cyrilzakka/clinical-trials huggingface dataset:
Use of a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis.

Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system for which the investigators now have many treatment alternatives. These treatments have a preventive goal and the data in the literature suggest the interest in rapidly achieving optimal control of the disease in order to decrease the risk of long-term disability progression.

One of the current unmet needs is to have markers that can be used at the individual level to predict the long-term prognosis in order to propose optimal and personalized therapeutic management.

Classically used clinical markers do not meet this need. It is recognized that there is a so-called silent course of MS (not measurable by clinical parameters), which may, after several months or years, be expressed as a physical or cognitive disability.

MRI is the reference examination for monitoring the sub-clinical activity of the disease but it does not allow the neurodegenerative side of the disease to be assessed. Other blood or imaging markers are being studied but are not yet usable in daily practice.

The project aims to evaluate the interest in using digital biomarkers, based on a rapid assessment of patients using a locally developed mobile application (MS Screen Test - MSST) to predict the evolutionary prognosis of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 60 years of age
* Presenting a diagnosis of relapsing-remitting MS defined according to McDonald 2017 criteria confirmed within 6 months prior to inclusion
* Starting first-line treatment (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate)
* Having an encephalic and cervical MRI in OFSEP format, within 6 months prior to inclusion
* No relapse within 30 days prior to inclusion

Exclusion Criteria:

* presence of a motor, visual or cognitive deficit not related to MS
Foveal Cone Outer Segment Tips Line Defect in Macular Pseudohole

Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole


Eligibility Criteria:
Inclusion Criteria:

* The patienst with macular pseudo hole

Exclusion Criteria:

* The patients with follow-up less than 6 months
Omega 3 in Intervention Spinal Cord Injured People

The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One hundred spinal cord injured patients who come to clinic of spinal injury repair research center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg) in the intervention group and placebo in the control group. Primary outcome measures are professionals evaluation of neurological function by using :

* ASIA scale for sensory and motor function
* FIM scale for Functional potential
* FAM
* SF_36 for quality of life

Lipid profile and Antioxidant profile evaluation by using:

* FBS
* 2hpp
* Insulin
* LDL
* Total cHOL
* TG
* HDL
* Leptin Adiponectin -Calcium-
* 25OHD
* PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL
* BMD

All no neurological evaluation will be done by experiment researcher under considering of a neurologist.All Sub clinical evaluation will be done by specific, sensitive and valid laboratory methods. Intervention time will be 14 months.Comparison of these variables will be done before and after intervention.

Eligibility Criteria:
Inclusion Criteria: no metabolic, malignant or kidney disorder, normal TSH, LH, FSH, prolactin, and testosterone in men and normal prolactin, estradiol, LH, FSH, and TSH in women

Exclusion Criteria:

* pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (sulfonylurea) throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus
* Treated with a sulfonylurea at defined doses for at least 3 months prior to screening
* BMI= 27-45 kg/m2
* HbA1c value between 7.5% and 11%

Exclusion Criteria:

* Treated with oral anti-diabetic medications other than a sulfonylurea within 3 months of screening
* Patients treated previously with AC2993
* Patients presently treated with insulin
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) .

To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Japanese men and women ≥ 50 years of age
* Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD, including juxta-foveal lesions that affect the fovea as evidenced by fluorescein angiography (FA) in the study eye
* Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study eye

Exclusion Criteria:

* Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser, intraocular corticosteroids, surgical interventions (except cataract surgery more than 30 days prior to screening) or systemic use of anti-VEGF products within 3 months prior to study entry
* Active or suspected infection in or surrounding of the study eye
* Active severe intraocular inflammation in the study eye
* Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
* Ocular condition in the study eye which may impact vision and confound study outcomes
Study Title: Food Rx

Researchers are trying to determine if subjects with lack of access to healthy food and a long term health problem, are helped by a weekly box of healthy groceries and nutrition education.

Participants that have a chronic preventable disease and food insecurity will be offered enrollment in the study. Once all participants are enrolled, they will be given weekly boxes of food which includes materials for a nutritious recipe and extra fruit and vegetables for a total of 6 weeks. The SNAP-Ed Educator and SHIP Public health coordinator will be present at food pick up to answer questions about the boxes, food preparation, etc. They will be given the option of participating in grocery store and farmer's market tours, as well as sign up for text messaging of nutrition information and recipes. At the end of 6 weeks, they will be asked to participate in a focus group. At baseline, 3 months and 6 months, they will be asked to complete a survey on lifestyle behaviors and food choices.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients that have been identified as having food insecurity based on a two question screening tool, AND
* Also has one of more of the following chronic diseases:
* Hypertension,
* Heart disease,
* Stroke/TIA,
* DM 2,
* Cancer/history of cancer,
* obesity
* osteoarthritis

Exclusion Criteria:

* Pregnant women
* Children
Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks

The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.

Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.

Eligibility Criteria:
Inclusion Criteria:

• Subject has completed their participation in the CYN20-FIRM-LIPO study.

Exclusion Criteria:

* The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site
* Patients with adequate bone marrow, liver and kidney function
* Patients with life expectancy of at least 12 weeks

Exclusion Criteria:

* Patients who have received chemotherapy, immunotherapy, radiotherapy or any investigational agent within 4 weeks of study entry
* Patients with have had a major surgical procedure within 4 weeks of study entry
The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.

Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.

Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. The study of the sample consisted of 60 patients in the ICU. Data were collected with the patient identification form and the hemodynamic parameters follow-up form. The patients were given different lying positions for 3 days. Hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. The measurement results obtained were compared with one-way ANOVA test.

Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.

Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between the dates of 15.11.2021 and 15.05.2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. Since repeated measurements were planned in the study when determining the sample, A-priori power analysis was performed based on ANOVA repeated measures analysis and the effect size was calculated according to the etasquared value (Abd El-Aziz et al., 2021). Accordingly, the sample of the study was calculated as 34 patients to reach at least 80% power within a 95% confidence interval. The research was completed with a total of 60 patients who were spontaneously breathing (n=30) and mechanically ventilated (n=30). Data were collected with the patient identification form and the hemodynamic parameters follow-up form. Right lateral, semi Fowler's, left lateral and supine positions were applied to the patients every 2 hours between 9 am 5 pm for 3 days and then pulse rate, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation (SpO₂) were measured at 10th minute, 1st hour and 2nd hour. In data analysis, number, arithmetic mean, standard deviation, chi-square, independent groups t test and one-way ANOVA test were used.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in intensive care for at least 3 days
* over 18 years of age
* monitored
* spontaneously breathing or connected to a mechanical ventilator,
* conscious or unconscious,
* receiving or not receiving oxygen support,
* with or without a tracheostomy,
* hemoglobin level of 8g/dl.

Exclusion Criteria:

* Patients with movement restrictions
* inotropic/vasopressor and sedative group medications
* body temperature of 38˚C and above
* patients receiving CPAP (Continuous Positive Airway Pressure) treatment
A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.

Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.

This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.

Eligibility Criteria:
Inclusion Criteria:

* able to understand and agree to informed consent;
* male or female patients 18-68 years of age
* no disease modifying therapy 60 days prior to Baseline
* EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient
* Labs within normal range no greater than 2 times the ULN or at the discretion of the PI
* weight 46 kilograms to 127 kilograms inclusive
* no active systemic infection
* not currently pregnant or breast feeding
* no history of corticosteroid treatment or relapse within 60 days prior to Baseline.

Exclusion Criteria:

* not able to understand informed consent
* if any of the inclusion criteria is not met
* HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB
* positive pregnancy test
* patient withdraws consent
* Coumadin use within 60 days prior to Baseline
A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs

The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.


Eligibility Criteria:
Inclusion Criteria:

* willing to comply with investigator's and protocol's instructions
* patients signature on the informed consent document
* open-angle glaucoma or ocular hypertension
* currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye

Exclusion Criteria:

* inability to understand the trial procedures
* inability to give informed consent
* inability to understand, read, or write English
* best corrected visual acuity of 20/200 or worse in each eye
* current moderate to severe infectious or inflammatory condition of the eye or eyelids including
* current moderate to severe dry eye syndrome
* current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months
* treated with 3 or more glaucoma medicines in both eye
A Study of the ECHELON Contour Curved Cutter Stapler Device in Colorectal Procedures

The purpose of this study is to prospectively generate device-specific clinical data related to the performance of Echelon Contour per its instructions for use (IFU).


Eligibility Criteria:
Inclusion Criteria:

* Elective colorectal procedure where Echelon Contour is planned to be used for transection and resection of the colon
* Willingness to give consent and comply with all study-related evaluations and visit schedule. If the participant is less than (\<) 18 years of age, the participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide written Informed Consent for the participant. In addition, assent must be obtained from pediatric participants who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric participant is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study); the parent/legal guardian's written Informed Consent for the participant will be acceptable for the participant to be included in the study
* Anatomical region must be of sufficient size for the device to be used

Exclusion Criteria:

Preoperative

* Females who are pregnant
* Physical or psychological condition which would impair study participation
* Participant previously enrolled into the study (example: participant enrolled for Hartmann's procedure then cannot be reenrolled for the Hartmann's reversal)

Intraoperative

- Study device use not attempted
Development, Reliability and Validity of the Telerehabilitation Satisfaction Questionnaire- TrSQ

Parkinson's disease (PD), stroke, and Multiple Sclerosis (MS) are the most common neurological diseases. Today, physiotherapy and rehabilitation approaches together with optimal medical and surgical treatment form the basis of treatment for these diseases. Recently, it has been stated that various telerehabilitation interventions in the field of physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches applied in the clinic. In addition, there are benefits such as continuity in patient education and rehabilitation, saving time and expenditure of individuals on the road. However, some problems arise in this form of treatment. Especially weak internet connection, sometimes requiring technical knowledge and expensive equipment can reduce the participation and satisfaction level of individuals. It is also important to evaluate the level of satisfaction in expanding the usability of telerehabilitation services and determining the best telerehabilitation service. For this reason, there is a need for questionnaires investigating the satisfaction level of physiotherapy and rehabilitation applied through telerehabilitation.

Questionnaire items were created in two stages. First, 5 experts will independently review the literature on "telerehabilitation" and "satisfaction". In addition, these experts will be asked to create a pool of questions based on their experiences in telerehabilitation and by taking the opinions of patients receiving telerehabilitation about satisfaction. Then, 5 experts will come together and obtain a single question pool containing the questions they deem important in their question pool. The second step will involve scaling the elements. In this study, scale items will be scored on a five-point Likert scale, ranging from 1, strongly disagree to 5, strongly agree.

Then, it will be applied to a pilot group of 10 people and it will be evaluated whether the items prepared by the experts are understood by the patients. In line with the expert opinion and the result of the pilot study, the final version of the scale will be decided and applied to MS, PD, and stroke patients who make up the study group. Finally, the validity and reliability of the questionnaire will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in research to accept
* Mini-Mental Test score more than or equal 24
* Previously receiving physical therapy through telerehabilitation

Exclusion Criteria:

* Any visual, hearing, and perception problems that may affect the answering the questionnaire items.
Effect of Valproate on Propofol

The aim of this study is to evaluate the effect of valproate on the required dose of propofol for sedation in patients with mental retardation.

The intravenous sedation with propofol is very useful for patients with mental retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedation depth because of the difficulty of verbal communication with them. Most of them have a epilepsy and take antiepileptic drugs. Antiepileptic drugs are thought to influence on the effect of anesthetics. Valproate is reported to inhibit the metabolism of propofol. Therefore, we divide the patients into two groups : patients receiving valproate (valproate group), patients receiving no antiepileptic drugs (control group), and compare the required dose of propofol and the recovery time.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 16 or over
2. American Society of Anesthesiologists (ASA) physical status 1 or 2
3. The treatment of dental caries, endodontics, periodontics and prosthesis were planed
4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

1. Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons
2. Patients needed premedication and inhalational anesthetics
3. Patients had uncontrolled or sever medical condition
Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

This study will investigate potential differences in how two puffs of salbutamol protects airway smooth muscle from contracting in people with asthma and chronic obstructive pulmonary disease (COPD).

In asthma, the administration (inhalation) of a selective β2 receptor agonist (e.g. salbutamol), prior to methacholine challenge has been shown to shift the dose response curve to the right and "bronchoprotect" the airway against airway smooth muscle contraction. The extent of β2 receptor agonist bronchoprotection in COPD is unknown.

Airway hyperresponsiveness (AHR) to direct acting agents such as histamine and methacholine is a feature of both asthma and COPD. In asthma, the abnormality leading to AHR is believed to be due to changes in airway smooth muscle (e.g. hypertrophy, hyperplasia, contractile apparatus) whereas in COPD the AHR is likely due to structural or geometric changes.

The investigators hypothesize that the bronchoprotection afforded by salbutamol against methacholine challenge will be greater in asthma than in COPD due to differences in underlying airway abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* asthma or COPD

Exclusion Criteria:

* asthma and COPD