cyrilzakka/clinical-trials huggingface dataset:
Cortical Excitability in Patients With Severe Brain Injury

The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that:

1. There is a continuous decrease in intracortical inhibition from healthy subjects to awake patients with severe brain injury, and to patients with impaired consciousness.
2. Decreased intracortical inhibition correlate with the degree of impairment assessed with the clinical scores in patients with severe brain injury.

Design: Prospective controlled non-randomized study. Materials and methods: 30 patients with severe brain injury and 15 healthy volunteers will be included in this study.

The study design is illustrated below:

1. Clinical assessment (Rancho Los Amigos Scale, Functional Independence Measure, Early Functional Abilities).
2. Somatosensory Evoked Potentials.
3. Transcranial Magnetic Stimulation: single and paired stimulation protocols.

Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (awake patients vs patients with disorders of consciousness vs control persons) and intra-individually factors as 1) interstimulus intervals for transcranial magnetic stimulation and clinical scores (RLAS vs FIM vs EFA).

Significance level is set to 0.05 for all effect parameters.

Eligibility Criteria:
Inclusion Criteria:

1. severe brain injury (Glasgow Coma Scale score (GCS) less than 8 on admission to the acute hospital);
2. stable vital functions;
3. age over 18 years old;
4. informed content from patient/relatives/legal guardian.

Exclusion Criteria:

1. other neurological diseases than brain injury;
2. pregnancy;
3. TMS contraindications (epilepsy, metallic implantants: pacemaker or medicine pump, ferromagnetic or electronically operated stapedial implants, haemostatic clips, metallic splinters in the orbit).
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI

The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker

This study aims to investigate the effects of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of the following:

1. Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
2. Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).
3. Echocardiography parameters

Patients and Methods:

Design: Prospective, randomized, open label, controlled clinical trial

Patients: A total of 76 STEMI patients undergoing primary PCI will be enrolled in the study and will be randomly assigned into one of 2 arms:

Group 1 (Control group) (n=38): STEMI patients undergoing PCI who will receive the standard of care Group 2 (Test group) (n= 38): STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes (L-Carnitine 1 gm / 5 mL Injection®, MEPACO, Egypt) prior to PCI and then 2 g orally (Carnitol 500 mg®, Global Napi, Egypt) daily for 4 weeks after PCI

Eligibility Criteria:
Inclusion Criteria:

* Female or male aged \>18 and \< 75 years.
* STEMI patients undergoing PCI.

Exclusion Criteria:

* Patients with a recent history of myocardial infarction (MI), a previous PCI, a previous coronary artery bypass graft, or any cardiac surgery.
* A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure),
* Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI,
* Concurrent Infectious or active inflammatory disease,
* Severe liver or renal disease, (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3x ULN or Total bilirubin \> 3 x ULN), (CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
* Neoplasm, or hematological disorders
* Pregnant or breast-feeding patients
* Active participation in another clinical study
* Patients taking antioxidant drugs.
* History of or known allergy or intolerability to the study medications
The Effect of Valerian on Insomnia in Menopausal Women

Menopausal women often complain that it is difficult to fall asleep and easy to wake up at night and early in the morning and it is in the middle of night difficult to fall asleep again. If the above symptoms persist for at least three months and occur at least three times a week, plus the impact on daytime work and rest, and meet the International Classification of Sleep Disorders (ICSD-3) )'S s "Insomnia" diagnostic criteria. According to statistics, 30% to 60% of women face sleep disorders during menopause.

The investigators expect to receive outpatient admissions in the hospital attached to China Medical University. Menopausal women aged 45-60 years old who have been diagnosed with insomnia who meet criteria of International Classification of Sleep Disorders (ICSD-3) will be randomly assigned for clinical trials. Patients will take two Valerian capsules (1000mg/day) per day for four weeks. Pittsburgh Sleep Index (PSQI) will be used to evaluate subjective sleep quality. TCM patterns will be evaluated by three physicians of TCM gynecology independently before and after taking Valeriana. The data will conduct a biological analysis to compare the difference in sleep quality between the trial group and the control group.

Eligibility Criteria:
Inclusion Criteria:

1. 45〜60 years old, and is menopaused for at least 1 year。
2. meet the criteria of ICSD-3 for insomnia
3. PSQI \> 5

Exclusion Criteria:

1. psychiatry disease
2. Heart, brain, liver diseases
3. Insomnia is caused by diseases.
4. Steroid used within 6 months
5. pregnant or breastfeeding
A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery

The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.

Blood samples are collected in the comfort and safety of your home by a certified medical professional. We have mobile phlebotomists located in major metropolitan areas around the nation for your convenience.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>18 to 100 years old
* A diagnosis of neurological condition
* Proof of diagnosis can be provided

Control group: Healthy donors, males and females, 18 to 100 years of age

Exclusion Criteria

* Receipt of blood products within 30 days of study enrollment
* Receipt of an investigational (unapproved) drug within 30 days of study enrollment
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.

The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.

Eligibility Criteria:
Inclusion Criteria:

* Primary procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b:

  1. Gastric procedures limited to laparoscopic gastric resection, robotic laparoscopic gastric resection, partial gastrectomy, gastric wedge resection, subtotal gastrectomy, laparoscopic Roux-en-Y gastric bypass, and robotic laparoscopic gastric bypass; or
  2. Lung resection procedures that include lobectomy, segmentectomy or wedge resection, and lung volume reduction surgery, and may be video assisted thoracic surgery (VATS) or open procedures;
* Willingness to give consent and comply with all study-related evaluations and visit schedule; and
* At least 18 years of age.

Exclusion Criteria:

- Preoperative:

1. Physical or psychological condition which would impair study participation;
2. Body mass index (BMI) ≥ 46.0 kg/m2;
3. The procedure is a revision/reoperation for the same indication or same anatomical location;
4. A procedure where extended wound or organ support is required;
5. Any medical condition that the investigator deems could impact inflammatory or immune response;
6. Concurrent treatment with medications that the investigator deems could have influence on wound healing;
7. History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
8. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

   * Intraoperative:
9. Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.
A Comparison of FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.

HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%, a sample size of 15 patients would be accrued in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Post operative patients of documented high grade gliomas (grade III and IV)
2. Patients who have not undergone any previous irradiation to brain.
3. Performance Scale as defined by ECOG PS 0-3

Exclusion Criteria:

1. Patients who are diabetic.
2. Patients who are pregnant.
3. Any documented contrast allergy to the agents used for imaging.
4. Patients who are unable to comprehend or cooperate effectively for treatment planning.
Safety and Performance Evaluation of the Magneto Wire

A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Wire in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke within defined timelines.
* Age 18-85 years old
* NIHSS ≥ 8
* No significant pre-stroke functional disability (mRS ≤ 1)

Exclusion Criteria:

* Life expectancy of less than 90 days
* Neurological signs that are rapidly improving prior to or at time of treatment
* NIHSS≥30 or state of coma
* Ongoing seizure
* Current use of cocaine or other vasoactive substance
* Known bleeding diathesis
* Known hemorrhagic or coagulation deficiency
* Evidence of active systemic infection
* Current use of oral anticoagulants INR \> 3
* Administration of heparin or Novel Oral Anticoagulants within 48 hours preceding the onset of stroke and have an abnormal aPTT at presentation
* Platelet count \< 50,000/mm3
* Glucose \<50 mg/dL (2.8 mmol, 2.6mM)
* Uncontrolled hypertension (SBP\>185 or DBP\>110) refractory to pharmacological management
* Known hypersensitivity or allergy to radiographic contrast agents
* Pregnancy or lactating female
* Subject already enrolled in a clinical study involving experimental medication or device
* CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score\<6, mass effect and/or intracranial tumor.
* Angiographic evidence of carotid dissection, or high grade stenosis that will prevent access to the clot, or cerebral vasculitis, or intracranial stenosis
* Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
* Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.
AAT-APP+: A Novel Brain-training App to Reduce Drinking

This study will explore the feasibility, acceptability, and preliminary effectiveness of a smart phone delivered form of cognitive training intervention (Approach Bias Modification (ABM)) in a non-clinical community sample of middle to older adults (\>55 years) reporting hazardous alcohol use in a pilot randomised controlled trial (RCT). This app is called AAT-APP+

Alcohol use in older adults is of particular concern, with the 55-74 year old cohort most likely to exceed lifetime alcohol risk. Approach Bias Modification (ABM) is a form of computerised cognitive training that is an efficacious intervention for alcohol use disorder. Previous studies are limited in that the stimuli are not personalised, nor are interventions readily accessible to non-treatment seeking problem drinkers. This has led to the development of a world-first, smart phone version of ABM called AAT-APP+

The current study aims to explore the feasibility, acceptability, and preliminary effectiveness of AAT-APP+ in reducing alcohol consumption and cravings in a pilot RCT with a non-clinical community sample of 100 older adults (aged 55+ years) reporting hazardous alcohol use (i.e. a score of 8+ on the AUDIT), recruited via targeted advertising. Participants in active training will upload (or select pre-selected) photos of beverages and meaningful activities, which will form the 'avoid' and 'approach' stimuli, respectively, then complete two training sessions per week for four weeks, with results compared to controls. AAT-APP+ holds promise as an innovate, cost-effective, and remotely accessible adjunctive support tool.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 55+ years
* Score 8 or higher on the Alcohol Use Disorders Identification Test (indicates 'hazardous' levels of alcohol use).
* Access to an Android or Apple smart phone and Australian contact number
* Wish to reduce their drinking
* Live within the Eastern Health Primary and Secondary Catchment (see map below)

Exclusion Criteria:

* Under age 55
* Not concerned about their drinking
* Do not wish to reduce their alcohol use in the next 4-6 weeks
* Do not reside with the appropriate catchment will be excluded.
* Experiencing severe alcohol problems likely to need professional treatment (i.e. presence of withdrawal symptoms in the past year)
Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis

Bronchiolitis is a common illness of the respiratory tract caused by infection of the tiny airways within the lungs called bronchioles. At present the standard care of hospitalized children with bronchiolitis is oxygen via nasal prongs. In this study the investigators would like to compare standard ward management with a new method of delivering oxygen called high flow nasal cannula oxygen therapy (HFNOT). HFNOT involves breathing warmed, moistened oxygen through nasal cannulae at a flow rate of 8 liters/minute. Accumulated experience suggests that HFNOT eases the child's work of breathing and reduces need for ICU admission and invasive respiratory support.

We propose a prospective open randomised controlled trial to compare high flow nasal cannula oxygen therapy (HFNOT) with standard oxygen therapy for infants hospitalised with bronchiolitis. This study will be the first of its kind, as currently there is no evidence in the published literature.

All children will be cared for by the same medical team on two wards. All aspects of care other than oxygen delivery will not be specified, and be at the discretion of the physicians. HFNOT will not be used as an escalation of care on the wards.

Randomisation will be performed by REDcap, in blocks of 6 patients. Patients will be identified in Emergency, informed consent obtained, and treatment started prior to transfer to the ward.

For patients randomised to HFNOT, the flow rate will be fixed at 8 liters/minute, and the inspired oxygen concentration titrated to maintain saturations above 92%.

Interim statistical analysis will be conducted to determine any positive or negative effect of HFNOT therapy. The first interval analysis will be performed after 50 subjects, the second after 100 subjects. If an effect is found, the study will be terminated following discussion with the hospital statistician and ethics board. Whichever treatment arm is found to be beneficial will be instituted as standard care for children with bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* All children under 18 months of age with a clinical diagnosis of bronchiolitis requiring admission to hospital for observation and oxygen.

Exclusion Criteria:

* Infants admitted directly to ICU from Emergency.
* Prior positive pressure home ventilation.
* Tracheostomy.
* Nasogastric tubes in situ on admission.
* Upper airway abnormality.
* Congenital heart disease.
Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.

Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.The purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration.

Eligibility Criteria:
Inclusion Criteria:

* 1、Patients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.

  2、Karnofsky/Lansky score of 60% or greater. 3、defined as alanine transaminase (ALT) \<3 x upper limit of normal (ULN),aspartate aminotransferase (AST) \<3 x ULN; serum bilirubin and alkaline phosphatase \<2 x ULN.

  4、No other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.

  5、Able to take oral medication or take medication via enteral feeding tube. 6、Ability to give informed consent. 7、No history of anaphylaxis attributed to the azole class of antifungal agents.

Exclusion Criteria:

* 1、Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.

  2、Subject is not considered eligible for this clinical research program with posaconazole.

  3、Use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.
Sepsis As a Cause of Death Among Elderly Cancer Patients

The goal of this retrospective study is to explore the association between sepsis and morality among the elderly cancer patients. Data were extracted from the Surveillance, Epidemiology and End Results( SEER) database using SEER\*stat software. The study included patients aged 65 years or more who were diagnosed with cancer from 2000 to 2021. The extracted data included age, race, marital status, sex, stage, surgery, chemotherapy and radiotherapy. Multiple primary session was used to calculate the standardized Mortality ratio (SMR) as Observed/Expected with excess risk/10,000 and significance was achieved at 0.05.


Eligibility Criteria:
Inclusion Criteria:

* cancer patients
* age 65 year or more
* latency exclusion period of 0 months.

Exclusion Criteria:

- Death certificate only and autopsy only cases
Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.

Primary objective:

To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.

Secondary objective:

To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5.
* 2.Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

* 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin \[HbA1c\>7.5%\]), or other diseases that may lead to secondary osteoporosis.
* 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, glucocorticoids, calcitonin, vitamin K, active vitamin D, gonadotropin-releasing hormone agonists, isotopes Flavonoids, selective estrogen receptor modulators, or hormone replacement therapy.
* 3.Patients with urolithiasis revealed by B-ultrasound at screening.
* 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (\> 0.4 mg/dL GF), or chronic kidney disease (eGFR \< 30 mL/min/1.73 m2).
* 5.Patients with malignant tumors or patients with a history of malignant tumors within the previous 3 years.
* 6.Patients judged by investigators to be unsuitable as subjects.
Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT

Atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating tachycardia (AVRT) are two similar supraventricular re-entry tachycardias (SVT) emerging in relatively young age in patients without apparent structural heart disease or significant comorbidities. The treatment of choice in those patients is radiofrequency ablation (RFA).

The PPRA study is a prospective observational study developed to thoroughly analyze quality of life, utility and willingness-to-pay of Polish patients undergoing RF ablation of AVNRT or AVRT.

Based on collected data the investigators will prepare a profile of patient who will benefit most from radiofrequency ablation and who should be scheduled in first place for the ablation in case of problems with accessibility to this service.

What is more an analysis of medical and indirect costs of care will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age above 18
3. Scheduled RFA due to AVNRT or AVRT
4. Sufficient knowledge of the Polish language to independently complete the questionnaires

Exclusion Criteria:

1. No written informed consent
2. Health states significantly impairing QoL (eg. stroke, advanced heart failure)