cyrilzakka/clinical-trials huggingface dataset:
Brain and Abdominal Aneurysm Study

Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year, 40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die do so before reaching the hospital. Most commonly, SAH results from rupture of an intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills 13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic aneurysm rupture but a high proportion of those who die did not have a diagnosis of aortic aneurysm prior to rupture.

The relationship between intracranial and aortic aneurysm has long been recognized, but poorly quantified. Recent genome-wide association studies (GWAS) provide a molecular biological evidence for a shared pathophysiology. The chromosome 9p21 locus confers increased risk for both intracranial aneurysms and aortic aneurysms. These GWAS data, along with linkage data for other susceptibility loci, indicate that individuals and families harboring one type of aneurysm may be at especially increased risk of the other.

The rationale for this project is that opportunistic screening for abdominal aortic aneurysms (AAA) may be warranted in patients who present with aneurysmal subarachnoid hemorrhage. This study is meant to see if the yield of screening in this population is too low to justify its routine use. The investigators plan to systematically screen for AAA in all cases of aSAH presenting to MCH for treatment. If no individual out of 81 consecutively screened cases of aSAH has evidence of AAA, then the investigators can have strong confidence that there is a less than 5% chance of finding an AAA in the patient population.


Eligibility Criteria:
1. Men and women age ≥ 18 years.
2. Diagnosis of intracranial aneurysm secured by magnetic resonance angiography (MRA), computed tomographic angiography (CTA), or catheter-based cerebral angiography.
3. Diagnosis of subarachnoid hemorrhage diagnosed by head CT, brain MRI or lumbar puncture.
4. Provides written informed consent.
5. No know diagnosis of aortic aneurysm
6. No history of prior screening for aortic aneurysm
7. No condition like recent abdominal surgical scar that would preclude abdominal ultrasonography
8. No therapy like abdominal hypothermia pads that would preclude abdominal ultrasonography
Evaluation Study of the Online High School Media Aware Program

The main aim of this study is to conduct a pretest-posttest RCT with a three-month follow-up to investigate the sustainability of outcomes in students who use the Media Aware program. Media Aware, a web-based media literacy education program for high school students to promote sexual and relationship health. Media Aware is designed to provide high school students with sexual health knowledge, media literacy skills, and the skills to make healthy decisions about sexual activity. This study will examine if behavioral indicators among students in the intervention group sustain, emerge, or diminish over time compared to students in the delayed intervention group.


Eligibility Criteria:
SCHOOL SITES:

Inclusion:

1. Schools must have students in 9th or 10th grade health education as this program is designed for use in these grades during health education classes.
2. Schools must agree to provide the Media Aware program during class periods as their sexual health education which means that an educator will facilitate the students taking the program.
3. Schools must have adequate technology for the students to use the web-based Media Aware program and complete the online questionnaires.
4. It must be feasible for iRT project staff members to travel to the school sites for the three data collection time points.

TEACHER PARTICIPANTS:

Inclusion:

1. Teacher's classrooms must have students in 9th or 10th grade as this program is designed for use in these grades.
2. Teachers must be able to ensure that participating students have computers and internet access during class periods as the program and questionnaires are web-based.

STUDENT PARTICIPANTS:

Inclusion:

1. Students must be in grades 9 or 10.
2. Students must be able to speak and read English because the study materials (e.g., questionnaires) are in English. However, parent permission and youth assent forms for the research study will be available in both English and Spanish.
3. Students must have appropriate parent permission to receive sexual health education per school districts' policy (i.e., opt-in policy or opt-out policy).
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?

The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.

Bupivacaine will be used for all the nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Undergoing two TKA
* Understanding PCA protocol

Exclusion Criteria:

* Skin infection near injection site
* Allergy to local analgesics
* Peripheral neuropathy
* Coagulopathy
* Dementia
* Proven opioid dependency
Pharmacokinetics and Safety Profile of CKD-333

Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Eligibility Criteria:
Inclusion Criteria:

1. Between 19 aged and 45 aged in healthy male adult
2. Body weight more than 50kg and within ideal body weight ±20%

Exclusion Criteria:

1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
2. Have a gastrointestinal disease history that can effect drug absorption or surgery
3. SBP(Systolic Blood pressure)≥140mmHg or SBP\<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP\<60mmHg
Dysthyroidism and Female Sexual Function

The aim of the study is to evaluate the incidence of sexual dysfunction in presence of dysthyroidism and the impact of restoring euthyroidism on female sexual function

Hormonal component plays a crucial role in sexual function. Hypothyroidism and hyperthyroidism may be associated with any form of sexual dysfunction in men but only a few studies reported the relationship between thyroid dysfunction and female sexuality.

The study is an observational study. An informed consent will be obtained from all patients before the study.

The aim of the study is:

* to evaluate the incidence of sexual dysfunction in presence of dysthyroidism and the impact of restoring euthyroidism on female sexual function (evaluated with the Female Sexual Function Index)
* to evaluate the influence of hormonal changes on the emotional and psychological wellness (evalueted with the Middle Sex Hospital Questionnaire)
* to evaluate the influence of hormonal changes on the satisfaction of body image (evalueted with the Body Uneasiness Test)
* to evaluate the influence of hormonal changes on the distress related to sexuality (evaluated with the Female Sexual Distress Scale).

The investigators espect to enroll a total of 50 sexually active hyperthyroidic/hypothyroidic women in this study in about 7 months. Statistical analyses will be performed using the Statistical Package for the Social Sciences

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* hyperthyroidic or hypothyroiditic women
* sexually active women

Exclusion Criteria:

* age \< 18 Y
* no sexual activity
* pregnancy
* psychiatric disease
Bone Graft Materials Observational Registry

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.


Eligibility Criteria:
Inclusion Criteria:

* The patient has failed conservative treatment and is a candidate for spinal fusion surgery.
* The patient is ≥18 years old and of legal age of consent.
* The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
* The patient is skeletally mature (epiphyses closed).
* The patient has signed the IRB approved informed consent.
* The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.

Exclusion Criteria:

* Patient has systemic infection or infection at the surgical site.
* Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
* Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
* Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
* The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
* Patient is participating in another investigational study, which could confound results.
V-Flex Plus PTX Drug Eluting Coronary Stent

The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
* Patient must be an acceptable candidate for coronary artery bypass surgery
* Patient or legal guardian must have given informed consent
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.

Exclusion Criteria:

* Patient must be less than 18 years old
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
* Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
* Women of child bearing potential.
* Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting

The purpose of this research is to compare two healthy diet styles during pregnancy. Sixty pregnant women between 8 and 16 weeks will participate. Participates will be randomly assigned (like flipping a coin) to either receive routine healthy diet advice and counseling, or to receive advice and counseling for the Mediterranean style diet. Our current routine healthy diet program follows the recommendations provided by the American College of Obstetricians and Gynecologists (ACOG). It recommends the consumption of grains, fruits, vegetables, protein foods, and dairy foods during pregnancy. The Mediterranean diet (MedDiet) is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with olive oil as the principal source of fat. Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally. Throughout their pregnancy, participants will receive free food and be assessed to determine how will they are following to the diet plan they were randomized to.

The Mediterranean diet (MedDiet) is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with extra virgin olive oil (EVOO) as the principal source of fat. Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally. A growing body of evidence demonstrates that outside of pregnancy, the MedDiet is associated with a reduction of cardiovascular disease, diabetes, metabolic syndrome, and certain cancers. However, the potential clinical benefits of MedDiet in pregnancy are understudied with most data originating from clinical trials in Europe. Proper nutrition during pregnancy has multiple health benefits. A mother eating a healthy diet has a higher probability of meeting the demands required for a normal fetal development. In addition, she is more likely to achieve the recommended gestational weight gain thereby reducing the risk of pregnancy-related complications. Finally, a healthy diet is associated with a reduction of chronic conditions such as cardiovascular disease and diabetes later in life for both the mother and the infant.

Eligibility Criteria:
Inclusion Criteria:

* Viable singleton pregnancy in the first trimester (6 0/7- 16 6/7 weeks); includes twins reduced to singleton spontaneously or vanishing twin syndrome
* BMI ≥ 25.0 kg/m2; calculated by dividing maternal weight in kilograms by height in meters squared using a calibrated scale and standard metric measure
* Confirmed intrauterine pregnancy by ultrasound exam (6-16 weeks)
* Age 18 years or older
* Primary language of English or Spanish

Exclusion Criteria:

* BMI \< 25.0 kg/m2
* Known pre-pregnancy diabetes
* Hemoglobin glycosylated (A1C) \> 5.7% at first prenatal visit
* Pre-pregnancy hypertensive disease
* Non-viable pregnancy
* Known allergies to an essential component(s) of MedDiet
* Inability to read or write in primary language
* Mental incapacity to make medical decisions
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy status
* Body weight: ≥45kg
* BMI: 18-34 kg/m2

Key Exclusion Criteria:

* History or presence of any clinically significant disease of any major system organ class.
* Heavy smoker status
* History /presence of clinically significant neurological or psychiatric disorders
* Any medical condition that might lead to or is associated with any cognitive deficit
* History or presence of severely impaired renal function
Randomized Trial of Preoperative Diets Before Bariatric Surgery

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

Morbid obesity, defined as a body mass index (BMI) of \> 40 kg/m² or \> 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of \> 40 kg/m² and another 10 million people have a BMI of \> 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities.

In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

Eligibility Criteria:
Inclusion Criteria:

* morbid obesity according to IFSO criteria

Exclusion Criteria:

* previous bariatric or gastric surgery
* severe psychiatric disorders
Compliance and Contamination in Soft Contact Lens Wearers

The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.

The purpose of this study is to assess the lens and lens case microbial colonization associated marketed care solutions used by experienced soft lens wearers.

Eligibility Criteria:
Inclusion Criteria:

* Successful contact lens wear on a daily wear basis
* Normal Eyes

Exclusion Criteria:

* Topical ocular medication use
* No active ocular issues
Pain Modulatory Profiles in Massage for Individuals With Neck Pain

One in ten adults experience widespread pain. Neck pain, for example, is a prevalent condition with a high rate of recurrence that affects between 10.4% and 21.3% of the population annually.

Massage is a common manual therapy intervention for individuals with musculoskeletal pain. However, the mechanisms of massage are not well established. Also, the conditioned pain modulation (CPM) paradigm is a dynamic quantitative sensory testing measure of a pain inhibitory process in which pain sensitivity is lessened in response to a remotely applied painful stimulus.

This study will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm in participants with a history of neck pain.

Conditioned pain modulation (CPM) is the physical manifestation of the diffuse noxious inhibitory control (DNIC), an endogenous pain inhibitory pathway in which pain inhibits pain. Conditioned pain modulation is less efficient in individuals with chronic pain conditions and it is a predictor for the development of chronic pain.

Massage is a common manual therapy intervention for individuals with musculoskeletal pain. Greater changes in pain sensitivity occur following pain inducing massage suggesting a mechanism dependent upon the efficiency of the conditioned pain modulation response. Previous research has indicated pain inducing massage is more effective than pain free massage suggesting a mechanism dependent upon conditioned pain modulation.

The study team will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or a coldpressor task. Pre-and post intervention pain will be assessed. The study team will determine if analgesia induced by pain inducing massage is similar to the conditioned pain modulation paradigm and if baseline conditioned pain modulation predicts responders to pain inducing massage and short term clinical outcomes in patients with a history of neck pain.

Eligibility Criteria:
Inclusion Criteria:

* currently experiencing neck pain with or without arm pain
* neck pain symptom intensity rated as 4/10 or higher during the last 24 hours
* neck pain for greater than or equal to 3 months

Exclusion Criteria:

* non-English speaking
* systemic medical conditions known to affect sensation (e.g. diabetes, hypertension)
* history of neck surgery or fracture within the past 6 months
* current history of chronic pain condition other than neck pain
* diagnosis of cervical radiculopathy or cervical myelopathy
* history of whiplash; g) currently using blood thinning medication
* any blood clotting disorder such as hemophilia
* any contraindication to application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.
Forecasting ED Overcrowding With Statistical Methods: A Prospective Validation Study

The aim of this study is to prospectively validate statistical forecasting tools that have been widely used retrospectively in forecasting ED overcrowding

Emergency department (ED) overcrowding is a chronic international issue that has been repeatedly associated with detrimental treatment outcomes such increased 10-day-mortality. Forecasting future overcrowding would enable pre-emptive staffing decisions that could alleviate or prevent overcrowding along with its detrimental effects.

Over the years, several predictive algorithms have been proposed ranging from generalized linear models to state space models and, more recently, deep learning algorithms. However, the performance of these algorithms has only been reported retrospectively and the clinically significant accuracy of these algorithms remains unclear.

In this study the investigators aim to investigate the accuracy of the previously reported ED forecasting algorithms in a prospective setting analogous to the way these tools would be used if used implemented as a decision-support system in a real-life clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting in the Emergency Department

Exclusion Criteria:

* No exclusion criteria
Dyslipidemia Management in Chinese Post Stroke Patients

The purpose of this study is to provide current and reliable data of dyslipidimia management together with control situation of blood pressure and glucose for post-stroke patients within 6-12 months from attack, and also the association between patient characteristics and control rate of lipids in this population.

It is an non-interventional study, no study specified treatment is required.Approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. Fifty centres from different regions of China will participate in this study.

This is a multicentre, cross-sectional, observational study, aiming to investigate the prevalence and control situation of dyslipidimia in China post ischemic stroke patients within 6-12 months from attack. Patients will be screened consecutively, eligible subjects will be interviewed by investigator and finish a questionire during the visit. Investigator will collect relevant medical history, physical exam results and lab test results including blood lipid (i.e. Triglyceride, Total Cholesterol, LDL-C, HDL-C) and glucose(HbA1c if available).Approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. Fifty centres from different regions of China will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female with age ≥ 18 years
2. Post ischemic stroke patients within 6-12 months from attack
3. written informed consent is provided to participant in the study

Exclusion Criteria:

1. Significant medical or psychological condition that make patients can not finish the questionnaire independently or with the aids of his/her legal representatives
2. The patient is or will be in another clinical study
3. Previous enrolment in the present study