cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Survey of the Indications for Esophagogastroduodenoscopy (EGD)

Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings through this multicenter study.

Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. And there are indications for EGD. Here, investigators want to find which symptoms can strongly support for positive endoscopy findings. So, investigators design the study to record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of endoscopic findings.

Eligibility Criteria:
Inclusion Criteria:

* All of the patients need esophagogastroduodenoscopic procedures

Exclusion Criteria:

* Patients whose parents reject to provide information for study
IMPACT: IMplementation of Physical Activity for Children and Adolescents on Treatment

Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.


Eligibility Criteria:
Inclusion Criteria:

1. Children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise)
2. Diagnosed with any oncological and/or hematological diagnosis
3. Currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment \<3 months

Exclusion Criteria:

1. Completed all treatment for their oncological or hematological diagnosis \>3 months
2. Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist
3. Parent and/or patient cannot understand verbal English
4. Parent is unwilling to be present (i.e., at home, in the same room depending on participant age and functional ability) during the physical activity sessions (required to ensure safety of the child/adolescent)
Treating Nightmares Among Domiciliary Patients

The purpose of the study is to assess the efficacy of a 2-session intervention to reduce nightmares among Veterans admitted VA mental health residential rehabilitation treatment programs.

Sleep disturbances and suicide are highly prevalent among Veterans and recent research also suggests high comorbid rates of sleep and suicide in Veterans discharged from VA mental health residential rehabilitation treatment programs (MHRRTP; domiciliaries). Nightmares are a frequent concern identified by MHRRTP patients and are a modifiable risk factor for suicide risk. Little is known, however, about the treatment of nightmares and subsequent impact in this setting. The primary aims of the present project are to investigate the efficacy and acceptability of delivering a 2-session intervention to reduce nightmares among Veterans admitted to a MHRRTP. This study will examine this intervention's impact on reducing nightmare distress and nightmare frequency, as well as assess treatment acceptability. Changes in suicide risk following intervention will also be explored. This research will be conducted within the Canandaigua and Bath VA domiciliary programs which currently accommodate \~150-175 Veterans. The study will be a randomized control trial with a hybrid design that uses stratification based on prescription use and randomly assigns individuals (N = 48) to either the treatment group or treatment as usual group (TAU). Veterans referred for the protocol will be screened for eligibility and then if appropriate, scheduled for a baseline evaluation, randomized to either the treatment group or TAU group, seen for two intervention sessions one week apart, and then be followed up with 4- and 8-weeks post initial treatment via telephone. This research has potential to highlight valuable targets for cross-cutting treatment in a rehabilitation setting that can be delivered in civilian and Veteran samples.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* endorses nightmares at least once a week
* score of 10 or greater on the Disturbing Dreams and Nightmares Severity Index

Exclusion Criteria:

* unable to consent
* diagnosis of serious mental illness (schizophrenia, schizoaffective disorder)
* active suicide ideation with plan and intent
Celect Vena Cava Filter Clinical Trial

The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term IVC filter.
* The patient must have a patent internal jugular vein.
* The patient or guardian must have given informed consent.
* The patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months.
* The patient must agree to have a clinical and imaging examination performed prior to filter retrieval.
* The patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval.

Exclusion Criteria:

* The patient is less than 18 years of age.
* The patient is pregnant.
* The patient has uncontrollable coagulopathy.
* The patient has a life expectancy less than 6 months.
* The patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
* The patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters.
* The patient has a contrast allergy that can not be adequately pre-medicated.
* The patient is simultaneously participating in another investigative drug or device study, or has a previous IVC filter.
The Non-Optical Resect and Discard Study (NORD)

Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study

Implementation of this approach by community-based gastroenterologists has failed to reach the required quality benchmarks and studies evaluating optical biopsy have not shown diagnostic test performance results that meet standards set by society guidelines in order to promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and discard approach are too complex for clinical adoption. Thus, clinical implementation of this valuable concept has not been achieved to date and its cost-saving potential has not been realized. In order to effectively operationalize a resect and discard strategy, one must find a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences in the proportion of polyps found to be adenomatous in the left and right colon. One recent study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be adenomas on histology. Since polyps located in the proximal colon are more likely to be adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized that a model based on polyp location might be able to replace optical biopsy and histopathology. Such an approach would be very simple to adopt by every clinician and would allow for easy adoption into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age 45 to 80 years
* Indication for full colonoscopy

Exclusion Criteria:

* Known inflammatory bowel disease
* Active colitis
* Coagulopathy
* Familial polyposis syndrome
* Poor general health defined as an ASA class \> 3
* Emergency colonoscopies.
Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).


Eligibility Criteria:
Inclusion Criteria:

* Patient meets ROME III criteria for functional dyspepsia (FD)
* Patient has a normal esophagogastroduodenoscopy (EGD) either during the Screening Period or within 2 years of the Screening Visit
* Patients who EITHER:

  1. Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR
  2. Have used a PPI at a stable dose for at least 4 weeks prior to the Screening Visit;
* Patient meets symptom severity criteria in the Pretreatment Period
* Patient is fluent and literate in Dutch, French, or English

Exclusion Criteria:

* Patient meets criteria for gastroesophageal reflux disease (GERD, stable regimen of PPIs acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis
* Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma
* Any significant neurological disease or a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable; complete remission of other cancers for 5 years or longer is also acceptable)
* History of active alcoholism or drug addiction within 12 months prior to the Screening Visit
* Hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the Screening Visit
* Any organic or structural disease that can cause abdominal pain or discomfort
Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children

The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.

This study will compare the effectiveness of a patch applied for 30 minutes (Synera-lidocaine 70 mg/tetracaine 70 mg) with the effectiveness of a cream (LMX-4- 4% liposomal lidocaine) and a placebo patch applied for the same length of time in reducing pain due to needle sticks in children. One hundred fifty children and adolescents 5-17 years old admitted to emergency department or presenting to the phlebotomy lab. will be randomly placed in each group. Children will rate their level of pain using the Faces Pain Scale-Revised (FPS-R) before the medication is applied, after the medication is removed and after the needle stick. Parents and research observer will fill out the Observed Behavioral Distress (OBD) score. The phlebotomist will rate how difficult it was to perform the needle sticks. Any skin reaction seen by the investigator after the cream or patch is removed will be noted and compared among the three groups.

Subjects will be monitored from the time of enrollment to 5 minutes post phlebotomy.The Time Frame for which data will be presented is one (1) year.

Eligibility Criteria:
Inclusion Criteria:

* Children requiring venipuncture for medical care
* The ability to demonstrate proper understanding of the Faces Pain Scale-Revised (FPS-R)
* Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain

Exclusion Criteria:

* Damaged or inflamed skin at the designated application site
* Known sensitivity to components of Synera or LMX-4 (lidocaine, tetracaine, or local anesthetics of the amide or ester type, PABA derivatives)
* Contraindications to Synera or LMX-4 use (severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
* Use of analgesics during the past 24 hours
* Teenage female participants who are pregnant or lactating
* If in the attending's judgment the patient cannot wait wait 30 minutes for a blood drawn. These conditions include but are not limited to: sepsis, trauma, surgical emergencies, severe dehydration.
Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine

This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.


Eligibility Criteria:
Inclusion Criteria:

* Meets the 2002 AECG or 2016 ACR/EULAR classification criteria of primary Sjögren's syndrome.

Exclusion Criteria:

* Comorbid connective tissue disease other than the disease under research.
* Women who are pregnant or breastfeeding.
* Combined severe cardiovascular or cerebrovascular disease, hepatic or renal failure, or severe malignant tumors.
* Other conditions (e.g., cognitive impairment) that the investigators consider ineligible for enrollment.
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Phase 3, multicenter, global, three-arm, parallel design, placebo-controlled, double-blind, randomized study to determine efficacy, safety and tolerability of tafamidis on clinical outcomes (all-cause mortality and frequency of cardiovascular-related hospitalizations) in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement,
* Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm,
* Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry

Exclusion Criteria:

* A New York Heart Association (NYHA) classification of IV.
* Presence of primary (light chain) amyloidosis.
* Prior liver or heart transplantation or implanted cardiac mechanical assist device.
Adolescents' Use of Complementary and Alternative Medicine

The purpose of this study is to help improve our understanding of when and why adolescents decide to use alternative and complimentary medicines, and to understand factors that lead to better communication between youth and their clinicians.

Alternative therapies and herbal remedies are increasingly recognized as having therapeutic value, and as many as 42% adults use some form of complementary and alternative medicine (CAM). The prevalence of CAM use among adolescents is not known. Questions remain about the safety and efficacy of some CAM therapies, and how to best facilitate communication about alternative medicine between patients and clinicians. Research with adults shows that most do not reveal their use of alternative therapies to their providers. Adolescence is a time of experimentation and the beginning of a shift from depending upon parents to taking responsibility for one's own care. Thus, the health practices begun in adolescence have an impact into adulthood. However, none of the current guidelines for the provision of care to adolescents advise asking about complementary or alternative medicine use. Finally, adolescents are exposed to increasing coverage of CAM in the media, and on the internet. The specific aims of this study are to: 1) determine the prevalence of complementary and alternative medicine use among a representative sample of adolescents, 2) describe the range of therapies adolescents use, and where they are procured, 3) describe adolescent and clinician factors that are associated with communication between adolescents and their providers about complementary and alternative medicine, and 4) describe adolescents' exposure to information about CAM from sources such as parents, providers, and the media, and how this impacts CAM use. We propose a cross sectional random digit dial telephone survey of 1200 adolescents in Monroe County, NY. Our findings will allow us to understand how adolescents use alternative medicine. Additionally, since alternative therapies can have potentially serious side-effects or drug interactions, insight into how and when alternative medicine use is disclosed may help clinicians provide better care to adolescents.

Eligibility Criteria:
Adolescents ages 14-19
Prehospital Transcranial Duplex in Patients With Acute Stroke

The aim of the study is to investigate patients with acute stroke prehospital with transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.

The investigation of the patients will be done by an anaesthesiologist who is part of the prehospital medical treatment in Germany. The main question is, wether a non neurologist can detect an infarction of the middle cerebral artery in a short time an lead the patient to the indicated clinic.

Eligibility Criteria:
Inclusion Criteria:

* clinical signs of acute stroke
* possibility of TCD

Exclusion Criteria:

* acute interventions for vital signs required
Autoantibodies and Clinical Symptoms in Infective Endocarditis Patients

The purpose is to evaluate autoantibodies in infective endocarditis patients before, at the beginning of treatment, and after the end of the treatment, and to correlate the autoantibodies in the presence of clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Infective endocarditis patients by DUKES criteria

Exclusion Criteria:

* HIV positive
* Patients suffering from other infective diseases other than endocarditis.
* Patient suffering from collagen diseases for example: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), mixed connective tissue disease, and scleroderma.
Gait Analysis in MPS IVA

The purpose of this study is to learn about gait (walking) characteristics in MPS IVA and possible changes in gait with enzyme replacement therapy.

The purpose of this 3-year study is to conduct a longitudinal investigation using motion analysis of gait to objectively and quantitatively assess gait characteristics of MPS IVA patients. Data documenting gait characteristics and abnormalities will be gathered in patients initiating enzyme replacement therapy.

Inclusion criteria Individuals with MPS IVA diagnosed by enzyme or molecular studies Exclusion Criteria Individual with MPS IVA previously enrolled in BMN-110 Individual is non-ambulatory The individual is unable to complete longitudinal study visits at least yearly

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of MPS IVA

Exclusion Criteria:

Non-ambulatory

* Previous enrolled in clinical trial BMN-110
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.


Eligibility Criteria:
Inclusion criteria:

* Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant;
* Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-HLA identical living related donor kidney;
* Graft must be functional (producing greater than or equal to 100 ml of urine within 24 hours after transplantation) at time of randomization.

Exclusion criteria:

* Donor organ with a cold ischemic time \> 30 hours;
* Males or females who produce less than 100 ml of urine in the first 24 hours post-transplantation;
* Males or females who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;
* Males or females with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);
* Males or females who have any surgical or any medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator, might alter the absorption, distribution, metabolism and/or excretion of study medication.

Other protocol related inclusion/exclusion criteria may apply.
Innovative Food Structures to Enhance Nutrient Bioavailability

This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups:

1. Vitamin D enriched (20ug) olive oil emulsion drink
2. Vitamin D enriched (20ug) coconut oil emulsion drink
3. Placebo emulsion drink
4. Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group.

Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention.

Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.


Eligibility Criteria:
Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

* Pregnant/lactating
* Smokers
* Individuals who are not free-living
* An inability to read, write or understand English
* Following a strict diet for any reason, insulin dependent diabetes, coeliac etc.
* Disease that requires chronic therapeutic nutritional or medical treatment
* Those with conditions that may affect kidney function
* Those with osteoporosis
* Those taking supplemental vitamin D
* Those who have been on a sun holiday in the last 2 months
* Those with a milk protein allergy or lactose intolerance