cyrilzakka/clinical-trials huggingface dataset:
Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients

The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are:

* Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program?
* How many patients will respond to a text message intervention to use the web app?

Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program.

Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.


Eligibility Criteria:
Inclusion Criteria:

* Have a phone number listed in the electronic health record
* Language preference of English in the electronic health record
* Have a scheduled primary care appointment within the next 15 days

Exclusion Criteria:

* Prior diagnosis of colorectal cancer
* Prior diagnosis of inflammatory bowel disease
* Have a record in the electronic health record of completing a colonoscopy within the last 10 years, a FIT-DNA test within the last 3 years, or a fecal immunochemical test (FIT) within the last 1 year
* Have an electronic Charlson Comorbidity Index \> 2
Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.

Phase I Primary Objective:

* Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan.

Phase II Primary Objective:

* Evaluate the response proportion and duration with Aroplatin/capecitabine therapy.

Phase II Secondary Objective:

* Evaluate the frequency of adverse events.

Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed colorectal cancer: unresectable local recurrence or distant metastases;
* Measurable disease (RECIST criteria);
* Refractory to 5-FU / leucovorin and irinotecan as described below;
* No prior therapy with oxaliplatin, any other platinum or capecitabine;
* ECOG score 0-2 (Karnofsky 100-70%);
* Life expectancy of greater then or equal to 5 months;
* Adequate hematopoietic, liver and renal function;
* Women of child-bearing potential have to practice adequate contraception;
* Signed written informed consent;
* Subjects must be willing to be followed during the course of treatment/observation and follow-up.

Refractory metastatic colorectal cancer

The following subjects are regarded refractory to treatment:

* Those with progression while receiving 5-FU/LV/irinotecan;
* Those with progression on irinotecan after prior 5-FU/LV treatment;
* Progression within six months of adjuvant 5-FU/LV/irinotecan;
* Progression within six months of adjuvant 5-FU/LV followed by progression on irinotecan

Subjects must have received at least one or more commonly used 5-FU/leucovorin and irinotecan regimens. Prior adjuvant therapy is allowed including 5-FU/leucovorin or other fluoropyrimidines except capecitabine and irinotecan.

Exclusion criteria:

* Previously diagnosed brain metastases if symptomatic and requiring active therapy;
* Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
* Concurrent chemotherapy or immunotherapy;
* Prior therapy for colorectal cancer within one month of admission to the present study;
* Primary or secondary immunodeficiency or use of corticosteroids or other immunosuppressive medication;
* Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study;
* Women must not be pregnant or breast-feeding;
* No participation in any clinical trial involving investigational drugs within 1 month from enrollment into the present study.
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female with age 18 - 75 years (inclusive).
2. Atopic dermatitis (AD) diagnosed at least half an year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

Exclusion Criteria:

1. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.).
2. History of exposure to active TB, and/or history or current evidence of TB infection.
3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.
RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER

Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To reduce this occurrence several studies have focused on the importance of support of the luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of OHSS (\<18 recovered oocytes) which performed GnRH trigger and rescue protocol.


Eligibility Criteria:
Inclusion Criteria:

AMH ( antimullerian hormone) \> 3.5 ng / ml, AFC (antral follicles count) \> 15 follicles and if more than 18 follicles with diam. 12mm to induction

Exclusion Criteria:

high risk of OHSS ( ovarian hyperstimulation syndrome)
Inhaled Heparin for Hospitalised COVID-19 Patients

This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies. Individual studies will be conducted in multiple countries, including Australia, the UK, the USA, Ireland, Argentina, Brazil and Egypt.

Adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, will be randomised to inhaled nebulised heparin or standard care for up to 21 days or until the patient has no respiratory symptoms. All studies will collect a minimum core dataset. The primary outcome for the meta-trial is the proportion of patients who receive invasive mechanical ventilation censored at day 28. Individual studies may have specific outcome measures in addition to the core set.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital with COVID-19
* No immediate requirement for mechanical ventilation (points 3-5 on the WHO ordinal scale)
* Age equal to or greater than 18
* Able to provide informed consent

Exclusion Criteria:

* Pregnant women
* Known allergy to Heparin
* Participant in another clinical trial that is not approved for joint enrollment.
* APTT\> 120 seconds, not due to anticoagulant therapy.
* Platelet count \<20 x 109 per L
* Lung bleeding.
* Uncontrolled bleeding
* Advanced neurological impairment
* Advanced oncological disease
Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa

Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).


Eligibility Criteria:
Inclusion Criteria:

* Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide
* Agreed to retrospective analysis and questionnaires

Exclusion Criteria:

* Non-compliance
Cognitive Function in Multiple Sclerosis

The aim of the study is to investigate the relationship between cognitive function, functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.

Cognitive impairment in patients with MS is a common problem that significantly affects quality of life. It shows an association between functional capacity and physical fitness levels and cognition in non-MS populations, and especially in the elderly.

Although cognitive dysfunctions are known, few studies have been found on its relationship with secondary problems caused by the disease and its correlation with other symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS diagnosis
* Expanded Disability Status Scale score \<5.5
* Being able to use a smart phone
* No relapse during the last 30 days
* Being between the ages of 18-65
* Mini-Mental State Examination score\>24

Exclusion Criteria:

* Severe Visual Impairment
* Severe Psychiatric Disorder,
* Severe Arthritis in Knee or Hip,
* Pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination
Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.

Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* Cardiac surgery with cardiopulmonary bypass
* Post cardiotomy cardiogenic shock
* ECMO-VA implanted in OR

Exclusion Criteria:

* LVAD
* Heart transplantation
* Incomplete data in relation to outcomes
* Cardiac arrest
A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening

This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution.

The study will determine the feasibility of implementing a SCT education program (SCTaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained SCT knowledge.

This is a single center, observational study to develop an education program for parents of young children diagnosed with Sickle Cell Trait. This will be accomplish by evaluating the current Ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis.

During phase I of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. This data will then be analyzed by the SCT Team in order to develop the Program.

During phase II of the study, population with the same criteria as phase I will be enrolled, however they will receive the revised "SCTaware" education. Pre and post education questionnaires will also be answered. In addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys.

In addition, the investigators will be using the Decisional Conflict Scale (DCS) to explore if parents experience decisional conflict about whether or not to obtain SCT testing and if SCTaware reduces this conflict

Eligibility Criteria:
Inclusion Criteria:

1. Adult biological parents of children \<3 years old with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
2. English proficiency will be required

Exclusion Criteria:

1. Parents who self-report that they do not have functional verbal English (report that they are not proficient) or if they request an interpreter for the education session.
2. Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
3. Parents who self-report that they have a child with SCD
4. Parents who self-report that they have SCD.
5. Parents who report that they or their partner is currently pregnant
16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients

To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* MMSE score of ≥ 10 and ≤ 26
* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks
* Be in stable medical condition
* Have signed off informed consent form by patients or his/her legal guardian

Key Exclusion Criteria:

* Severe AD
* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition
* Attending other clinical trials or taking other clinical trial drugs
* A score of \> 4 on the Modified Hachinski Ischemic Scale (MHIS);
* Patients who is using any AChEI or memantine
The Correlation Between Cirrhotic Cardiomyopathy and Perioperative Cardiovascular Events in Liver Transplantation

Liver transplantation is an effective treatment for end-stage liver disease. Cardiovascular complications are the common causes of death in liver transplant recipients. The presence of cirrhosis cardiomyopathy has a potential impact on the prognosis of liver transplant recipients. Therefore, it is important to identify the high risk factors with cirrhotic cardiomyopathy before transplantation, so as to intervene earlier and improve the prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic criteria for decompensated liver cirrhosis: according to the guidelines for diagnosis and treatment of liver cirrhosis in 2019;
2. Diagnostic criteria for cirrhotic cardiomyopathy: in accordance with the revised criteria of CCM of international multidisciplinary Alliance for cirrhotic cardiomyopathy in 2019, the preoperative echocardiographic images of all patients were reviewed, and the systolic and diastolic dysfunction of all patients were evaluated.

Exclusion Criteria:

1. the compensatory liver cirrhosis, primary liver cancer without liver cirrhosis
2. Multiple organ transplantation or multiple organ transplantation
3. The preoperative echocardiographic data were not fully recorded, so that the exact diagnosis could not be made
4. There was no follow-up data or baseline data
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1

Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL).

The objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.


Eligibility Criteria:
Inclusion Criteria:

Patient group

* Unilateral or bilateral, primary or secondary Lower limb lymphedema (LLL)
* Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
* Age ≥ 18 years
* Able to read, understand and speak Dutch

Healthy controls

- Age, gender \& BMI-matched healthy controls

Exclusion Criteria:

* Pregnant participants
* Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
* Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
MRI Predictors of Response to Tumor Treating Fields

Patients with glioblastoma, an aggressive brain tumor, are recommended to undergo treatment with tumor treating fields using the Optune device as part of standard of care therapy. While undergoing treatment, patients are monitored regularly with brain MRI scans to look for tumor progression, but there are currently no means to predict which, or when, patients will progress. The purpose of the current study is to prospectively analyze these MRI scans to look for subtle imaging markers that can predict for future brain tumor progression while undergoing tumor treating field therapy.

The proposed trial involves the prospective collection of imaging data at standard clinical time points before and during treatment with TTFields. All patients who are offered treatment with TTFields will also be offered enrollment in this non-randomized, observational study. Imaging data will include the standard battery of MRI sequences, which includes DWI and ADC reconstruction. These data will be collected at standard time points and the proposed study will not rely on any additional imaging or tests outside of the clinical standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 or older with newly diagnosed WHO grade IV glioblastoma or patients with recurrent glioblastoma not previously treated with TTFields.
* Patients may have undergone surgical resection or biopsy.
* Residual tumor, absence of treatment with temozolomide or radiation therapy will not be an exclusion criteria for the study.

Exclusion Criteria:

* Patients previously treated with TTFields will not be included in the study.
* Patients will also be excluded if they are undergoing active treatment with systemic agents, including bevacizumab, during treatment with TTFields.
Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP

Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).

This Phase 3, multicenter, open label study will evaluate the efficacy, safety, and population pharmacokinetics (PK) of avatrombopag in Japanese adults with chronic ITP. At least 19 subjects will be enrolled. The study will consist of 3 phases: Pre-enrollment, Primary Investigation, and Extension Phase until market authorization in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of chronic immune thrombocytopenia (ITP) (≥12 months duration) and has had an insufficient response to a previous ITP treatment, in the opinion of the Investigator.
* Subject has an average of 2 platelet counts \<30×10\^9/L (no single count can be \>35×10\^9/L). The 2 samples must be obtained ≥48 hours and ≤2 weeks apart.

Exclusion Criteria:

* Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or subjects with known systemic lupus erythematosus).
* Subjects with known inherited thrombocytopenia (e.g., Myosin Heavy Chain 9 (MYH-9) disorders) or hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency).
* History of myelodysplastic syndrome (MDS).
* History of arterial or venous thrombosis.
* Subjects with a history of significant cardiovascular disease (e.g., congestive heart failure (CHF) New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events \[e.g., atrial fibrillation\], angina, coronary artery stent placement, angioplasty, coronary artery bypass grafting).
* Subjects with a history of cirrhosis, portal hypertension, or chronic active hepatitis.
* Subjects with concurrent malignant disease or receiving cytotoxic chemotherapy for a reason other than ITP treatment.
* Use of immunoglobulins (IVIg and anti-D) or corticosteroid rescue therapy within 1 week of Day 1/Baseline.
* Splenectomy or use of rituximab within 12 weeks of Day 1/Baseline.
* Use of romiplostim or eltrombopag within 1 week of Day 1/Baseline.
* Use of chronic corticosteroid treatment or azathioprine within 4 weeks of Day 1/Baseline, unless receiving a stable dose for at least 4 weeks.
* Use of mycophenolate mofetil, cyclosporin A, or danazol within 4 weeks of Day 1/Baseline, unless receiving a stable dose for at least 12 weeks.
* Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of Baseline Visit.
* Currently receiving moderate or strong dual inhibitors/inducers of CYP2C9 and CYP3A4.
* Serum creatinine ≥1.5× the upper limit of normal (ULN).
* Serum bilirubin ≥2×ULN.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×ULN.
* Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG) test) or breastfeeding.
* Received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) before Day 1/Baseline.