cyrilzakka/clinical-trials huggingface dataset:
RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM

The purpose of this research study is to find out what effects RAD001 has on angiomyolipomas of a person with Tuberous Sclerosis Complex and to determine the safe dose of RAD001 without toxicity.

The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly even cause regression.

Tuberous sclerosis complex is a genetic disorder with a birth incidence of approximately one in six thousand. Angiomyolipomas occur in eighty percent of persons with TS, and in up to 60% of persons with LAM. They are fatty tumors that often occur in kidney or liver as well as other parts of the body. They can grow and cause damage to surrounding kidney tissue and even renal failure. They may also leak blood causing potentially life-threatening hemorrhage.

Laboratory studies have shown that RAD001 suppresses the chemical that cause tumors to grow in tuberous sclerosis and sporadic LAM.

The primary goal of this study is to evaluate the clinical effectiveness of RAD001 in a 24 month trial. Although the primary goal is to determine if the drug RAD001 has effects on angiomyolipomas, other diseases associated with tuberous sclerosis will be monitored too, specifically any change in involvement of your brain or lungs with tuberous sclerosis. The use of RAD001 to treat angiomyolipomas in tuberous sclerosis or sporadic LAM is considered experimental

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with angiomyolipomas and have either Tuberous Sclerosis Complex or lymphangioleiomyomatosis
* Angiomyolipoma one centimeter or greater in largest diameter
* Between the ages of 18 and 65 years old.
* If female, documentation of negative pregnancy test prior to enrollment and, where applicable, use of appropriate non-estrogen containing birth control contraceptive regimen while on study.
* Adequate renal function (creatinine \< 3 mg/dl)

Exclusion Criteria:

* Pregnant or lactating women
* Continuous requirement for supplemental oxygen
* Surgery within past 2 months
* Use of an investigational drug within last 30 days.
The Effect of Carer Training on Pressure Ulcers in Palliative Patients

The aim of this article is to examine the effect of the training of carers caring for palliative care patients on the prevention and management of pressure ulcers. In this context, how the training affects the level of knowledge and practices of the carers will be evaluated. The findings obtained will contribute to improving the quality of patient care by providing strategic recommendations for the improvement of palliative care services.

Palliative care is an approach that improves the quality of life of patients and their families facing problems related to life-threatening diseases. This care model focuses on meeting the physical, psychological, social and spiritual needs of patients. . Pressure ulcers are one of the most common and serious problems in palliative care. Pressure ulcers are injuries occurring on the skin or soft tissue. They develop due to pressure on certain parts of the body over a long period of time. If not treated immediately, they may cause fatal complications. Pressure ulcers affect more than 1 in 10 adult patients admitted to hospital and are highly preventable.

Most palliative care patients cannot provide self-care. Therefore, caregivers are one of the most important determinants of the patient's health status. At this point, the knowledge and skill levels of carers who provide direct care to patients are of great importance. Increasing the level of knowledge and awareness of caregivers to prevent pressure ulcers is a critical strategy to prevent the formation of these wounds and to accelerate the healing of existing wounds. In a systematic review of thirty-one articles, it was stated that pressure ulcers significantly limit many aspects of an individual's well-being, including mental and physical health and quality of life. Therefore, caregivers should have adequate knowledge about practices to prevent bedsores.

The aim of this article is to examine the effect of the training of carers caring for palliative care patients on the prevention and management of pressure ulcers. In this context, how the training affects the level of knowledge and practices of the carers will be evaluated. The findings obtained will contribute to improving the quality of patient care by providing strategic recommendations for the improvement of palliative care services.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Being the sole informal caregiver of the palliative care patient
* Being able to use physical abilities such as sight and hearing
* No cognitive and communication problems

Exclusion Criteria:

* Palliative care patient is not the only informal caregiver
* Cognitive and communication problems
Hip External Rotation Physical Therapy Trial

This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.

The study interventions used in the feasibility study will be training of (1) Hip Extension Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.

Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy practice for the treatment of stress urinary incontinence (SUI) despite little evidence compared to the proven effective standard of care treatment, pelvic floor muscle (PFM) exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise alone or in combination with PFM is more or less effective than PFM exercises alone.

Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.

Interventions: The interventions used in the feasibility study will be training of (1) HER exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.

Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention.

Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training, appropriateness of outcome measures and completion rates. The design of the proposed RCT will be based on these feasibility outcomes.

Outcome measures for the proposed RCT will include pelvic floor muscle strength, external hip rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of life, and (to test patient mobility) six minute walk test and timed up and go test.

Sample size: The proposed sample size is 30 participants. Duration of study: After recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at the end of that period, and a further follow up at 24 weeks from recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence
* Attending Lois Hole Hospital for Women Urogynecology Clinic
* Referred for physiotherapy for stress urinary incontinence
* Able to toilet independently
* Able to undertake hip rotation exercises
* Able to speak and read English

Exclusion Criteria:

* Urge urinary incontinence
* Using a pessary
* Neurological or cognitive impairment
* Using other treatment for incontinence
* Unable to complete study forms
* Unable to understand educational instruction
Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer

Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.

Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.

Eligibility Criteria:
Inclusion Criteria:

* 50-75 years old people;
* People sign an "informed consent form"

Exclusion Criteria:

* People with history of colorectal surgery;
* People with history of colorectal cancer;
* People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract;
* People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool;
* People are in pregnancy, lactation or menstrual phase;
* People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns

Evaluation of PMMA pediatric crowns

The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:

I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to zirconia crowns and stainless steel crowns after 6 months, and 12 months.

II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.

III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's satisfaction regarding the appearance and clinical performance of PMMA crowns when compared to stainless steel crowns and zirconia crowns through a given questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Children included in the study should conform to the following criteria:

  1. Aged 5-8 years old
  2. Medically free
  3. Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
  4. The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.

     Exclusion Criteria:

     Children with the following criteria will be totally excluded from the study:

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  1. Children who are extremely uncooperative and difficult to manage.
  2. Children suffering from any medical conditions that can't be managed in the clinic.
  3. Teeth with decay extending beneath the free gingival margin.
  4. Teeth that were grossly broken down, that cannot be restored.
  5. Presence of uncontrolled bleeding.
  6. Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.
Korean Regulatory Post Marketing Surveillance for Somavert

Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)


Eligibility Criteria:
Inclusion Criteria:

All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.

Exclusion Criteria:

Patients who are contraindicated for Somavert
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries

The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-55
* Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C)
* Definitively treated with a plate
* Ambulatory prior to injury
* Able to participate in rehab starting 28 days after definitive fixation
* Meets AlterG requirements (4'8- 6'4; 85-400lbs)

Exclusion Criteria:

* Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.)
* Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility
* Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device
* Pregnancy
* Unable to speak English
* Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
* Unable to provide informed consent.
Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRLSHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

The goal of this pilot project is to assess adherence with home blood pressure monitoring in hypertensive patients with a history of cerebral infarction and to determine if a social incentive improves adherence with monitoring. Enrolled subjects will all have a history of cerebral infarction and uncontrolled blood pressure, defined by SBP\>140 or DBP\>90 mm Hg at the time of enrollment. To be eligible subjects will also be required to own a smart phone (iOS or Android operating system). After enrollment, patients will be given a home blood pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be randomly assigned to a social incentive program, in which a social supporter receives updates via email and/or text message on the subject's adherence with BP monitoring and their average blood pressure. This study will provide important pilot data which will inform the design of future studies utilizing connected health and automated systems to improve home blood pressure monitoring and blood pressure control in patients with a history of stroke.


Eligibility Criteria:
Inclusion Criteria:

* Adult, age ≥ 18 years
* History of ischemic stroke or high risk TIA (defined by ABCD2 ≥ 4)between 2 weeks and 12 months prior to enrollment
* Hypertensive at time of enrollment, defined by SBP\>140 mm Hg or DBP \>90 mm Hg at the time of study screening
* Must own a smart phone capable of interacting with the connected blood pressure cuff (Apple iPhone 3GS or higher; Android 4.0 or higher with Bluetooth connectivity)
* Willingness and ability to sign informed consent by patient

Exclusion Criteria:

* Moderate or severe disability, defined by modified Rankin Scale ≥ 3.
* Expected residence in a rehabilitation hospital, nursing facility or assisted living community during the study period.
* Upper arm circumference \<9 inches or \>17 inches
* Inability to monitor BP in both of the upper arms (i.e. history of bilateral radical mastectomy, bilateral severe subclavian stenosis, or bilateral arterial venous fistulas for dialysis).
* Blood pressure discrepancy between arms of \>10 mm Hg.
* Inability to follow-up at 90 days and return BP monitor
* Active participation in another clinical trial
* Pregnant women
Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.

Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.

The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.

Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge


Eligibility Criteria:
Inclusion Criteria:

* all patients with cancer hospitalized for an acute medical illness

Exclusion Criteria:

* current use of oral or parenteral anticoagulant treatment
* no informed consent to participate
Eye Diseases "Treated" with Interoperable Medical Informatics

The overarching goal of EyeMatics is to promote an interoperable, sustainable infrastructure for the integration and sharing of data from clinical research to improve personalized medicine in ophthalmology. To achieve this, EyeMatics bundles the expertise and preliminary work of the four consortia of the Medical Informatics Initiative (MII) and the ophthalmological centers of excellence in Germany. The perspective and concerns of patients will be strongly incorporated into the project work through close cooperation with patient representatives and the inclusion of patient feedback on quality of life and treatment success.

EyeMatics aims to improve the understanding of the therapeutic success of eye diseases that are usually treated with intravitreal surgical medication (IVOM). To this end, an exemplary analysis platform for "real" clinical data will be provided and a dashboard for data visualization and analysis will be developed as a web application. The dashboard is to be introduced at all participating hospital sites for research purposes.


Eligibility Criteria:
Inclusion Criteria:

* OPS code: "5-156.9 Injection of drugs into the posterior segment of the eye"
MR Evidence of Cardiac Inflammation Post-Stroke

The present study is an investigator initiated, single-centre, prospective, proof-of-concept cohort study aiming to enroll 44 patients with acute middle cerebral artery (MCA) ischemic stroke, involving the right (n=22) and left (n=22) MCA territories and 24 control patients with acute focal neurological symptoms but no evidence of acute brain infarct on DWI-MRI.

The present study is an investigator-initiated, single-center, prospective cohort study. The study aims to enroll 44 patients with acute/subacute middle cerebral artery (MCA) ischemic stroke. The investigators will compare inflammatory markers among 44 patients with MCA ischemic stroke within 10 days post-stroke vs. 60±15 days post-stroke. Other measures to be determined at both time points include B-Type Natriuretic Peptide and systemic inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

• Acute ischemic stroke in the right or left MCA territory. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on Head computed tomography or diffusion-weighted imaging (DWI) MRI of the brain showing restricted diffusion.

Exclusion Criteria:

* History of known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention.
* Previous stroke (occurred within 3 months before the index event)
* Impaired renal function defined as a creatinine clearance \<97 mL/min in men or \<88 mL/min in women, according to the Cockcroft formula.
* hs-TnT \>100 on routine acute stroke baseline bloodwork upon admission.
* Clinically or neurologically unstable patients as per the treating physician.
* Ongoing infection or recent infection within the previous 3 months
* Surgery within 3 months before the stroke
* Concurrent and active inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications
* Pregnancy, Stage IV renal insufficiency, eGFR \<30, and any other contraindications to the use of gadolinium.
* Stroke with symptomatic hemorrhagic transformation
* Subjects will be excluded if they fail the LHSC standard MRI screening questionnaire (cardiac pacemakers/wires, aneurysm clips, shunt/surgical clips, shrapnel/bullets, dentures or metal braces, intra-uterine devices, heart valves, ear implants, prostheses, medication patches such as Nicoderm, Habitrol, or Transderm-Nitro, claustrophobia, history of a head or eye injury involving metal fragments.
Physical Activity in IBS - a Long Term Follow up

Increased physical activity has in the investigators recent study been shown to improve symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term effects of the investigators previous intervention in IBS patients to improve physical activity. The investigators aimed to assess the long term effects on IBS symptoms as well as quality of life, fatigue, depression and anxiety.

86 patients who had been included in the investigators previous study "Physical Activity Improves Symptoms in Irritable Bowel Syndrome: A Randomized Controlled Trial" were contacted and asked to participate in a long term follow up 5 years after the previous study. The subjects attended one visit at which they underwent a bicycle ergometer test to calculate the oxygen uptake and filled out questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Baseline data from the previous study

Exclusion Criteria:

* pregnancy
* organic gastrointestinal disorders
* cardiac disease
* respiratory disease