cyrilzakka/clinical-trials huggingface dataset:
Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD) are long-term autoimmune diseases in which the immune system attacks parts of the body. The abnormal immune reaction causes inflammation of and damage to various body parts and can affect joints, skin, kidneys, heart, lungs, blood vessels, and the brain. SLE and MCTD often affect young women, especially black and Hispanic women, and there is no known cure. Knowing more about SLE and MCTD will help in developing new and effective treatments. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD.

Systemic lupus erythematosus (SLE) is an autoimmune disease in which the immune system produces antibodies against the body's healthy cells and tissues. These antibodies, called autoantibodies, contribute to the inflammation of various parts of the body and can cause damage to organs and tissues. Mixed connective tissue disease (MCTD) is another autoimmune disease that overlaps in terms of signs and symptoms with three other connective tissue diseases, including SLE. In both SLE and MCTD, the immune system appears to be abnormally activated by small nuclear ribonucleoprotein (snRNP) autoantigens. Furthermore, lung tissue, in particular, appears to be affected by the immune response induced by snRNP autoantigens. The causes of SLE and MCTD remain unknown. However, it is likely that a combination of genetic, environmental, and possibly hormonal factors work together to cause the diseases. Past studies suggest that several different genes may be involved in determining a person's likelihood of developing SLE or MCTD, which tissues and organs are affected, and the severity of the disease. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD.

Participants will attend up to four study visits, at intervals of at least 3 months, over the course of this study. Each study visit will include questionnaires, a physical exam, and possibly blood and/or urine collection. At the end of the study period, participants may choose to continue or discontinue participation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known rheumatic diseases including systemic lupus erythematosus, rheumatoid arthritis, connective tissue disease, undifferentiated connective tissue disease

Exclusion Criteria:

* Poor venous access, unstable medical problems or significant cardiopulmonary disease, anemia, leukopenia, thrombocytopenia, anticoagulation therapy, recent significant changes in medication or pregnacy. Patient cannot be taking large dose of corticosteroids (above 30mg per day) or cytotoxic drugs (cyclophosphamide, azathiprine, cyclosporine, methotrexate).
Physical Function and Mental Health in Cancer Survivors

The goal of this observational study is to evaluate the joint prognostic effects of physical function and mental health on survival of cancer survivors.

Cancer survivors were selected from the National Health and Nutrition Examination Survey (NHANES) between 2007 and 2018. Total sedentary time was assessed by self-reported daily hours of sitting and depressive symptoms were assessed by Patient Health Questionnaire 9 (PHQ-9). Kaplan-Meier (KM) curves and the Cox regression analyses were used to evaluate the separate and joint prognostic effects of sedentary behavior and depressive symptoms with mortality outcomes of cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Adults with aged above 18 year old

Exclusion Criteria:

* Without a history of cancers
* Without records of sedentary behavior or depressive symptoms test
* Incomplete follow-up information
CGM and Lifestyle Changes in Patients with Impaired Glucose Tolerance

The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.

The purpose of this research is to evaluate if having blood sugar information from a continuous glucose monitor (CGM) during activities of daily living provides additional benefit to lifestyle modifications in reducing the risk of developing diabetes and achieving a healthier weight. A CGM is a small device often worn on the back of the arm that uses a very small needle to insert a small sensor just under the skin in the fatty tissue. The CGM device transmits the blood sugar level to either a smartphone or a special receiver.

The investigators expect patients will have an overall improvement in health by decreasing weight and therefore improving the way the child's insulin works in their body. This could result in decreased risk of obesity-related complications such as diabetes mellitus, cardiovascular disease, kidney disease, and loss of vision and/or limbs, among others.

Eligibility Criteria:
Inclusion Criteria:

1. Children 10 to \<17 years old (i.e., before their 17th birthday)
2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
3. Overweight or obese (BMI ≥85th percentile for age/sex)
4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL

Exclusion Criteria:

1. Existing diagnosis of type 1 or type 2 diabetes
2. Prepubertal
3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
* Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
* Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.

Exclusion Criteria:

* Participation in any other clinical studies involving investigational drug(s) within 14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to the first dose of bosutinib.
* Prior treatment with bosutinib.
* Prior treatment with ponatinib.
* Known T315I or V299L mutation.
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes

This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. The purpose of this study is to compare efficacy and safety of THDB0206 injection with insulin lispro injection combined with insulin glargine injection U-100 in Chinese participants with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index: 18.0 kg/m\^2\~35.0 kg/m\^2 (both inclusive) at the time of screening.
* HbA1c: 7.0%\~10.0% (both inclusive) at the time of screening.
* Diagnosed with T2DM for 6 months or longer at the time of screening based on the World Health Organization (WHO) classification.
* Treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug:

  1. Basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin.
  2. Premixed insulin at least twice daily.

Exclusion Criteria:

* Have other types of diabetes other than T2DM.
* Have used Glucagon-Like Peptide 1 (GLP-1) receptor agonist within 3 months prior to screening.
* Have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.
* Have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening.
* With concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.
Impact of Intermittent Fasting and Mediterranean Diet on the Physical Health of the Elderly

The prevalence of chronic diseases is increasing globally. In recent years, intermittent fasting has emerged as an effective dietary pattern against some of the most common chronic diseases in the elderly, alongside the Mediterranean diet.

The objective was to determine whether a 12-hour daily intermittent fasting regimen combined with a Mediterranean diet can improve analytical and anthropometric values in the elderly.

A total of 17 individuals of both sexes, over 60 years old, autonomous, and with preserved cognitive capacity participated. They were randomly divided into two groups: 8 people in the intervention group performed intermittent fasting along with a Mediterranean diet, and 9 in the control group adopted only a Mediterranean diet. The intervention lasted 3 months, with measurements taken at the beginning and end of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Over 60 years of age.
* Belong to the Bombarda health centre.
* Preserved cognitive capacity.
* Autonomy for basic and instrumental activities of daily living.
* Ability to follow a TRF and/or adopt a Mediterranean dietary pattern.

Exclusion Criteria:

* Underweight (BMI \<18.5).
* Serious or chronic uncontrolled disease.
* Specific treatment that could alter blood and/or anthropometric values.
* Poorly controlled type 1 or type 2 insulin-dependent diabetes mellitus.
* Present or past episode of eating disorder (ED).
* High alcohol consumption.
Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.


Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced breast cancer, with or without metastatic disease
2. Patient to receive systemic therapy
3. Breast size and epithelial integrity adequate to allow alternate imaging exams.
4. Patient able to provide written informed consent.
5. No serious associated psychiatric illness
6. Age ≥ 18 years old

Exclusion Criteria:

1. Cardiac pacemaker
2. Any implanted electronic device
3. Severe claustrophobia
4. Allergy to the MRI contrast agent gadolinium
Effect of the PIPAC on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status \<3.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or over
* Patients with adenocarcinoma-type gastric non-resectable péritonéale carcinomatosis.
* Patients without metastasis other than peritoneal.
* WHO performance status \<3
* Patients treated either with PIPAC administered in alternation with systemic chemotherapy (PIPAC_CHEM) or by systemic chemotherapy alone (ONLY_CHEM)
* Patient informed

Exclusion Criteria:

- Patients opposed
Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.

Re-infection of the liver graft occurs universally following liver transplantation for HCV-induced end stage liver disease. Interestingly, the manifestation of HCV infection ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is extremely variable from one patient to another. The host and viral factors being responsible for the different course of HCV infection are poorly understood. Our study will focus on dendritic cells which are known to play a critical role in the control of viral infection. Viral factors (quasispecies evolution) will also be analysed and Th1 Th2 cytokines produced in the serum evaluated.Thirty liver transplanted patients will be included : 20 patients transplanted for HCV-related disease and 10 controls transplanted for non HCV-related disease. Blood samples will be taken just before transplantation and at different time -points up to 5 years after transplantation. Function of blood monocyte-derived DC will be evaluated. Circulating blood plasmacytoid (pDC) and myeloid DC (mDC) sub-populations will be enumerated. HCV quasispecies evolution will be analysed. This study may help to define prognostic markers on progression of hepatitis C in liver transplantation and allow the development of new immunotherapeutic drugs


Eligibility Criteria:
Inclusion Criteria:

Liver transplanted HCV infected patients :

* Adults, HIV(-),HBV(-)
* liver transplanted for an end stage liver disease associated to HCV.
* Genotype determined
* written agreement to participate to the study

Control patients :

* Adults, HIV(-), HBV(-), HCV(-)
* liver transplanted for a non HCV liver disease
* written agreement to participate to the study.

Exclusion Criteria:

* HIV(+), HBV(+)
UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

This study for a six-month trials, Randomized, open, and parallel comparison before and after its own, Stage test includes screening stage, treatment period and follow-up period. In accordance with chronic wound criteria for the patient, By producing the principle of random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according to the situation of wound healing time and decided to use the secondary treatment, To observe the clinical efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Older than 17 year old male or female (pregnancy);
* Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years of age must be signed by the guardian informed consent;
* The process of psychological stability, can finish the tes

Exclusion Criteria:

* Allergic constitution, or known allergic to pork or beef source products, gao min physique person;
* The wound is more than 10 cm by 10 cm;
* People with mental illness, drug abusers and or other items;
* 1 month used or are using the sugar metabolism of drugs, such as corticosteroids, thiazide diuretics, tricyclic antidepressants, etc;
* 3 month participated in other similar test;
* Serious infectious disease not controller;
* With surgery, such as severe trauma stress situation;
* Always had a history of tumor;
* Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.
Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment.

The primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (D2O) labelling experiment in patients with postprandial hyperinsulinaemic hypoglycaemia (PHH) and non-surgical non-PHH controls.

Despite an increased prevalence, the underlying pathophysiology of PHH remains incompletely understood. It is generally assumed that PHH is caused by excess insulin secretion, either due to an intrinsic beta-cell abnormality (histology showing increased beta-cell mass or signs of hyperfunction) and/or increased postprandial insulinotropic signals (also known as the incretin-effect) as a consequence of the re-arranged gastrointestinal tract and accelerated nutrient transit and absorption. Either of the two explanations would imply an altered insulin turnover in these patients with higher amounts of pre-stored insulin and/or accelerated de-novo insulin synthesis in response to stimulus-depletion of the available insulin pool. A non-invasive in vivo technique to study insulin turnover has not been established yet and data related to PHH are consequently lacking.

The primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (D2O) labelling experiment in patients with postprandial hyperinsulinaemic hypoglycaemia (PHH) and non-surgical non-PHH controls. The investigators hypothesize that the suggested methodological approach is feasible to assess insulin turnover and provides the foundation for further studies in different target groups.

Eligibility Criteria:
Inclusion criteria for PHH patients:

* Aged ≥18 years
* Roux-en-Y gastric bypass ≥1 year ago
* PHH defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia

Inclusion criteria for non-PHH non-surgical controls:

* Aged ≥18 years
* Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption

Exclusion Criteria:

* Clinically relevant weight changes (≥5%) within the past 3 months
* Incapacity to give informant consent
* Historical or current diabetes based on HbA1c ≥6.5% without glucose-lowering treatment
* Haemoglobin level below 13.5 g/l
* Ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility
* Active heart, lung, liver, gastrointestinal, renal or neurological disease
* Inability to follow study procedures
* Pregnancy or breast-feeding
Allergy Diagnostic Test Based on Microchip Technology

The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum.

The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum samples and to assess the sensitivity and specificity of the developed system.

Eligibility Criteria:
Inclusion Criteria:

* Type I allergy (food, drug, pollen)
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* Acute or chronic diseases in the stage of decompensation (except allergy)
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
Student 4 Best Evidence as a Tool to Improve Evidence-Based Practice Competencies

Objective. The aim of the study was to evaluate the effectiveness of an educational program, based on Students 4 Best Evidence (S4BE) Blog, on Evidence-Based Practice (EBP) competencies (attitudes, knowledge and skills) through an EBP laboratory, in undergraduate students of Physiotherapy.

Design. An observational perspective study. Setting. Physiotherapy School of Italian University. Participants. 70 undergraduate physiotherapist students of the first year, of both genders, were included. Mean age was 20.48+/-3.20 years and 66% were male and 34% were female.

Interventions. The intervention consisted of the use of S4BE to teach EBP competence. The section S4BE "about" has been used to teach the EBP principles and their key steps and the section S4BE "topics" has been used to teach critical thinking and the clinical practice in rehabilitation for a total of 24 training hours.

Main Outcome Measure. The evidence-based practice questionnaire (EBP2Q) has been used to evaluate EBP attitude, knowledge and skills, at the start of laboratory (T0), after 24 training hours (T1) and after 3 months of clinical practice training (follow-up). Statistical analysis was performed with SPSS 17.0 An intra-group analysis has been conducted to verify the improvement during the time. Statistically significant was set at p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* undergraduate physiotherapist students of the first year
* both genders

Exclusion Criteria:

* N/A
Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age
* Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days
* The presence of fever (within 24 hours before randomization)

Exclusion Criteria:

* Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days).
* Hospitalization within 14 days before the onset of symptoms.
* Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms.