cyrilzakka/clinical-trials huggingface dataset:
Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced Melanoma

This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in RIC-Mel Database:

  * Diagnosed with melanoma and cared for in the participating sites
  * Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out
* Patients included in French nivolumab ATU program

Exclusion Criteria:

• Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial

Other protocol defined inclusion/exclusion criteria could apply
Feasibility of Passive Data Collection in Dementia Subjects With Agitation

This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch).

The purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 years and older.
* Subjects who have met DSM-5 criteria for Dementia (all cause)
* Subjects with a recent history of agitation in the past 6 months to a point that impairs social activities, requires staffing or medical intervention (kick, bite, flailing, etc.), impairs ability for functional activities of daily living, as disclosed by a caregiver or documented in the medical record.
* Subjects resident in a group home, nursing home, or assisted living are eligible to participate.
* Subjects who can read, understand and provide written informed consent or who have a Legally Acceptable Representative (LAR)
* Subjects who are willing and able to carry a smartphone and wear an activity tracker on their wrist or hand, alone or with the help of a caregiver.
* Subjects who, either alone or with a caregiver, are able to operate a smartphone and wrist or hand-worn activity tracker, alone or with the help of a caregiver.
* Subjects who are in good general health prior to study participation as determined by a detailed medical history, and in the opinion of the Principal Investigator.
* Subjects, who are able to ambulate without an assistive device, or with a single point cane.

Exclusion Criteria:

* Subjects who are unwilling or unable to carry a smartphone and wear an activity tracker on their wrist or hand.
* Subjects with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic or hematologic disease.
* Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate.
Immunogenicity of HPV Vaccine in Immunosuppressed Children

Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause of several other cancers and conditions. There are now effective vaccines against the main oncogenic HPV types, HPV16 and 18.

Most research and discussion has focused on targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls commenced in 2007, in Australia. However, at the time of commencement, there had been no research on the use of this vaccine in immunosuppressed. Therefore, information on the immunogenicity, safety and duration of efficacy of HPV vaccine when administered to immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity, followed for 5 years for duration of immunity.

To determine the immunogenicity, safety and persistence of immunity following human papillomavirus (HPV) vaccination in three groups of immunosuppressed children: recipients of allogenic bone marrow transplant, recipients of renal and liver transplants, and patients with juvenile chronic arthritis, inflammatory bowel disease and other autoimmune conditions who are on longterm immunosuppressive therapy.

Significance: Immunosuppressed populations are diverse in terms of degree, type and duration of immunosuppression. The study compares several groups in order to address the heterogeneity of immunosuppression and how this affects vaccine response. BMT patients have extreme, severe immunosuppression in the short term, but recover immune function with time. In contrast, solid organ transplant recipients have ongoing, chronic immunosuppression. Although successful cessation of immunosuppressives in liver transplant patients has been reported, most patients require ongoing treatment. The inflammatory bowel disease group of patients represents a non-transplant group who require ongoing, often low level immunosuppression, often with corticosteroids. Our study will compare these three groups, followed up for five years for duration of immunity. Time of vaccines, time of serological measures of immune response are as follows.

Serum collections:

0 - Baseline (before HPV vaccine dose 1); 2 months - At the time of receipt of HPV vaccine dose 2 (to measure response to dose 1); 6 months - At the time of receipt of HPV vaccine dose 3 (to measure response to dose 2); 7 months - 1 month after HPV vaccine dose 3; 12 months - after HPV vaccine dose 1; 2 years after HPV vaccine dose 1; 3 years after HPV vaccine dose 1; 4 years after HPV vaccine dose 1; 5 years after HPV vaccine dose 1.

Eligibility Criteria:
Inclusion Criteria:

- Immunosuppressed patients with following diseases; Bone marrow transplant recipients, liver transplant patients, renal transplant, Children with inflammatory bowel disease, juvenile Idiopathic arthritis and autoimmune conditions.

Exclusion Criteria:

* A platelet count of \<50
* Immunoglobulin therapy within 3 months.
* Yeast allergy
* Any other known allergies to one of the vaccine component
Testing Methods of Screening for Woman Abuse in Health Care Settings.

Recent reviews have identified the need for additional high quality exploratory and evaluative research to understand 1) the actual impact on all women of instituting mass screening procedures versus using indicator-based approaches to identifying woman abuse and 2) the extent to which early identification through screening -- either universal or indicator-based is effective in preventing or ameliorating important outcomes. This is a critical first step in developing a larger randomized controlled trial (RCT) which examines the effectiveness of screening in preventing woman abuse, improving quality of life and other associated outcomes. This study prepares for the RCT by testing the optimal method of administration for the two screening instruments that will be used in the RCT. The administration formats are: computer-based screen, paper and pencil screen and face-to-face screen. They study will also determine recruitment rates.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-64 years
* Patients at the health care site
* Able to participate in English
* Able to separate from accompanying person(s)

Exclusion Criteria:

* Too ill to participate
* Unable to separate from accompanying person(s)
* Unable to speak, read, or write English
Anthocyanin & Phenolic Acids Bioavailability & Antioxidant Capacity After Consumption of Purple Wheat Products in Adults

This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. The purple wheat granola bars are an example of a food product that requires much less intensive preparation and cooking, compared to the crackers. A comparison of bioavailability between these two products should provide insights about how different processes and food matrix influence anthocyanin bioavailability and metabolism.

This study will determine the bioavailability of anthocyanins and phenolic compounds from two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product. The purple wheat granola bars are an example of a food product that requires much less intensive preparation and cooking, compared to the crackers. A comparison of bioavailability between these two products should provide insights about how different processes and food matrix influence anthocyanin bioavailability and metabolism. The study is a crossover investigation with 8 men and 8 women who will adhere to a low anthocyanin and low phenolic diet for the duration and complete 2 postprandial study visits where, in random order, they will consume either the crackers or granola bars. Blood and urine will be collected at baseline and postprandially for the analysis of anthocyanins and their metabolites and phenolic acids and determination of antioxidant capacity.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18 - 27 kg/m2
* Generally healthy as determined by screening questionnaire
* Non-smoking
* Non to moderate alcohol drinkers (Typical consumption less than 5 drinks per sitting and no more than 14 per week)

Exclusion Criteria:

* Pregnant or breast-feeding females
* History of any major disease or medical condition, including any disorder of the gastrointestinal system or food intolerances
* Taking any prescription medications (including hormonal contraceptives) or over the counter medications prescribed by a medical professional
* Taking any natural health products or dietary supplements, other than a multivitamin low in anthocyanins and phenolic acids
* Oral antibiotic use in the past 3 months
* Any food allergies, and any anaphylactic or life-threatening allergies - food or otherwise
* Smokers or use of recreational drugs (marijuana, magic mushrooms, etc)
* Elite or training athletes
* Following a vegan or vegetarian diet
Impact of the Introduction of ORKAMBI on Anxiety, Depression, Quality of Life and Adherence of Adolescents and Young Adults

The aim of this project is to evaluate the psychological reshuffle induced by ORKAMBI. The particular focus of this study is the consequence of its introduction on anxiety, depression, quality of life and adherence to all cystic fibrosis (CF) treatment. To answer this question investigators will monitor the psychological function of CF adolescents and young adults treated with ORKAMBI and compare them to CF adolescents and young adults not treated with ORKAMBI.

Introduction of KALYDECO then ORKAMBI, as a personalized medicine in the therapeutic strategy of Cystic Fibrosis (CF) may deeply modify the prognosis of patients with CF. These approaches realize the dream of short-circuiting the molecular mechanism of the disease and therefore opens the perspective of an extended and functional survival. It suddenly offers the possibility of a completely new future to the patient and his family, and therefore must deeply impact on the psychological function of all involved. Moreover, those new therapies may also modify the adherence to CF basic treatment, as it brings a new feeling of good health and the hope of a longer life. For that reason there is a need to investigate modifications of the psychological state of mind induced by the treatment with ORKAMBI in CF adolescents and young adults.

This project aims to understand the psychological impact and to study the consequences of the introduction of ORKAMBI on adherence to CF treatment, anxiety, depression and quality of life.

To answer this question, investigators will evaluate the psychological function of adolescents and young adults, aged 12 to 20 years, with CF treated with ORKAMBI, and compare it to other adolescents and young CF adults not treated with ORKAMBI.

This is a cohort prospective study, with a 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Treated group: Patients with proven CF (sweat-test \> 60 mEq, 2 DF508 CF causing mutations, 12 to 20 years, and treated with ORKAMBI
* Control group: Patients not carrying 2 DF508 CF causing mutations, not treated with ORKAMBI, and not carrying the G551D, G178R, S549N, S549R, G551S, G1244E,S1251N, S1255P or G1349D mutation or treated with Kalydeco

Exclusion Criteria:

* Transplanted patients
* Patients younger than 12 years
* Patients older than 20 years
LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa

The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with age +/\>18 years
* Recruited from Duke University
* Local community members

Exclusion Criteria:

* Any pre-existing skin conditions
* Skin allergies to tegaderm or other adhesive products contained within the study and control rings
Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale

To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing factors, construct models that influence prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for migraine in the International Classification of Headache (ICHD-3);
* Confirmation of patent foramen ovale through transthoracic echocardiography(TTE) or transesophageal echocardiography(TEE)/right heart contrast echocardiography
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Can not sign the informed consent form or cooperate with follow-up.
Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities

Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.


Eligibility Criteria:
Inclusion Criteria:

* uncontrolled asthma

Exclusion Criteria:

* other chronic lung disease such as cystic fibrosis
Tumor Markers in Lung Cancer: DCAMLK-1LK-1

DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung cancers.

The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking status.

In the investigators' preliminary study DCAMKL1 antigen was detected not only in malignant tissue, but also in BAL fluid from patients with benign lung disease. This suggests that DCAMKL1 expression might be induced by smoking or benign lung diseases. To examine this hypothesis, the investigators will compare DCAMLK1 expression in blood from patients with lung cancer to controls who are current or former smokers with benign lung disease.

Previous work has showed that DCAMLK1 is not detectable in the blood of healthy non smoking individuals. To determine whether smoking and or pulmonary inflammation induce DCAMLK1 expression, the investigators will obtain serum samples from 20 control patients with lung disease who are seen in the Chest Clinic at the Oklahoma City VAMC. Smoking histories will be obtained for all participants and DCAMLK1 levels will be correlated with smoking status.

Eligibility Criteria:
Inclusion Criteria:

* \>45 years of age

Exclusion Criteria:

* Unable to provide informed consent
Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop (HCL) systems in achieving glucose control of patients on Multiple Daily Insulin Injections (MDI).

Goal

The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop systems in achieving glucose control of patients on MDI.

Methods

This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 40 subjects (age 18-65) will be enrolled in order to reach 34 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from Continuous Glucose Monitoring (CGM) will be performed at baseline and at the end of the 3-month study period. The following parameters will be analyzed" % patients achieving glucose readings Time in Range (TIR) \> 67% in (70-180 mg/dl); % patients achieving \<3% Time below Range ( \<70 mg/dl) and % patients achieving both TIR \> 67% and \<3% Time below Range.Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
2. HbA1c \< 12.5%
3. Age18-65 years at the initiation of the 670G system
4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period
5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software
6. Clinically planning to and be able to start the Medtronic 670G HCL system
7. History of 3 clinic visits in the last year
8. With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist.

Exclusion Criteria:

1. Diabetic Ketoacidosis in the 6 months prior to screening visit
2. Type 2 diabetes
3. Hyperthyroidism at time of screening
4. Using Pramlintide, Dipeptidyl peptidase 4 (DPP-4) inhibitor, Glucagon-like peptide-1 (GLP-1) agonists, metformin, sodium-glucose transport protein 2 (SGLT2) inhibitors at time of screening.
5. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study.
Biomechanical Effects of Wearing a Sacroiliac Belt in Women

Women with pelvic girdle pain PGP) often get relief from using a sacroiliac belt. The study will explore if there are differences and in the changes of lower body movement in stability with the belt on and with the belt off. Women with PGP will be matched with women without to explore if there is a difference between these two groups. This will be looked at in standing and in walking.

SacroIliac (SI) joint dysfunction (also called pelvic girdle pain) has been associated with impaired load transfer across the lumbopelvic region. This can result in lower back pain as well as poor biomechanical adaptation during walking. Sacroiliac (SI) belts have typically been prescribed in order to mitigate pain and improve load transfer in individuals with SI joint dysfunction. It has been speculated that SI belts have the ability to instantaneously increase joint stability, and as a result improve load transfer and muscle activation and recruitment. However, this speculation is primarily based on anecdotal evidence; there is little biomechanical research supporting the effects of wearing an SI belt. In order to gain an improved understanding of the biomechanical effects of wearing an SI belt, the investigators propose to conduct a study with the following key objectives:

1. Determine if there are differences with respect to neuromuscular, kinematic, or pressure patterns during walking and/or standing between healthy stable individuals and individuals with SI joint dysfunction
2. Determine if wearing an SI belt affects neuromuscular, kinematic, or pressure patterns during walking and/or standing in women with sacroiliac instability

Variables measured will include:

1. Kinematics will be collected to quantify posture and joint angles
2. Kinetics will be collected to quantify ground reaction forces
3. Plantar pressure will be collected to quantify force distribution and center or pressure
4. Joint moments (Lumbar-pelvic and Hip) will be added as variables. The investigators will use inverse dynamics to calculate various joint moments during walking.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Individuals with isolated SI joint dysfunction
* Individuals with shoe size 6, 7, 8 or 9 US

and matched controls by age (within 5 years), BMI (within one point) and parity

Exclusion Criteria:

* Pregnancy in the last year or presently pregnant
* Significant lumbar dysfunction
* Significant hip dysfunction
* Leg length discrepancy of 1 cm or more
* Women who have previously undergone prolotherapy or SI joint injections
* Women with previous lower back, hip, knee or ankle surgery
* Inability to stand for 60 sec unaided or to walk unaided.