cyrilzakka/clinical-trials huggingface dataset:
Development and Evaluation of A Mailed Arthritis Self-Management Program

The purpose of this study is twofold, to develop and test the effectiveness of a mailed arthritis self-management education intervention.

Effective self-management education programs for persons with arthritis have been developed, delivered in various formats, and found effective. Because of limited resources, however, many state health departments have found dissemination difficult, particularly to vulnerable populations. Researchers at the University of North Carolina at Chapel Hill and Stanford University will develop an evidence-based mail-delivered arthritis self-management program (Arthritis Yes I Can) that is feasible for state health department use and that can be self-tailored to meet the needs of diverse populations. The study will be conducted in three phases.

During Phase One (Development) researchers will collaborate with CDC advisors, arthritis experts from state health departments, and Project consultants to develop the curriculum and compact disc (CD) and print materials for mail-delivery. We will base Arthritis Yes I Can on curricula of two evidence-based programs, the Arthritis Self Help Course (ASHC) and the Chronic Disease Self Management Program (CDSMP), and develop English and Spanish versions.

During Phase Two (Evaluation) we will utilize both a randomized pre-test post-test (four month) delayed treatment control group design and a longitudinal cohort design to evaluate program effectiveness. We will recruit 900 individuals, 300 African Americans, 300 other English speakers, and 300 Spanish speakers, who: 1. Have been diagnosed with osteoarthritis or rheumatoid arthritis, or meet CDC criteria for chronic joint symptoms; 2. Are at least 18 years of age; and 3. Are able to complete informed consent, enrollment forms, and interviews/questionnaires. In addition, participants must not have participated in a previous arthritis self-management program and have access to a CD player. They must be willing to commit 8-12 hours of self-study over 4-6 weeks. We will use multiple recruitment methods, emphasizing collaboration with state and local health departments. We will measure: 1. Knowledge of Arthritis and Arthritis Self-Management, 2. Health-related Quality of Life (Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, Health Distress, and Depression); 3. Health Care Utilization; 4. Self-Management Behaviors; and 5. Self-Efficacy for Arthritis Self-Management and Arthritis Helplessness. We will also evaluate participant satisfaction with mail delivery, and determine the relative success of all recruitment efforts.

If the intervention is found effective in Phase Two, we will offer guidance to the Arthritis Program of the Centers for Disease Control and Prevention in adopting and distributing Arthritis Yes I Can (Phase Three, Dissemination).

Eligibility Criteria:
Inclusion Criteria:

* Report MD diagnosis of osteoarthritis or rheumatoid arthritis, or meet CDC criteria for chronic joint symptoms
* Are at least 18 years of age
* Are able to complete informed consent, enrollment forms, and interviews/questionnaires
Assessment of Esophageal Motility With Transnasal Endoscopy

The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.

Esophageal manometry is a gold standard for diagnosis of esophageal motility disorder. However, esophageal manometry can not detect non-occulsive contraction. Endoscopic evaulation of esophageal motility is difficult becausea swallowing is nearly impossible during endoscopy. Simplified trans nasal endoscopy (E.G. ScanTM, IntroMedic Co.,Ltd.)composed with dysplay system,controller,and disposable probe with compact size.

The esophageal motor function will be assessed with both esophageal manometry and simplifed trnasnasal endoscopy in patients with esophageal motility disorder (such as achalasia) and healthy volunteer. The results of simplifed trnasnasal endoscopy is compared with the results of esophageal manometry.

Eligibility Criteria:
Inclusion Criteria:

* 1) Healthy volunteer without organic esophageal or gastric disorder 2) Patients knwon esophageal motility disorder (such as achalasia)

Exclusion Criteria:

* severe organic esophageal disorder including severe reflux esophagitis, stricture, and bleeding.
* previous opertion of esophagus or stomach
* GI bleeding, mechanical obstruction
* medication which can infulence GI motility
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma

This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.


Eligibility Criteria:
Inclusion Criteria:

* Mild stable allergic asthma
* Positive skin-prick test to at least one common aeroallergen
* Positive methacholine challenge
* Positive allergen-induced early- and late-phase airway bronchoconstriction
* General good health

Exclusion Criteria:

* Lung diseases other than mild allergic asthma
* History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
* Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
* Use of tobacco products within one year starting study or smoking history \>10 pack years
* If female, pregnant or lactating or have positive pregnancy test at screening
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). In case of afebrile for 72 hours with empirical antibiotics treatment, patients will be randomized into 2 groups. In the early de-escalation group, antibiotics treatment will be stopped and prophylaxis with levofloxacin will be resumed. In the control group, the empirical treatment will continue until recovery of neutropenia or at least for 7 days.

This is a randomized study to evaluate the safety and feasibility of early de-escalation treatment of empyrical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). All patients undergoing HSCT will receive levofloxacin as regular prophylaxis. After patients develop neutropenia fever, the empirical antibiotics protocol will be impenem. In case of persistent for 48 hours, vancomycin will be added. If afebrile is achieved for 72 hours, all patients will randomized into early de-escalating group or control group. In de-escalating group, the empirical antibiotics treatment will be stopped and then levofloxacin prophylaxis will be resumed. In the control group, the empirical antibiotics treatment will be continue until recovery of neutropenia or at least 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18，patients undergo hematopoietic stem cells
* Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC \<0.5x109/L or predicted to be \<0.5x109/L in 24 \~48 hours；
* Patients achieved afebrile （T\<37.5°C）for at least 72 hours；
* Inform consent given

Exclusion Criteria:

* Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.
* Patients with septic shock
* Levofloaxin allergy or contra-indication
Safinamide Renal Impairment Trial

The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

1. Renally impaired subjects - Subject with different degrees of renal impairment: moderate and severe renal impairment as assessed by Estimated Glomerular Filtration Rate (eGFR) according to Modification of Diet in Renal Disease (MDRD) equation at screening
2. Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, electrocardiogram (ECG) and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to dosing
3. All subjects have given written informed consent before any study-related activities are carried out

Exclusion Criteria:

1. Any other clinically relevant disease, condition, or therapy, which in the Investigator's opinion would exclude the subject from the trial, may pose a risk to the subject or interfere with the trial objectives.
2. Existence of surgical or medical condition, which, in the judgment of the Investigator, might interfere with the absorption, metabolism, or excretion of the drug and/or gastrointestinal motility
3. Renally impaired subjects - Acute renal failure of any etiology (including viral, toxic, or drug induced), renal transplantation within the previous 12 months, uncontrolled diabetes mellitus as judged by the Investigator, use of any drug affecting gastric acid secretion, such as proton pump inhibitors and antacids received within 48 hours prior to drug administration and for 24 hours after administration, Chronic heart failure (CHF) New York Heart Association (NYHA) class III and IV despite treatment at screening, change in used medication (prescribed by a physician or over-the-counter \[OTC\] medication) within 14 days prior to safinamide administration. Concomitant medication used for the treatment of renal impairment and accompanying diseases may be continued during the trial.
4. Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to drug administration (or within six times the elimination half-life, whichever is longest), except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before trial drug administration.
Impact of Perioperative Shedding of the Endothelial Glycocalyx on Short-term Postoperative Complication in Patients Undergoing Robot-assisted Esophagectomy

The aim of this study was to determine whether changes in serum levels of syndecan-1 before and after surgery, which is an index related to injury of the endothelial glycocalyx layer, are associated with postoperative short-term complications and mortality in patients undergoing robotic esophagectomy.


Eligibility Criteria:
Inclusion Criteria:

1. patients 20 years or older who undergo robotic esophagectomy

Exclusion Criteria:

1. Emergency surgery
2. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
3. Chronic kidney disease (eGFR \<30 mL / min / 1.73 m2)
4. Pregnant and lactating women
5. Use of oral anticoagulants
CWT Versus AT on Selected Cardiovascular Indices and Functional Capacity in Patients With Ischemic Cardiomyopathy.

To compare between the effect of circuit weight and aerobic training on selected cardiovascular indices and functional capacity in patients with ischemic cardiomyopathy.

Ischemic cardiomyopathy (ICM) is a term that refers to the heart's decreased ability to pump blood properly due to myocardial damage brought upon by ischemia. Ischemic cardiomyopathy has a spectrum of clinical changes which eventually leads to congestive heart failure (CHF). Initially, there is a reversible loss of cardiac contractile function because of decreased oxygen supply to the heart muscle; however, when there is ischemia for a prolonged period, there is irreversible cardiac muscle damage resulting in cardiac remodeling. Remodeling is primarily achieved by myocardial fibrosis which results in decreased cardiac function, arrhythmia, and possible cardiac conduction system impairment. In ischemic cardiomyopathy, there is a significant impairment of the left ventricular systolic function, with a left ventricular ejection fraction (LVEF) less than 40% (Bhandari et al., 2021).

Eligibility Criteria:
Inclusion Criteria:

* Sixty male patients with ischemic cardiomyopathy as a result of a recent acute myocardial infarction event (≤2 months) with 40%\<LVEF\<50%.
* They are functionally classified as class II according to New York Heart Association (NYHA).
* Their age will be ranged from 45 to 55 years old.
* Their BMI will be ranged from 25 to 29.9 kg/m².
* They will have good mentality.

Exclusion Criteria:

* Recurrent coronary heart disease.
* Severe valvular diseases.
* Underlying pulmonary disease (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc.).
* Inability to ambulate owing to physical problems (paresis induced by cerebral stroke, spinal cord injury, amputation, severe pain, dyspnea, etc.).
* muskloskletal problems (e.g. severe osteoarthritis or ankylosing spondylitis).
* Impaired cognitive function (vascular dementia, Alzheimer's dementia, other psychological disease, etc.)
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18 to 45 years of age inclusive
* Body mass index 18.0 - 32.0 kg/m2, weight \>/= 50 kg
* Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Non-smoker
* Medical history without major, recent or ongoing pathology
* Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration

Exclusion Criteria:

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
* Routine use of more than 2 g of acetaminophen daily
* History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
* History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
* Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults with Inflammatory Genodermatoses

The goal of this clinical trial is to learn about deucravacitinib treatment in adults with inflammatory epidermal genodermatoses . The main question it aims to answer are: describe efficacity and safety of this treatment.

Participants will take treatments and have to use bullets during the study period.

The patient will have 8 visits After Confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the study Treatment Period (Period 1); challenge period This period will be the first treatment period that will occur from 16 weeks. During this period the patient will see the doctor at the hospital, he will perform the study procedures The second period : dechallenge (period 2): All patients stop their treatment for 12 weeks.

The second treatment period - rechallenge (period 3) the patient will take the treatment for a second 16 weeks period At week 44 - End of study

At each visit:

The investigator at each visit compliance to the treatment and adverse events, Measure vital signs and perform clinical examination.

The patient will assess the different questionnaires, for the study and have blood sample

Eligibility Criteria:
Inclusion Criteria:

* Subject has congenital skin fragility with skin and/or mucosal blisters, a clinical phenotype of EBS-sev and a laboratory confirmed diagnosis of EBS by KRT5 and/or 14 mutation (autosomal only) OR a clinical phenotype of inflammatory ichthyosis (IC) including keratinopathic ichthyosis due to KRT1/10 mutation, ECI with identified genetic mutations (TGM5, NIPAL4, ABCA12, etc...).
* Subject has at least a mean daily number of 4 new blisters (EBS-sev) OR an ISS \> 50/128.

  * Subject agrees not to use any topical therapies other than the investigator approved.

Exclusion Criteria:

* Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
* Infectious/Immune-related Exclusions
* Medical History and Concurrent Diseases
A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia

The purpose of this study is to compare the efficacy and safety of daily topiramate versus placebo for the treatment of obese subjects with dyslipidemia.

Topiramate is not approved for the treatment of obesity. Studies have shown that topiramate reduces weight in obese patients with or without Type 2 diabetes, and may have the adjunctive benefit of reducing triglyceride and cholesterol levels in these patients. This double-blind, placebo controlled study evaluates the long-term efficacy of topiramate for reduction of weight and triglyceride levels in obese patients with borderline to high hypertriglyceridemia, and the safety and tolerability of topiramate in this patient population. The study consists of four phases: 4-week enrollment (screening) phase, 8-week titration phase (topiramate dose will be increased from 16mg/day to the assigned dose), 52-week maintenance phase, and 6-week follow-up. Effectiveness of topiramate will be evaluated by multiple measurements such as change in body weight, body mass index, fasting serum triglyceride levels, cholesterol and other lipid profiles. Safety evaluations will include incidence/severity of adverse events, vital signs, clinical laboratory results. The hypothesis is that topiramate as compared to placebo will provide a greater percent reduction in body weight and in fasting serum triglycerides from Week 0 (baseline) to Week 60. After the initial 8-weeks titration phase, the patients will be randomized to receive either 96mg (48mg twice daily) or 192mg (96mg twice daily) topiramate or placebo (twice daily) by mouth for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A Body Mass Index (BMI) \>= 27 kg/m\^2 and \<50 kg/m\^2
* Stable weight at least four months prior to the first enrollment visit
* Diagnosis of dyslipidemia (serum triglycerides representative of mild to moderate hypertriglyceridemia and low HDL or high LDL)
* Patients on lipid lowering medication should be on monotherapy with the same drug for at least 4 months and on the same dose for at least 2 months prior to the first enrollment
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Contraindication or hypersensitivity to topiramate
* Pregnancy, nursing or women who plan to become pregnant during the study
* Enrollment fasting triglycerides \<175 or \>= 1000 mg/dL, and/or LDL \>= 190 mg/dL
* Hyperlipidemia secondary to known disease
* Other significant medical conditions such as cardiovascular or liver disease
Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes

The investigators are doing this study to see the effect of insulin degludec in pregnant women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin degludec is compared to another medicine called insulin detemir. Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance. Participants will get pre-filled insulin pens. Participants will need to take blood sugar measurements several times a day. The study will last between 10 and 25 months depending on whether participants are already pregnant when they join the study. The number of visits and the tests ( for example blood and urine samples and ultrasound scans) the participants will have also depends on whether they are pregnant at study start.


Eligibility Criteria:
Inclusion Criteria: - Female, age at least 18 years at the time of signing informed consent - Diagnosed with type 1 diabetes mellitus for at least 1 year prior to the day of screening - Treated with multiple daily subcutaneous insulin injections or continuous subcutaneous insulin infusion (CSII) or inhaled insulin for at least 90 days prior to the day of screening - The subject is planning to become pregnant within 12 months from randomisation and willing to undertake pre-pregnancy counselling or the subject is pregnant with an intrauterine singleton living foetus (gestational week 8 to 13 (+6 days)) without any observed anomalies at randomisation, confirmed by an ultrasound scan - HbA1c at screening below or equal to 8.0% (64 mmol/mol) by central laboratory Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening - Pregnant and having proteinuria as evaluated by urine protein-to-creatinine ratio above or equal to 300 mg/g in urine sample measured at screening - Subject being treated or became pregnant with assistance of in vitro fertilisation or other medical infertility treatment - Receipt of any concomitant medication contraindicated in pregnancy according to local label within 28 days before screening and between screening and randomisation for non-pregnant subjects and 28 days before conception and between conception and randomisation for pregnant subjects - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or pharmacologically dilated fundoscopy performed within the past 90 days prior to randomisation for non-pregnant subjects or within 28 days prior to randomisation for pregnant subjects. - History of severe hyperemesis gravidarum (requiring hospitalisation)