side effects has been recorded by home nurses throughout the study period.


Eligibility criteria: Inclusion Criteria:

* PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient under a legal protection procedure
* Patient denying to participated to the study
* Lack of affiliation to a social security system

Primary outcomes:
measure: Effects of subcutaneous apomorphine on pain
timeFrame: 6 months
measure: Effects of subcutaneous apomorphine on quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
References: