cyrilzakka/clinical-trials huggingface dataset:
Acute-to-chronic Glycemic Ratio (ACGR) is a Marker of DFUs .

Diabetic foot ulcers (DFUs) have resulted from peripheral arterial ischemia and peripheral neuropathy that are complicated with infections and amputation of the lower extremities. Uncontrolled glycemic status and significantly higher glycosylated hemoglobin (HbA1c) are associated with DFUs. This study aimed to assess the acute-to-chronic glycemic ratio (ACGR) in type 2 diabetes (T2D) with DFUs and compare it with those without DFUs, considering the relationships of this ratio with other indices that characterized the pathogenesis of T2D. This cross-sectional study was conducted on T2D with DFUs and non-DFUs. The primary outcome is ACGR. The secondary outcomes are indices related to the anthropometric, metabolic, and hematological variables.

DFUs are a macrovascular complication of diabetes mellitus resulting from peripheral artery disease and peripheral neuropathy that commonly affects the lower extremities. The DFUs are usually classified and scored according to the clinical findings. The ACGR is computed by dividing the acute (or current, or on admission in hospital) plasma glucose level by the chronic plasma glucose level calculated using the current (or on admission) HbA1c value.

Eligibility Criteria:
Inclusion Criteria:

Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin

Exclusion Criteria:

History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.

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Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

OBJECTIVES:

* Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy.
* Compare the quality of life and survival of these patients.
* Determine the toxicity of this regimen in these patients.
* Determine the health economics associated with this study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days.
* Arm II: Patients receive no further therapy after completion of prior chemotherapy.

Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically or histologically confirmed small cell lung cancer

  * Documented extensive disease before the initiation of chemotherapy
* Responsive disease after 4 to 6 courses of initial chemotherapy

  * No more than 5 weeks since completion of prior chemotherapy
* No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* No concurrent corticosteroids

Radiotherapy:

* No prior radiotherapy to the brain
* No prior radiotherapy to the head and neck

Surgery:

* Not specified
PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

To assess the application of partially randomized patient preference (PRPP) trial model which concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies (acupuncture and cupping therapy) for fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with fibromyalgia diagnosed according to criteria formulated by American College Rheumatology 2002;
* Patients whose scores for pain intensity is more than 30mm;
* Patients who are 20 to 60 years old;
* Patients who fully understand the process of this research and who are willing to provide informed consent.

Exclusion Criteria:

* The widespread muscular-skeletal pain is caused by some kind of disease, surgery, or other external interference factors (except fibromyalgia);
* Patients with mental disorders, or other serious organic diseases, such as organ failure;
* Patients who take oral anodyne medications or accept other interventions for pain relief during the treatment;
* Pregnant or lactating women;
* Patients currently participating in another clinical trial.
Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease

The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.


Eligibility Criteria:
Inclusion Criteria:

* patients with congenital heart disease attending regular follow up

Exclusion Criteria:

* missing main data in medical documentation
Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.

The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).

Children experiencing traumas, such as sexual abuse, physical abuse, domestic violence, serious accidents, or natural disasters, may develop severe health problems.

This study will examine the short and long-term effects of trauma-focused cognitive-behavioural therapy on children exposed to serious trauma, and moderating factors of treatment outcome.

The study will use a random control design, and will be implemented in regular clinical practice in Norway.

More knowledge within this field is important for practitioners as well as policy makers in planning interventions and therapy for children and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Children between the age of 10-18
* referred to a guidance clinic
* who have experienced trauma
* present with PTSD reactions
* participants and the primary caretaker must be able to speak Norwegian.

Exclusion Criteria:

* Severe psychosis
* Severe mental retardation.
* The youth must not have had severe conduct disorders previous to the trauma experience
Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.

The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patient (\> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).

Exclusion Criteria:

* Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).


Eligibility Criteria:
Key Inclusion Criteria:

* Provide written, informed consent to participate in the study and follow the study procedures
* Karnofsky Performance Status (KPS) of at least 70%
* Measurable disease per mRECIST 1.1 criteria
* Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
* Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma.
* No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC

Key Exclusion Criteria:

* An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
* Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
* Any tumor invading the wall of a major blood vessels
* Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization
* Need for \>2 medications for management of hypertension (including diuretics)
* History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization

Additional protocol defined inclusion/exclusion criteria and exceptions apply
a Water Training Program to Improve Balance in Chronic Stroke Patients

The proposed project is a case control study design. Subject's suffer from stroke willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.

The whole project will be conducted over a period of 3 months. A total of 36 subjects will be assigned to water based exercise program. The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.

Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques 1) Medical background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument. 4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5) step execution test under single and dual task; 5) stability tests. 6) also fall will be monitored a year after the completion of the study. The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. For example, the instructor can increase the difficulty of a certain water-exercise by instructing a participant to use less external support, close the eyes, decrease the support area (stand on one leg or narrow the stance, or on unstable surface). These "tools" allow the instructor to implement step exercises on a group level that are still challenging for each individual even if the skill level in the group varies. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects suffer from chronic hemiplegia (a year or more)
2. able to stand independently 90 seconds;
3. able to walk 10 meters (with cane if necessary);
4. able to understand verbal instructions.

Exclusion Criteria:

1. Serious visual impairment;
2. Inability to ambulate independently (cane acceptable, walker not).
3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
4. Persons with impaired communication capabilities.
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one or more native coronary target lesions
* Written informed consent

Exclusion Criteria:

* Primary PCI for STEMI as index procedure
* Prior STEMI within 48 hours before randomization
* Prior PCI within 30 days before randomization
* Planned staged PCI within the subsequent 24 hours after index PCI
* Use of abciximab within 7 days before randomization
* Use of tirofiban or eptifibatide within 12 hours before randomization
* Use of low-molecular weight heparin within 12 hours before randomization
* Use of bivalirudin within 12 hours before randomization
A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad following single and multiple oral doses of dotinurad in Chinese healthy male and female participants.


Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy Chinese participants living in China.
2. Non-smoking, male or female, age greater than or equal to (\>=) 18 years and less than or equal to (\<=) 45 years old at the time of informed consent.
3. Participants with serum uric acid level less than \>=5.5 milligrams per decilitre (mg/dL) at Screening (Cohort B only).

Key Exclusion Criteria:

1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] or human chorionic gonadotropin \[hCG\] test). A separate baseline assessment of serum β-hCG (or hCG) or urine pregnancy test is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
2. Females of childbearing potential.
3. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
5. Any history of gastrointestinal surgery that may affect PK profiles of dotinurad, example, hepatectomy, nephrectomy, digestive organ resection at Screening.
FoxO3a and PU.1 in Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is one of the four major types of leukemia which is common in both children and adolescents; however, it is the most common pediatric malignancy diagnosed in children younger than 20 years .The disease pathogenesis results from blockade at any stages of normal lymphoid differentiation with uncontrolled proliferation of lymphoid cells. According to the World Health Organization (WHO) definition, ALL is categorized in B-Lymphoblastic Leukemia (B-ALL) And T-Lymphoblastic Leukemia (T-ALL), originated from B- and T-Lineage lymphoid precursor cells, respectively.

Proto-oncogenes and tumor suppressor genes are the most important genes involved in leukemogenesis , which their alterations disrupt normal regulatory processes such as self-renewal, proliferation, differentiation and apoptosis in target cells. Among those genes FoxO3a gene and PU.1 gene.

FoxO(Fork head box ,class O) transcription factors function as a tumor suppressor gene and are important for stem cell maintenance.They are key regulators of the cellular differentiation, growth, survival, cell cycle, metabolism, and cellular stress. There are four members of the foxO transcription factors in humans : foxO1, foxO3a, foxO4, foxO6 .FoxO3a is expressed in various tissues including B - and T-lymphoid cells. Over expression of FoxO3a in B and T cell lines induces cell cycle arrest in G1 phase , so it inhibits cell proliferation . FoxO3a is an important target of PI3K/AKT signaling pathway,which is hyperactivated in various types of cancers .Hyperactivation of this pathway in leukemia leads to inactivation of foxO3a in leukemic cells and enhances tumor growth .

PU .1(Purine-rich box 1) is a member of the E26 transformation-specific (ETS) Family . Normal hematopoiesis is securely controlled by asmall number of lineage-specific transcription factors, so that the disturbed expression or function of this group may be involved in the development of leukemia . PU.1 plays an important role in hematopiotic stem cell (HSC) self renewal and in myeloid and B-lymphoid differentiation. It controls the expression of several genes involved in hematopoiesis.

Eligibility Criteria:
Inclusion Criteria:

* children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia

Exclusion Criteria:

1. age more than 17 years
2. presence of other hematological disorders, history of other malignancies ,or relapsed ALL
3. patients under chemotherapy or radiotherapy
Fecal Microbiota Transplantation for Chronic Functional Constipation

Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.

Patients who meet the inclusion crit chronic functional constipation will be separated into two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal motility.

Eligibility Criteria:
Inclusion criteria:

1. subjects voluntarily participate in the trial and sign informed consent;
2. sex is not limited,ranging from 18 to 75 years old;
3. meet the diagnostic criteria for chronic functional constipation in patients;
4. patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month;
5. be able to communicate well with the researchers and follow the verification requirements.

Exclusion criteria:

1. does not meet the diagnostic criteria;
2. with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases;
3. severe anemia and severe systemic infection;
4. suspected or indeed have alcohol, drug abuse history;
5. pregnancy or are preparing for pregnancy, and breastfeeding women;
6. Those who are unwilling to accept the research measures or other reasons can not cooperate;
7. due to mental disorders can not give adequate informed consent;
8. Participated in other clinical trials within 3 months before the start of the study;
9. researchers believe that participates are not suitable for other reasons in this clinical trial.
The Effect of a Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.

The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work.

Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to perform a brief intervention. This study is intended to investigate the difference between the effect of workplace-based physical exercise (using elastic bands and body weight exercises) and a group control on musculoskeletal pain, physical exertion during work, physical function, need for recovery, self-rated use of analgesics, and work ability among healthcare workers.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare Workers at the Hospital
* Informed consent

Exclusion Criteria:

* Unable to perform exercises
ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients

This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.


Eligibility Criteria:
Inclusion Criteria:

Patient:

* Over the age of 18
* Undergoing allogeneic HCT for any cancer or noncancer illness
* English speaking
* Has a caregiver willing to participate

Caregiver:

* Over the age of 18
* English speaking

Exclusion Criteria:

* Under the age of 18
* Non-English speaking
* Has a caregiver unwilling to participate