cyrilzakka/clinical-trials huggingface dataset:
Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs

Ageing is known to increase the risk of fall and posturographic stabilometry, both static and dynamic, are useful tools to assess postural stability. To our knowledge, no published normative data for a healthy elderly population are available.

The risk of fall rise with ageing and is huge after 85yrs becoming one of the major problems associated with aging.

The computed dynamic posturographic EquiTest® System and Smart BalanceMaster by NeuroCom® International, Inc, Clackamas, OR, USA) provide a qualitative and quantitative analysis of the balance function through the description of the subject's center of gravity (COG) sway.

Sensory Organization Test and Sensory Analysis norms are provided for age groups (20-59; 60-69; 70-79) up to 79yrs, whilst they lack in the international literature for subjects 80+yrs, nonetheless being necessary in the understanding of balance performance from a quantitative point of view.

Subjects 80+yrs are evaluated with EquiTest® System and Smart BalanceMaster to provide mean values and normative data.

In order to assess the reliability of the instrumental evaluation was repeated (T1) two weeks later (±2 days).

Eligibility Criteria:
Inclusion Criteria:

* Age older than 79 years
* Free gait, without aids, for at least 50 mt
* Cognitive skills allowing the providing of valid informed consent and the understanding of the instructions during clinical and instrumental evaluations

Exclusion Criteria:

* Pathologies affecting Central Nervous System (i.e., cerebrovascular, neurodegenerative, Alzheimer Disease, Parkinson disease, etc) or vestibulum
* Previous traumatic brain injury and/or coma lasting more than 24 hrs and occurred within last 20 years
* Impairment affecting the Peripheral Nervous System i.e., pallesthesia \<4/8
* Hip or knee joint replacement within the last 10 years
* Surgeries or pathologies affecting the lower limbs or the spine
* Pain, acute or chronic
* Use, within the last 12 hours, of painkillers or drugs interfering with Central Nervous System or balance
A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ

This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).

This study was initiated following the approval of the Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) (CecolinⓇ) in China. We undertook a retrospective-prospective real-world study to assess the incidence of new-onset autoimmune conditions (10 conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic) and adverse pregnancy conditions (e.g., premature birth, birth defects) among 9-45 yoa females during the pre- and post-marketing period of CecolinⓇ.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center;
* Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.

Exclusion Criteria:

-
Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques

The aim of this study is to evaluate and compare two prosthetic conditioning techniques to create natural-like peri-implant emergence profile.

Twenty four patients having a non-restorable tooth will be rehabilitated with flapless immediate implant placement after tooth extraction. The emergence profile will be conditioned with either a stock or a customized healing abutment. A definitive screw retained restoration will be inserted 4 months postoperatively. Peri-implant tissues will be evaluated using pink and white esthetic score, radiographs and periodontal parameters at 3,6 and 12 months after implant placement.

Eligibility Criteria:
Inclusion Criteria:

* Presence of non-restorable maxillary anterior or premolar tooth and its healthy contra-lateral.
* The gingival contour of the tooth to be extracted should be in harmony with the healthy contra-lateral tooth.
* Having thick gingival biotype.

Exclusion Criteria:

* Any medical disorder that could interfere with osseointegration or soft tissue healing.
* Active oral infections or periodontal disease.
* Presence of dehiscence or fenestration defects related to the tooth to be extracted.
* Poor oral hygiene.
* Heavy smokers (\>10 cigarette / day).
Evaluation of Optical System in the Treatment of - Dry Eye Disease

Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.

Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.

All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).

Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older of any gender or race.
* Provide written informed consent before study participation.
* Willingness and ability to return for all study visits.
* Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
* Tear break-up time (TBUT) \<10 seconds in both eyes.
* Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.

Exclusion:

* History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
* Patients with giant papillary conjunctivitis.
* Patients with punctal plugs or who have had punctal cautery.
* Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
* Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
* Aphakic Patients.
* Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
* Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).

Criteria:

-
Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain

The primary purpose of this study was to characterize the pain control achieved with long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic cancer pain and the secondary purpose was to characterize the effects of pain on the patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow release) taken by patients with chronic cancer pain.

Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking at least 8 mg of OROS hydromorphone (slow release) or its equivalent morphine sulfate SR (slow release) dosage. Patients were started on the dose of OROS hydromorphone equivalent to the opioid dose on which they had achieved dose-stable pain control in the SR (slow release) phase of Study DO-118. Patients returned to their study clinic once a month for 1 year. Dosage adjustments to study medications and breakthrough pain medication were permitted. OROS hydromorphone HCI (slow release) tablets in 8, 16, 32 and 64mg doses administered orally every 24 hours

Eligibility Criteria:
Inclusion Criteria:

* Patients who have chronic cancer pain, and who have successfully completed the OROS hydromorphone SR (slow release) study, DO-118
* Patients must have been in dose-stable pain control in the last two days of the slow release phase of the study
* Patients who require at least 8mg of OROS hydromorphone slow release every 24 hours for the management of chronic cancer pain

Exclusion Criteria:

* Pain which is not considered to be potentially responsive to opioids
* Gastrointestinal disease of sufficient severity to be likely to interfere with oral analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within the 5 days prior to the start of the trial, severe gut narrowing that may affect the absorption or transit of orally administered drugs, particularly the insoluble OROS outer coating
* Any patient in whom the risks of treatment with hydromorphone outweigh the potential benefits. Such risk categories include: raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders and Addison's disease
Selective CT for Anticoagulated Head Injured Patients

The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications.

The objectives are to:

1. Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and,
2. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.

This is a prospective cohort study enrolling 4000 anticoagulated patients presenting with blunt head trauma to the emergency department. Emergency physicians will record the presence or absence of clinical predictors for traumatic brain injury at the time of assessment. All patients will undergo head CT scanning and are followed for 30 days.

The adjudicated primary outcome is clinically important traumatic brain injury diagnosed at the index ED presentation. The secondary outcome is delayed clinically important traumatic brain injury, diagnosed within 30 days of normal index head CT scan.

The primary analysis will be to derive a novel clinical decision rule which excludes clinically important traumatic brain injury diagnosed at the index ED visit. The secondary analyses will include:

1. The diagnostic accuracy of existing head injury clinical decision rules in diagnosing clinically important traumatic brain injury on index ED visit, in patients who take anticoagulation; and,
2. The sensitivity and specificity of the new and existing rules for the diagnosis of both index and delayed clinically important traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years
* Presents to the emergency department after a head injury
* Patient has a head CT in the emergency department
* Is a current anticoagulant user

Exclusion Criteria:

* Head injury occurred \>48 h before patient's arrival to the emergency department
* Penetrating head injury
* Previously enrolled
* Patient resides outside of the hospital's catchment area
* Patient was transferred from another emergency department following neuroimaging
* Patient was not managed by the emergency or trauma physician in the emergency department
* Leaves the emergency department prior to completion of their medical assessment
Progesterone for the Treatment of Traumatic Brain Injury III

The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe brain injury (GCS 12-4)
* Age 18 years or older
* Blunt, closed head injury
* Study drug initiated within 4 hours of injury

Exclusion Criteria:

* Non-Survivable injury
* Bilateral dilated unresponsive pupils
* Severe intoxication (ETOH \> 250 mg %)
* Spinal cord injury with neurological deficits
* Inability to perform activities of daily living prior to injury
* Cardiopulmonary arrest
* Status epilepticus on arrival
* Systolic blood pressure (SBP) \< 90 on arrival or for at least 5 minutes prior to enrollment
* O2 Sat \< 90 on arrival or for at least 5 minutes prior to enrollment
* Prisoner or ward of state
* Pregnant
* Active breast or reproductive organ cancers
* Known allergy to progesterone or intralipid components (egg yolk)
* Known history of clotting disorder
* Active thromboembolic event
* Concern for inability to follow up at 6 months
* Anyone listed in the Opt out registry
Effects of Dual-task Aerobic Exercise

The aim of this study was to examine the acute effect of dual-task aerobic exercise on cognitive load and myocardial oxygen consumption in healthy sedentary individuals. In this study: 1. Does dual-task exercise applied in addition to aerobic training have an acute effect on cognitive load in healthy sedentary individuals? 2. Does dual-task exercise applied in addition to aerobic training in healthy sedentary individuals have an acute effect on myocardial oxygen consumption, which reflects the indirect oxygen consumption of the heart? The questions were answered.

To find answers to the questions of the study, healthy sedentary participants were randomized into two groups by online randomization method. One of the groups was the group that received only double-leg aerobic exercise. The other group was the double-leg aerobic exercise group integrated with dual-task-oriented training. Before and after the interventions, the blood pressure and pulse rate of the participants were measured, their cognitive functions were evaluated with the MOCA Test, their reaction times were evaluated with the Nelson Reaction Test, and the acute effect of the trainings was examined.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* No comorbidities
* Absence of comorbid diseases of the orthopedic, neurological, cardiopulmonary system
* Participants who have not been involved in another clinical trial in the last 1 month

Exclusion Criteria:

* Participants who had hip, pelvis, knee, ankle surgery in the last year
* Sensory loss
* Participants with leg length inequality
* Participants with known balance disorders in the last three months due to vestibular disorders, pregnancy, concussion
* Presence of systemic disease (diabetes, blood pressure, etc.)
* Those using bronchodilator drugs
* Having a neurological disease
* Not being in good psychological condition
Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)

To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age at screening visit
* Ocular Surface Disease Index (OSDI) score of less than 12 (without contact lens wear)
* Contact Lens Dry Eye Questionnaire (CLDEQ)-8 score of greater than 12.18
* Regular contact lens wearer who wears them less than 6 hours per day due to discomfort
* The presence of at least one microneuroma on in vivo confocal microscopy
* Self-reported good compliance with healthy contact lens regimen (replace contact lenses per manufacturer's recommendations, use of multipurpose or hydrogen peroxide contact lens solution nightly)
* Have had an eye exam within the last two years that included dispense of a contact lens prescription
* Proparacaine drops relieve at least 75% of ocular symptoms to ensure that patients do not have centralized neuropathic corneal pain
* If a soft lens wearer, use a contact lens that was released within the last 15 years

Exclusion Criteria:

* Use of topical drops other than artificial tear substitutes
* Ocular surgery or other ocular disease within 3 months prior to study enrollment
* Concurrent ocular disease that may impact results
* Have dry eye (as defined by 2 or more of the parameters below)

  * Schirmer's wetting test \< 10mm
  * TBUT \<7sec
* NEI scale corneal staining of 4 out of 15 at the time of enrollment
* Improper CL fit
* No microneuroma by in vivo confocal microscopy
* Overnight wear within 1 month of screening visit
* Use of colored or cosmetic lenses
* Contra-indication to ITN

  * Chronic or recurrent epistaxis, coagulation disorders.
  * Nasal or sinus surgery or significant trauma to the nose.
  * Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
  * Chronic or recurrent nosebleeds
  * Bleeding disorder
  * Known hypersensitivity (allergy) to the hydrogel material
  * Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.
  * History of migraines
  * Under 21 years of age
Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent

ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it

All 14-20-year-old patients admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during 2017-2028 are requested to participate. At admission (baseline), the patients are interviewed by the research nurse and asked to fill out questionnaires. The interview includes a semi-structured diagnostic interview (SCID). The participants are interviewed again in six months (follow-up), and the interview is identical to the one conducted in the admission phase.

Eligibility Criteria:
Inclusion Criteria: Admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during the years 2016-2019

Exclusion Criteria: Unable to understand the questionnaires
Psychological and Physical Effects of an 8-Week Electromyostimulation-Workout

The study investigates the midterm, longterm and acute psychological and physical effects of an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals.

EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical effects which are comparable to conventional strength training. Therefore EMS could lower the barrier to physical activity. The present study focusses on psychological and physical effects of an 8-week EMS workout. Physical activity is notably important for mental and physical health, but is on average far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological and physical effects through a less (subjective) cost-intense strength training.

Eligibility Criteria:
Inclusion Criteria:

* Subject familiarized with experimental procedure and had given written informed consent
* Able to understand German
* Reachability of participant for the eight training sessions

Exclusion Criteria:

* Contraindications for physical exercise or EMS-use
* Current EMS-use or intense regular exercise (\> 60 min / week)
* Pregnancy
* Current presence of any mental disease
* Acute suicidality
* Substance dependencies with actual consumption (except nicotine)
Reducing Obesity in Underserved Postpartum African American Women

In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum African American (AA) adult women that can be integrated into a postpartum care model within a clinical setting.

The investigators proposal adapts The Diabetes Prevention Program (DPP) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the DPP to address the needs of our AA population in several ways: 1) The reference materials and lesson handouts include information about the types of foods and cooking methods used by an AA culture (see Other Study Documents); 2) Topics are selected for group classes that are most appropriate for our participants such as Hip Hop or Salsa dancing for physical activity.

Participants will be randomized during the early postpartum period to either usual care or intervention. Usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the Nutrition and Weight Management Center. Intervention participants will be assigned a Birth Sister for the postpartum period. They will also attend 8 weekly sessions for the weight loss program. All participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Pre-Natal:

  1. BMI greater than or equal to 25
  2. Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
  3. English-speaking
* Post-partum:

  1. Live birth (based on medical record review)

Exclusion Criteria:

* Pre-Natal:

  1. Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
  2. Previous enrollment in the Birth Sister's program prior to the study
* Post-partum:

  1. Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)
Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops

Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft.

Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.


Eligibility Criteria:
Inclusion Criteria:

* Newly transplanted corneal patients
* Patients able to instill correctly topical corticosteroid treatment
* Patients able to come to control visits
* Patient affiliated or entitled to a social security system
* Patient informed about the study and having signed a consent

Exclusion Criteria:

* Patients under guardianship
* Patients unable to give their consent or to correctly use the collection box
The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular bowel movements and bloating. It may be caused by loe degree inflammation of the intestine. The ingredients of coltect which contains green tea, selenium, and curcumin have been proven very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to see whether the use of Coltect can improve symptoms in IBS patients.

The etiology of Irritable bowel syndrome is unknown but some evidence suggests it may be caused by a certain degree of inflammation, another theory is that intestinal flora has an influence on IBS. Coltect combines 3 ingredients: green tea, selenium and curcumin, all of which have been shown to have anti inflammatory and anti oxidant activity. the aim of the study is to investigate if use of coltect can improve symptoms in IBS patients

Eligibility Criteria:
Inclusion Criteria:

* IBS as defined by the Rome III criteria
* for those above age 40 a colonoscopy within the last 5 years
* no new treatment in the last 2 weeks
* not receiving any antibiotics in the last 2 weeks

Exclusion Criteria:

* any large abdominal operation (such as colectomy) in the past
* a known disease of the gastrointestinal tract
* any significant debilitating disease such as sever heart failure, un controlled diabetes,