cyrilzakka/clinical-trials huggingface dataset:
Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient With Gait Disturbance

The goal of this clinical trial is to explore the usefulness of information from insole-type gait analyzer in adults with subjective gait and balance disorders.

The main questions it aims to answer are:

How useful is an insole-type gait analyzer for collecting gait data from patients with gait disturbances?

Researchers will explore the usefulness of collected data and does not establish a control group.

Participants will:

Participants will conduct survey and perform the Timed up and go test wearing an insole-type gait analyzer.

A screening test is conducted after obtaining consent. The screening test assesses whether participants can walk independently on flat ground, following an inquiry into their baseline symptoms and signs.

Participants will conduct A history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire (IPAQ).

Participants will wear insole-type gait analyzer and undergo the Timed Up and Go test.

The measurement values of the accelerometer and pressure sensors recorded in the insole-type gait analyzer will be examined to determine the presence of missing or outlier data. Researchers will explore the data collection frequency and analysis methods to extract clinically significant data.

Eligibility Criteria:
Inclusion Criteria:

1. adults aged 19 and over (based on the age on their national ID at the time of consent)
2. adults complaining subjective gait or balance disorders
3. individuals who voluntarily agree to participate in the study and sign a consent form

Exclusion Criteria:

1. individuals unable to walk independently on flat ground for more than 6 minutes
2. individuals who cannot read ordinary print with glasses due to visual reasons
3. individuals who cannot understand conversation even with a hearing aid due to auditory reasons
4. individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems
5. individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings.
CoStar Catheter System Evaluation

To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years of age.
2. Eligible for percutaneous coronary intervention (PCI).
3. Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification \[CCS\] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia.
4. Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks.
5. Acceptable candidate for coronary artery bypass graft surgery (CABG).
6. Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
7. Willing to comply with all specified follow-up evaluations.

Inclusion Criteria (Angiographic):

1. A single de novo lesion per study subject may be treated with the study device.
2. Each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent.
3. Cumulative target lesion length per vessel is ≤24 mm based on a visual estimate.
4. RVD of ≥2.5 mm to ≤3.0 mm based on a visual estimate.
5. Target lesion diameter stenosis ≥50% and \<100% based on a visual estimate.
6. Target vessel has not undergone prior revascularization within the preceding 6 months.
7. Target lesion must be a minimum of 10 mm distance from any previously treated segment of the target vessel

Exclusion Criteria:

1. Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA.
2. Planned treatment with any other PCI device in the target vessel(s).
3. Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q wave, or creatinine kinase (CK) \>2 times the laboratory upper limits of normal and elevated MB.
4. The patient is in cardiogenic shock.
5. Cerebrovascular Accident (CVA) within the past 6 months.
6. Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L).
7. Contraindication to ASA or to clopidogrel.
8. Thrombocytopenia (platelet count \<100, 000/mm3).
9. Active gastrointestinal (GI) bleeding within the past three months.
10. Any prior true anaphylactic reaction to contrast agents.
Effects of SGLT2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With HFpEF

The main aim of this study is to identify the underlying mechanisms of Sodium-glucose co-transporter-2 (SGLT2) inhibitors which are associated to better outcomes in patients with Diabetes mellitus type 2 and Heart Failure with preserved Ejection Fraction.

Double design study including a clinical trial and a nested case-control study.

A) Experimental study (clinical trial): Phase IV, prospective, randomized, double-blind placebo-controlled with 12 months follow-up. Inclusion criteria are: 1) diagnosis of DM2, 2) HF with preserved EF with a hospital admission in the previous 6 months with demonstration of diastolic dysfunction. 3) Stable clinical situation at inclusion. 4) Clinical indication of cardiac catheterization.

Patients will be randomized 1:1 to received Dapagliflozin 10 mg/day or placebo. The main objective is to compare the impact of the drug on LV diastolic properties at the peak of effort and in levels of plasma deposit and cross-linking biomarkers of type I collagen between the two treatment groups at baseline and after 12 months.

52 patients will be recruited.

B) Descriptive study: Nested case-control study, considering patients from the experimental study as cases and 10 additional patients with HF with preserved EF but no type 2 DM as controls. The main aim will be compare the histological, molecular, biochemical and biomechanical features of the HFpEF patients with and without DM2.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DM2 based on the established criteria: HbA1c ≥ 6.5% (48 mmol / mol) and fasting plasma glucose ≥ 7.0 mmol / L (≥126 mg / dL) or 2-h after overload ≥ 11.1 mmol / L ( ≥ 200 mg / dL).
* LVEF ≥ 50%.
* Diagnosis of ICFEP according to clinical criteria, with a hospital admission in the previous 6 months with demonstration of diastolic dysfunction according to the echocardiographic criteria.
* Stable clinical situation (\> 1 month after hospitalization due to IC decompensation).
* Clinical indication of cardiac catheterization.
* Signature of informed consent.

Exclusion Criteria:

* Previous treatment with iSGLT2.
* Significant coronary disease.
* Aortic or mitral valve disease ≥ moderate (grades 3 or 4/4 for valve regurgitations)
* Contraindications for dapagliflozin treatment according to the data sheet (hereditary galactose intolerance, Lapp lactase insufficiency or glucose-galactose malabsorption, moderate-severe renal failure -CrCl \<60 ml / min or eGFR \<60 ml / min / 1 , 73 m2-, severe hepatic insufficiency).

The inclusion/exclusion criteria for Descriptive Study will be the same as previously described without the diagnosis of DM2.
Treatment of Japanese Encephalitis

Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.


Eligibility Criteria:
Inclusion Criteria:

* Child between 6 months and 12 years age
* Acute febrile encephalopathy
* Positive IgM ELISA test for Japanese encephalitis in serum

Exclusion Criteria:

* Consent not obtained
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus

This is a research study designed to look at how pomegranate juice (or a placebo juice) affects the body through the measurement of specific biomarkers, which are indicators of health.

This research study will evaluate how pomegranate juice (or a placebo juice) affects the body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers, which are indicators of health, will be measured throughout the study. They are present in blood and urine. The placebo is a juice that is not made from pomegranates, but resembles pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of general health. The investigators want to know if drinking pomegranate juice daily for 12 weeks is effective at improving a variety of biomarkers in diabetic adults.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and read English
* Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication
* Have an HbA1C level ≤9.0% at Screening
* Have an hsCRP level ≥ 1.0 at Screening
* 35 - 70 years old (inclusive)
* Non-smokers
* Willing to maintain his/her normal activity and eating patterns for the duration of the study
* Willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)

Exclusion Criteria:

* Allergy to pomegranates
* Currently using insulin
* Currently taking steroidal drugs
* HIV positive or AIDS
* Chronic infectious disease
* Recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
* Cancer treated within the past two years
* Participation in a therapeutic research study within 30 days of baseline
* Women who are pregnant, lactating, or planning to become pregnant during the study period
Physical Characteristics of Retrieved Massive Allografts

This purpose of this study is to measure the strength of tissue allografts that have been in the body various lengths of time.

Allograft bone is the primary source of graft material for large skeletal defects resulting from trauma, disease, oncological resection, or reconstruction of failed total joint arthroplasties. The physical characteristics of such grafts after various intervals of remodeling and incorporation in vivo have never been studied.

The purpose of this study is to obtain tissue from allografts retrieved at autopsy, at amputation for oncological complications and from patients undergoing revision procedures for failed allograft transplantation. We will evaluate the mechanical properties, histomorphometric indices and presence of microfractures.

Our hypotheses are:

* histomorphometric parameters of porosity and microfracture density will predict allograft strength,
* microfracture density will be correlated with time in vivo and allograft strength,
* the rate of host-allograft nonunion and fracture will correlate with radiation therapy and chemotherapy.

The retrieved tissue will be processed using standard undecalcified histology and quantitatively assessed for degree of incorporation, allograft porosity, and microfracture density. The biomechanical characteristics of the bulk allograft and allograft-host junction will be quantified and compared to allograft bone prior to transplantation.

Eligibility Criteria:
Inclusion Criteria:

* failed allograft bone
* removal of allograft due to oncological complications
* amputation due to oncological complications

Exclusion Criteria:

* none
Low Dose Aspirin for the Prevention of Preeclampsia

Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 13 and 16 weeks of pregnancy
* High risk of preeclampsia, based in clinical risk factors as:

Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index \> 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.

Exclusion Criteria:

* Blood coagulation disorders of any kind
* Peptic ulcers
* Allergy to aspirin
* Chronic use of anti-inflammatory drugs
* Fetus with mayor anomalies
Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)

This study is intended to assess the exposure, safety, biological activity, and durability of UBX1325, a phosphate pro-drug, and its active parent molecule (UBX0601) following a single intravitreal (IVT) injection of UBX1325 in patients with diabetic macular edema (DME).

This is a Phase 2a Proof-of-Concept (POC) study. The study will enroll approximately 62 patients randomized 1:1 into either the UBX1325 or sham study arms, in order to assess safety and tolerability as well as impact on visual function and retinal anatomy. Patients will be followed for 24 weeks for the primary outcome measure and for an additional 24 weeks (48 weeks total) for the secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years.
* Diabetic retinopathy patients (nonproliferative (NPDR) and proliferative (PDR)) with DME (ETDRS-DRSS Score at 65C \[or DR severity level of 8\]or less severe as determined by a Central Reading Center), who had at least 2 anti-VEGF intravitreal (IVT) injections (one or more of the following agents: aflibercept, bevacizumab or ranibizumab) in the preceding 6 months prior to Day 1, with the last anti-VEGF given between 3 and 6 weeks prior to Day 1.
* Center-involved DME with central subfield thickness (CST) ≥300 µm on SD-OCT at Screening
* BCVA in the study eye (most affected) of 73 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1.

Exclusion Criteria:

* Concurrent disease in the study eye or structural damage, other than DME, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or color fundus photography (CFP) in the study eye.
* Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening
* History of vitreous hemorrhage in the study eye within 2 months prior to Screening
* Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
* Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
The Ailliance Post-Market Clinical Study

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s).

Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.


Eligibility Criteria:
Inclusion Criteria:

1. Subject provides written informed consent per institution and/or geographical requirements.
2. Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
3. Subject is at least 18 years of age or minimum legal age as required by local regulations.
4. Subject agrees to complete all required assessments per the Schedule of Events.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
2. Subject who is, or is expected to be, inaccessible for all required follow-up visits.
3. Subject with exclusion criteria required by local law.
4. Subject is considered vulnerable at the time of obtaining consent.
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)

The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Chronic Angle Closure Glaucoma (CACG)
* 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
* Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
* Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
* Peripheral anterior synechiae (PAS)

Exclusion Criteria:

* Traumatic damage of the anterior chamber angle
* History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
* Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
* Visual Acuity ≥ 1.0
* Contact lenses wearer
Effectiveness of Abdominal Binder Use During Colonoscopy

Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

Between the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.

Participants with ASA I-III (American Society of Anesthesiologists Class III)

Exclusion Criteria:

Previous colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia
Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II

Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Specular microscopy photos will be taken pre-. and 3 month postoperatively. Cellular parameters will be compared between the two groups prior and post surgery. Clinical significant difference is defined as 1 SD (300 cell/mm2)

Eligibility Criteria:
Inclusion Criteria:

* Cataract, diabetes

Exclusion Criteria:

* Corneal disease
* Uveitis
* Previous intraocular surgery and diabetes type I