cyrilzakka/clinical-trials huggingface dataset:
Added Value of Gadoxetic Acid-enhanced Liver MRI

It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1\~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC.

Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.

In terms of confirmative diagnosis, HCC is unique compared with other malignant tumors, as it can be diagnosed noninvasively based on its characteristic imaging features, that is, arterial hyperenhancement (washin) and hypoenhancement (washout) on portal or delayed phase at contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) using extracellular contrast media (ECCM). According to Liver Imaging Reporting and Data System (LI-RADS), hypointensity and isointensity on hepatobiliary phase (HBP) at gadoxetic acid-enhanced MRI are suggestive of malignancy and benignity, respectively, and those features are uniquely provided by only hepatocyte-specific contrast agent. However, these features are not included in diagnostic criteria because of its non-specificity, and indeed, gadoxetic acid-enhanced MRI is not yet included in AASLD and EASL guidelines as a diagnostic modality. If gadoxetic acid-enhanced MRI would provide better performance to diagnose HCC than CT, gadoxetic acid-enhanced MRI should be considered as a next step before biopsy in those small and/or atypical nodules to avoid potential diagnostic pitfall and morbidity, which is currently depending on physicians' decision. Thus, it would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1\~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC.

Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic hepatitis B or cirrhosis of any etiology
* signed informed consent AND
* being referred to radiology department for gadoxetic acid-enhanced MRI due to small nodule (10-19mm) at contrast-enhanced CT scan within 30 days as an radiofrequency ablation (RFA) work-up OR
* being referred to radiology department for percutaneous biopsy for atypical hepatic nodules (≥20mm) detected at contrast-enhanced CT within 30 days before biopsy

Exclusion Criteria:

* Any contraindication for MRI and MR contrast agent
A Study of the GRIP Influenza and SARS-CoV-2 POC Assays

The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.

Eligibility Criteria:
Inclusion Criteria:

* Patients being tested for COVID 19 or Influenza

Exclusion Criteria:

* Patients \< 18 years of age
NoL Index Response to Stimulation in Anesthetized Children

The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Age 5-12 years
* Elective surgery under general anesthesia
* Written informed consent

Exclusion Criteria:

* Cardiac surgery
* Opioid intake \< 24 hours before surgery
* Cardiac arrhythmia
* Pace maker
* Pheochromocytoma
* Anti-arrhythmic medication
* Anticholinergic medication
* Raynaud syndrome
* Digital anomaly (malformative, traumatic)
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.

Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric
* Signed informed consent
* Willing to return for follow-up visits

Exclusion Criteria:

* Crohn's Disease
* Ulcerative Colitis
* HIV Positive
* Immune System Disorder
* Collagen Disorder
* Tuberculosis
* History of radiation to anorectal region
* Allergies to pig tissue
* Religious or cultural objection to use of pig tissue in this surgical application
* J-pouch fistulas
* Previous Surgisis AFP Plug placement in target fistula tract
* Tracts with acute abscess, infection or inflammation
* Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy
Homebased Monitoring Cardiac Rehabilitation Program

The current state of mobile communication and technology is a tool to support home programs for chronic disease management, useful to facilitate access to these types of programs, because the investigators could obtain telematics information about the parameters, reducing cardiovascular risk factors and cardiovascular morbidity and mortality.

The current state of mobile communication and technology is a tool to support home programs for chronic disease management, useful to facilitate access to these types of programs, because the investigators could obtain telematics information about the parameters, reducing cardiovascular risk factors and cardiovascular morbidity and mortality.

Once the patient qualifies for inclusion in the study and has signed informed consent it is included in a list where randomized 7 patients in the experimental group (home-based cardiac rehabilitation Nuubo monitoring vest) and 7 patients are assigned to traditional cardiac rehabilitation group.

Eligibility Criteria:
Inclusion Criteria:

All of them:

* Age ≤ 80 years.
* Stable Ischemic heart disease, revascularized by angioplasty or underwent surgery by coronary bypass \<= one year from the acute episode.
* Good cognitive level.
* Ability to perform aerobic exercise tape or cycle ergometer.
* Understand the use of a mobile Smartphone or Tablet.
* Signature of informed consent.

And at least one of the following:

* Ventricular dysfunction by Ejection Fraction (FE) 40 - 50%.
* Functional capacity 5-7 metabolic equivalents (METS).
* Raising the blood pressure with the effort.

Exclusion Criteria:

* Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (\> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled.
* Previous infarcts.
* Hypotensive response to exercise.
* Myocardial Ischemia valued at exercise test.
* Unstable Angina.
* Nonrevascularizable disease.
* Poorly controlled hypertension baseline.
* Killip III and IV Killip.
* No collaborator.
* Valvular heart disease associated.
* Pacemaker or Implantable Cardioverter Defibrillator.
* Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.
Dietary Determinants in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18
* NAFLD was diagnosed by Fibroscan and other hepatic disorders ruled out

Exclusion Criteria:

* not completing more than 10% of the questionnaire
Yoga, Mother's Stress and Baby

The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems.


Eligibility Criteria:
Inclusion Criteria:

Parents living together The child must have at least one of the 3 problems listed below on the Infant/Child Sleep Problem Brief Diagnostic Form.

1. Waking up more than three times a night
2. Waking up at night and being sleepless for more than 1 hour
3. Total sleep time is less than 9 hours Having a score above 25 on the Infancy Adaptive Eating Behavior Scale

Exclusion Criteria:

The child has any developmental, neurological, orthopedic and/or psychiatric diagnosis Presence of a condition that prevents the mother from exercising (neurological, cardiovascular, orthopedic, etc.)

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Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.


Eligibility Criteria:
Inclusion criteria:

1. Age \>= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal;
5. FVC\>= 50% predicted of normal

Exclusion criteria:

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \> 1.5 x Upper Limit of Normal (ULN)
2. Bilirubin \> 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC \< 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) \> 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \> 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone \> 15mg/day or equivalent received within 2 weeks of visit 1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;
Baclofen Treatment of Ataxia Telangiectasia

This research is being done to find out if Baclofen, a medicine that is often used for the treatment of abnormal stiffness, might also be useful to treat some of the neurologic problems caused by ataxia telangiectasia (A-T). The investigators also want to find out if there are better ways to measure the problems of ataxia and abnormal eye movement for future studies of medication in ataxia telangiectasia.


Eligibility Criteria:
Inclusion Criteria:

* Teenagers over 12 years old and young adults with A-T may join if they have been evaluated previously in the A-T Clinical Center at Johns Hopkins Hospital and have a measurable abnormality of eye movement.
* Patients who are presently taking Baclofen will be eligible for the study if they are presently receiving the medication under the direction of Dr. Crawford in the ATCC, and are willing to withdraw from the medication for a period of one month prior to the initial screening visit.
* Female patients who are sexually active will be given a standard serum HCG pregnancy test.
* Those who are sexually active will be counseled about necessary precautions against pregnancy during the duration of the trial.

Exclusion Criteria:

* A positive pregnancy test.
Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia

The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2

Exclusion Criteria:

* Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives
* Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy
* Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet
Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.

Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Eligibility Criteria:
Inclusion Criteria:

* During the first trimester of pregnancy
* Singleton pregnancies

Exclusion Criteria:

* Women have pregnancy-related complications
* Women have diagnosed a psychiatric or sleep disorder
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

There is a need for effective weight control methods for obese children. Environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food consumption while watching television may reduce food intake without requiring conscious, cognitive self-control. The investigators propose to test these methods when added to a current state-of-the-art behavioral program.

Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.

Eligibility Criteria:
Inclusion Criteria:Inclusion criteria: 8-15 year old obese children (BMI \&#8805; 95th percentile on the 2000 CDC BMI reference) on the date of randomization. Our standard Stanford Pediatric Weight Control Program eligibility criteria will apply: both child and parent/guardian must want to join, both child and at least one parent/guardian must agree to attend sessions, and must agree to not miss more than 2 consecutive sessions. As we interested in testing generalizable strategies for weight control in diverse populations, the eligibility criteria are designed to be liberal, to maximize the generalizability of the results, but also maintain the internal validity of the test of the intervention. Exclusion Criteria:Exclusions: To enhance internal validity, children will not be eligible if they:

1. have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder \[present or past\], AIDS or HIV infection, pregnancy);
2. are taking medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
3. have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);
4. have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language);
5. are unable to read, understand or complete informed consent in English or Spanish;
6. plan to move from the San Francisco Bay Area within the next 18 months.
Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.

This study is being done to compare usefulness of data collected in uroflowmetry, a test that measures the amount of urine released from the body, at home versus in the doctor's office. Additionally, investigators are assessing patient satisfaction when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in person visit.

The three devices being investigated have not been used in the home setting to make urinary measurements as is typically done in clinic. The goal is to test the effectiveness and accuracy of these devices compared to our standard clinical practices and demonstrate their ability to provide useful information in the home setting.

This study is being done to improve the availability of telehealth urology visits. In this study, investigators will compare the usefulness of data collected by three home devices to understand the amount of urine released from the body, how empty the bladder gets after urinating, and if there is an infection present in the bladder. These will be compared to being at home versus in the doctor's office. Additionally, the study will determine how satisfied patients are when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in-person visit. The three devices being investigated have not been used in the home setting to make urinary measurements as is typically done in clinic. The goal is to test the effectiveness and accuracy of these devices compared to standard clinical practices and demonstrate the ability of these devices to provide useful information in the home setting. The study involves two cohorts. Cohort 1 are new patients who will be randomized to either telehealth visits or in office visits. If randomized to the telehealth group, the patients will use various devices to perform a standard workup at home. If randomized to the clinic visit, similar tests will be performed in the office. Cohort 2 are existing patients who will use one of the devices at home, but will also complete similar in-office tests in order to compare device accuracy.

Screening will be performed prior to patient's first scheduled visit based on chief complaints of urinary retention, BPH, or LUTS. Patients will be initially identified by study personnel or qualified research coordinator when the patient is identified to have qualifying issues through reviewing medical records of patients. Patient will be contacted by phone by the study personnel. If the patients are interested, the patients will be screened for inclusion criteria.

Eligibility Criteria:
Inclusion Criteria

* ≥18 years of age
* New patient referral for urinary retention, BPH, or LUTS (Cohort 1)
* Established patient for urinary retention, BPH, or LUTS (Cohort 2)
* Male

Exclusion Criteria

* \<18 years of age
* Inability to provide informed consent
* Visually or hearing impaired
* Concomitant condition requiring in-person exam or evaluation
* History of allergic reaction or issues with ultrasound gel
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with CD22-positive ALL with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the study must be due to receive salvage 2 or later therapy.
* Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
* Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
* Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
* Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).