cyrilzakka/clinical-trials huggingface dataset:
Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER): Pilot Study

The purpose of this study is to determine the feasibility and acceptability of delivering the KINDER intervention to family caregivers to persons living with dementia. Further, the investigators will examine the preliminary efficacy of the KINDER intervention at improving caregiver resourcefulness, relationship quality, and quality of care, including reduction of potential verbal-type elder mistreatment.

During this study, participants will be asked to complete two (2) 30- to 45-minute surveys asking about their demographic information, caregiving situations, and relationship with the care recipient. The first survey will be sent within two weeks of beginning the KINDER intervention, the second will be sent within one week after participants complete the KINDER intervention so we can compare outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Is age 18+
* Provides care to a family member or friend living with Alzheimer's Disease or a related dementia.
* Helps with at least 1 activity of daily living (e.g., bathing) or 2 instrumental activities of daily living (e.g., shopping)
* Provides at least 8 hours of assistance to the care recipient per week
* Does not intend to place the care recipient in a skilled nursing facility within 3 months of consenting into the study

Exclusion Criteria:

* Does not read and speak English
* Cannot reliably access a computer and internet
Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of tuberousclerosis Angiomyolipoma \>2cm age\>10 years

Exclusion Criteria:

Creatinine \>4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit\<27% Thrombocytopenia (\<100.000/mm3) Leukopenia (\<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(\>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides
Text4Peds: Short Message Service Evaluating Medical Student Education

In this study, third year medical students on the pediatric clerkship will be randomized to receive either only written educational material (review journal articles) or written educational material plus daily text messages consisting of board style questions with online answers. The students' performance on the National Board of Medical Examiners (NBME) Pediatric Subject Evaluation will be compared between the two groups.

In the last decade, the use of smartphone and text messaging (SMS) has increased significantly; during this time, text messaging has become the primary means of communication in some instances. Despite the popularity, text messaging and smartphones have been rarely utilized in the context of medical education. Few studies have been performed examining the effect of text messaging as an adjunct to traditional medical education. A previous study with the Saint Louis University (SLU) Pediatric Residency program, showed the feasibility of using text messaging to deliver medical information to pediatric residents through the Text4Peds program.

This study aims to expand Text4Peds to third NBME Pediatric Subject Evaluation performance. The NBME Pediatric Subject Evaluation is a national, standardized pediatric knowledge based exam from the NBME taken by all medical students at the end of their pediatric clerkship.

Eligibility Criteria:
Inclusion Criteria:

* Third year medical students on the Pediatric Clerkship at Saint Louis University School of Medicine

Exclusion Criteria:

* Third year medical students who did not have a mobile phone capable of receiving a short message service (SMS) text message
Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting (AcTi)

The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves.

Insufficient physical activity, hazardous use of alcohol, tobacco use and unhealthy eating habits increase the risk of cardiovascular diseases, cancer and type 2-diabetes. Health-promoting work reduces the disease risk and mortality and should thus be integrated in clinical care processes.

Despite support by the National guideline for prevention and treatment of unhealthy life-style habits, there is a chasm to bridge when integrating evidence into clinical practise. Prerequisites for changing work-ways are often underestimated and left to the individual co-workers to full fill on their own.

Too few patients are asked about life-style habits and too few receive evidence-based measures. The measures taken may also depend on sex, language, residence and caregiver's profession. The investigators strive to support the implementation of a health-promoting way of working that includes self-reporting of life-style habits before a visit and that takes measures for those with at least one unhealthy lifestyle habit.

The aim is to identify effective implementation strategies for health-promoting efforts in the primary care. The perceptions of barriers and opportunities when changing way of working from the target groups (leaders, co-workers, patients) will be used to enhance the possibility of successful implementation. Strategies are enhanced by theories of leading change. External and internal facilitators support the implementation.

The study will evaluate the effects and the implementation process at the level of leaders, patients, co-workers and organisation.

The project provides generalizable knowledge on strategies to overcome the gap between evidence and praxis, contributing to utilize an existing synthesized knowledgebase regarding health-promoting and preventative workways in a Swedish primary care setting.

It is central for the health care system to identify successful implementation strategies in order to manage their future mission.

Eligibility Criteria:
Inclusion Criteria for co-workers:

* being a caregiver meeting patients and/or
* being assigned a role as internal facilitator in the project

Inclusion criteria for patients filling in the study specific questionnaire:

* 18 years or older
* visiting primary care units a specific time pre- or post implementation support

Inclusion criteria for personcentered processmapping:

\* : having one or more unhealthy life-style habit 18 years or older
A Study, Called UV Population, to Learn More About the Safety of the Study Drug Ultravist, Which is Given to Get Clearer X-ray Pictures, in People of Different Sexes, Races, and From Different Countries/Regions

This is an observational study in which patient data from the past of people who received Ultravist prior to an X-ray based scan are studied.

In observational studies, only observations are made without specified advice or interventions.

X-ray based imaging like computed tomography or angiography is used to make pictures of the structures inside the body. These pictures are needed in various medical situations. In some X-ray tests, the patient is given a compound called "contrast agent" that is injected into the vein. It helps to create clearer pictures as it makes internal body structures easier to see. With such contrast-enhanced imaging techniques, doctors can better see certain problems.

Ultravist is an iodine-based contrast agent. It is also called iopromide, and it is available for doctors to give patients before they have X-ray based scans.

Clinical studies on the overall safety of Ultravist have shown that hypersensitivity reactions (HSRs) may rarely occur. HSRs are undesirable reactions of the body's defense system (immune system) to the study drug. However, more information on HSRs is needed.

The main aim of this study is to find out whether certain groups of people are more likely to have HSRs after Ultravist injection than others (e.g., depending on gender, race, or country/region).

To do this, researchers will collect data from people with HSRs (all ages) after contrast-enhanced X-ray scans with Ultravist. These data come from four observational studies that have already been completed. Participants who had HSRs will be compared with participants in these studies who had no medical problems after receiving Ultravist to learn more about the characteristics of people at higher risk.

Data will be from the year 1999 up to 2011. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all age groups which were referred to any iodine-based contrast-enhanced procedure after administration of either Ultravist 300 mg I/mL or 370 mg I/mL.
The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study

This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.

Many patients on hemodialysis treatment require hemodialysis, which requires hospitalization three times a week for four hours each dialysis session. Therefore, practices such as color therapy may be useful in the management of psychological symptoms in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Be on hemodialysis treatment for at least 6 months,
* No sleeping pills or sedative medication,
* No physical or cognitive impairment that prevents them from understanding the education and no diagnosis of a psychiatric illness,
* The patient or someone living in the same household with the patient is literate,
* Patients have no vision problems,
* Patients must be 18 years of age or older.

Exclusion Criteria:

* Being on hemodialysis treatment for less than 6 months,
* Taking sleeping pills or sedative medication,
* Being diagnosed with a physical illness or cognitive impairment or psychiatric illness that prevents understanding the education provided,
* Illiteracy of the patient and relatives,
* Patients have vision problems,
* Refusing to participate in the research,
* Under 18 years of age
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age
* Patients with HBeAg-negative chronic hepatitis B
* Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
* Serum HBV DNA levels ≥ 2,000 IU/mL at screening
* Increased alanine aminotransferase (ALT) levels \[greater than the upper limit of normal (ULN) and less than 10xULN}
* No signs or symptoms of advanced liver disease
* Patient has had a liver biopsy within 1 year of screening

Exclusion Criteria:

* Patient had previous treatment with IFN, peg-IFN, and/or entecavir
* Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
* Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
* Patients with liver cancer
* Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
* Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir
* Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug
Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.

Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Eligibility Criteria:
Inclusion Criteria:

1. 6-13 years old;
2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
3. Monocular best corrected visual acuity (VA) of 1.0 or better;
4. Acceptance of random group allocation and the masked study design
5. Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion Criteria:

1. Strabismus.
2. Ocular and systemic abnormalities.
3. Prior experience of myopia control.
4. Only one eye meets the inclusion criteria.
A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome

This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the medial branch nerves of the lumbar facet joint is effective for the treatment of low back pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that the brain does not receive the message that the low back is in pain. This technique is commonly performed by burning these nerves rather freezing them, but it is suspected that freezing them results in better pain relief. The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation.
* Low back pain for at least 6 months.
* Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care.
* Pain diagram suggesting possibility of facet-mediated pain.
* Referred pain when present not beyond the knee.
* Positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as \> 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).

Exclusion Criteria:

* Focal neurologic signs or symptoms.
* Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
* Previous radiofrequency ablation treatment for similar symptoms.
* Patient refusal.
* Lack of consent.
* Active systemic or local infections at the site of proposed needle and electrode placement.
* Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
* Allergy to medications being used for injection procedures (contrast dye, local anesthetic, IV sedative).
* Inability to read English, communicate with staff, or participate in follow up.
* Pregnancy.
* Cognitive deficit.
* Negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as \< 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).
* Daily opiate analgesic use more exceeding 3 months prior to study inclusion.
* Unstable medical or psychiatric illness.
Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism

To clarify the effectiveness and safety of the direct factor Xa inhibitor rivaroxaban in domestic clinical use for patients with deep vein thrombosis and pulmonary embolism

Research design: multicenter collaboration, prospective, non-interventional, observational research

Research outline:

Registration period: Dec 2016 (after ethics committee approval) to May 2018 (1 year and 6 months) Investigation period: Dec 2016 (after ethics committee approval) to Nov 2019 (At least 1 year and 6 months) Target number of participants: 1,000 participants Estimated number of participating institutions: 150 medical institutions Research secretariat: Mebix, Inc.

Research procedure:

* Perform patient registration within 3 weeks of first prescription
* Also record when the drug was discontinued for any reason, such as an event or bleeding etc, between the time of first prescription and registration
* Track progress as much as possible until the end of the study period, regardless of continuation or discontinuation of study drug administration, and also in cases where there is manifestation of efficacy or safety events
* Track progress of all cases as much as possible until the end of the study period, regardless of continuation, discontinuation or termination of study drug administration. Patients transferred to the hospital are managed in the same way.

Registration method:

Register case information in the WEB registration system (EDC) after obtaining written consent from the research participant him/herself or the legal guardian for all cases compliant with the registration criteria and not in conflict with the exclusion criteria. Administer rivaroxaban in compliance with the approved dosage in the separate attached document. Furthermore, when the usage or dose are adjusted at the discretion of the research doctor, record the dose adjustment and reason. EDC will be used for case data entry.

\[EDC; Items to be entered into the case registration screen\]

1. Registration date
2. Facility name
3. Case registration number
4. Patient identification code (appropriate number within the facility)
5. Gender
6. Birthdate
7. Rivaroxaban commencement date
8. Age at first prescription (automatic calculation display)
9. Date of obtaining written consent
10. Other

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban

Exclusion Criteria:

1. Contraindication to rivaroxaban
2. Chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis)
3. Active bleeding
4. Patients determined to be inappropriate for the study by the attending doctor
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.

Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Primary Sclerosing Cholangitis (ALPINE-PSC)

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to give informed consent
2. Confirmed diagnosis of PSC based on either:

   1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
   2. Liver biopsy consistent with PSC
3. LSM by VCTE, indicative of at least F2 liver fibrosis stage
4. Laboratory parameters:

   1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
   2. ALT and ALT \<5x ULN
   3. MELD score ≤12

Exclusion Criteria:

1. Clinically significant acute or chronic liver disease of an etiology other than PSC
2. Alternate causes of sclerosing cholangitis including IgG4 related sclerosing cholangitis
3. Subjects with moderate to severe hepatic impairment
4. Subjects with moderate to severe renal impairment
5. Placement of bile duct stent or percutaneous bile duct drain within 12 weeks of Screening
Lesion Dosimetry with Iodine-124 in Metastatic Thyroid Carcinoma

The purpose of this study is to evaluate a new diagnostic imaging test, positron emission tomography (PET), with a different radioactive form of iodine called iodine-124. This form is able to accurately measure the amount of radioactive iodine uptake in the cancer. If the new test determines sufficient radioiodine uptake in the cancer, treatment will continue as usual. However, if the new test shows only low radioiodine uptake, a decision may be made that the benefit from radioiodine therapy is insufficient and that another form of therapy is preferred.


Eligibility Criteria:
Inclusion Criteria:

* Adults with thyroid carcinoma confirmed by pathology.
* Adult thyroid carcinoma patients who have undergone total thyroidectomy
* Adult thyroid carcinoma patients have metastatic disease or suspicion for metastatic disease, or are under a protocol intended to explore re-induction therapy for 131I uptake, and are about to undergo Thyrogen-assisted dosimetry, unless Thyrogen-assisted dosimetry is not required per standard of care.
* The patient and physician are planning to administer 131I for therapy if persistent radioiodine-avid metastases are present.
* All subjects must have measurable disease, documented within the previous six months by ultrasonography (US), MRI, FDG PET/CT, or CT scanning.

Exclusion Criteria:

* Age less than 18 years.
* Patients who are pregnant.
Placenta Development Study

This study will help us learn more about how the placenta develops.

The primary purpose of this study is to understand the epigenetic signaling events in placental trophoblast development.

Eligibility Criteria:
Inclusion Criteria:

* BMI - 18-25 kg/m2
* at least 18 years of age
* singleton pregnancy
* less than 36 weeks and plan to deliver in the Little Rock/North Little Rock Area

Exclusion Criteria:

* Women with pre-existing medical conditions (e.g. diabetes, hypertension, pre-eclampsia, STD, gestational diabetes)
* Women who are using recreational drugs, tobacco, or alcohol during their pregnancy.
* Women who plan on keeping their placenta following delivery for non-medical reasons.
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

Eligibility Criteria:
Inclusion Criteria:

Subjects are required to meet the following inclusion criteria:

* Community-acquired pneumonia
* initial hospitalization, or treatment in an emergency room or urgent care setting
* infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

* CAP suitable for outpatient therapy with an oral antimicrobial agent
* respiratory tract infections not due to community-acquired bacterial
* Non-infectious causes of pulmonary infiltrates
* Pleural empyema
* Infection with an atypical organism
* History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
* History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide