cyrilzakka/clinical-trials huggingface dataset:
Evaluation of COPD Co-Pilot

The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in COPD patients outside of the geographic base of HGE's existing patient population (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to additional geographic sites and to examine whether similar outcome measures are achieved in patients under the supervision of health care providers that are new to the program.

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Eligibility Criteria:
Inclusion Criteria:

1. Subject has read, understood and signed an informed consent form prior to enrollment.
2. Males or females age ≥35 years old
3. Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
4. Must be able to read and understand English and consent for themselves
5. Subject is willing and able to use an iPad mini device.

Exclusion Criteria:

1. Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
2. Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
3. Subject has any condition that in the opinion of the provider may adversely affect their participation
4. Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
5. Subject has a planned procedures at time of enrollment that will occur within timeframe of study that will require hospitalization or otherwise adversely affect their ability to participate
6. Subject has no cellular coverage at their primary residence
7. Subject plans to travel to a location with no cellular coverage for a significant period (\>1 week) during their program participation
The Tick App: Changing Behaviors With Educational Messaging

The goal of this work is to evaluate the use of ecological momentary assessments as a tool to assess risk and risk factors for tick encounters and tick-borne diseases. This study will be conducted across the United States, with a focus the upper Midwest and Northeast and with a focus on Wisconsin and will enroll up to 1000 people.

In the United States, several online and smart-phone apps are available to ID a tick (TickID app, North Carolina State University), submit a picture of a tick (TickSpotters.org, an outreach tool within the larger TickEncounter resource center by the University of Rhode Island) or submit a tick for testing (among other public health agencies, TickReport.com by the University of Massachusetts Amherst). Although these tools are accessible throughout the U.S., they focus on the Northeast. In addition, they do not assess human behavior and tick encounters nor do these tools evaluate prevention and education strategies. A recent study in the Netherlands evaluated the use and effectiveness of a preventative and educational tick app ("Tekenbeet"). This app was well-appreciated, well-used, and improved the user's intention to implement preventative measures. This also illustrates the move of information acquisition from in-hand leaflets to information provision through smartphones.

In this study, data on human behavior regarding tick encounters and tick prevention measures will be obtained from a smartphone application using momentary assessments methodology to assess real time behavior and movement. Ecological momentary assessments are a methodological tool for gathering quantitative behavioral data in real-time, or within the framework of a participant's daily routine.

The daily logs feature provides researchers information about what the participant's activity, location, tick encounters, and prevention measures used. This study will analyze participants who complete 7 daily logs. Their daily logs will be analyzed against the types of educational messaging presented to them within the Tick App.

During a portion of the year the opening screen will contain a prevention message and daily log reminder instead of the home screen. The screen will provide a tick check reminder, a link to the daily log and for half the users the screen will also include a reminder about another prevention behavior (for example bathing/showering). Users will be randomly assigned to the two groups to assess if the additional prevention message increases prevention behavior (tick checks and showering/bathing) and the number of tick encounters.

Eligibility Criteria:
Inclusion Criteria:

* Will to participate in 7 days worth of daily activity logs within the Tick App.
* be able and willing to provide informed consent

Exclusion Criteria:

* Completes less than 7 days worth of daily logs or completes 7+ daily logs but not within 12 months.
Migraine Manager (R01)

The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura
* Frequency of 8 or more headaches per month
* Access to the internet whether public (e.g., library) or private (e.g., home, personal)
* English fluency for patient and caregiver

Exclusion Criteria:

* Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review
* Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review
Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux).

Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects (120 000 subjects in France). The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 man.

Many different treatments exist, depending on the severity of the pathology and the evolutivity of the disease. It is very important to understand that some treatments are not compatible with pregnancy. In these circumstances, a regular gynecological follow-up seems to be essential, to discuss contraception and pregnancy. Besides, some treatments have an immunosuppressive activity that is why a gynecological aftercare is necessary, especially in the detection of papillomavirus for cervical cancer.

The neurologist can advise about gynecological issues, but he cannot take care of the gynecological follow-up, that is why it is very interesting to study the quality of the gynecological follow-up. The investigators aim to study gynecological care of patients with multiple sclerosis using a questionnaire made especially for this project. The questionnaire will be filled by patients when they come in the neurology department for a consultation or during their visit at day hospital. At the same time, they will fill a standardized questionnaire about sexuality and quality of life.

This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center (CRCSEP).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 to 40 years old ;
* Diagnosis of multiple sclerosis based on McDonald Criteria 2017 ;
* Patient whose clinical data are referenced in the European Database for Multiple Sclerosis (EDMUS) clinical database (OFSEP database for collecting clinical data from patients followed in the neurology department) ;
* French-speaking, without comprehension disorders ;
* being affiliated to health insurance ;
* Willing to participate and to sign informed consent.

Exclusion Criteria:

* pregnant or breastfeeding women ;
* patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
Polish Registry of Takotsubo Syndrome

Polish registry of takotsubo syndrome


Eligibility Criteria:
Inclusion Criteria:

all patients with takotsubo syndrome

Exclusion Criteria:

-
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
* Phase 1: Subjects with advanced or metastatic solid tumors.
* Phase 1: Subjects who have disease progression after treatment with available therapies.
* Phase 2: Subjects with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
* Presence of measurable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Exclusion Criteria:

* Laboratory and medical history parameters not within the Protocol-defined range
* Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
* Active autoimmune disease.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
* Known history of human immunodeficiency virus (HIV); HIV 1/2 antibodies.
Estrogen, Diabetes, and Endothelial Function

This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.

Participants completed two study visits. The baseline study visit occurred during the early follicular phase of the menstrual cycle, confirmed via take-home ovulation testing. On the day of the baseline study visit, all participants underwent ovarian sex hormone suppression with GnRHant therapy (cetrorelix acetate, 0.25 mg/day) delivered daily as subcutaneous injections for a 1-week period. Participants were randomized to one of two concurrent intervention groups: transdermal estradiol patch (0.075 mg/day) (+E2) or placebo patch (+PL) and returned for a follow-up visit after 1 week of the intervention. Both study visits included collection of anthropometric measures, a fasting blood sample, measures of arterial stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Euthyroid
* Not currently planning to become pregnant
* Not currently breastfeeding
* No recent history of amenorrhea in the previous 6 months
* Consent to data and specimen banking
* No use of hormonal contraceptives

Inclusion Criteria, type 1 diabetes only:

* Diagnosis of type 1 diabetes for at least 5 years
* On insulin within a year of diagnosis
* Current insulin therapy
* Hemoglobin A1c \< 9.5%
* No macroalbuminuria (AER \< 200 ug/min)

Inclusion Criteria, non-diabetic controls only:

* Hemoglobin A1c \< 5.7%

Exclusion Criteria:

* Pregnant and/or breastfeeding
* Have not had a menstrual cycle in the last 6 months
Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
* Completed written informed consent
* Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
* A detectable PSA ≤ 2.0 ng/ml
* Two consecutive rises in PSA and final PSA \> 0.1 ng/ml OR three or more consecutive rises in PSA

Exclusion Criteria:

* Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
* Histological or radiological node +ve (N1) or distant metastases (M1)
* Prior pelvic radiotherapy
* Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
Effectiveness of Cultural Sensitive Collaborative Treatment of Depressed Chinese

This study is a randomized controlled trial to test whether Culturally Sensitive Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting non-psychiatric settings in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who attend non-psychiatric clinics at the above site.
* Patients with Major Depressive Disorder (MDD), defined as a positive screen using the PHQ-9, confirmed with the SCAN interview.
* Men or women aged 18 or older.
* Able to participate in a clinical diagnostic interview in either Mandarin or Fukienese dialects.
* Individuals who are willing to be followed up concerning their depression symptoms.
* Individuals who have completed a written consent form.

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or planning pregnancy within the next year.
* Patients with serious suicidal risk.
* Patients with unstable medical illnesses.
* Clinical or laboratory evidence of hypothyroidism.
* Patients with comorbid severe mental disorders
* Patients with history of treatment by a psychiatrist in the past 4 months.
Treatment of BV With First Deqularum and Then Direkt After Clindamycin

Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.

The hypoteses is that deqularum cloride takes away the biofilm so that clindamycin will kills the bacteria.

Cure rate will be followed up after 1 month and then after 6 month

Eligibility Criteria:
Inclusion Criteria:

* healthy women with BV

Exclusion Criteria:

* women treated with antibiotics within 1 month
Feasibility and Performance Evaluation of INVSENSOR00024

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.


Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 1 month (28 days) of age
* Weight ≤ 5 kg at the time of consent or last recorded weight prior to consent.
* Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria:

* Subjects with both significant abnormal aortic arch and radial line in place
* Subjects with suspected or diagnosed critical congenital heart disease (CCHD)
* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Deformities of limbs, absence of feet, severe edema, and other at the discretion of the Principal Investigator
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

This is a multicenter, international study where all participants will receive triple therapy with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection, pegylated interferon alfa-2a (PegIFNα-2a), and ribavirin (RBV). PegIFNα-2a and RBV are commercially available therapies for HCV infection. Participants will receive treatment with TMC435, PegIFNα-2a, and RBV for 12 weeks. If blood levels of HCV ribonucleic acid (RNA) monitored at Weeks 2, 4, and 8 are below 25 IU/mL, all treatment will be stopped at Week 12. If HCV RNA values are above 25 IU/mL at Weeks 2, 4, or 8, treatment with PegIFNα-2a and RBV will continue for an additional 12 weeks (up to Week 24) unless protocol-specified stopping criteria are met at Week 4 or 12, at which time all treatment will be discontinued. The study will be conducted in 3 phases: a screening phase of maximum 6 weeks, a treatment phase extending from Day 1 (baseline) up to 12 or 24 weeks depending on the response to treatment, and a posttreatment follow-up period of 24 weeks after the participant's last planned dose of study drug. The duration of the participation (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending on the response to treatment. Blood samples for laboratory analysis will be obtained from participants at protocol-specified time points during the study and participant safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection
* liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
* liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)

Exclusion Criteria:

-Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study
Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers

Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* chronic non-healing foot ulcers (\>4weeks)

Exclusion Criteria:

* Charcot foot
* Non-diabetic ulcers
* Ulcers healing under conventional therapy
* Sepsis
* Hematologic disorders
* Pregnancy
* Acute inflammatory disorders
* Chemotherapy
Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects

Our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose tissue (AT). Inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic acid, has proved valuable to combat the metabolic syndrome. Our proposal will determine whether part of the beneficial effects of this antilipolytic compound is due to a diminution of AT inflammation.

To this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects with or without a training program which goal is to enhance lipolysis.

24 male obese insulin resistant subjects will receive nicotinic acid or placebo for 16 weeks. The last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid. Insulin sensitivity and glucose tolerance will be assessed using, respectively, fasting-based estimates of insulin sensitivity (plasma and muscle) and oral glucose tolerance test. Plasma parameters of adipokines and, inflammatory and metabolic parameters will be determined. As an index of AT inflammation, the percentage and the phenotype of macrophages will be determined using flow cytometry of cells of the stromavascular fraction of subcutaneous AT. Macrophage infiltration will be investigated by light microscopy. The characterization of the inflammatory profile of AT will be completed by measurements of the expression of genes that are either specific markers of human AT macrophages or inflammatory and anti-inflammatory adipokines. This combination of approaches has never been carried out during a pharmacological intervention in humans. The following points will be addressed:

* determine the influence of lipolysis on AT inflammation, specifically on macrophage activation and adipokine production.
* examine the causal relationship between adipocyte FA metabolism, AT inflammation and insulin sensitivity.
* establish whether the beneficial effect of antilipolytic drugs may be attributable at least in part to a decrease in AT inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent form
* Age 25 to 45 year-old
* Male, insulin resistant obese subjects (30\<BMI\<40 kg/m2),
* Blood arterial pressure\<140/90 mmHg

Exclusion Criteria:

* History of cardiovascular disease
* Treatment with drugs which can interfere with cardiovascular system and autonomic nervous system (i.e. beta blockers).
* Treatment with nicotinic acid
* Treatment with fibrates, statins, cholestyramine and ezetimibe
* Treatment with thiazidics
* Fasted hyperglycaemia \> 1,26 g/l (Diabetes)
* Triglycerides \>5 g/l
* Blood arterial pressure \> 140/90 mm Hg
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits

This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits


Eligibility Criteria:
Inclusion Criteria:

* Between 18-28 years old

Exclusion Criteria:

* History of diagnosis with a neurological or psychiatric disorder.