cyrilzakka/clinical-trials huggingface dataset:
Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients

COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles.

The most prominent independent risk factor for cognitive impairment in COPD patients is reduced oxygen availability as a result of lung dysfunction. The prevalence of cognitive impairment in COPD patients ranges from 10% to 61%. A wide variety of tools have been developed for screening cognitive functions. The most widely used tests covering multiple cognitive domains are the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

When two tasks are performed at the same time, they compete for sources of attention, resulting in decreased performance on one or two tasks. Balance or postural control is a complex skill required for independent mobility and preventing falls. Balance performance naturally decreases with age; however, certain conditions are associated with more pronounced and rapid declines. Balance problems and fall risk are increased in COPD patients.From this perspective aim of this study is to assess the effect of square-step exercise and strengthening exercise applied with telerehabilitation on cognitive status and balance in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with mild / moderate COPD by Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Chest Diseases.
* Mini mental score is 23 or higher
* Being between the ages of 50-80
* Spirometric evaluation result is forced expiratory volume at one second / Forced vital capacity \<70% and airflow restriction is 50% forced expiratory volume at one second \<80% (expected) degree compared to post-bronchodilator forced expiratory volume at one second.
* No drug change or antibiotic use due to acute exacerbation for at least three weeks

Exclusion Criteria:

* Individuals who need continuous oxygen support
* Individuals with partial pressure of carbon dioxide≥70 mmHg
* Having a history of uncontrolled illness that may affect cognitive skills
* Have uncorrected vision and hearing impairment
* Having kyphoscoliosis and/or severe postural impairment
* Having additional risk factors (stroke, neurological disease, dementia, depression, postural hypotension, diaphragm dysfunction)
Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort

Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators...). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.

There is few data on the stability of these antibodies, most of the studies are cross-sectional. There are conflicting results among scarce longitudinal data. One study reported a negativation of anti-glycan antibodies in some cases but not of ASCA or ANCA.

On the cohort of 195 patients included in the first study, the investigator would like to assess at 3 years the immunological profiles of these patients and thus to compare them. In case of modification of the serological status for some antibodies, the search for associated factors (clinical, biological or therapeutic) will be performed. In case of sero-negativation of anti-glycan antibodies, this could be linked with a decrease or a normalization of the increased intestinal permeability in IBD. Indeed, in this subgroup of patients, we will test this hypothesis by analyzing intestinal permeability in anti-glycan positive group on the 2 samples and in the group with a sero-negativation on the second sample.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in previous study (AOL 2010) and followed in our department, accepting blood sampling and stool analysis
* Written consent of the patient

Exclusion Criteria:

* Patient who decline to participate to the study
* Patient in the incapacity to give consent
* Patient deprived of their liberty by a judicial or administrative decision
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents

The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 years.
* Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
* Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

* Patients with identified causes of diarrhea other than E. histolytica.
* Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
* Females who are pregnant, suspected of being pregnant or breastfeeding.
* Serious systemic disorders incompatible with the study.
* History of hypersensitivity to nitazoxanide.
* Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
* Patients with amebic liver abscess.
* Patients known to have or suspected of having AIDS.
* Patient with immune deficiencies.
An Explanatory Factors Analysis of Inflammatory Bowel Diseases(IBD's) Management Costs for Adults Patients Treated by Biotherapy and Followed at Nancy University Hospital

The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

1. Patients consulted at the Gastroenterology services of Nancy University Hospital during the period of inclusion
2. Patients over 18 of age the day of consultation
3. Patients treated at least one time by biotherapy during the last 12 months preceeding inclusion
4. Patients with crohn's disease or ulcerative colitis.
5. Patients accepting to respond to the questionnary

Exclusion Criteria:

* Age under 18 years , the day of consultation
* Patient that not accept or unable to complete the retrospective questionnary
Selonsertib in Adults With Pulmonary Arterial Hypertension

The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug- and toxin-induced PAH, or PAH associated with connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital heart defects (repaired greater than 1 year prior to Screening)
* Meet all of the following hemodynamic criteria by means of a screening right heart catheterization (RHC) completed prior to randomization:

  * Mean pulmonary artery pressure (mPAP) of greater than or equal to (≥) 25 millimeters of mercury (mm Hg)
  * Pulmonary vascular resistance (PVR) ≥ 400 dyne\* second/centimeter\^5 (dynes\*sec/cm\^5)
  * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of less than or equal to (≤) 12 mm Hg if PVR ≥ 400 and less than (\<) 500 dynes\*sec/cm\^5, or PCWP/LVEDP ≤ 15 mm Hg if PVR ≥ 500 dynes•sec/cm\^5
* Be able to walk a distance of at least 100 meters
* Have World Health Organization (WHO) Functional Class II or III symptoms
* Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:

  * Forced expiratory volume in one second (FEV1) ≥ 55 percent (%) of predicted normal
  * FEV1: forced vital capacity (FVC) ratio ≥ 0.60
* Receiving treatment with one or more drugs approved for PAH for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks

Key Exclusion Criteria:

* Diagnosis of PAH associated with significant venous or capillary involvement (PCWP greater than \[\>\] 15 mm Hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects
* Pulmonary hypertension (PH) belonging to groups 2 to 5 of the 2013 NICE classification
* Left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease
* Uncontrolled hypertension (≥ 180/110 mm Hg) at Screening
* End stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation)
* Severe liver disease (Child-Pugh Class C, with or without cirrhosis)

Individuals may be rescreened one additional time with prior notification to and approval by the sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

Obesity is an ongoing major public health problem in most countries of the world for which the agrifood industry still remains criticized because of the abundant offer of high sugar-lipid-energy dense foods, particularly in the fast-food sector. The resulting societal pressure on the food industry probably explains in part the efforts that have been deployed to seek natural active ingredients and to develop functional foods favorably influencing energy balance. Capsaicin is a food non-nutrient constituent that was shown to decrease appetite sensations and subsequent energy intake. The measurement of heart rate variability revealed an association between the increase in sympathetic nervous system (SNS) activity and the satiating effects induced by capsaicin. This is concordant with the observation that pre-prandial intake of capsaicin, be it in capsules or diluted in tomato juice, increased satiety and reduced energy intake.

The objective of this study is to evaluate the long effects of Capsimax on appetite sensations and energy expenditure under conditions of moderate energy restriction and to evaluate the long-term effects of Capsimax on energy intake and expenditure under conditions of moderate energy restriction.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* Between 18 and 50 years
* Healthy
* Non-smoker
* BMI between 25 and 35 kg/m2
* Weight stability

Exclusion Criteria:

* Pregnant or menopausal woman
* History of losing and gaining weight (yo-yo)
* Taking medication for diabetes, hypertension, depression, or hypothyroid
* Taking a supplement for weight loss
* Vegetarian, vegan, intolerant to gluten or pepper (investigational product), and severe allergy to peanuts or nuts
* Suffers from Irritable Bowel Syndrome or gastro-oesophageal reflux
* Suffers from stomach ulcers or inflammation
* Other serious conditions such as cardiovascular, renal, liver, and lung diseases
* History of drug abuse and current alcohol abuse
* Use of any medication (including over-the-counter medications and herbal remedies) such as grapefruit juice, piperine, NSAIDs, etc.
MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease

Since prostate specific antigen (PSA) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. The present choice of treatment for men with localized prostate cancer lies between active surveillance and radical therapy. Thus, the option of treating only the cancer within the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very controversial. At present there are no consistent scientific data on focal therapy and its major effectiveness.

Focal therapy for prostate cancer is defined as therapy that selectively ablates known disease while preserving existing functions, with the overall aim of minimizing lifetime morbidity without compromising life expectancy.

The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.

The study i designed as Phase 1, treatment \& resection protocol. With this project the investigators further aim to evaluate the safety and identify side effects of Magnetic Resonance guided Focused Ultrasound in treating focal prostate cancer.

This design will also expand knowledge of the effect of Magnetic Resonance guided Focused Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted after this non-invasive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient of age between 40 to 85
* Patient with organ-confined Pca (cT1c and cT2a, N0, M0), diagnosed with TRUS biopsy (min:12 cores)
* Patient with PSA ≤ 10 ng/mL
* Gleason score 6 (3+3) or max 7 (3+4)
* Up to two (2) MR identifiable lesions
* No definite evidence of extracapsular extension

Exclusion Criteria:

* Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
* Any rectal pathology, anomaly or previous treatment
* Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall
* Bladder cancer
* Seminal vesicle/lymph node
* Prostate with multiple cystic lesions
Tissue Repository: CTCL Collection Protocol

This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.

CTCL is a heterogeneous group of non-Hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant T cells in the skin. In order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from CTCL patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations.

Scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. This type of information will thus be of great advantage to future patients with these diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CTCL or Lymphomatoid Papulosis (LYP): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed CTCL or LYP who are initiating or changing therapy.
* Patients with Sézary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) ≥1000/μL Sézary cells by morphology; (2) Cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) ratio ≥10; (3) CD4+cluster of differentiation 7 (CD7)- cells ≥40 percent; (4) or CD4+cluster of differentiation 26 (CD26)- cells ≥30 percent.
* Ability to understand and willing to sign a willing informed consent document.
* Age ≥ 18 years.

Inclusion Criteria for Age and Sex Matched Controls:

* Matched for sex, and age +/- 10 years.
* Ability to sign informed consent document.
* Patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or Patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents.

Exclusion Criteria:

* Patients with a history of previous lymphoma other than CTCL or SS or LYP.
* Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.
* Current, viable pregnancy.
* Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.

Exclusion Criteria for Age and Sex Matched Controls:

* Previous history of CTCL, SS, LYP, or any lymphoma.
* Previous history of Human Immunodeficiency Virus (HIV) infection.
* Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.
Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis

Cognitive behavioral therapy for insomnia (CBT-I) has been the 'gold standard' for the treatment of insomnia. There is a need to increase access to treatment, particularly for patients in more rural locations where providers may be scarce. One solution is to utilize telemedicine which is "the use of electronic communications to provide and support health care when distance separates the provider from the patient." So the purpose of the study is to determine if receiving CBT-I by video teleconferencing works just as well as in-person treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meet current DSM5 criteria for Insomnia Disorder as determined by clinician interview
* ISI score greater than 14, with self-reported duration of insomnia of at least 3 months
* Ability to read and speak English
* Own a personal computer with an internet connection sufficient to utilize the SleepTM and REDCap platform
* BMI less than 30
* Between the ages of 21-50

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Individuals with an untreated sleep disorder other than insomnia (Individuals with sleep apnea who are adherent with CPAP treatment (average 4 hours use per night) will be eligible to participate)
* A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months
* Individuals with substance abuse/dependence, bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
* Individuals with prominent current suicidal or homicidal ideation
* Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing, or cognitive impairment
* Any use of medications or OTC products that might impact sleep or metabolism
Social Dysfunction and Brain Dysfunction in Patients With Schizophrenia

There were a few studies about the relationship of structural or functional abnormalities of brain and social cognitive dysfunctions in patients with schizophrenia. In addition, default network, which increases activity during mental explorations referenced to oneself including remembering, considering hypothetical social interactions, and thinking about one's own future, may be associated with social cognitive dysfunctions in patients with schizophrenia. Therefore, we will investigate the dysfunction of default network in patients with schizophrenia compared with healthy controls and the effect of default network dysfunctions on the social cognition in patients with schizophrenia.


Eligibility Criteria:
Patients group inclusion criteria:

* Right-handed
* Intelligent Quotient(IQ) above 80
* can read and understand the informed consent
* schizophrenia patients who was diagnosed from Structured Clinical Interview for Diagnostical and Statistical Manual of Mental Disorder 4th edition(DSM-IV, nonpatient version(SCID-NP) scales
* patient who has had reality distortion symptoms (like delusion or hallucination) in 5 years

Control group inclusion criteria :

* Right-handed
* IQ above 80
* do not have any diagnosis from SCID-NP scales
* do not have any family members who have psychiatric disorder

Exclusion criteria:

* have Illness which can affect brain structures and functions
* can't be taken magnetic resonance imaging(MRI)
Advanced Diffusion Tensor MRI for Breast Cancer

The purpose of this research is to evaluate the accuracy of the BIT-Motion (Breast Imaging Tensor-Motion) software with non-contrast MRI scanning to detect breast cancer.

The goal of this study is to answer the question: what is the ability of the BIT-Motion (Breast Imaging Tensor-Motion) software to detect and discriminate between benign and malignant breast lesions that are identified on mammogram (MG) and ultrasound (US) examinations. Women over the age of 18 who have a breast lesion that is seen on MG or US will be eligible to enroll. Participation in this study will involve one non-invasive non-contrast MRI scan of the breasts.

Eligibility Criteria:
Inclusion Criteria:

* Female
* scheduled for ultrasound or stereotactic guided breast biopsy
* \> 18 years of age
* able to tolerate up to 90 minutes in the MRI scanner

Exclusion Criteria:

* Male
* Has a medical condition that, in the opinion of the investigator, puts the subject at significant risk
* Has any contraindication to the MRI examination as determined by standard NorthShore University Health System relative to MRI safety
* Cannot comprehend or complete the Informed Consent Form
Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors

This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.

PRIMARY OBJECTIVES:

I. To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT.

SECONDARY OBJECTIVES:

I. To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.

OUTLINE:

Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes.

This study compares the experimental images to the regular medical care images in the same participant.

Eligibility Criteria:
Inclusion Criteria:

* Patient provides written informed consent
* Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)

Exclusion Criteria:

* Patient is pregnant or nursing