cyrilzakka/clinical-trials huggingface dataset:
Using mHealth to Aid Opioid Medication Adherence Pilot Study

The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.

The purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named SubAID. The SubAID system is a smartphone application and medication monitor designed to optimize adherence behaviors of an OD patient responsible for administering bup/nal maintenance therapy medication.

Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing OST.

* Stage 1 - 1 week: Participants will use only an electronic medication monitor (MedSignals) in control mode to passively record baseline adherence to medication.
* Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone application.
* Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone application.

After each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Physician diagnosis of opioid dependence (OD)
* Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.
* Able to speak and read English
* Willing to provide written informed consent prior to study entry
* Able to understand the study
* Ownership of an Android or iPhone smartphone

Exclusion Criteria:

* Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
* Cognitive or other impairment that would interfere with completing a self-administered questionnaire.
Prevalence of Oral Findings in Chronic Kidney Disease

There are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to achieve a proper management for all oral problems.

The study will be held in the Nephrology units at the Kasr Al-Ainy Cairo university hospital. The data collected through the questionnaire will be obtained through an interview between the investigator and the patient. Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. For patients undergoing dialysis, examination will be performed before dialysis therapy.

Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic.

Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study.

Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record.

Sample size estimation:

Using a precision of 5, a design effect set at 1 with 90% CI (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. The sample size was calculated by Epi info software.

The sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients \>18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4.
2. Adult patients \>18 years old with a diagnosis of end stage renal disease "stage 5".
3. Recorded data of Glomerular Filtration Rate for every patient.
4. Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time).

Exclusion Criteria:

1. Adult patients \<18 years.
2. End stage renal disease undergoing peritoneal dialysis.
3. Patients not physically able to participate in oral examination.
4. Patients with kidney transplantation.
5. Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning.
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)

The purpose of this study is conduct a pilot open trial of a web-based cognitive bias modification intervention to reduce anxiety symptoms in persons with Huntington's disease and persons with Parkinson's disease.

After being informed about the study and giving informed consent, participants will enroll in a pilot open trial of MindTrails, a web-based cognitive bias modification intervention. Participants will complete five, 20-minute MindTrails training sessions over five weeks. Additionally, assessments of anxiety, interpretation bias, and other related outcomes will be completed at baseline, week 3, week 5, and 2 months following the last training session. Participants will each complete a semi-structured interview to provide qualitative feedback about their experiences with MindTrails and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Huntington's disease or Parkinson's disease
* Age 21 or older
* Has anxiety symptoms (NeuroQoL Anxiety short form \>12)

Exclusion Criteria:

* Unable to read and understand English
* Previously diagnosed with dementia
* Not located in the USA
Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/Gastroesophageal Junction Cancer.

In this project, based on the information of advanced gastric/gastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen potential molecular markers/dominant microbiota for predicting the efficacy of immunotherapy and establish a multimodal predictive model for patients that benefit from immunotherapy. Our project could provide evidence to predict response to immunotherapy for patients with advanced gastric/gastroesophageal junction cancer and potentially optimize the clinical decision-making about therapy for advanced gastric/gastroesophageal junction cancer.

Main objective: to extract and identify multi omics information tags related to the efficacy of immunotherapy for advanced gastric / gastroesophageal junction cancer

Secondary objective: to construct and validate the efficacy prediction model of chemotherapy combined with immunotherapy for gastric cancer, in order to optimize the scheme decision of advanced gastric cancer treatment

Exploratory purpose: to screen potential molecular markers / dominant flora for predicting the efficacy of immunotherapy in patients with advanced gastric / gastroesophageal junction cancer

Eligibility Criteria:
Inclusion criteria：

* Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by pathology and with advanced or metastatic disease that cannot be resected
* HER2 negative
* Not received any anti-tumor treatment before.
* After evaluation, the treatment plan is chemotherapy combined with immunotherapy.
* Aged 18 to 75 years old, gender is not limited.
* Expected survival time is greater than or equal to 3 months. Exclusion criteria：
* Patients with malignant tumors other than gastric cancer or those with tumors metastasized to the stomach from other sites.
* Patients who have previously received anti-tumor treatments such as surgery, radiotherapy and chemotherapy, targeted therapy or immunotherapy.
* Patients with severe infections.
* Those with a history of mental illness cannot cooperate with the research.
* Patients with severe heart, liver, kidney and other diseases.
* Pregnant or lactating patients.
* HER2 positive.
Viscontour® Serum Med in Hydration of Facial Skin

The objective of this study is to confirm the clinical safety and efficacy of Viscontour® Serum Med in the hydration of facial tissue.


Eligibility Criteria:
Inclusion Criteria:

1. Females ≥ 18 years of age and in good general health condition
2. Signed informed consent
3. Existing Viscontour® Serum Med recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream)

Exclusion Criteria:

1. Known hypersensitivity to one of the Viscontour® Serum Med components
2. Known pregnancy or lactating females
3. Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
4. Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.

Two groups randomized in a ratio of \[1:1\] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject, aged 2 to 12 years inclusive
* Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid.

Exclusion Criteria:

* Subject presenting bacterial, viral, fungal or parasite skin infection
* Subject with ulcerated lesions, acne or rosacea
* Immunosuppression
* Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor
* Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid
* Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators
Brilinta Taiwan Post Approval Safety Study

A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction

This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged at least 20 years
3. Patient who is considered as ethnic Taiwanese
4. Index event of non-ST elevation myocardial infarction

Exclusion Criteria:

1. Contraindication or other reason that ticagrelor should not be administered
2. Index event is an acute complication of Percutaneous coronary intervention (PCI)
3. Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
4. Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
5. Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
Erlotinib for Hepatocellular Carcinoma Chemoprevention

This phase IIa trial studies long-term low-dose erlotinib hydrochloride treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years-old)
* Clinically and/or histologically diagnosed cirrhosis
* No active hepatic decompensation
* No prior history of HCC
* Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70
* Both sexes and all racial/ethnic groups will be considered

Exclusion Criteria:

* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
* Uncontrolled intercurrent, use of CYP3A4 modulators
* Failed biopsy
* Erlotinib treatment \<4 weeks or \<80% of planned regimen at the end of week 4
* HCC development during the study
Effects of Supervised (BRACE) Balance, Resistance, Aerobic &Cognitive Exercises

In the elderly risk of fall increases due to balance dysfunction, cognitive impairment and low vision. In this research, the aim is to find the effects of Supervised BRACE (Balance, Resistance, Aerobic, Cognitive Exercises) protocol on mobility to reduce the risk of fall in the elderly. Randomized controlled trial 10-12 weeks follow-up. The sample size is 40. The subjects are divided into two groups, 20 subjects in the control group and 20 in the experimental group. The study duration is of 6 months. The sampling technique will be purposive sampling and consecutive random assignment through the sealed envelope method. Individuals of age 60-80, either gender with Berg balance score (BBS) 20-40 will be included. Individuals with musculoskeletal conditions (fractures, severe arthritis), neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition and other systemic diseases or co-morbidities will be excluded. Assessments tools that will be used in the study are Mini-Mental State Exam, Berg balance Scale, timed up and go test (TUG), elderly mobility scale, Fullerton Advanced Balance (FAB) scale, Activities of Balance Confidence.

In terms of morbidity and mortality fall is a major concern in older adults. Fall is defined as unintentional contact with the ground. Tinetti in 1988 defined fall as "an event in which a person rest unintentionally on the ground or lower surface". There are many reasons for fall which can be intrinsic or extrinsic. The risk factors of fall can be ageing (e.g. cognitive impairment, poor balance or low vision), nutrition (vitamin D and calcium deficiency), medication (sedatives, antidepressants etc), environmental factors (improper shoes, poor lighting and unsafe stairs) and lack of exercise.

Previous studies considered age 60 and above in the geriatric population. The number of falls increases day by day due to balance dysfunction which is the key impairment. Age 60 and above along with any impairment or disease which makes a person weak can be included in the group of geriatric population. The fact supported by previous researches that the person who involved in rehabilitation therapies can decrease fall rate and fall associated problems. Through these rehabilitation exercises Activity of Daily Living (ADLs) can be improved and disabilities could be prevented. Wii Fit gaming system can be used to uplift lifestyle and improve balance in the geriatric population.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of age 60 -80 years
* Either gender
* Berg balance score 21-40

Exclusion Criteria:

* Musculoskeletal conditions (fractures, severe arthritis grade iii and iv)
* Neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition
* Other systemic diseases or co-morbidities
Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).

OBJECTIVES:

* Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation.

OUTLINE: This is a pilot, multicenter study.

* Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2, cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to -2.
* Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days.

Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months after transplantation.

PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with matched unrelated donors) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of recurrent or metastatic renal cell carcinoma
* Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2
* Clinically evident and followable disease
* Availability of 1 of the following compatible donors:

  * Related HLA-identical or 1-Ag mismatched donor
  * Unrelated HLA-A, B, DRB1-matched donor

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Karnofsky 70-100%

Life expectancy

* No concurrent illness that severely limits life expectancy

Hematopoietic

* Not specified

Hepatic

* No episode of hepatitis within the past month
* No evidence of chronic active hepatitis or cirrhosis

Renal

* Creatinine no greater than 2 mg/dL

Cardiovascular

* LVEF at least 40%
* No uncontrolled arrhythmias
* No symptomatic cardiac disease

Pulmonary

* FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)

Other

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No active infection
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas

Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. Due to the heterogeneity of these patients and the lack of specific markers, therapeutic is currently based on clinical and laboratory analysis. The research for predictive biomarkers may better characterize the kidney cancer therapeutic management. The objectives are to identify a predictive gene expression profile in patients with advanced clear cell renal carcinoma treated with first-line sunitinib and correlate it with rate response, seeking to identify a predictive gene expression profile. As secondary objectives, the investigators will compare the gene expression profile found, with global survival and clinical-pathological characteristics. Materials and methods: To determine through systematic data collection the epidemiological profile, clinical-pathological characteristics, response rate, disease free survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For evaluation of gene expression profile, the investigators will use a panel of a panel with 770 genes related to disease progression using nanostring technology.

Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* At least 18 years
* Metastatic clear cell renal carcinoma
* Primary tumors sample of nephrectomy or core biopsy

Exclusion Criteria:

* insufficient sample for molecular analysis
* Patients with no record of treatment response data
* Patients with a history of previous systemic treatment for Metastatic clear cell renal carcinoma
* Patients with second primary synchronic or metachronic tumor undergoing treatment
* Patients having received less than one cycle of sunitinib in the first line
* Patients have received previous adjuvant and/or neoadjuvant treatment with an interval \< 1 year between the end of treatment and the diagnosis of metastasis.
Comparisonbetween Primary Hypertension Monitoring Methods for Detection of Early Kidney Dysfunction

The present study aims to show the difference of blood pressure monitored centrally and automated BP monitoring among patients with primary hypertension for early detection of kidney dysfunction

Hypertension is well known as the silent killer, There is a close relationship between blood pressure levels and the risk of cardiovascular events, strokes and kidney disease.

Diabetes and hypertension cause up to two-thirds of chronic kidney disease , chronic kidney disease is a common condition characterized by evidence of kidney damage or dysfunction.

chronic kidney disease is currently classified based on a patient's estimated glomerular filtration rate and urinary albumin excretion rate , clinicians look for markers of renal damage (e.g., abnormalities of urinary sediment or organ structure) to diagnose chronic kidney disease in people with estimated glomerular filtration rate of \<60 mL/min/1.73 m2.

Age distribution for hypertension showed progressive rise in blood pressure with increasing age. Age-related hypertension appears to be predominantly systolic rather than diastolic. The third NHANES survey reported that the prevalence of hypertension grows significantly with increasing age in all sex and race groups. In another study, the incidence of hypertension appeared to increase approximately 5% for each 10-year interval of age Because Central blood pressure is considered better than peripheral blood pressure in predicting cardiovascular events, due to wave reflections and viscoelastic properties of the arterial wall Now a day several non-mercury techniques have been developed during the last ten years in order to gradually supplant the mercury-auscultatory method, such as the automatic electronic devices using algorithms based on the oscillometric technique.

Over the last ten years , different protocols are used to validate the accuracy of blood pressure measuring devices , several automated devices have been successfully validated using established protocols.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 Years to 70 Years old .
2. Patients who have history of primary hypertension either on medical treatment or not .

Exclusion Criteria:

1. All patients with 2ry hypertension.
2. Diabetic patients.
3. Patients with ESRD on regular dialysis .
4. Patients with creatinineclearance \>30ml/min .
5. collagen diseases