cyrilzakka/clinical-trials huggingface dataset:
Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)

The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.

This observational applied research international study aims to assess the validity of breathing maneuvers as a vasoactive maneuver and Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) in a patient population. OS-CMR results will be compared to the clinical gold standard of Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR) as a secondary objective, to determine if this non-invasive, no pharmaceutical agent imaging technique can identify areas of oxygenation deficit in myocardium perfused by a stenosed coronary artery.

Eligibility Criteria:
Inclusion Criteria:

Healthy Participants

* Age: \> 40y
* No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system.

CAD Patients

* Age \> 18 y
* Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.

Exclusion Criteria:

ALL participants:

* General MRI contraindications: Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
* Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam.
* Regular nicotine consumption during the last 6 months.

Patients only

* Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam Contraindications to adenosine (2nd or 3rd A-V block, sinus node disease, asthma, bronchoconstrictive diseases).
* Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
* Previous myocardial infarction within 1 month
* Clinically unstable condition
* Significant or uncontrolled arrhythmia
Abuse Potential of Buprenorphine/Naloxone

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone.

Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

Eligibility Criteria:
Inclusion Criteria:

* Actively abusing illegal opioids
* Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry
* Meets DSM-IV criteria for opioid dependence

Exclusion Criteria:

* Significant medical problems (e.g., insulin dependent diabetes mellitus)
* Non-substance use psychiatric disorders (e.g., schizophrenia)
* Seeking substance abuse treatment
Soft Robotic Hand System for Stroke Rehabilitation

The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.


Eligibility Criteria:
Inclusion criteria:

1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);
2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
3. able to sit up for 45 minutes (with or without assistance).

Exclusion criteria:

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication;
2. any additional medical or psychological condition affecting their ability to comply with the study protocol;
3. history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.
The Effects of Inositol on Glucose Metabolism in Patients with Metabolic Syndrome At Risk of Cardiac Fibrosis

The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis


Eligibility Criteria:
At least 3 of the following inclusion criteria:

* triglycerides levels ≥ 150 mg/dL
* HDL ≤ 40 mg/dL
* Fasting glycemia \> 100 mg/dL \<126 mg/dl
* Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg
* Hip circumference \> 102 cm in men or 88 cm in women
Management of Childhood Pancytopenia

Pancytopenia is an important hematologic Problem.it is a decrease in all three cellular elements of peripheral blood leading to aneamia, leucopenia and thrombocytopenia.

Pancytopenia usually presents with symptoms of bone marrow failure such as pallor, dysnea, brusing and increased tendency to infections.

The incidence of various disorders causing pancytopenia varies according to Geographical distribution and genetic mutations. It can result from :

* Failure of production of hematopoietic progenitors in bone marrow as in aplastic aneamia.
* Bone marrow infiltration by malignant cells as in acute leukemia.
* Antibodies mediated bone marrow suppression as in systemic lupus.
* Ineffective hematopoiesis and dysplasia as in nutrition deficiency.
* Peripheral sequestration of blood cells in over active reticuloendothelial system as in hypersplenism.

Pancytopenia is not a disease entity but a triad of findings that may result from primary or secondary bone marrow involvement.

Bone marrow aspiration and biopsy evaluation along with clinical correlation are important to evaluate the causes of pancytopenia and plan further investigations and treatment.

Pancytopenia can result from damage to bone marrow evidanced by low reticulocyte count, or increased destruction of the peripheral blood with increased reticulocyte count.

Bone marrow examination is a simple and safe invasive procedure for evaluating the causes of pancytopenia.

The hypoplastic marrow which occurs in 2% of pediatrics acute lymphoblastic leukemia may be misdiagnosed as aplastic aneamia.

Studies done have shown leukemia to be the second most common cause of pancytopenia in pediatrics, marginally behind aplastic aneamia.

Eligibility Criteria:
Inclusion Criteria:

* All childrens and adolescents suffering from pancytopenia attending heamatology unit of pediatric department Assiut University Hospital will be included.

Exclusion Criteria:

* childrens and adolescents suffering from pancytopenia due to malignancy.
Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 20-80 years;
2. Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
3. Patients had histologically confirmed gastric adenocarcinoma (tumor size\<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
4. Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.

Exclusion Criteria:

1. Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
2. Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
3. Patients had any concurrent or previous malignant tumor;
4. Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
5. Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).
Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa

This study aims to retrospectively analyze the efficacy and safety of secukinumab combined with surgery in treating moderate to severe HS in real-world clinical practice, providing clinical practioners with real-world evidence in HS treatment.

Hidradenitis suppurativa (HS) is a chronic, recurrent, and disabling inflammatory disease that occurs in apocrine distribution sites such as the axilla, groin, and perianal region with a worldwide prevalence of approximately 1.5% -4.6%.The pathogenesis is excessive activation of the Th17 type immune response mediated by IL-17, IL-23, resulting in abnormal keratinization of hair follicles, obstruction of sebaceous ducts, and bacterial infection, culminating in abscesses, sinus tracts, and scarring.Patients with moderate to severe HS (Hurley stage II-III) often suffer from a severe decline in their quality of life due to recurrent infections, pain, and dysfunction, and their risk of depression is markedly elevated.Traditional treatments such as antibiotics, glucocorticoids, surgical debridement have limited efficacy, and the recurrence rate of surgery alone is as high as 50% -70%.In recent years, the use of biologic agents such as TNF-α inhibitors has dramatically improved HS outcomes, but 30% to 40% of patients still have an inadequate response to TNF-α inhibitors. Accumulating evidence suggests that the IL-17 pathway plays a key role in HS pathogenesis, that IL-17A expression is upregulated in the skin lesions of HS patients and positively correlates with disease severity. The efficacy and safety of secukinumab in combination with surgery remain unclear.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS
2. The diagnosis of HS was confirmed by histopathological examination in the Department of Pathology of our hospital
3. Patients with HS who received secukinumab combined with surgery in the Department of Dermatologic Surgery of our hospital
4. Patients with complete clinical data followed up for at least 1 year

Exclusion Criteria:

1. Patients lost to follow-up
2. Patients with less than one year of follow-up
3. Patients who received additional adjuvant therapy during the follow-up period
Effectiveness of Musical Training in Children Surviving Brain Tumours

This study aims to examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.

Children surviving brain tumours have the highest risk of suffering neurocognitive late effects, such as impairment of intellectual development and deficits in attention and concentration, working memory, processing speed and executive function. Such effects severely affect their levels of academic achievement, psychosocial function and quality of life. Musical training is considered to have potential for treating neurocognitive impairment,mostly because the extensive brain networks engaged in musical training can induce substantial neuroplasticity changes in cortical and subcortical regions of motor, auditory and speech processing networks. A review of musical training for neuro-rehabilitation revealed that it can enhance motor recovery and neuroplasticity after stroke and improve motor deficits observed in Parkinson's disease. A growing body of evidence points to the beneficial effects of musical training on the cognitive development of children. The results of a longitudinal study on the effects of musical training on children's brain and cognitive development demonstrated that such training results in long-term enhancement of visualspatial, verbal and mathematical performance. Moreover, engaging in musical practice in childhood predicts academic performance and IQ at the university level. Thus, there appears to be some support for the effects of music lessons on intellectual development.

Nevertheless, although musical training is popular and is considered to be a beneficial intervention in the treatment of neurocognitive impairment, longitudinal studies that examine the efficacy of music-making in clinical settings are limited. Importantly, there is to date no study that examines the effects of musical training on induction of neuroplasticity in childhood cancer survivors with neurocognitive impairment. There is an imperative need for rigorous empirical scrutiny of the ability of musical training, in particular, to achieve neuroplasticity and thus promote the cognitive function and psychological well-being of children surviving brain tumours.

Eligibility Criteria:
Inclusion Criteria:

* surviving germ cell tumours of the brain
* be aged from 7 to 19 years
* be able to speak Cantonese and read Chinese
* have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
* have completed treatment for at least two months

Exclusion Criteria:

* have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
* with evidence of cancer recurrence or second malignancy in their medical records
Vinorelbine for Recurrent ALCL-2017

The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.

Eligibility Criteria:
Inclusion Criteria:

Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include:

Diagnosed as ALCL, already received first-line treatment, but get disease progression; After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis.

Exclusion Criteria:

Patients with other systemic diseases, severe infections or critically illness.
Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)

The research project is a component of another research project that applies the protocol of the World Health Organization for screening of cervical cancer, with testing of high-risk Human Papilloma Virus (hrHPV) as first screening. In the screen, triage and treat approach women who tested positive for hrHPV are undergoing Visual Inspection of the cervix with Acetic Acid (VIA). This procedure is applied in Uganda, India and Bangladesh. However the quality of VIA by lower-trained staff is variable because Low and Middle Income Countries face limited numbers of qualified health care professionals. Artificial intelligence (AI) might be a solution to improve consistency of VIA assessment. This research validates an AI decision support system (AI-DSS) under field conditions.

This research project aims to validate an image processing algorithm in order to study if the AI can function as decision support system (DSS) for healthcare workers, who perform VIA. The AI-DSS has been designed by the Manipal Academy of Higher Education in India and has shown a sensitivity of 99.05% and specificity of 97.16% for detection of aceto-white lesions.

The first step of the validation process is a dry run using a database of VIA pictures with pathology confirmation. The accuracy, sensitivity and specificity of healthcare workers, an expert team and the AI will be analysed, based on the ground truth of database pictures.

Thereafter, the AI-DSS will be validated under field conditions. Women who are hrHPV-positive in Uganda, India and Bangladesh will undergo a VIA. The AI is incorporated in a device, that can take pictures of the cervix and provide and instant report (positive = needs further investigation or negative = no lesions found). The user experience of the device will be evaluated.

The AI-DSS will be validated by comparing the VIA assessment by health workers, the AI with assessment by the expert panel. Accuracy, sensitivity and specificity of the AI algorithm will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Female in eligible age group
* Women who tested HPV positive and are eligible for VIA
* Ability to give informed consent and participate in study

Exclusion Criteria:

* Clinical signs of cervical carcinoma
* Menstruation or other vaginal blood loss
* HPV negative women
Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire

Starting from Chronic Cough Impact Querstionnaire (CCIQ), of which we are the authors and copyright holders, it will be developed and validated a shortened version with psychometric properties allowing the use in the evaluation of single patient (Chronic Cough Patient Perspective).

The CCPP will allow to unmask the problem, reduce underdiagnosis, increase awareness on chronic cough, measure the impact of the chronic cough and its treatments on the patient's life.


Eligibility Criteria:
Inclusion Criteria:

diagnosis of RCC (Residual Cough VAS:\>10/100 mm) according to ERS guidelines

Exclusion Criteria:

difficulty in understanding the italian language in both spoken and written form
Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection

This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc

Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone.

In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area.

Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.

Eligibility Criteria:
Inclusion Criteria:

* Clinicoradiologically diagnoses Spinal Tuberculosis
* receives Anti TB drugs
* minimun destruction 1/3 vertebral body

Exclusion Criteria:

* patient under 15 years old
* reject to be included in the study
TME Neoadjuvant Breast Registry

Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.

Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded.

Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website.

All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy
* Ages 18-90
* Written informed consent

Exclusion Criteria:

* Patients who have had excisional biopsy or axillary dissection
* Patients with confirmed metastatic disease
* Patients who have had recent chemotherapy
Application of Intracavity Electrocardiogram Positioning Technique in PICC

This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice;
* No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.;
* patients who did not participate in other clinical studies;
* Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up

Exclusion Criteria:

* patients with local malformation or scar formation;
* Patients with infection or damage at the puncture site;
* patients with tumor compression of blood vessels;
* Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia
* Patients diagnosed or suspected to be allergic to silicone material
* Patients with a history of radiotherapy at the pre-intubation site
* Patients with a history of venous thrombosis, trauma or vascular surgery
* Patients with superior vena cava syndrome
* Patients with poor medical behavior
* Patients with severe peripheral vascular edema
* High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula