cyrilzakka/clinical-trials huggingface dataset:
Normal Values in Ano-rectal 3D High Resolution Manometry

Ano-rectal manometry is indicative in patients with either fecal incontinence or constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure variations are measured circumferentially along the anal canal. It may allow a better understanding of anorectal disorders by displaying anal pressure asymmetry and it could be useful to assess the functional anatomy of the pelvic floor better than conventional manometry.


Eligibility Criteria:
Arm 1: 50 healthy volunteers Inclusions will be stratified on gender (10 males, 40 females), age (15 subjects under 40 years; 20 subjects between 40 and 60 years; and 15 subjects \>60 years) and parous (10 nullipara and 30 parous women).

Inclusion criteria:

Subject older than 18 years Absence of anorectal symptoms (no constipation, no fecal incontinence) Absence of pelvic floor disorders Vaizey score = 0 Kess score \< 9 Subject with health insurance Written informed consent Non inclusion criteria: Patient younger than 18 years Pregnancy Incapability to give consent No written informed consent Participation to another study at the same time Previous ano-rectal surgery Pelvic radiotherapy Neurological disorder Diabetes mellitus

Arm 2: 50 patients with fecal incontinence

Inclusion criteria:

Subject older than 18 years Patient referred for anorectal manometry and/or ultrasound examination Fecal incontinence as main complain Vaizey score \> 6 Kess score \< 9 Subject with health insurance Written informed consent

Non inclusion criteria:

Patient younger than 18 years Pregnancy Incapability to give consent No written informed consent Participation to another study at the same time Rectal tumor Rectal stenosis Ileo-anal or ileo-rectal anastomosis Anal fissure Anal fistula Arm 3: 50 patients with constipation

Inclusion criteria:

Subject older than 18 years Patient referred for anorectal manometry and/or ultrasound examination Constipation as main complain Feeling of incomplete evacuation and/or manual disimpaction defined as needing to press in or around the anus to aid defecation Vaizey score \< 6 Kess score \< 9 Subject with health insurance Written informed consent

Non inclusion criteria:

Patient younger than 18 years Pregnancy Incapability to give consent No written informed consent Participation to another study at the same time Rectal tumor Rectal stenosis Ileo-anal or ileo-rectal anastomosis Anal fissure Anal fistula
Evaluation of Atorvastatin Treatment on Carotid Plaque.

The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.

Exclusion Criteria:

* Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
* Subjects currently on high dose statin, and
* Subjects with contraindications for MRI or statin therapy.
Machine-Learning Prediction and Reducing Overdoses with EHR Nudges

The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction model as having an elevated risk for an opioid overdose.

The clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without behavioral nudges/best practice alerts (BPAs) as compared to usual care by primary care clinicians.

The primary goals of the study are to improve opioid prescribing safety and reduce overdose risk.

In response to the opioid overdose crisis, health systems have instituted multiple interventions to reduce patient risk, including decreasing unsafe opioid prescribing among high-risk patients and dispensing naloxone. However, these interventions face two key challenges. First, there are limited and poorly performing tools to identify who is truly at risk of overdose, leading to burdensome interventions targeting an overly broad population or missing key high-risk individuals. Second, even with more accurate identification of high-risk patients, highly effective strategies to change clinician behavior remain limited. Common cognitive biases may underlie clinicians' lack of response to risk factors for overdose.

This project aims to address both of these limitations by combining more accurate risk prediction tools to identify those at elevated risk of opioid overdose with novel "nudge" interventions based on principles of behavioral economics that have been shown to address cognitive biases and change prescribing behavior. The primary hypothesis is that high-risk patients in primary care practices randomized to the elevated-risk flag + nudge intervention will have safer prescribing compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Received an opioid prescription within the past year
* Age 18 years or older at the time of the opioid prescription
* At least one visit to an internal medicine or family care practice within the past year

Exclusion Criteria:

* Diagnosis of malignant cancer within the past year
* Enrollment in hospice care
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer

This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged 18 years and over.
2. Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines:

   i. 1o-90o contact between tumor and the superior mesenteric artery, celiac axis or common hepatic artery. Or; ii. 90o-270o contact between tumor and superior mesenteric vein or portal vein, without occlusion.

   iii. The discussion on resectability has to be made in consensus at multidisciplinary meetings/discussions and may overrule the above criteria (i, ii).
3. Patient is deemed eligible for surgical resection of the pancreatic cancer, however, during open surgery a more advanced disease than initially anticipated is found and resection is no longer feasible.
4. Life expectancy of 12 weeks or longer.
5. World Health Organisation (WHO) Performance status 0-1.
6. One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
7. Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

1. Radiation therapy within the last 4 weeks before the start of study therapy.
2. Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
3. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0) grade 2 from previous anti-cancer therapy.
4. Leukocytes \< 4.0 109/l and/or platelet count \< 100 109/l.
5. Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
6. Patient is deemed ineligible for implantation of 166Ho by an expert panel (surgeon, nuclear medicine physician and researcher) due to tumour anatomy or nearby structures.
7. Pregnancy or breast feeding (women of child-bearing potential).
8. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
9. Patients who are declared incompetent.
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study

To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.


Eligibility Criteria:
Inclusion Criteria:

≥18 years of age. A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.

Exclusion Criteria:

An inability to provide informed consent. Enrolled in another clinical study other than a registry. Hyperacute or acute aortic dissection (\<15 days from symptom onset). Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).

Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.

Prior treatment of the FL. Planned use of investigational devices to treat the primary entry tear and/or TL.

Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.

Planned use of FL embolic devices other than the investigational product. Prior abdominal aortic aneurysm (AAA) treatment. Planned concomitant major surgery (e.g., gastrointestinal surgery). Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome). Coagulopathy or uncontrolled bleeding disorder. Serum creatinine level \>2.5 mg/dL (within 90 days prior to the procedure). Cerebrovascular accident within 90 days prior to the procedure. Myocardial infarction and/or major heart surgery within 90 days prior to the procedure.

Atrial fibrillation that is not well rate controlled. Unable or unwilling to comply with study follow-up requirements. Life expectancy of \<2 years postprocedure. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.

A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.

History of allergy to contrast medium that cannot be managed medically. Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.

Participant is planning to become pregnant or is currently pregnant or lactating. For participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.
Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

To evaluate the effect of octreotide acetate injections (200 µg 3 times daily \[tid\]) on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single-dose telotristat etiprate in healthy male and female subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females ≥18 to ≤55 years of age
* Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening
* Vital signs (after at least 5 minutes resting in a supine position) at Screening that are within the following ranges: Systolic blood pressure, 90 to 140 mm Hg; Diastolic blood pressure, 50 to 90 mm Hg; Heart rate 40 to 100 beats per minute (bpm)
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Able to comprehend and willing to sign an Informed Consent Form

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or electrocardiogram (ECG) findings at Screening or Check-in (Day 1) that, in the opinion of the Investigator and/or the Sponsor or Sponsor's representative, may interfere with any aspect of study conduct or interpretation of results
* Use of any medications (prescription or over-the-counter), herbal tea, energy drinks, herbal products (eg, St. John's Wort, garlic, milk thistle, etc.), or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study, with the exception of those approved by the Investigator and/or the Sponsor or Sponsor's representative
* Prior exposure to telotristat etiprate
* Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
* History of any major surgery within 6 months prior to Screening
* History of renal disease
* History of hepatic disease, or significantly abnormal liver function tests (\>1.5 x upper limit of normal \[ULN\])
* History of gall bladder abnormalities
* History of any endocrine disorder
* History of alcohol or substance abuse within 2 years prior to Screening
* Positive urine screen for drugs of abuse and cotinine
* Consumption of caffeine- and/or xanthine containing products (eg, cola, coffee, tea, chocolate) within 72 hours prior to Check-in
* Consumption of alcohol within 48 hours prior to Check in
* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange containing products within 72 hours prior to Check in
BLYS and IFN in SLE

This protocol tests whether changes in BLyS or IFN can be detected in a normal immune response to a vaccine and, if so, whether the response differs between those with lupus and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* ACR lupus criteria
* 18\<age\<65

Exclusion Criteria:

* chronic infection or cancer
* pregnancy
Caring for the Caregiver Network

The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.


Eligibility Criteria:
Inclusion Criteria:

1. Speak and understand English or Spanish
2. Provide care to a loved one with memory decline
3. Not having terminal illness/condition
4. 18+ yrs old

Exclusion Criteria:

1. Not providing care to a loved one with Alzheimer disease or dementia
2. Not speak English or Spanish
3. Have cognitive deficit
4. Have terminal illness
5. Plan to place their loved one in a facility
6. Plan to move away in the next 12 months
The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human

To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human

Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected coronary heart disease
2. patients received coronary angiography

Exclusion Criteria:

1. NYHA III-IV
2. malignant tumor
3. acute infection
4. thyroid dysfunction
AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study

The purpose of this study is to identify whether changes in age-related macular degeneration (AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging, can be used to predict vision loss and the advancement of AMD in people at moderate to high risk for progression.

The primary objective of this study is to identify whether SDOCT patterns such as: drusen size, OCT reflectivity within drusen, photoreceptor (PR)change over drusen, microfoci of subretinal fluid (SRF), or retinal thickening are predictive of vision loss, progression of drusen, progression of photoreceptor loss over drusen, development of choroidal neovascularization (CNV), or development of geographic atrophy (GA).

The secondary objectives of this study are:

1. To define the relationship between SDOCT imaging, autofluorescence (AF)imaging, and color photographic or other fundus imaging of AREDS 2 patients in both a cross-sectional study of baseline data and a longitudinal study in data collected over the 5 year AREDS 2 study.
2. To compare the extent of geographic atrophy on SDOCT versus color photographs and autofluorescence.
3. To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2.

Eligibility Criteria:
Inclusion Criteria:

AMD subjects and controls

* Men and women between the ages of 50 and 85 years

AMD subjects

* Enrollment in the AREDS 2 trial;
* Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

Exclusion Criteria:

* Ocular media not clear enough to allow good fundus photography.
Flaxseed Intervention on Metabolic Syndrome

The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).

Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes).

Compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in MetS management. Flaxseed is a complex food source containing high amounts of alpha-linolenic acid (ALA) - an omega-3 fatty acid - as well as fiber, lignan precursors and other substances that may have an impact on our health. Therefore, the aim of this study is to investigate the effect of flaxseed supplementation on the management of MetS in adult Chinese men and women in a randomized, controlled clinical trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a flaxseed-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects of flaxseed supplementation will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.

Eligibility Criteria:
Inclusion Criteria:

* with metabolic syndrome Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol \<1.03 for men or \<1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin. - Being able to comply with the specified feeding conditions
* Being able to eat flaxseeds
* Being between the ages of 35 and 60 years

Exclusion Criteria:

* Pregnancy or lactation
* Use of insulin
* Severe kidney disease
* Cardiovascular diseases, stroke, cancer and psychological disorders
* Flaxseed allergies or frequently eating flaxseeds or sesame (\>90 grams/week)
* Drug or alcohol abuse.
WatchPAT Device Validation Study Compared to Polysomnography

Validation study of a novel sleep Device compared to a traditional sleep study.

This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 5 through 12 years of age.
2. Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:

   * snoring,
   * witnessed apneas,
   * daytime sleepiness, and
   * mouth breathing, etc.
3. Informed consent obtained.

Exclusion Criteria:

1. Medical conditions that can affect the tonometer reading such as:

   * peripheral vascular disease,
   * cyanotic heart disease,
   * systemic hypertension, and
   * sickle cell crisis.
2. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:

   * autism spectrum disorder,
   * Trisomy 21, and
   * neurodevelopmental disorders.
3. History of neuromuscular malformation
4. History of current supplemental oxygen use
5. History of current vasoactive, cardiac or seizure medication use
6. Inability or unwillingness to provide informed consent
Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction

Erectile dysfunction (ED or impotence) is a common medical condition affecting many men world wide. The most commonly used treatment for ED are oral medications like Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the use of an injection into the penis (intracavernosal injection or ICI) is necessary. However in some men neither of these therapies is successful.

Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile dysfunction, when they are treated with a therapy of combination of tablet and penile injection, when a single treatment therapy has failed for these men.

Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet Impulse in a group of men who had failed to achieve an adequate response to the maximum recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these treatments were used alone.

20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or the combination in a single-blind randomised study.

Informed consent will be signed prior to any study procedures being carried out. All participants are 'blinded' to their study treatments. Participants who have satisfactory response to any of the tablets or penile injections, will be excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 years and over
* History of ED for at least 6 months
* IIEF score \<26
* Failure to achieve an adequate response to the maximum recommended therapeutic dose of an approved ED treatments, when either of these treatments was used alone.

Exclusion Criteria:

* Concurrent treatment with nitrate-containing medications
* Significant cardiac, hepatic, renal or respiratory dysfunction
* Systolic blood pressure of less than 100mm Hg
* Myocardial infarction, serious cardiac arrhythmia, cardiac surgery, or stroke within the last 6 months
* Significant penile fibrosis, curvature or infection
* Reported significant side effects of using PDE5 inhibitors or alprostadil
* Hypersensitivity to PDE5 inhibitors or alprostadil