cyrilzakka/clinical-trials huggingface dataset:
Women's Responses to Adjusted Product Placement and Its Effects on Diet - 2

This study is the largest supermarket trial internationally and will assess the effectiveness and cost-effectiveness of improving the placement of fresh fruit and vegetables in discount supermarkets in improving the fresh fruit and vegetable purchasing of women aged 18-45 years.

WRAPPED2 (Women's Responses to Adjusted Product Placement and its Effects on Diet - 2) is a natural experiment with a prospective matched controlled cluster design. The setting is a discount supermarket chain in the United Kingdom regularly used by disadvantaged families for their main shop. The intervention is a store refurbishment programme that involves creation of a new fresh fruit and vegetable section in the store entrance. Control stores keep the existing layout with a limited range of fresh fruit and vegetables and placement of fresh fruit and vegetables at the back of the store.

A total of 45 participants will be recruited from each of 18 intervention and 18 matched control stores through the retailer's loyalty card scheme (postal letter) and shop floor recruitment; these methods proved effective during the pilot. Participants will be women aged 18-45 years who shopped at a study store in the 12 weeks before recruitment. This study is unique in its collection of individual level sales data, as well as demographic and dietary information, and is the first to collect outcome data for more than one family member. Participant's weekly sales data will be obtained through the retailer's loyalty card scheme and will cover 3 months before refurbishment, plus 0-3 months and 3-6 months after. Change in women's fresh fruit and vegetable purchasing from baseline to 3 months is the primary outcome. Secondary outcome data about women's diets, their young child's diet (2-6 years), food shopping habits, perceptions of supermarket environment, and psychosocial and demographic characteristics will be collected by telephone survey before refurbishment, and 1, 3 and 6 months after. Weekly sales data for study stores will be provided by the retailer.

Cost-effectiveness will be assessed from individual, retailer and societal perspectives. Process evaluation will assess implementation, mechanisms of impact and context.

This study is politically and scientifically important being one of the first field studies of this kind. The findings could provide strong evidence for future public health policy interventions to help address inequalities in diet and non-communicable disease risk by supporting development of a healthy store layout that could be adopted more widely in food retail outlets.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-60 years
* Hold a store loyalty card
* Shop regularly in a study store
* Shoppers who choose items in-store but opt for home delivery

Exclusion Criteria:

* Women under the age of 18 or over 60 years
* Males or children
* Irregular shopper or online-only shopper
* Do not hold store loyalty card
A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
* CD4 count ≥100 cells/mm3 at Screening.
* Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.

Exclusion Criteria:

* Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
* Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
* X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.
Pronostic and Predictive Value of EMT in Localized Lung Cancer

The goal of the present research is to identify an "EMT signature", associated with long term disease-free survival after surgery in NSCLC. This study will potentially lead to specific treatment recommendations, thanks to an integrated molecular approach including DNA, RNA and miR profiling In vitro analyses using lung cancer cell lines will subsequently be conducted to validate markers identified in tumor screenings.

One critical issue in studying oncogenesis is the comprehensive understanding of tumor genome complexity. Molecular subtypes may be identified through large-scale molecular screenings or gene expression analyses and molecular signatures are recognized as a relevant source of disease stratification.

The investigators will focus on NSCLC patients with localized diseases included in the ONCOHEGP tissue collection project (OncoHEGP, Ministere de la Recherche n° DC 2009-950). The investigators had previously shown that in EGFR mutated cancer, reactivation of TWIST1 was reversibly linked to EMT and to survival. To go further, the investigators plane to investigate EMT in a large cohort of patients with lung cancer to identify prognostic and predictive markers of long term survival.

The investigators will integrate mutation, and copy number alterations to EMT gene expression analyses and to EMT related miR quantification. Tumor phenotype, miR signatures, mutation status will help classify patients according to survival.

Clinical data will be assessed thanks to the epithor database. Epithor is a government-recognized clinical database, accredited by the French Health Authorities (Haute Autorité de Santé) and is supported by the National Cancer Institute (Institut National du Cancer).

EMT characterization and scoring will be done using 10 markers by qPCR, mutation and CNV screenings by targeted NGS analysis, miRs signature by MIRSeq and qPCR.

Eligibility Criteria:
Inclusion Criteria:

* Patient with NSCLC stage I II IIIA IIIB, treated by surgery at Georges Pompidou Hospital (HEGP) Informed consent ONCOHEGP signed

Exclusion Criteria:

* Informed consent ONCOHEGP not signed
Trial of New Dietary Treatment of Diabetes

This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes.

Study terminated December 19, 2005 for administrative reasons.

Traditional dietary treatment of type 2 diabetes is complicated and often fails.

This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals.

A series of 10 overweight type 2 diabetic patients not well controlled, or needing medication for control, will be recruited to follow this plan; followup is to be until 6 months after the last patient is enrolled, or when all patients have normal A1Cs with no medication, whichever comes first.

Primary endpoints to be measured are A1C, weight loss (in pounds and BMI reduction) and medication reduction. Secondary endpoints are occurrences of hypoglycemia, reduction of medications for hypertension and hyperlipidemia, and patient satisfaction. As this is a Phase 1 trial, the only control group is historical controls (the patients themselves and the medical literature).

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, type 2
* Obesity
* Ability to attend office visits in Manassas, Virginia

Exclusion Criteria:

* Dementia
* Institutionalized living
* Retinopathy, neuropathy
* Pregnancy
* Serious health problems such as heart disease or stroke
Clinical Image Evaluation for the DREX-KL80 Imaging System

The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patient 18 years and older
* Not pregnant
* Not a safety risk patient

Exclusion Criteria:

* Male and female patient under 18 years old
* Pregnant subjects
* High safety risk subjects
* Subjects and/or Legal Guardian Unable to provide informed consent
Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study

The goal of this pilot clinical trial is to assess a program of Home-based Adapted Physical Activity in Anorexia Nervosa.

The main questions it aims to answer are: Determining the acceptability of this program / Determining the feasibility and safety of this program / Determining patient satisfaction / Measuring the evolution of the symptomatology. Participants will follow a program of Home-based Adapted Physical Activity.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age between 18 and 60 years
* Subjects able to give informed consent
* Eating disorders such as anorexia nervosa
* BMI \< 18.5 kg/m2
* Affiliated in a social security plan
* Having given informed consent to the research

Exclusion Criteria:

* Indication for in-patient care or BMI \< 12 kg/m2
* Subject presenting a contrindication to the practice of an adapted physical activity
* Anorexia nervosa in partial or complete remission for more than 1 year
* Patient unable, for technical or any other reason, to connect via the Internet for tele-monitoring and/or tele-rehabilitation
* Persons concerned by the articles L1121-5 to L1121-8 of the public health code
* Subjects who cannot be contacted in case of emergency
* Subjects in a period of exclusion from another study
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)

This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab will result in a clinically meaningful Overall Response Rate (ORR).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
* At least one measurable lesion
* Radiographic progression of NSCLC after treatment with a platinum-containing doublet for Stage IIIB/IV or recurrent disease
* Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1
* Adequate organ function

Exclusion Criteria:

* Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
* Systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
* Expected to require any other form of systemic or localized antineoplastic therapy while on trial
* History of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
* Active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
* Concurrent or past history of interstitial lung disease
* Pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab
Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy

The PRECISE study is a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.

The PRECISE project takes the positive results achieved with the DigiRehab application (https://digirehab.dk/en) in home rehabilitation and takes a further step in this direction by combining the personalized training delivered through the application with an artificial intelligence-based predictive model (Artificial intelligence - Decision Support Systems platform, AI-DSS platform) for fall risk assessment in the elderly. In particular, 20 senior participants will test the DSS beta prototype. This new system, called DigiPrehab, will enable early identification of the elderly with significant risk factors for falling and propose an individualized physical training plan to attend to the identified critical areas.

The PRECISE study will be a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.

Eligibility Criteria:
Inclusion Criteria:

* Independent ambulation
* Fall risk assessed by Tinetti test
* Mini Mental State Examination ≥ 24
* Residents at home
* Familiarity with web applications
* Ability and willingness to sign informed consent

Exclusion Criteria:

* Unstable clinical condition by judgment of the physician
* Severe visual and/or hearing impairment
* Severe impairment (Activities of Daily Living) in medical record
* Absence of primary caregiver
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients

This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :

* one group of patients receiving anthracyclines and taxanes
* a second group of patients receiving anthracyclines, taxanes and trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

For group 1 without trastuzumab :

* Patients must be ≥ 18 years old
* Patients with breast cancer stage I to III
* Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab
* Patients must have a social security coverage
* Patients able to speak, read and understand French

For group 2 with trastuzumab :

* Patients must be ≥ 18 years old
* Patients with breast cancer grade I to III
* Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, with trastuzumab
* Patients must have a social security coverage
* Patients able to speak, read and understand French

Exclusion Criteria:

* History of cancer
* Previous chemotherapy
* Patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease)
* Pacemaker implantation
* Contraindication to physical condition evaluation
* Contraindication to local anesthesia required for microbiopsy
* Patients \< 18 years old or patients ≥ 18 years old under guardianship, or supervision
* Psychiatric, musculoskeletal or neurologic disorders
* Women that are pregnant or breast-feeding
The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions im Patients With Retinitis Pigmentosa

Retinitis pigmentosa is a genetically determined disease consisting of progressive centripetal retinal degeneration starting in the rods outer segments. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 \[7% of all blindness\]. The investigators tried to treat a non-progressive form of the disease \[Fundus Albipunctatus\] by oral therapy of the food supplement made from alga Dunaliella bardawil composed of approximately 50% 9-cis β-carotene. The alga Dunaliella bardawil accumulates high concentration of β -carotene when grown under appropriate conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene.

The 9-cis β -carotene has shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested. The visual field was also improved significantly.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study.
* Men or women aged 18 years or older.
* Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa

Exclusion Criteria:

* Current smokers.
* Current use of Vitamin A/ beta carotene supplements.
* Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery.
* History of malignancy, except basal or squamous cell skin carcinoma.
* Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.
* Uncontrolled hypertension defined as either resting diastolic blood pressure of \>95mmHg (taken from the mean of 3 readings) or resting systolic blood Pressure of \> 180 mmHg.
* History of alcohol abuse or drug abuse, or both.
* Patient plans to engage in vigorous exercise or an aggressive diet regimen.
* Uncontrolled endocrine or metabolic disease.
* Participation in another investigational drug study within 4 weeks of entry into this study.
* Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
* Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Objectives:

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Primary end-point(s):

To evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg.

Secondary end-point(s):

Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS) after intake of 150 or 200 mg of Methylene Blue MMX® tablets during the intake of the bowel cleansing preparation.

To collect data about safety and tolerability of Methylene Blue MMX® tablets after administration of single oral doses of 150 or 200 mg.

Methodology:

Open label, staining efficacy exploratory study.

Eligibility Criteria:
Inclusion Criteria:

1. Sex: males and females;
2. Age:18 to 70 years;
3. Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
4. Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
5. Informed Consent: signed written informed consent prior to inclusion in the study.

Exclusion Criteria:

1. Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
2. Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
3. Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, inflammatory bowel diseases in active phase, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other relevant disease that might interfere with the aim of the study.
4. Comprehension: inability to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator and to comply with the requirements of the entire study.
Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.

Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals

Data will be collected in three aspects by three different forms as following:

Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system Form

Eligibility Criteria:
Inclusion Criteria:

* Patients using Dengzhanxixin injection from 2012 to 2014

Exclusion Criteria:

* none
Post Market Evaluation of Acessa With TAG

The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).

The intent of the TAG system is to assist the gynecologist in getting the tip of the Acessa Handpiece to the fibroid by creating an animated image overlay of the movements and placement.

The study will be conducted in two parts:

Part 1: User Preference Testing - users will be presented with various statements pertaining to the features of the system and asked to indicate their degree of agreement.

Part 2: Time to target - will be measure by fibroid.

Eligibility Criteria:
Inclusion Criteria: Women who:

* Are planning to undergo the Acessa procedure
* Are willing and able to comply with all procedures
* Are capable of providing informed consent

Exclusion Criteria: Women who:

* In the medical judgement of the investigator should not participate in this study