cyrilzakka/clinical-trials huggingface dataset:
Telemedical Examination of a Three-Component Oculomotor Testing Battery

The study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol. Previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral causes of acute vestibular syndrome. In this study the three tests will be executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany) connected to a mobile wireless-workstation for bidirectional audiovisual communication in a clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video conferencing solution allows the execution and evaluation of the HINTS protocol in a telemedical setup.

The examination is guided by a remote physician using the help of a trained assistant attending to the subject. Corresponding clinical bedside tests will be executed for comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical setting. Safety as well as accuracy of the telemedical versus bedside examination will be analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy for patients with acute vestibular syndrome in remote areas where specialists are rare.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adults

Exclusion Criteria:

* Acute vertigo or dizziness, acute neck pain, history of stroke, history of acute vestibular syndrome, strong unilateral or bilateral visual impairment, complete movement restriction of cervical spine
CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer

The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy

Primary objective:

I To determine if dietary alternations designed to downregulate the dominate molecular drivers of an individuals' breast cancer will enhance the effect of neoadjuvant chemotherapy and allow for an increase in the pathologic complete response rate.

Secondary objectives

I) Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven invasive breast cancer
* Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist
* The patient must be female
* Age ≥ 18
* Non-metastatic and non-inflammatory breast cancer
* History/physical examination, including breast exam and documentation of weight and Karnofsky Performance Status of 80-100% for at least 60 days prior to study entry.
* Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during chemotherapy
* Patient must capable of and provide study specific informed consent prior to study entry
* BMI ≥21
* Weight ≥120lbs
* No prior history of non-breast malignancies in the past 1 year unless it was a non- melanomatous skin lesion or carcinoma in situ of the cervix.
* Patient must not have Acquired Immune Deficiency Syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism.
* Patient may not have any active Gastrointestinal/Malabsorption disorder at the discretion of the Principal Investigator which may include:
* Chronic Pancreatitis
* Chronic Diarrhea or Vomiting
* Active Eating Disorder
* No history of or current active drug/alcohol dependence.
* No patients with decisional impairment.

Exclusion Criteria:

* Patient is male.
* Age \<18 years
* Clinical stage IV cancer
* Inflammatory breast cancer (T4d)
* Women of childbearing potential with a positive serum beta hCG.
* Decision impaired patients.
* BMI \< 21
* Weight \< 120lbs
* Weight loss ≥10% in the last 3 mos
* Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 1 year prior to registration
* Non-epithelial breast malignancies such as sarcoma or lymphoma
* Active Gastrointestinal/Malabsorption disorder at the discretion of the Principal -Investigator which may include:

  * Chronic Diarrhea or Vomiting
  * Active Eating Disorder
  * Active drug/alcohol dependence or abuse history.
Soluble Advanced Glycation End Product (sRAGE) Levels

The aim of this study is to evaluate sRAGE levels in children with obesity and to determine the relationship between metabolic status and sRAGE levels in childhood obesity


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Obesity BMI over 95th percentile BMI z-score over 2

Exclusion Criteria:

Primary hyperlipidemia Primary liver disease Hypothyroidism Diabetes
Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)

Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted.

Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response


Eligibility Criteria:
Inclusion Criteria:

* 6-17 DSM IV criteria for ADHD Parents willing to complete measures

Exclusion Criteria:

* Mental retardation psychoses seizure disorder
Ai Chi Method for Children With Asthma

This study has the aim to assess the effectiveness of the Ai Chi method as an adjunct therapy in the treatment of children with asthma.

Children from 7 to 12 years old with asthma diagnosis will be included. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma, based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2017.Children in the intervention group will perform 12 sessions (twice a week) of treatment with the Ai Chi Method and educational interventions similiar to the control group. The investigators will assess pulmonary function (spirometry), asthma control by the Childhood Asthma Control Test (c-ACT Questionnaire), quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), anxiety symptoms by the SCAS (Spence Children's Anxiety Scale) and Disturbed Sleep by the Sleep Disorders Scale in Children. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage.

Eligibility Criteria:
Inclusion Criteria:

* Children from 7 up to 12 years old with asthma diagnose;
* Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
* Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), obesity, retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.

Exclusion Criteria:

* Children that are not able to perform some of the necessary procedures;
* Give up participating in the research and present acute symptoms of respiratory tract during the assessments.
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug (NSAID)therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months.
* Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally;

Exclusion Criteria:

* History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
* History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases

To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients.

Subjects with various CXCR4-related disease patients underwent 68Ga/18F-Pentixafor/Pentixather PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Pentixafor/Pentixather PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
* 18F-FDG PET/CT within two weeks
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
Painless Local Anaesthesia With Bicarbonate Admixture

This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1.

Therefore the investigators compare two groups with 24 healthy individuals in each group in a cross-over study. One group receives four injections (two in each forearm) and one group receives only two injections (one in each forearm)

The four injections of group 1 are:

* IMP1: Lidocaine and sodium bicarbonate ratio 3:1
* IMP 2: Lidocaine and sodium bicarbonate ratio 9:1
* IMP 3: Lidocaine
* IMP 4: Sodium cloride 0.9% (=placebo)

The two injections of group 2 are IMP1 and IMP2.

After each injection the individual has to rate their pain sensation on a NRS scale and afterwards the anesthetic effect gets tested by a standardized laser application.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female individuals between 18 and 75 years
* able to understand and speak German
* able to follow the instructions

Exclusion criteria:

* oversensitivity to lidocaine or other local anesthetics of amide type or sulfites
* prone to bleeding, intake of aspirine or anticoagulation
* pregnancy
* skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)

  * previous participation at the same study
Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)

Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate.

The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI


Eligibility Criteria:
Inclusion Criteria:

* Men with high DNA fragmentation (\>20%) undergoing TESA-ICSI or Zymot-ICSI

Exclusion Criteria:

* Spouse with advanced maternal age (\> 40 years)
* Egg donation cycle
Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain

Population aging makes it necessary to identify factors related to unhealthy aging. The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles and biological risk factors (either clasical or emergent) and the risk of physical and cognitive function impairment and mortality in a cohort of community-living individuals aged 65 years and over.


Eligibility Criteria:
Inclusion Criteria:

* Non-institutionalized residents in the region of Madrid, Spain.
* 65 years and over

Exclusion Criteria:

* None
Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery

To evaluate the anatomical and visual outcomes after vitrectomy and internal limiting membrane (ILM) peeling with indocyanine green (ICG) or trypan blue (TB) for idiopathic macular hole repair in a prospective randomized trial.

In several clinical trials the positive effect of inner limiting membrane peeling (ILM) on anatomical and functional outcome in macular hole surgery has been reported. Controversies, however, exist regarding the application and possible toxicity of dyes, facilitating the surgical procedure. Since dyes were introduced for ILM peeling several authors reported on the use of indocyanine green and trypan blue (TB) for membrane peeling or ILM removal. Recent experimental and clinical reports raise concern about the safety of ICG-assisted membrane peeling. Morphological and functional damage was described in an animal model, in human donor eyes, in cultured human pigment epithelial cells and in clinical studies using ICG in macular surgery. The intraocular tolerance of TB has been demonstrated in rabbit eyes and in retinal pigment epithelium cell viability studies. Higher concentrations of TB (0.6 or 4 mg/ml) lead to toxicity on cultured RPE cells, but the application of lower clinically relevant levels did not show any significant effect. A recent retrospective comparative analysis indicates that TB may be the safer dye. They found better anatomical and functional results than with the use of ICG.

Therefore, the aim of this study was to compare the anatomical and functional outcome after dye-assisted peeling of the ILM in patients with idiopathic macular holes using ICG or TB in a prospective and randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic macular holes stage II-IV according to the classification proposed by Gass and a visual acuity of at least 20/200 entered this study.

Exclusion Criteria:

* Patients with secondary macular holes, previous intraocular surgery, except for uneventful cataract extraction and patients with ocular disorders that might interfere with vision such as severe cataract, exudative age-related macular degeneration or diabetic retinopathy.
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique

Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).

Exclusion Criteria:

* Acute Myocardial Infarction (STMI);
* Chronic occlusion;
* Cardiogenic shock;
* Ejection fraction ≤ 20%;
* Thrombocytopenia (≤ 50 mil);
* DAPT contraindication;
* Life expectancy of less than 12 months.
Alinity s Anti-HCV II - Clinical Evaluation Protocol

The objective of this study is to demonstrate the performance and intended use of the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food and Drug Administration (FDA) licensed Alinity s Anti-HCV assay as the comparator method. The data will be used to support regulatory submissions and/or publications.

This study evaluates the Alinity s Anti-HCV II investigational assay using the Alinity s System.

The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. The Alinity s Anti-HCV II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV.

The performance of the Alinity s Anti-HCV II assay will be evaluated by performing specificity, and sensitivity testing of the Alinity s Anti-HCV II assay.

To evaluate specificity, approximately 15,000 random unique donor specimens will be collected.

To evaluate sensitivity, Abbott will provide a minimum of 400 frozen samples from U.S. individuals characterized as HCV positive and a minimum of 400 frozen specimens from U.S. individuals at increased risk for HCV infection.

Eligibility Criteria:
Inclusion Criteria:

* Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.

Exclusion Criteria:

* Previous participation in this study. Each subject must be represented only once in the study.

Note: Frozen samples (sensitivity) provided by Abbott (403 specimens characterized as positive for HCV and 404 specimens with Increased risk of HCV infection) have no specific inclusion/exclusion criteria that the clinical sites need to verify prior to testing. Inclusion and exclusion criteria only apply to specificity specimens.
An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy

observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.

observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Diagnosis of partial epilepsy, defined as active, drug-resistant in accordance to the 2010 ILAE (International League Against Epilepsy) definition and actually taking an add-on therapeutic regimen.
* Able and willing to give the written informed consent (to be obtained before any study assessment)

For each drug-resistant patient, will be enrolled a patient with the same diagnosis and actually taking an add-on therapy but with controlled epilepsy according to the 2010 ILAE definition.

Exclusion Criteria:

* Patient currently included in a clinical trial for an AED (Anti-Epileptic Drug)
* Hospital record data on epilepsy not available in the Investigator's files
* Patient unable to fill in self-questionnaires (quality of life instrument)
* Patient currently hospitalized
* Patient who, according to the Investigator's judgment, is not able to follow the study procedures
The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus

Double-blind, randomised, placebo-controlled, parallel group study with two intervention arms. The study will be conducted in 150 subjects and the primary objective is to show a fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.

The main aim of the study is to investigate the effect of plant sterols on fasting triglycerides and LDL-cholesterol concentrations.

This study also aims to study the effect of plant sterols on fasting total cholesterol, HDL-cholesterol concentrations and Lipoprotein (a). Furthermore the effects of plant sterols on fasting blood glucose and insulin will be explored. At last, in a sub-group, at end of intervention the acute, chronic and acute upon chronic effect of plant sterols on postprandial blood lipids, glucose and insulin responses during a mixed meal challenge rich in fat and carbohydrates will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Triglycerides \>150 mg/dL or 1.74 mmol/L
* LDL-cholesterol: Subjects at high risk for developing T2DM: 115-190 mg/dL or 2.95-4.94 mmol/L. Subjects with established T2DM that are on statins: 85-190 mg/dL or 2.15-4.94 mmol/L.
* HbA1c: Subjects at high risk for developing T2DM: \<6.50% or ≥ 48 mmol/mol. Subjects with established T2DM: ≤ 8.5% or ≤ 69 mmol/mol.
* BMI \> 20.0 kg/m2.

Exclusion Criteria:

* Recently (within 1 year) diagnosed with cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions
* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. ezetimibe, fibrates and Niacin), to be judged by the principal investigator.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Macular Hole

To evaluate the correlations between anatomical and functional changes studied with microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of idiopathic macular hole (MH).


Eligibility Criteria:
Inclusion Criteria:

* Closure of the hole seen on the OCT at 1 year postoperative

Exclusion Criteria:

* Patients with an axial length over 26 mm, diabetes, macular diseases, glaucoma, or postoperative retinal detachment were excluded
Factors Associated With Post-induction Hypotension in iNPH Patient Undergoing VP and LP Shunt

This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. The incidence of post-induction hypotension according to our institution's pilot study November 2019-January 2020) was 47%. With 10% addition for missing data and other possible reasons, the sample size was 426. The primary objective of the study is to report the factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures. Our secondary objective is to determine the incidence of post-induction hypotension in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Elective cases of iNPH scheduled for VP and LP shunt
* Patients aged \> 18 years old

Exclusion Criteria:

* Emergency cases