cyrilzakka/clinical-trials huggingface dataset:
Impact of Hidradenitis Suppurativa on Quality of Life Functions

The goal of this study is to get a better understanding of the impact of Hidradenitis Suppurativa (HS) on the quality of life of patients with this condition. Patients with HS will be asked questions about demographics including gender, age, and ethnicity. They will also be asked to complete questionnaires to determine how their skin condition affects their life. Study participation will last for 1 day, with potential for follow-up in the future. We hope this information will help us improve our treatment for this skin condition.

The goal of this study is to get a better understanding of the impact of the skin condition, Hidradenitis Suppurativa, on quality of life function of patients. Patients with HS will be asked questions about demographics including gender, age, and ethnicity. They will also be asked to complete questionnaires to determine how their skin condition affects their life. The questionnaires include Beck Depression Inventory form, which gives us information how you feel about your skin condition and how it changes your mood; Dermatology Life Quality Index (DLQI), which gives us information about how your skin condition affects your quality of life; Skindex, which gives us more specific information about how your skin condition affects your quality of life; SF-36 health survey, which gives us information about your general health status; the Quality of Life Enjoyment and Satisfaction Questionnaire- short form (Q-LES-Q-SF), which gives us information on your enjoyment and satisfaction of your life; and the Employment/Productivity Health Economic Questionnaire, which will give us more information on your work and school status as well as household income. Study participation will last for 1 day, with potential for follow-up in the future. Through potential follow up visits we hope to determine the longitudinal effect of treatment modalities on QoL through future survey performance of the patient cohort. We hope this information will help us improve our treatment for this skin condition.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hidradenitis suppurativa
* Subject age \>/= 18 years
* Able to be evaluated by a Montefiore physician

Exclusion Criteria:

* No clinical diagnosis of hidradenitis suppurativa
* Subject age \< 18 years
* Subject unable to understand or answer provided questionnaires
* Unable to evaluated by a Montefiore physician
Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)

The aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active RA who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland. The length of the entire study will be 24 months.


Eligibility Criteria:
Inclusion Criteria:

* participants at least 18 years of age
* a diagnosis of moderate to severe RA
* treating physician has made the decision to commence tocilizumab in first line biologic treatment (population of DMARDs inadequate responders or participants who are intolerant to DMARDs) in a routine clinical practice in Poland
* informed consent

Exclusion Criteria:

N/A
Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules

This study evaluates the viability and accuracy of preoperative mixed reality technique combined with three-dimensional printing navigational template guided localizing pulmonary small nodules.

Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. Mixed reality (MR) technique aims to enhance the simple self-visual effect and facilitate visualization of the surrounding environment in any situation. The three-dimensional model can be visualized by MR technique through MR glasses. Investigators project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest, and then use this as a guide for percutaneous lung puncture localization. At the same time, investigators design an three-dimensional printing navigational template based on the 3D reconstruction model and place it on the surface of the body to help to guide the localization. This study is designed to evaluates the viability and accuracy of preoperative mixed reality technique combined with 3D printing navigational template guided localizing pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

* a maximum target lung nodule (one or more) diameter ≤20 mm
* a target nodule CTR \<0·25 or a minimum distance from the outer edge of the nodule to the nearest pleural surface \>10 mm if the target nodule CTR was \>0·25.
* Plan to perform VATS lung wedge resection

Exclusion Criteria:

* Inability to comply with research protocols or research procedures
* Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease
* Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture
* Pregnant or lactating women
* Other circumstances that the investigator believes are not suitable for enrollment
Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants

The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.

In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: Flexible Ch-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate and vital parameters during laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born less than 37 weeks of gestation
* Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)
* Written informed consent signed by caregivers or legal representative to participate

Exclusion Criteria:

* Refusal to participate in study or not providing written informed consent by caregivers/parents
* Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.
* Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth
* Estimated birth weight \< 3rd percentile using 2013 Fenton growth trajectories
* Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery
* Contraindications listed in the LISAcath® or Nasogastric Tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)
Evaluation of the QuantiFERON-TB Test.

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.

Eligibility Criteria:
Low-exposure Risk Group

Inclusion Criteria:

* No identified risk factors for TB infection

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Identified Risk Factors For TB Infection

Non-tuberculous mycobacterial infection Group

Inclusion Criteria:

* history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Identified Risk Factors For TB Infection
Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis

Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis.

The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old,
* Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria,
* Hospitalisation at any point for treatment of ulcerative colitis disease relapse,
* Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay,
* Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks,
* Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data.

Exclusion Criteria:

* Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,
* Receiving JAKi prior to admission,
* Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.
Adaptive Cardiac Resynchronization Therapy Study

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

The trial has 3 primary end points:

* to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm
* to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings
* to demonstrate that aCRT does not result in inappropriate AV or VV delay settings

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign and date the study Informed Consent form
* Subject is at least 18 years of age (or older, if required by local law)
* Subject is expected to remain available for at least six months of follow-up visits
* Subject is indicated for a study device that will be implanted within 30 days after signing the Informed Consent form
* Subject has an intrinsic QRS duration greater than or equal to 120 milliseconds (documented within 30 days prior to enrollment)
* Subject has a left ventricular ejection fraction less than or equal to 35 percent (method per physician discretion) (documented within 180 days prior to enrollment)
* Subject is diagnosed with New York Heart Association (NYHA) class III or IV (within 30 days prior to enrollment) despite optimal medical therapy which is defined as: ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least one month prior to implant, AND beta-blocker for at least three months preceding implant, if tolerated, and stable for one month, OR subject has an urgent medical need for an implantable cardioverter defibrillator (ICD) that precludes waiting the one or three months for the medication requirements for ACE inhibitor, ARB or beta-blocker

Exclusion Criteria:

* Subject has chronic (permanent) atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject has existing CRT system
* Subject has non-intact or unstable leads
* Subject has medical conditions that would limit study participation (per physician discretion)
* Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) (documented within 30 days prior to enrollment)
* Subject has a mechanical right heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study
* Subject is post-heart transplant (subjects on the heart transplant list for the first time are not excluded)
* Subject has a limited life expectancy that would not allow completion of the 6 month visit
* Subject is pregnant (In the United States, all women of child-bearing potential must undergo a pregnancy test within seven days prior to aCRT download into device)
* Subject meets the exclusion criteria required by local law
Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status

This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires.

The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation Unit.

During this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home.

The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.

Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on the Neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-24,
* Presenting a normal BMI (18-25),
* Right-handers,
* Affiliated to a social security scheme
* Having given a free, informed and written consent.
* Having a low frequency of consumption of fatty and / or sugary / salty foods, or on the contrary, a high frequency of consumption of these foods.

Exclusion Criteria:

* Related to the study:
* High level athletes, (determined on the basis of the Ricci \& Gagnon questionnaire - excluded if score \> 32);
* Food abstinents for religious, ideological or health reasons (intolerance, vegetarianism, allergies, etc.);
* Family history of obesity or diabetes;
* Personal history of TCA, anxiety or depressive disorder, or proven addictive behaviour;
* Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the AUDIT questionnaires - excluded if score \> 7 and CRAFT - excluded if score\> 2 " yes ");
* Smoking daily or having stopped for less than 6 months;
* History of bariatric surgery;
* On-going treatment in the nutrition unit;
* Insufficient command of French;
* Pregnant or nursing women;
* Persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
* Simultaneous participation in another research protocol involving the human person

Related to fMRI:

* Implantable cardiac pacemaker or defibrillator;
* Neurosurgical clips;
* Cochlear implants;
* Neural or peripheral stimulator;
* Foreign orbital or brain metallic foreign bodies;
* Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
* Claustrophobia.
Cranberry Consumption Improves γδ T Cell Function

The purpose of this study is to determine the extent to which consuming a cranberry beverage modifies immune function, specifically related to γδ T cells and other innate immune cells. It is hypothesized that cranberry components will interact with immune cells to activate signaling pathways that enhance cell function. Enhanced immune cell function should result in reduced number, duration, and severity of cold and flu symptoms.


Eligibility Criteria:
Inclusion Criteria:

* between 21 and 35 years of age and in good health
* have a BMI between 18.5 and 29.9
* willing to consume the study beverage for 12 weeks
* willing to have a small amount of blood drawn two times
* willing to stop consuming tea and immune-enhancing dietary supplements (e.g. antioxidant-, probiotic-, or flavonoid-containing supplements, fish oil, and Echinacea) before and during the 12 weeks of the study
* willing to consume no more than 7 servings of fruits and vegetables a day
* willing to limit your alcohol consumption to no more than 14 glasses a week
* willing to limit your yogurt consumption to no more than one 8oz. serving per day

Exclusion Criteria:

* have food allergies
* have hypertension
* taking non-steroidal anti-inflammatory drugs on a chronic basis, antibiotics, or immunosuppressive drugs
* sensitive to aspirin or prone to kidney stones
* current smoker
* pregnant, lactating, or on hormone therapy, except for birth control pills
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Biopsy-proven IgA nephropathy
* Proteinuria ≥ 2g/24hr or equivalent
* Receiving physician-directed optimized standard of care that includes ACEI and/or ARB.
* Estimated glomerular filtration rate (eGFR) \>40mL/min/1.73m2

Exclusion Criteria:

* Clinical or histologic evidence of non-IgA-related glomerulonephritis
* IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
* Meets eGFR criteria
* Malignancy within past 5 years
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
* Liver disease
* Neutropenia
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
* History of active tuberculosis or a history of tuberculosis infection
* Pregnant or nursing
Evaluating Tolerability of EPUHRT with Brachytherapy Boost

The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Capable of providing informed consent and HIPAA authorization
3. Karnofsky performance score ≥ 70
4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
6. Up to date colon cancer screen per per American Cancer Society guidelines

Exclusion Criteria:

1. Prior pelvic irradiation treatment
2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
3. Evidence of nodal or distant disease on screening diagnostic work up.
4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
5. International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy
GW572016 For Treatment Of Refractory Metastatic Breast Cancer

This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent.
* Histologically confirmed Stage IIIb or IV breast cancer.
* Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
* Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
* Documented disease progression of the most recent treatment is required.
* Archived tumor tissue available for testing.
* Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
* At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
* Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
* Able to swallow and retain oral medication.
* Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
* Adequate kidney and liver function.
* Adequate bone marrow function.

Exclusion criteria:

* Pregnant or lactating.
* Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
* Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
* History of other malignancy.
* Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
* Active or uncontrolled infection.
* Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
* Known history of or clinical evidence of leptomeningeal carcinomatosis.
* Active infection.
* Concurrent cancer therapy or investigational therapy.
* Use of oral or IV steroids.
* Unresolved or unstable serious toxicity from prior therapy.
* Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.