cyrilzakka/clinical-trials huggingface dataset:
The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults

This is a multicenter cross-sectional study on the prevalence of Irritable Bowel Syndrome and the risk factors associated with it. The Rome IV criteria is used for diagnosing IBS. A questionnaire-guided interview will be applied to all subjects.

: Irritable Bowel Syndrome (IBS) is a common functional bowel disorder characterized by abdominal pain or discomfort associated with defecation or an altered bowel habit. IBS can be divided into four subtypes according to the predominant bowel pattern: diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), and both diarrhea and constipation (IBS-M), and when a stool pattern cannot be categorized under any of the above three patterns (IBS-U).

For clinicians, diagnosis of IBS can be challenging because symptoms can be variable over time, and what makes it a real challenge is the absence of a gold diagnostic standard for this syndrome. That is why experts developed the Rome criteria in 2006, which is constantly revised. The latest update of these criteria was published in 2016 as Rome IV.

Unfortunately, studies have indicated higher rates of psychological comorbidity including suicidal ideation and depression among IBS patients, and a significant reduction in health-related quality of life, this negatively affects the productivity of the individual in society. Epidemiological studies of this syndrome have indicated a greater prevalence among women than men, and adolescents among other age groups.

However, despite these attempts by researchers to determine the prevalence patterns and risk factors for this syndrome, many of them are still not sufficiently defined. Hence, our study came to determine the prevalence and risk factors of Irritable Bowel Syndrome among adults.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study

Exclusion Criteria:

* Poorly-controlled hyperthyroidism
* Poorly-controlled hypothyroidism
* Poorly-controlled hyperparathyroidism
* Liver disease
* Paralysis
* Parasitic diseases (worms ...)
* Celiac disease
* Inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
* Lactose intolerance
* Cancer or tumor in the digestive tract
Laparoscopic Versus Open Appendectomy? Let the Patient Decide

This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.

Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.

The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* age 18 or older
* imaging positive for perforation; ultrasound or CT scan
* pain for greater than 2 days
* children with a body mass index \> 95% for age and sex
* surgeon decision for non-equivalent procedure based on patient presentation
Radiation Dose From Computed Tomography Before and After Implementation of a High Pitch Dual Spiral Technique

The purpose of this study is to compare the radiation exposure of a variety of chest CT examinations performed on the current state of the art CT scanners (64 slice, dual source CT scanner) with the radiation exposure for identical chest CT examinations performed on the Siemens Flash CT scanner (high pitch dual source spiral technique).

Computed tomography has emerged as the "gold standard" for the diagnosis of a broad range of medical diagnoses. For cardiac imaging alone, the installation of CT scanners in US cardiology practices alone has tripled over the past 2 years. Patients who undergo cardiac CTA (computed tomography angiography) may be subjected to relatively high doses of ionizing radiation (ie. 4 times annual background radiation) during the diagnosis and management of coronary artery disease. Current radiation doses for cardiac CT examinations are comparable to the effective doses for patients undergoing nuclear stress tests or cardiac catheterization (ie. approximately 10-15 milliSieverts). In addition, non cardiac CT protocols, such as chest CT examinations for the evaluation of pulmonary arteries, thoracic and abdominal aorta, and lung nodules, are associated with significant radiation exposure. Many patients undergo repeated CT examinations over several years for such pathology. There is a growing public concern regarding the cancer risk associated with such radiation.

Recent major technological advances have been made with the advent of newer generation CT scanners which allow significant radiation dose reduction. One such scanner, the dual source CT, is a new high pitch dual source spiral technique that offers the ability to image a patient's chest with ECG gated imaging protocols within a single second. These technological advances allow significant radiation dose savings, often resulting in effective radiation doses of less than one millisievert (mSv).

Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo chest CT examinations (including cardiac CTA, and non cardiac CT examinations including pulmonary embolism, lung nodule and aortic pathology protocols)
Troponin Elevation in the Elderly Patient With Hip Fracture

Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS. However, non specific (non cardiac) troponin elevation is a common finding among hospitalized patients and worse prognosis too.

The aim of this study is examine the prevalence of incidental cardiac troponin rise in a group of patient aged 65 and over admitted to geriatric department with hip fracture, and influence of troponin elevation on outcomes like ACS, death, motor and cognitive function.

data collection will include epidemiological data (age, gender, living arrangement, basic functional status, fracture date, surgery date, surgery type, length of stay) as well as previous comorbidities. in addition, routine blood tests and baseline ECG will be recorded.

troponin levels will be studied within 24 hours from admission, and 24 hours following surgery. in case of elevated troponin levels, ECG will be repeated, and echocardiography together with a cardiologist evaluation will be carried out.

data regarding in-hospital complications, motor and cognitive function (by FIM scale) and lab will be recorded. after discharge. followup will be recorded every 3 months, up to 1 year period, recoding the above mentioned data.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and over with hip fracture

Exclusion Criteria:

* None
Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)

Objectives: An investigator-initiated, double-blind, randomized, placebo-controlled, multi-center study to evaluate the efficacy of early intensive rosuvastatin therapy (rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter) versus low dose conventional statin therapy (placebo for pre-PCI loading and rosuvastatin 10 mg daily after primary PCI) on infarct size measured by cardiac MRI and clinical outcomes in STEMI patients undergoing primary percutaneous coronary intervention (PCI). Hypothesis: The infarct size in the early high dose rosuvastatin group is smaller than that of the control patients treated with low does conventional statin therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patient had the symptoms of acute myocardial infarction within 12 hours with ST-segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
2. Male or female over 20 years of age
3. Signed written informed consent to participate in the study

Exclusion Criteria:

1. Congestive heart failure (NYHA Class III or IV) or LVEF \<35%.
2. Clinically significant heart disease requiring CABG, cardiac transplantation, surgical repair and/or replacement during the course of the study.
3. Previous MI or CABG
4. Known serious or hypersensitivity reactions to statin, antiplatelet agents (aspirin or clopidogrel), or heparin.
5. Known familial hypercholesterolemia
6. Known skeletal muscle disease
7. Known active liver disease such as hepatitis or liver cirrhosis (except for fatty liver)
8. Renal failure (Cr \>2.0 mg/dL)
9. Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism, and/or nephrotic syndrome
10. Non-cardiac comorbidity with a life expectation \< 1 year
11. Contraindications to CMRI (eg, implanted pacemaker or cardiac defibrillator, claustrophobia, etc.)
12. Pregnant or lactating women or women of childbearing potential
13. Participation in any investigational drug or device study within 30 days prior to study entry
Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice setting.

The secondary objectives of this study in this study population are as follows: to evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; to evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate)
* Naïve to dimethyl fumarate and fumaric acid esters

Key Exclusion Criteria:

* Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
* History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7 consecutive days of gastrointestinal-related symptomatic therapy
* Known active malignancies
* History of anaphylaxis or severe allergic reactions or known drug hypersensitivity
* Current use of B vitamin supplements
* In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.

* Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.
* The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.
* Reference standard: Biopsy or 1 year of follow-up examination.
* The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30 years or older screened with breast ultrasound without specific symptoms
* Women who underwent mammography within 3 months which showed no abnormality except for dense breast
* Women who had at least one breast mass of BI-RADS category 3 or higher.

Exclusion Criteria:

* Women with breast implants
* Women who are unwilling or unable to provide informed consent
* Lesions larger than 3 cm
* Lesions that are previously noted and followed-up in the same hospital
Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer

The researchers doing this study think that performing scans of the brain and testing cerebrospinal fluid (CSF) in people with HER2-positive breast cancer may be an effective way of identifying the early onset of CNS metastases (such as brain cancer). If the researchers can identify the early onset of CNS metastases, they can immediately treat that cancer and possibly prevent it from worsening. Currently, people with breast cancer don't usually have scans of the brain or CSF testing unless they are experiencing symptoms of CNS metastases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy (Cohort A Only)
* Patients with Stage II-III HER2+ breast cancer without CNS disease (Cohort B Only)
* Male and Female participants Age ≥18 years
* HER2+ as defined by ASCO/CAP guidelines\*
* Ability to undergo bedside Lumbar puncture to obtain cerebrospinal fluid; if beside LP is not successful due to patient discomfort or inability to obtain spinal fluid then patients will be offered LP through interventional radiology and patients will continue to be monitored on study
* Patients with breast implants and/or tissue expanders are eligible if they are able to safely undergo an MRI
* Able to provide written informed consent \*ASCO/CAP guidelines: HER2+ defined as IHC 3+ positive and/or by ISH average copy number ≥ 6 signals/cell

Exclusion Criteria:

* Patients who are unable to undergo MRI with gadolinium
* Patients with CNS Metastases on Screening MRI
* Patients with Positive Cytology on Screening Bedside lumbar puncture
A Study of XmAb®18087 in Subjects With NET and GIST

This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST.

The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion cohorts to collect additional data on safety and potential efficacy of XmAb18087.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed well differentiated low or intermediate grade (World Health Organization \[WHO\] Grade 1 or 2) NET of pancreatic, gastrointestinal, lung, or undetermined origin that is locally advanced or metastatic and has progressed within the past 12 months
* Histologically confirmed GIST that is locally advanced or metastatic
* NET and GIST tumors must be unresectable
* NET subjects must have progressed on or been ineligible for treatment with somatostatin analogues (SSA) and at least one other FDA-approved targeted therapy (everolimus or sunitinib).
* GIST subjects must have previously received all FDA-approved therapies (imatinib mesylate, sunitinib malate, and regorafenib) for which they are eligible
* Must have disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Diagnosis of high-grade (WHO Grade 3) or poorly differentiated NET; high-grade neuroendocrine carcinoma; large cell neuroendocrine carcinoma, small cell carcinoma, or mixed small and large cell carcinoma.
* Subjects currently receiving anti-cancer therapies (other than SSAs, which may continue).
* Subjects who have received anti-cancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, immunotherapy, etc.).
* Must not be experiencing a Grade 3 or 4 toxicity from previous anti-cancer treatment
* Must not be receiving other anti-cancer therapies (except somatostatin analogues, which may be allowed)
* Must not have poorly controlled diabetes mellitus, known central nervous system involvement by malignant disease or insufficient bone marrow, renal, or hepatic function
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration
3. Subjects who are undergoing colonoscopy for foreign body removal and decompression
4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
5. Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
6. Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.

The aim of this clinical study is to:

1. Found the new diagnostic markers or imaging sequences.
2. Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.


Eligibility Criteria:
Inclusion Criteria:

* According to the Bartley criteria，diagnosed TAO at our hospital after 2024/8/31
* Moderate to severe patients defined by EUGOGO
* CAS ≥3 (on the 7-item scale) for the study eye

Exclusion Criteria:

* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
* History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \&gt;1 g of methylprednisolone for the treatment of TAO.
* Any major illness/condition or evidence of an unstable clinical condition that, in the investigator\&#39;s judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant\&#39;s participation in the study
* Pregnant or lactating
* Any other condition that,would impair the ability of the participant to undergo orbital MRI
* Incomplete information