louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03575182: Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome
Official title: Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Joint Hypermobility
Ehlers-Danlos Syndrome
Hyperextension Knees
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of gait retraining with biofeedback in the treatment of neuromusculoskeletal symptoms in patients with Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome. Half of participants will participate in a gait retraining program, while the other half will continue standard care.


Eligibility criteria: Inclusion Criteria:

* Ehlers-Danlos Syndrome Hypermobile type as defined in the 2017 international Ehlers-Danlos Syndrome classification

Exclusion Criteria:

* Other heritable and acquired connective tissue disorders, autoimmune rheumatologic conditions, pregnancy, history of lower limb surgery, cardiovascular limitations, visual limitations.

Primary outcomes:
measure: Knee Joint Range of Motion
timeFrame: 4-5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00826982: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer
Official title: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care

Brief summary: The major goal of this project is to reduce unnecessary pancreatic resections, namely resection in those patients with non-regional lymph node metastatses that cannot be cured with surgical resection. By combined minimally invasive methods for non-surgical biopsy and highly sensitive molecular assays for cancer cells, we believe we can increase the ability to detect distant lymph node metastases prior to surgical resection, and direct those patients for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR) of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases.
* Patients who are scheduled for clinically indicated EUS

Exclusion Criteria:

* Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease.
* Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.

Primary outcomes:
measure: To determine the if molecular biomarkers increase the sensitivity by at least 5% for detection of malignant lymph nodes in patients with pancreatic ductal adenocarcinoma as compared to EUS-FNA cytology of lymph nodes alone.
timeFrame: End of study
Secondary outcomes:
measure: To determine the degree of RNA overexpression of pancreas cancer specific biomarkers in the pre-operative fine needle aspirate of lymph nodes and tumors of patients with pancreatic cancer using a set of pancreas cancer specific biomarkers
timeFrame: End of study
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael Wallace, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793282: The Benefits of Telephone Follow-up (TFU)
Official title: The Benefits of Telephone Follow-Up After a Mental Health Assessment in an Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Keywords: Telephone follow up
Lead sponsor: Brandon University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate the impact of a brief telephone follow-up following a mental health assessment in the emergency department. The purpose of the telephone call will be to provide psycho-education, clarify any questions and reinforce discharge planning.

Detailed description: This is a randomized controlled trial. The experimental group will receive a phone call within 72 hours of discharge to provide psycho education, clarify any questions they may have and to reinforce discharge plans made in the ED. The control group will not receive this phone call. Within 30 days of discharge, both groups will receive a phone call to collect data on treatment compliance including medication and follow-up adherence and if any additional visits to the Emergency Department were necessary.

Eligibility criteria: Inclusion Criteria

* Discharged from the ED
* Age of majority
* Competent.

Exclusion Criteria

* Incompetent,
* Under 18
* Admitted to the hospital

Primary outcomes:
measure: Emergency Department readmission rates
timeFrame: 30 days.
Secondary outcomes:
measure: Satisfaction with care in the Emergency Department using a 7 point Likert Scale as a function of the telephone follow up.
timeFrame: 30 days.
measure: Adherence to pharmacological interventions and follow-up appointments.
timeFrame: 30 days.
measure: Understanding of Treatment plan
timeFrame: 30 days.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: Brandon University
name: Alana E Prejet, BScPN, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001182: Evaluation of Patients With Unusual Diagnostic or Treatment Considerations
Official title: General Dental Diagnostic and Therapeutic Study: A Pilot Program for Evaluating the Research Potential of Referred Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Tooth Disease
Keywords: General Dental
Diagnostic
Therapeutic
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study offers evaluation and treatment of patients with unusual diagnostic or treatment considerations. It is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purposes of the study are: 1) to allow NIDCR staff an opportunity to maintain and improve their clinical skills; and 2) to evaluate referred patients for research potential. (Participants in this protocol will not be required to join a research study; the decision will be voluntary.)

Patients in need of dental/oral diagnosis and therapy of interest to NIDCR staff dentists may be eligible for this protocol. Participants will have a comprehensive dental examination and may receive part or all of their treatment at the NIDCR clinic. Diagnostic procedures, materials and treatments used in this study are limited to those widely accepted in dentistry and are non-experimental in nature.

Detailed description: The proposed pilot project will allow the staff of the Dental Clinic Oral Medicine Fellowship Program to accept patients, for diagnosis and conventional therapy, which do not otherwise meet the criteria for any of the current NIDCR research protocols. This clinical examination and therapy by Dental Clinic practitioners will provide an excellent forum for the observation of oral conditions and phenomena that may generate scientific inquiries and provide valuable educational experiences consistent with the goals of the Oral Medicine Program.

Eligibility criteria: Patients in need of dental/oral diagnosis and therapy which are of interest to one or more of the staff dentists.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Dental And Craniofacial Research (NIDCR)
state: Maryland
Study officials:
References:
Clinical trial NCT00817882: Working Well With Back Pain (Feasibility RCT of Vocational Rehabilitation)
Official title: Changing Perceptions of Work Ability in People With Low Back Pain: Feasibility Randomised Controlled Trial and Economic Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: vocational
rehabilitation
work
ability
low back pain
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Arthritis Research UK
First posted: 2009-01-07
Enrollment: 52
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Back pain has a major impact on people's ability to work. Health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. Vocational rehabilitation is the process that helps people with health problems to stay at, return to and remain at work. This study comprises the second phase of a three year study of back pain and vocational rehabilitation. The first phase gathered data from patient interviews and postal surveys of GPs and GP practice managers. These findings have been used to inform this second phase; a feasibility randomised controlled trial. The participants will be thirty employed people with back pain who have been offered an NHS rehabilitation programme, and who are concerned about their ability to work with low back pain. Those who consent will be randomised into two groups. One group will receive routine rehabilitation. The other will receive routine rehabilitation plus an individually tailored vocational intervention carried out by the researcher. Following the trial, individual interviews will be carried out with each of the participants by an independent researcher. An economic study will evaluate the possibility of measuring the cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational intervention plus routine rehabilitation will be more effective in improving patients' work ability than routine rehabilitation alone.


Eligibility criteria: Inclusion Criteria:

* low back pain
* offered routine rehabilitation
* employed
* concern about work ability due to low back pain
* referral by GP in South Nottinghamshire

Exclusion Criteria:

* not fluent in English

Primary outcomes:
measure: work ability
timeFrame: prospective
Secondary outcomes:
measure: self-efficacy
timeFrame: prospective
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Carol M Coole, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Avril Drummond, PhD
role: STUDY_DIRECTOR
affiliation: University of Leicester
name: Paul J Watson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01634282: Along-term Study of OPC-262 in Patients With Type 2 Diabetes
Official title: A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes, Type 2
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 222
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262


Eligibility criteria: Inclusion Criteria:

* Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24）
* Patients who are capable of giving informed consent prior to participating in this clinical study
* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

* Patients who withdrew from Study 262-09-001
* Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
* Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
* Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
* Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
* Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Primary outcomes:
measure: Change in HBA1c form baseline
timeFrame: 52 Weeks
measure: Incidence and severity of adverse events
timeFrame: 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Kansai Region
country: Japan
city: Kanto Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
References:
Clinical trial NCT01782482: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Official title: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Refractive Error
Keywords: Color contact lenses
Refractive error
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 574
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.


Eligibility criteria: Inclusion Criteria:

* Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
* Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
* Manifest cylinder less than or equal to 0.75 diopter in each eye.
* Wear contact lenses within protocol-defined specifications.
* Require spherical contact lenses within the available range of powers.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear.
* Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Moderate or severe ocular findings upon examination.
* Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
* Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
* Previous corneal or refractive surgery or irregular cornea.
* Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
* Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
* History of intolerance or hypersensitivity to any component of the test articles.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Subjective Rating of Overall Satisfaction
timeFrame: Day 7
Secondary outcomes:
measure: Positive Purchase Intent
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sharon Holden Thomas, O.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02215382: Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure Changes During Tracheal Extubation
Keywords: two reversal methods
changes in IOP
heart rate
blood pressure
tracheal extubation
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation.

This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure during tracheal extubation period.


Eligibility criteria: Inclusion Criteria:

* ASA I-II physical status
* elective surgery
* endotracheal intubation under general anesthesia

Exclusion Criteria:

* emergency surgery
* pregnancy
* laparoscopic surgery
* prone position
* BMI \> 30 kg/m2
* sedative drug use in last month
* patients with glaucoma.
* ASA \> II physical status

Primary outcomes:
measure: intraocular pressure
timeFrame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
Secondary outcomes:
measure: heart rate
timeFrame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
measure: blood pressure
timeFrame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
Other outcomes:
Locations:
city: Altınordu
country: Turkey
facility: Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
state: Ordu
Study officials:
References:
Clinical trial NCT01504282: Mitomycin-c Application for PRK
Official title: Mitomycin-c Application for Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria was ablation depth less than 65 µm,
* a stable refractive error for at least 1 year
* corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.

Exclusion Criteria:

* Patients with keratoconus suspect,
* excessive dry eyes,
* impaired wound healing processes,
* lenticular changes,
* corneal dystrophy,
* history of ocular surgery,
* anterior or posterior uveitis,
* glaucoma and retinal diseases were excluded.

Primary outcomes:
measure: Central corneal endothelial cell density (ECD) 6 months after the PRK
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT01501682: Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias
Official title: Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventral Hernia
Keywords: ventralex
ventral hernia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: operated for ventral hernia from the year 2004 to the year 2009 at Koege Hospital

Brief summary: The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed.

Detailed description: The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Based on a questionnaire selected patients will be invited to clinical examination for recurrence and more detailed interview.

Eligibility criteria: Inclusion Criteria:

* operated for ventral hernia from the year 2004 to the year 2009

Exclusion Criteria:

* liver cirrhosis
* pregnancy
* combined hernia
* operation for ventral hernia and other operation
* laparoscopic operation
* acute operation
* recurrence of hernia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: Koege hospital
city: Køge
country: Denmark
facility: Køge sygehus
Study officials:
affiliation: Køge Hospital
name: Liv Erritzøe-Jervild
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erritzoe-Jervild L, Christoffersen MW, Helgstrand F, Bisgaard T. Long-term complaints after elective repair for small umbilical or epigastric hernias. Hernia. 2013 Apr;17(2):211-5. doi: 10.1007/s10029-012-0960-z. Epub 2012 Jul 14.