cyrilzakka/clinical-trials huggingface dataset:
Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments

The aims of this three-year study are to explore symptom experience and its related factors for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin for 24 weeks and further to predict the relative risk of failure or occurence of severe side effects which interrupt the treatment.

The antiviral treatment, interferon-α with ribavirin, has been used in treating chronic hepatitis C patients to prevent the development of liver cirrhosis and hepatocellular carcinoma. However, the duration of this treatment needs at least 6 months and severe side effects such as anemia, fatigue, depression with suicidal thoughts can occur at any time throughout the treatment. There has been no study related to the issue of the risk to the population of developing these severe side effects and failing the treatment. Therefore, the aims of this three-year study are to explore symptom experience and its related factors for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin for 24 weeks and further to develop a prediction model for individuals to predict the relative risk of failure or occurence of severe side effects which interrupt the treatment. Patients will be recruited from outpatients in two hospitals in Northern and Middle Taiwan. A longitudinal study is designed with a one-year follow-up at pre-treatment, and at the 1, 2, 4, 6, 8, 12,16,20, 24 weeks during treatment, and at the 4, 12, 24 weeks of post-treatment. The basic information including the laboratory data, the Symptom Distress Scale, the Fatigue Symptom Inventory, the Hospital Anxiety and Depression Scale, MOS, and the Short-Form 12 Health-Related Quality of Life questionnaires will be used to assess patients' demographic characteristics, symptom experience, fatigue, depression, anxiety, sleep disturbance, and quality of life during the treatment. Three hundred patients will be interviewed within three years. The data will be analyzed using descriptive, independent t-test, Pearson's correlation, Analysis of Variances, generalized estimating equations, logistic regression, and classification tree. We expect this study to explore the characteristics of the population with high risks of treatment failure to severe side effects during treatment in Taiwan. In addition, the results can provide the information for clinicians and researchers to tailor interventions to individual needs.

Eligibility Criteria:
Inclusion Criteria:

* patients with Chronic Hepatitis C Infection Receiving 24-week Interferon-α with Ribavirin Treatments
* Those Who willing to participate in the research
* Aged above 18

Exclusion Criteria:

* None
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.

Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.

Eligibility Criteria:
Inclusion Criteria:

1. Infants \< 366 days,
2. Ileostomy / Jejunostomy,
3. double loop enterostomies and split enterostomies (with mucous fistula)
4. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child

Exclusion Criteria:

1. resection of ileocecal valve,
2. colostomy,
3. small bowel atresia,
4. multiple ostomies (more than just an enterostomy and a mucous fistula),
5. chromosomal abnormalities (if known at the time of randomization),
6. Hirschsprung's disease,
7. participation in another drug-intervention study
8. Intestinal perforation due to a hemodynamic heart defect
The Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic Dermatitis

Since 2000 therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced as therapeutics of atopic dermatitis (AD). These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. S. aureus induces further dysregulation of the inflammatory process and increased colonization with S. aureus is correlated with increased AD severity. Based on the theoretical mode of action and clinical experience, we assume a higher effectiveness of antimicrobial therapeutic clothing compared to control therapeutic clothing on reducing AD severity. The goal of this study is to assess the effectiveness of antibacterial clothing based on silver or chitosan on the doctor-reported AD severity in patients with moderate to severe AD. Secondary goals are to retrieve information about the effect of antimicrobial clothing on clinical symptoms, quality of life, S. aureus colonization, AD medication use and the satisfaction regarding the clothing.

This is a multi-center, double-blind, randomized controlled trial. Patients will be randomized in a 1:1:1 fashion to either therapeutic clothing without antimicrobial agents, antimicrobial therapeutic clothing based on chitosan or antimicrobial clothing based on silver for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
* Atopic dermatitis severity according to EASI at t = 0: \> 6.0.

Exclusion Criteria:

* Treatment with oral antibiotics until 1 month before inclusion;
* Treatment with topical antibiotics until 1 week before inclusion;
* Treatment with systemic immunosuppressive agents or light therapy until 1 month before inclusion;
* Treatment with (antibacterial) therapeutic clothing until 1 month before inclusion;
* Impaired kidney function (anamnestic assessed)
* Pregnancy or pregnancy wish during study (anamnestic assessed)
* Hypersensitivity to silver (anamnestic assessed)
* Evidence of past non-compliance to treatments or appointment
Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

The thymus gland is a specialized organ in the chest that plays a central role in the adaptive immune system throughout development until puberty. In response to stress, the fetal thymus gland may shrink, or involute. The investigators propose a prospective cohort study that will enroll pregnant women admitted to labor and delivery for the management of preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on sonographic thymus measurements, the investigators will develop a clinical prediction tool to identify babies who are at increased risk for adverse neonatal outcomes. A reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has the potential to affect clinical management, improve outcomes for premature babies, and direct further research efforts.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy between 28-36 weeks gestation
* Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM)

Exclusion Criteria:

* Non-singleton pregnancies
* Gestational hypertension/preeclampsia
* Major fetal anomalies
* Known fetal aneuploidy
* Intrauterine Fetal Demise
Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* For Part 3 subjects, the following cardiovascular abnormalities:

  * QRS duration \>110 ms
  * Incomplete right bundle branch block or any complete bundle branch block
  * Heart rate \<40 or \>90 beats per minute (per vital sign capture while rested)
  * History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
  * Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
  * PR interval \>220 ms or any 2nd or 3rd degree AV block
  * Ventricular pre-excitation
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at Screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons with Diabetes

Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
* Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
* Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.

Exclusion Criteria:

* Known sensibility to any of the ingredients in the products.
* Other diagnosed skin disease on the feet.
* Active lesions on either foot.
* Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
* Potential study subjects judged unable to comply with treatment schedule and study specific information.
* Female of childbearing potential that do not use effective medically accepted contraception.
Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy

Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.

The incidence of cancer is always increasing and it is predicted that the incidence will increase to 45% by 2030(1). The introduction of new chemotherapeutic agents significantly improved survival, but also revealed large spectrum of cardiotoxicity manifestations (2). There are many factors that increase the risk of cardiotoxicity caused by different chemotherapeutic agents, such as type of chemotherapy, cumulative dose, concomitant or previous radiotherapy, and comorbidities (3). Chemotherapeutic regimens which contain anthracyclines, cyclophosphamide, fluorouracil, cisplatin, taxanes and trastuzumab cause early and late cardiotoxicity (4).

The majority of published studies are focused on left ventricle dysfunction in patients receiving cardiotoxic chemotherapy. However, the right ventricle has been ignored for a long time and a little attention has been directed to show the effect of chemotherapy on right ventricle function. Right ventricle dysfunction is associated with increased morbidity and mortality in many cardiovascular diseases (5). The structure of cardiomyocytes and blood supply between the left and right ventricles are similar. Given the smaller mass and fewer myofibrils of right ventricle, chemotherapy may theoretically cause a more significant impact on it (6).

The right ventricle has a complex geometric shape which includes smooth muscular inflow, outflow and a trabecular apical region so echocardiographic assessment of right ventricle is difficult (7).

M-mode echocardiography, two-dimensional echocardiography, conventional Doppler echocardiography, and myocardial Doppler tissue imaging are all used to evaluate right ventricular function and provide accurate prognostic information especially when used in combination

Eligibility Criteria:
Inclusion Criteria:

* Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy

Exclusion Criteria:

1. patients with left ventricular (EF) \<50% before chemotherapy
2. Previous heart disease
3. Renal failure
4. significant valvular disease
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
* Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
* Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
* Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
* Disease amenable to serial biopsy

Exclusion Criteria:

* Uncontrolled or significant cardiovascular disease
* Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
* Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)

Other protocol-defined inclusion/exclusion criteria apply
Relationship Between Serum N/OFQ and Brain-heart Syndrome

Choosing the neurology patients in the Second Hospital of Shanxi Medical University, diagnosed with patients with cerebral syndrome into the experimental group; patients who did not have cerebral syndrome included in the control group, and all selected people had no intimate relationship with each other.Specimen collecting control group and the study group serum inflammatory factor IL-6, solvent peptide and catecholamine content. The difference between the two groups of data was observed.According to the literature, it is guess: The solitary peptide content of the experimental group will be higher than the control group, and is positively correlated with IL-6, catecholamine content.The difference was statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria in compliance with cerebral syndrome
* Acute ischemic stroke patients in line with the "Chinese Acute Ischemic Stroke Treatment Guide 2018" related diagnostic criteria
* There is no intimate relationship between all selected people and knows this study, and signs informed consent

Exclusion Criteria:

* Heart-type cerebral infarction, hemorrhagic stroke, brain tumor and past intracranial hemorrhage
* Complicated with severe cardiovascular complications (such as coronary heart disease, acute coronary syndrome, acute myocardial infarction, chronic heart failure, atrial fibrillation, etc.)
* Complicated with severe liver and kidney dysfunction (such as coagulous dysfunction, cirrhosis, nephrotic syndrome , Renal failure, etc.)
* Complicated with severe diabetes complications (such as diabetic nephropathy, diabetic foot, diabetic acidosis, high blood sugar hypertonic state, diabetes coronary heart disease, etc.)
* Complicated with Psychological disease
* Complicated with chronic obstructive pulmonary disease(COPD)
* BMI\> 40
Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease

Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18-85 years old, male or nonpregnant women
* asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients
* at least one target lesion length ≥ 20 mm (Visual method)
* Target lesion diameter 2.5mm-4.0 mm (Visual method)
* Target lesion diameter stenosis ≥ 70%
* Patients who has indications for coronary artery bypass graft (CABG) surgery
* Patients who is voluntary, understand the purpose of the study, willing to accept angiography and clinical follow-up

Exclusion Criteria:

* Acute myocardial infarction for less than 1 week
* Bridge vascular disease
* In-stent restenosis lesions
* Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet
* Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal
* Life expectancy is less than 12 months
* Patient who has participated in other clinical trials but does not meet the deadline of the primary endpoint
* Poor patient compliance
* Heart transplant recipient
* Patient who had other stent implanted within 1 year
* Patient who has multi-vessel disease(Long lesions) and has already received other stent implantation
Efficacy of the MovinCog Intervention in Children

This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise regimen, based on high-intensity training, and a cognitive training component. The design will contrast the intervention with an active control group, matched for expectancy effects.

Specifically, the investigators will compare both components together (exercise and cognitive training) against either one of the components (exercise alone, or cognitive training alone) and against an active control group. The study will include measures of scholastic aptitude, as well as of working memory and cognitive control (primary outcome measures), two cognitive abilities that are critical to daily life activities, and that respond well to training. In addition, the investigators will measure physiological responses to training, to monitor changes associated with exercise (secondary outcome measures). Finally, the investigators will relate training-specific improvements with transfer gains, to better model the interaction between training and transfer. This will provide a comprehensive understanding of the dynamics associated with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 7-15

Exclusion Criteria:

* Age outside inclusion criteria
* History of seizures, brain trauma
A Study Of The Selective PKC-β Inhibitor MS- 553

A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following criteria:

1. Age 18 years or older
2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):

   1. History of histologically documented CLL or SLL that meets IWCLL diagnostic criteria according to the 2008 guidelines, and
   2. Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for disease reduction prior to allogeneic transplantation

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study:

1. Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL), non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the inclusion criteria for the optional cohort.
2. Active and uncontrolled autoimmune cytopenia(s)
3. Any of the following prior therapies within 14 days prior to cycle 1, day 1:

   1. Major surgery
   2. Corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used by inhalation or topical route, or unless necessary for premedication before iodinated contrast dye, or for autoimmune hemolytic anemia
   3. Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which no wash out is required (but must be stopped before cycle 1 day 1)