cyrilzakka/clinical-trials huggingface dataset:
Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab

PRIMARY OBJECTIVES:

I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.

SECONDARY OBJECTIVES:

I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.

II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.

ARM II: Patients apply topical placebo lotion BID for 28 days.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.
* Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
* Willing to have photographs taken to assess rash.

Exclusion Criteria:

* Any active facial and/or chest rash, including adult acne, at the time of randomization.
* Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
* Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
* Any type of ongoing therapy for rash.
* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
* Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.
Vitamin D Plus Fluticasone Propionate

The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.


Eligibility Criteria:
Inclusion Criteria

1. Males and females between 18 and 45 years of age.
2. History of tree, grass and/or ragweed allergic rhinitis.
3. Positive skin test to tree, grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
A Study to Assess the Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of Participants From PEDISTAD Study (OBS15333; NCT03687359)

Primary objective: To explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (AD) using an innovative Emerald touchless sensor.

Secondary objective: To evaluate the feasibility of using the Emerald touchless sensor in a pediatric clinical trial setting.

16 weeks

Eligibility Criteria:
Inclusion Criteria:

* Participation in OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites.
* Enrolled in PEDISTAD, age more than or equal to 6 years to less than 12 years at the time of enrollment.
* Peak pruritus Numeric Rating Scale (NRS) last night more than or equal to 4 at screening.
* Participant must have home access to reliable and operational Wi-Fi and broadband internet at screening and throughout the study period.
* Participants/parents must have a device (mobile phone, tablet or computer) to record daily itch and sleep disturbance at screening and throughout the study period.
* Participant agrees to sleep by himself/herself (ie, with no other individuals or pets) in the monitored bedroom for the duration of the study (if not all times, at least 5 days a week for a minimum of 5 hours/night for a total of 16 weeks).
* Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.

Exclusion Criteria:

- Known history of a childhood sleep disorder such as parasomnias (sleep walking, talking, terrors, etc.), behavioral insomnia of childhood, or restless leg syndrome.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy

Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy


Eligibility Criteria:
Inclusion Criteria:

1. left ventricular maximal wall thickness ≥ 15mm on echocardiography
2. hypertrophic cardiomyopathy patients' relatives

Exclusion Criteria:

1. other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)
2. who deny the study entrance, especially in patients' relatives
The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts.

More than 200,000 new cases of renal cancer are diagnosed in the world each year, with more than 63,000 new cases in Europe alone. Of those, renal cell carcinoma (RCC) is the most common type in adults, making up more than 90% of the cases. Deciding on the benign or malignant nature of some RCC on the basis of medical images (CT, MRI, US) is an issue, which often leads to unnecessary surgery, morbidity and costs.

A categorization for renal cysts was introduced in the late 1980s known as the Bosniak classification. The Bosniak classification system classifies them into groups that are benign (I and II) and those that need surgical resection (III and IV), based on specific imaging features. However, defining the malignancy of category III lesions still remains a challenge. Though Bosniak classification for renal cysts is used worldwide and underwent a number of modifications, Bosniak III cysts still have almost a 1:1 chance of being malignant. So the problem is that approximately half of the Bosniak category III cystic lesions prove to be benign after surgery.

The proposed project aims to develop a quantitative image analysis (QIA) based multifactorial decision support system (mDSS) capable of classifying renal cysts with high accuracy into benign or malignant status, thus reducing the amount of unnecessary surgeries performed. Using standard-of-care CT images and clinical parameters, the customized DSS will then guide experts in planning a safe and effective diagnostic and treatment strategy for all RCC patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent contrast-enhanced CT-Scan, with radiological findings suggestive of Bosniak 3 renal cyst and have available results for pathology analysis of the cyst.

Exclusion Criteria:

* CT-Scans that are reformatted or secondary.
Medication Dispenser to Improve Care at Home for the Elderly

The purpose of this study is to investigate the efficacy of the Karie Automated Medication delivery device in enhancing medication adherence among a group of elderly patients with mild to moderate cognitive decline.

Given the risks associated with poor adherence and the apparent contribution of good adherence to reducing hospitalizations and emergency department (ED) visits, interventions for promoting good adherence should be pursued. To this end, a number of devices have been developed to promote medication adherence, though with limited success due to reliability, cost, etc. The purpose of this study is to investigate the efficacy of the Karie Automated Medication Delivery Device in enhancing medication adherence among a group of community-dwelling patients immediately following discharge from inpatient rehabilitation.

This study will utilize a multi-site randomized controlled trial design. One week prior to discharge from inpatient rehab, consenting patients will be randomly assigned to receive medication self-management education only (SME) or medication self-management education + Karie (SME+K). Both sites (West Park Healthcare Centre, and CapitalCare) will recruit 150 participants for the study. At each site, 75 patients will be in the intervention group (SME + Karie) and 75 will be in the control group (SME only).

Eligibility Criteria:
Inclusion Criteria:

* Need to manage medications independently at home
* Stabilized on medication, as per pharmacist/physician discretion; and
* Mild-moderate cognitive/physical impairments, as per OT assessment
* Montreal Cognitive Assessment (MoCA) score not less than 16
* English speaking

Exclusion Criteria:

* Absent from community for more than one month during study
* Inability to access study site pharmacy following discharge
Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

A digital tool, called ReferID has been developed to facilitate the review of asthma patients. It aims to assist in the identification of patients with uncontrolled and/or severe asthma and to ensure a timely referral to secondary care where appropriate. To validate the tool, patients will be randomised to have a review with a healthcare professional using tool to facilitate the review or to continue receiving usual care. Outcome measures including exacerbation frequency and level of asthma control will be assessed at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* All asthma patients with 1 of more exacerbations in the last 12 months or receiving high dose inhaled corticosteroids.
* Patients able and willing to provide informed consent.
* Patients aged 18 and over.

Exclusion Criteria:

* Patients who lack capacity.
* Patients who do not have a diagnosis of asthma
* Patients who are unable to provide informed consent
* Patients under the age of 18
* Patients already under a severe asthma centre
Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers

To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologic/cytologic diagnosis of advanced or metastatic solid tumors
* Life expectancy \>= 3 months
* Able to swallow tablets/capsules

Exclusion Criteria:

* Pregnant or breastfeeding women
* No more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Eligibility Criteria:
Inclusion Criteria:

- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion Criteria:

* Mild or severe rosacea
* Rosacea with marked ocular manifestations
* Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
* Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
* History of hypersensitivity to propylene glycol
Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)

The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin less than or equal to 11 g/dL
* History of Chronic Kidney Disease
* eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
* Tsat (transferrin saturation) greater than 15%

Exclusion Criteria:

* Uncontrolled hypertension
* Erythropoietic protein use within 12 weeks of randomization
Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room

The purpose of this study is to determine the usefulness of CCTA (Coronary Computed Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of patients with chest pain who have a low to moderate risk of heart disease.

And to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more cost effective (cost less) than the current standards of care treatments. To determine if patients who present to the emergency room w/low to moderate probability of having an ACS (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care compared to standard algorithm based care.


Eligibility Criteria:
Inclusion Criteria:

* 25 years of age or older
* Experiencing chest pain

Exclusion Criteria:

* Pregnant
* At high risk for ACS (Acute Coronary Syndrome)
Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury

"Severe traumatic brain injury (TBI) is a serious condition, common in young adults. It leads to sensorimotor and cognitive sequelae that hinder social reintegration. Neuronal plasticity must be used quickly before natural recovery impedes neuronal regrowth. In this respect, stopping sedation as soon as possible and early mobilization, even if the patients are unconscious, are recognized as useful measures to promote recovery. However, at the early stage, the environment of the ICU and the acute condition of the patients limit the rehabilitation possibilities. In such a context, functional proprioceptive stimulations (Vibramoov™ system, Techno Concept, France) could be a tool of interest.

By using the proprioceptive signatures of cyclic movements, proprioceptive stimulations can elicit the illusion of these movements. A motor response can even be obtained through the interactions between the peripheral nervous system and the central nervous system. Finally, such stimulations facilitate the initiation of the mimicked movements. Some studies have already shown the benefits of proprioceptive vibrations. However, so far, these benefits have only been studied at the chronic stage of neurological diseases. The investigators hypothesized that early functional proprioceptive stimulations (FPS) may reduce spasticity and promote recovery in patients with severe traumatic brain injury.

To test the hypothesis, the investigators conduct a randomized controlled trial on patients with severe traumatic brain injury. Every patient will be included as soon as possible in the ICU and receive either FPS, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. The primary outcome measures will assess spasticity. The investigators also assess pain, coma recovery; muscle wasting and cognitive impairments. "


Eligibility Criteria:
Inclusion Criteria:

* Severe TBI : Glasgow coma score (GCS) ≤ 8 (11)
* Age ≥ 18 years old
* No pregnancy
* Not being under guardianship
* Be affiliated to the French social security system

Exclusion Criteria:

* Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
* Traumatic SCI
Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

Chronic pelvic pain (CPP) is one of the common symptoms of women at childbearing age. The aim of this study is to assess the efficacy of acupuncture for female with non-cyclic chronic pelvic pain. A three-arm randomized controlled trial (RCT) using acupuncture, sham acupuncture and waiting list with a total sample of 150 will be conducted.

Chronic pelvic pain (CPP) is a persistent pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months. According to a WHO epidemiological study, the worldwide prevalence rate of CPP in childbearing age women was 2.1%-24%. At present, nearly 55% of the patients had unclear etiology, and there is no universally accepted diagnosis, evaluation and treatment. CPP is often associated with gynecological and non gynecological diseases, including endometriosis, abdominal visceral adhesion, myofascial pain and dysfunction, irritable bowel syndrome and interstitial cystitis/bladder pain syndrome. CPP are also accompanied by psychological and physiological dysfunction, the most common is depression and anxiety, which seriously affects the quality of life of patients.

Acupuncture may have effect on non-cyclic CPP in female, however, there is a lack of evidence of effectiveness of acupuncture. A multi-center randomized three-armed controlled trial will be conducted. The aim of this study is assess the efficacy and safety of acupuncture for female patients with non-cyclic CPP.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of non-cyclic CPP.
* Age 18 to 50 years.
* Have moderate to severe pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months.
* The mean degree of pelvic pain in the past week rated by Visual Analogue Scale is ≥40 scores.
* Sign informed consent and participate in the study voluntarily.

Exclusion Criteria:

* Have endometriosis (including adenomyosis), ovarian cyst (larger than 3cm), hysteromyoma (larger than 3cm), severe pelvic adhesion, pelvic malignant tumor (relevant examination must be within the last 6 months).
* Have acute pelvic/urinary tract infection.
* Have pain after pelvic surgery.
* Have recurrent gastrointestinal or bladder diseases such as irritable bowel syndrome, interstitial cystitis / bladder pain syndrome, etc.
* During pregnancy or in lactation or have a pregnancy plan within 8 months.
* Have heart, lung, liver, kidney, mental disorders or cognitive dysfunction.
* Have acupuncture treatment in recent 3 months.
Diabetes Journey: An Adolescent Adherence Barriers Intervention

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.

Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in \>50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.

Eligibility Criteria:
Inclusion Criteria

* T1D diagnosis \>1 year
* Adolescents with T1D ages 13-17
* Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous clinic visit scores
* Ability to read/speak English (all measures are in English)

Exclusion Criteria

* Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, moderate/severe developmental or intellectual disability)
* Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of endocrine disorders (e.g., Celiac disease, thyroid)
* No use of/plans to use non-insulin medication for blood glucose control
The Atherogenic Index of Plasma（AIP） in Patients With Atrial Fibrillation

The goal of this observational study is to learn about The Atherogenic Index of Plasma(AIP) in patients with atrial fibrillation(AF). The main questions it aims to answer are: (1)To investigate the correlation between AIP and the occurrence rate of AF. (2) To investigate the correlation between AIP and the occurrence rate of cardiovascular outcome events (MACE events, heart failure, embolism events) in patients with AF. Patients's clinical data including medical history, laboratory tests, and imageological examination will be collected and further analysed.

Baseline demographic data: age, gender, height, weight, systolic blood pressure, diastolic blood pressure, smoking habit, drinking habit, physical activity, fasting blood glucose, medication use (statins, ACEI/ARB, anticoagulant related drugs), basic medical history (hypertension, diabetes mellitus, coronary heart disease).

Eligibility Criteria:
Inclusion Criteria:

1. Atrial fibrillation was detected by electrocardiogram or 24-hour holter or portable electrocardiogram monitor;
2. age ≥18 years old;
3. "low-intermediate" risk group of AF cardioembolic stroke: male patients with CHA2DS2-VASc score 0-1 or female patients with CHA2DS2-VASc score 1-2

Exclusion Criteria:

1. patients with rheumatic heart disease, congenital heart disease, cardiomyopathy, hematological diseases, severe hepatic and renal insufficiency and connective tissue diseases;
2. Echocardiography showed valvular heart disease;
3. patients with transient atrial fibrillation secondary to reversible causes: hyperthyroidism, acute pulmonary embolism, recent surgery, acute myocardial infarction, etc.
4. severe carotid artery stenosis and intracranial artery stenosis;
5. AF patients with recent major surgery.
6. patients with serious lack of clinical data.