cyrilzakka/clinical-trials huggingface dataset:
Bacterial Load for Integra™ in Operative Wounds

Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™

This is a study examining the use of Integra™ for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications. Wounds requiring operative application of Integra™ alone or Integra™ followed by a planned subsequent application of a STSG will be enrolled into this study.

The tolerance of Integra™ to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts, qualitative culture results, and bacterial and wound protease levels at the time of Integra™ alone application or Integra™ followed by STSG application.

Patients will then be followed until complete healing has occurred or until 16 weeks, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18-90.
* Full-thickness wounds below the knee.
* Patients who require, in the opinion of the Investigator, operative application of Integra™.
* Patients able and willing to comply with the study protocol.

Exclusion Criteria:

* Male or Female under 18 or over 90
* Patients that do not have Full-thickness wounds below the knee
* Patients who do not require, in the opinion of the Investigator, operative application of Integra™.
* Patients that are not able or willing to comply with the study protocol.
ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction

The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and \<75 years;
2. First-time acute anterior STEMI;
3. The time from onset of ischemic symptom to the time of initial PCI balloon inflation ≤6 hours;
4. \>0.1 mV ST segment elevation in at least two contiguous precordial leads according to electrocardiogram;
5. Scheduled for primary PCI;
6. The presence of left anterior descending branch (LAD) occlusion in proximal or middle segment with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram;
7. Written informed consent.

Exclusion Criteria:

1. Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis, or myocarditis;
2. Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class III and above) or mechanical complications;
3. Patients after cardiopulmonary resuscitation (CPR) (including cardioversion);
4. Patients who have already received thrombolytic therapy;
5. Prior myocardial infarction or coronary artery bypass surgery;
6. Known serious hepatic, renal, blood, respiratory, or neuropsychiatric diseases;
7. Malignant tumor, lymphoma, HIV-positive, or hepatitis;
8. Uncontrolled hypertension (systolic BP \>160 mm Hg or a diastolic BP \>100 mmHg on at least two consecutive readings);
9. Patients with active bleeding, major surgery or trauma within 3 months and cerebrovascular accident within 6 months;
10. History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte\<90×109/L);
11. Multi-vessel disease with non-culprit vessel intervention;
12. Breastfeeding, pregnant, or potentially fertile women;
13. Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect;
14. Patients with potential contraindication to CMR;
15. Participation in other clinical trial in recent 3 months;
16. Patients who cannot complete this trial or comply with the protocol.
One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) \[adults and children\] and Ulcerative Colitis (UC) \[adults for both treatments and children only for Flixabi\].


Eligibility Criteria:
Inclusion/ Exclusion Criteria

Key Inclusion Criteria:

* Adult participant (18 years and over)

  * treated for one of the following conditions: RA, AS, PsA, CD, UC.
  * either active substance naïve or treated with the originator or another biosimilar at baseline.
  * for whom the treating physician has decided to treat by (naïve) or switch from originator or another biosimilar to Flixabi or Imraldi.
  * participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.
* Paediatric participants (6-17 years):

  * treated for one of the following conditions: CD, UC.
  * either active substance naïve or treated with another biosimilar at baseline.
  * for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (for both indications) or Imraldi (only for Crohn's disease).
  * participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.

Key Exclusion Criteria:

* Participant treated for psoriasis.
* Participant who are not to be followed up in the same investigator site for 2 years after baseline.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
* The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
* Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
* Life expectancy ≥ 3 months;
* Adequate hematologic function;
* Adequate hepatic function;
* Adequate renal function;
* At least 2 weeks away from the last chemotherapy;
* Patients signed written informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* History of anticipatory vomiting;
* Radiation therapy on the abdomen or pelvis within one week prior to study entry;
* Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
* Patients with gastrointestinal obstruction;
* Patients with severe heart disease, liver or renal disease, or metabolism disorders;
* Patients with epilepsy or using sedative or psychotropic drugs;
* Patients with diabetes or with contraindication for corticosteroids;
* Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
* Patients with brain metastasis or intracranial hypertension;
* Hypersensitivity to 5-HT3 receptor antagonist;
* Patients with active infection;
* Other conditions that the investigator considered as unsuitable for chemotherapy;
* Subjects participating in other clinical trials.
Value of Von Willebrand Factor and Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital

Febrile seizures are one of the most common clinical diseases in pediatric neurology. It occurs between 6 months and 6 years of age and occurs in \~2-5% of children. According to the age, frequency, duration, and type of seizures FS is divided into simple febrile seizures and complex febrile seizures Differentiation between febrile seizures and non-ictal events associated with fever such as shivering or dizziness is challenging. Therefore, precise diagnosis of FS after paroxysmal episodes associated with fever is often hindered by the lack of an objective biomarker With the widespread application of technologies, such as molecular biology, in medicine, some biomarkers for predicting or diagnosing FS have attracted attention. Imuekemhe et al in 1989 and 1996 found that lactic acid in the serum and cerebrospinal fluid of children with FS was significantly increased . Arginin-vasopressin hormone AVP released by the pituitary gland, has been shown to be involved in the thermoregulatory response to fever and convulsions Although AVP is unstable in the peripheral blood and, therefore, unsuited for diagnostic use the C-terminal portion of the AVP precursor copeptin has been recognized as a robust marker of AVP secretion . Wellman et al. found that the serum copeptin and Von Willebrand factor of children with FS were significantly higher than those of the control group .


Eligibility Criteria:
Inclusion Criteria:

* Age from 6 months to 6 years.
* Seizures.
* Fever (≥38°C).

Exclusion Criteria:

* Central nervous system infection.
* Epilepsy.
* Previous neurological abnormalities.
* Inborn errors of metabolism.
* Immunological diseases.
* Endocrinal diseases (e.g., diabetes mellitus).
* Obesity.
* Eating disorders.
* Gastrointestinal disorders (e.g., diarrhea).
Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0

Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Research Design:

The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing clinically indicated coronary or peripheral angiography

Exclusion Criteria:

* None
The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake

High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations.

This study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* BMI 18.5-29.9 kg/m2
* Age: 18-40 years

Exclusion Criteria:

* Smokers
* Food allergies
* Metabolic disorders (ie. type 2 diabetes)
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa

This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.

The study will take place during routinely scheduled ART visits as per Ministry of Health guidelines. Routinely collected programmatic data will be used to assess general HIV outcomes (CD4 response, loss to follow-up, death) as well as collecting study specific data (hepatitis testing, questionnaire regarding risk factors for hepatitis/liver disease, and non-invasive liver scan) to address other aims. The study will be implemented at two sites in Southern Africa (Zambia and Mozambique) with a total enrollment across all sites of 1,900 participants. The Zambia site will only enroll 900.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Male or female aged ≥18 years
* ART naïve
* ART eligible as defined by Zambian or WHO treatment guidelines
* Initiating an ART regimen including at least 3 drugs at one of the study sites.
* Willing to provide signed informed consent and be followed at the clinical site.

Exclusion Criteria:

* Patients who are not planning to remain in the catchment area from which they were recruited for the duration of the study
XY-Zone Program Evaluation: A School-Based Dropout Prevention Program for At-Risk Youth

The objective of this study is to build upon preliminary research and conduct a pilot feasibility randomized controlled trial on a promising culturally-grounded and gender-specific treatment program, the XY-Zone. The central hypothesis underlying this study purports that through receiving the XY-Zone treatment, adolescents will decrease their risk for dropping out of school. This hypothesis is supported by two years of preliminary data investigating the effectiveness of the XY-Zone.

To test the central hypothesis, the following specific aims will be pursued:

1. Identify school dropout risk and protective factors (protective factors defined as: adult support and peer support; risk factors defined as: low school attendance, inability to achieve grade promotion, substance use, delinquency, school disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a result of XY-Zone intervention.
2. Determine the extent to which moderating variables (affective strength, duration in the program, family functioning, interpersonal strength, intrapersonal strength, level achieved in the program, and resiliency) effect change in outcome variables (risk and protective factors).
3. Identify participants' beliefs about the impact of the mechanisms of change (respect, responsibility, relationship, role modeling, and reaching out) on outcome variables (risk and protective factors ) to enrich understanding of quantitative data.


Eligibility Criteria:
Inclusion Criteria:

* Students eligible to receive the XY-Zone must display one of the following risk factors:

  * academic risks (failed classes, failed state examination text, lack of class participation, and homework incompletion)
  * attendance risks (absences and tardies)
  * behavioral risks (gang involvement, substance use, classroom conduct, social skills, self-esteem, violence, delinquent conduct, and family or emotional crisis)and
  * social service issues (difficulty with the following: college readiness, life skills, health, career/employment, housing, day care, and grief or loss).

Exclusion Criteria:

* Youth who do not display any of the identified risk factors
Effects of Vitamin D and Calcium Supplementation on Health and Well-being of Vitamin D Deficient UAE Citizens

The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU), calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D deficiency will lead to a clinical benefit. The proposed study will also determine the threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's health

The proposed study is a two by two factorial, randomized controlled intervention trial. Following informed written consent of eligible subject's blood and urine samples will be taken for measurements of vitamin D, markers of bone turnover and related biochemical variables. Patients who have evidence of vitamin D deficiency will then be randomly assigned to receive daily vitamin D(3) (2000 IU), calcium (1000 mg), both, or a placebo for 6 months. All subjects will have a calcium and vitamin D rich food and other lifestyle modification advises during the study period. Patients will otherwise be managed according to standard practice. Clinical assessment that includes general and self-rated health, bone density, muscle strength, physical activity and dietary intakes will be performed at baseline, and repeated at 3, 6 and 12 months post-randomisation.

Information on other important variables likely to influence vitamin D status including age, reproductive \& menopausal history, smoking, medications, adiposity, exposure to sunlight, dietary intake including supplements, skin pigmentation, chronic illness and medications will be collected and adjusted for during the analysis

Eligibility Criteria:
Inclusion Criteria:

1. biochemical evidence of vitamin D deficiency

Exclusion Criteria:

1. renal disease or stones or hypercalcaemia,
2. Use of calcium and/or vitamin D supplementation, bisphosphonates, steroid medications, hormones or diuretics.
A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC

This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years old (inclusive), Female or male
2. Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
3. Previously treated by EGFR-TKI；
4. At least one measurable tumor lesion according to RECIST v1.1
5. ECOG performance score of 0-1;
6. Expected survival time ≥ 12 weeks;
7. Adequate bone marrow and organ function
8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastases.
2. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
3. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
4. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
5. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
6. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
7. Serious cardiovascular disease
8. Presence of severe infection within 4 weeks prior to first dose of study drug
9. Arterial/venous thrombotic events within 3 months prior to the first study dose
10. History of immunodeficiency, including a positive HIV test
11. Presence of active hepatitis B or C;
12. History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.
Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation

One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. However, there is still a controversy which anesthetic would be more appropriate during one-lung ventilation in the perspective of oxygenation and microcirculation. The investigators hypothesized that intravenous and inhalational anesthetics may affect oxygenation and microcirculation differently during one-lung ventilation.

Patients undergoing thoracic surgery including one-lung ventilation will be randomized to receive intravenous (propofol) or inhalational (desflurane) anesthetic.

Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare arterial partial pressure of oxygen and recovery slope during one-lung ventilation between propofol and desflurane group.

Eligibility Criteria:
Inclusion Criteria:

* undergoing thoracic surgery including one-lung ventilation

Exclusion Criteria:

* refuse to enroll
* BMI over 30 kg/m(2)
* severe obstructive or restrictive lung disease
* preoperative supplemental oxygen, intubated, or mechanical ventilatory support
* preoperative arterial partial pressure of oxygen \< 60 mmHg
* pregnancy
* history of coronary artery disease
* preoperative continuous infusion of vasopressor or inotropes
* cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women

The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and to assess the association between the changes in bone turnover parameters and plasma cytokine levels in postmenopausal diabetic women

Fifty-six obese, drug naive patients with type 2 diabetes mellitus were enrolled and completed the study. Twenty-six healthy subjects matched for age and body mass index (BMI) served as nondiabetic controls. All subjects were postmenopausal women with last menses at least 2 years. After the baseline measurements, all subjects were instructed to follow a weight-maintaining diet, based on ADA recommendations, and were also encouraged to walk or to jog at least 30 min daily. Subsequently, 28 of the diabetic subjects were randomly assigned to receive rosiglitazone (4 mg/day). Twenty-eight of diabetic subjects were on diet alone. The randomization procedure was based on a random sequence.

All subjects had a complete clinical examination, anthropometric measurements, and laboratory tests at baseline and at the end of the 12th week of the study. Laboratory investigations included assessment of: (i) glycemic control (HbA1c, fasting plasma glucose and insulin levels, and homeostasis model assessment (HOMA) index (22); (ii) serum bsALP and active human osteocalcin concentration (OCL) as markers of bone formation; (iii) urine deoxypyridinoline (DPD) as marker of bone resorption. Other non-specific bone markers including serum total ALP activity, urinary calcium (Ca) and phosphate (PO4) concentrations were also measured. Urine concentrations of DPD (nmol/L), Ca and PO4 (both in mmol/L) were corrected for their respective urine creatinine (Cr) concentrations in mmol/L (Urine DPD/Cr, Urine Ca/Cr and Urine PO4/Cr respectively). In addition, fasting blood samples were analyzed for plasma cytokine levels including IL-1β, IL-6 and TNF-α, and for haptoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes mellitus
* Postmenopausal period

Exclusion Criteria:

* Recent fracture or osteoporosis
* Drugs that may affect calcium or bone metabolism or drugs known to interfere with cytokine release
* Thyroid, parathyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorders
* Severe cardiovascular disease