cyrilzakka/clinical-trials huggingface dataset:
Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.

The consequences of untreated acute pain are known and can also contribute to chronification in pain.

Surgical correction of adolescent idiopathic scoliosis (AIS) is indicated for severe deformity. Posterior Spinal fusion (PSF) for AIS is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. All of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.

The consequences of untreated pain are known and can also contribute to chronification in pain.

The incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. It is therefore important to minimize the pain during the first postoperative days. Untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. To date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after PSF a challenge makes for all healthcare providers involved.

Eligibility Criteria:
Inclusion Criteria:

* approved written informed consent by parent or legal representative
* idiopathic adolescent scoliosis
* planned for elective surgery: posterior spinal fusion

Exclusion Criteria:

* other types of scoliosis
* chronic opioid usage (more than 3 months)
* known unstable psychiatric medical condition
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female, between 18 and 55 years of age
* Body mass index ≥ 18 and ≤ 32 kg/m2
* Laboratory values meeting defined laboratory ranges
* Males or non-pregnant, non-lactating females

Exclusion Criteria:

* History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
* Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
* Positive alcohol, drug or tobacco use/test
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent.
2. Require placement of an ICP monitor or ventriculostomy catheter for clinical purposes.
3. Be between the ages of 4 and 70 years old.
4. Have baseline vision correctable to within 20/500 bilaterally.
5. Have no prior history of ocular dysmotility.
6. Be awake with spontaneous eye opening at the time when eye tracking is performed.

Exclusion Criteria:

1. Have a prior history of strabismus, diplopia, or palsy of CN-III, IV or VI.
2. Be blind (no light perception), have missing eyes, be unable to open their eyes.
3. Have a prior history of ocular motility dysfunction.
4. Have had extensive prior eye surgery.
5. Have any physical or mental injury or baseline disability rendering task completion difficult.
6. Be intoxicated or have blood alcohol level greater than 0.2.
7. Be a prisoner or in the company of a police officer or law enforcement officer pending arrest.
Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis.

This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.

Rationale: Iron deficiency is common in kidney transplant recipients. The presence of iron deficiency is associated with an unfavourable prognosis in these patients. In patients with heart failure and iron deficiency, treatment with intravenous iron improved exercise capacity and quality of life. Whether such beneficial effects may also occur in kidney transplant recipients is unknown.

Objective: Our main objective is to address whether correction of iron deficiency with ferric(III) carboxymaltose improves exercise tolerance and quality of life in iron-deficient kidney-transplant recipients.

Study design: A multicentre double-blind, placebo-controlled randomized controlled clinical trial will be performed to compare the effects of ferric(III) carboxymaltose with placebo.

Study population: 158 iron-deficient kidney transplant recipients. The intervention arm will receive 10 mL of ferric(III) carboxymaltose (50 mg Fe3/mL, intravenously) every six weeks, with a total of four dosages. The control arm receives an intravenous placebo solution (saline).

Main study parameters/endpoints: The primary endpoint is the distance walked in six minutes, as quantified by the six-minute-walking-test at the end of follow-up.

The investigators expect that iron-deficient kidney transplant recipients will benefit from ferric(III) carboxymaltose treatment as a result of an improvement in exercise tolerance and general wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipient
* Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20%
* At least six months after transplantation at baseline
* Age ≥18 years
* Ability to comply with the study protocol
* Informed consent

Exclusion Criteria:

* Intolerance to any intravenous iron solution
* Severe anemia (Hb \<10.5 g/dL, \<6.5 mmol/L), microcytic anemia (MCV \<80 fl) or progressive anemia (˃3.2 g/dL per month decline for two months or more)
* A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
* Blood transfusion in the past six weeks
* Polycythemia (Hb \>15.3 g/dL, 9.5 mmol/L)
* Estimated glomerular filtration rate (eGFR) of ≤ 30 ml/min per 1.73 m2
* History of haemochromatosis
* Unstable angina or myocardial infarction during the previous month
* Disability to walk
* Severe hypophosphatemia in the month before baseline (serum phosphate \<0.35 mmol/L)
* Pregnancy or inability to take adequate contraceptive measures when at childbearing age (women)
* Any signs of an active systemic infection
* Participation in another interventional study
Comparative Effects of Action Observation and Motor Imagery on Upper Limb in Chronic Stroke Patients

To Compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients.

The study is Randomized controlled trial. The study will be conducted on 44 stroke patients. The study will be conducted in Civil Hospital Shujaabad and Riphah rehabilitation centre Lahore. Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks. For the pre- and post-evaluation of all participants, Fugl-Meyer Assessment Upper Extremity (FMA UE) and Wolf Motor Function Test (WMFT) will be used. Data will be analyzed by using SPSS (Statistical package for Social Sciences) 25 version.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic stroke by a neurologist
* 03 months post stroke
* Score 1+ on modified ashworth scale
* Having a score of 24 or higher in the Mini-Mental State Examination

Exclusion Criteria:

* Patient with neurological condition other than stroke e.g. Parkinson's or multiple sclerosis
* Presence of an attached artificial pacemaker
* Presence of a metal implant in the brain
* Presence of visual impairment
* Presence of unilateral neglect in Line bisection test (25)
* Use of antipsychotic drugs
Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging

Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of vascularization features.In a prospective study 207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These polyps were imaged and subsequently removed for histological analysis. the polyp images were analyzed by a computer algorithm. The proposed computer-based method consists of several steps: preprocessing, vessel segmentation, feature extraction and classification. The results of the automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy)were compared to those of human observers, who were blinded to the histological gold standard.


Eligibility Criteria:
Inclusion Criteria:

* All patients who did not meet the exclusion criteria were included in the study

Exclusion Criteria:

* Patients with chronic inflammatory bowel disease, adenomatosis coli, coagulopathy, insufficient bowel preparation, or previous colonoscopy within the last 3 years; age under 18 years; no written informed consent for participation in the study
Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2

The purpose of this study is to determine and compare the persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.

Actual number of patients enrolled for UK : 15242 patients

Actual number of patients enrolled for Germany : 22880 patients

Eligibility Criteria:
Inclusion Criteria:

* Have an apixaban, rivaroxaban, dabigatran or VKA prescription during the study period
* Are ≥18 years old at index date
* Have ≥12 months of computerised medical data prior to index date
* Have a record of AF on or ever prior to index date (index OAC prescription)

Exclusion Criteria:

* Have a record for a valvular condition (ie, rheumatic valvular disease and prosthetic valves) on or ever prior to index date
* Have a history (ever prior to index date) of the Oral anticoagulant (OACs) which are prescribed during the study period
Fecal DNA Methylation Detection for Gastric Cancer

The study is a prospective, multicentre, cross-sectional study to evaluate the efficacy of fecal methylation-based testing in comparison with the 'gold standard' imaging tests, such as CT, gastroscopy and/or pathology, for the prediction of gastric cancer in an enrolled population.

Aims of the study Primary study aim: To assess the sensitivity and specificity of fecal methylation site-based tests for the prediction of gastric cancer.

Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal methylation locus test for the prediction of gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumour markers, such as CA19-9, CEA, and CA72-4, etc.; 3. The predictive ability of the combined fecal H. pylori gastric cancer susceptibility test was assessed.

Study design Prospective, multicentre, cross-sectional study. Study period 2 years from the start of the project as approved by the Institutional Ethics Committee.

Target population The target population is over 40 years old in areas with a high incidence of gastric cancer.

Sample size The sample size of this study should not be less than 10,800 cases.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 years, male or female.
* Have or will have gastroscopy and/or pathology results.
* No contraindications to endoscopy and able to cooperate with endoscopy.
* Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria:

* Have severe cardiac, hepatic, or renal insufficiency, or mental disorders.
* Previous history of upper gastrointestinal malignancy.
* Women during pregnancy.
* Those with unspecified pathology.
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension

This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients, 18-75 Years
* Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and \< 180mm/110mmHg)
* Written informed consent

Exclusion Criteria:

* Patients with secondary hypertension
* Patients with severe hypertension
* Have to take other drugs that can influence blood pressure during the study
* Allergic to DHP calcium antagonists
* Evidence of congestive heart failure, unstable angina or severe arrhythmia
* Renal or hepatic dysfunction
* Women who are taking contraceptive pills or are likely to be pregnant
* Participate in other clinical trials within 3 months prior to this study
Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL

Extra corporeal shock wave therapy (ESWL) is recommended for pain management in patients with stone formation in pancreatic duct. ESWL can cause complete stone fragmentation and removal in 70% patients, associated with 85 to 90% pain relief.

Investigators aim to study, predictors pain relief in patients who undergo ESWL, to find out which patients will improve and which patients won't improve in terms of pain.

The study will be a single center observational study.

General information of the patient in form of duration of symptoms and duration of diagnosis,exocrine and endocrine insufficiency. Imaging findings such as main pancreatic duct stone,size,parenchymal calcification , ductal stricture and its location, using any medications such as antioxidants and pain killers .

The pain score will be estimated by Izbicki's pain score in last 6 months. Patients will receive standard of care during study period, and they won't receive any experimental therapy.

After 6months of ESWL further general information of the patient any addictions, a formal imaging and determining main pancreatic duct stone ,size ,calcifications and strictures and also usage of any medications for decreasing pain.

Pain will be calculated by Izbick's pain score in last 6 months . Comparing pain score and information investigators will evaluate predictive factors of pain relief after ESWL by logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pancreatitis patients undergoing ESWL

Exclusion Criteria:

* Patients with multiple pancreatic duct stones
* Patients with multiple pancreatic duct strictures
* Pancreatic head mass
* Patients with ascites
* Pregnancy
* Patients not giving consent for participation
* Pseudocyst
Emergency Medical Services and Epilepsy in Switzerland

Retrospective data analysis, all emergency medical services of the city of Zurich interventions due to epileptic convulsions during June 2013 and December 2014 have been analyzed regarding the type of drug used, its application mode and the application mode based success. Furthermore, children versus adults were compared. Continuous variables were summarized as mean ± standard deviation (SD) and also presented as median \[minimum; maximum\]. Groups were compared using the independent samples t-test. P-values \< 0.05 are considered significant.


Eligibility Criteria:
Inclusion Criteria:

* emergency calls for epileptic seizures received by the emergency medical system of Zurich,Switzerland,
* the use of midazolam or diazepam or no drug used.

Exclusion Criteria:

* the use of any other first line drug to stop seizures than the two mentioned above e.g. thiopental
Rhythm Control of AF in Patients With Acute Stroke

Prospective randomized (rhythm control or rate control) Objective of study

1. To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
2. To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Atrial fibrillation (20\~80 years old)
2. patients with Acute stroke within 7 days
3. LA diameter \< 55mm
4. patients possible to anticoagulation and anti arrhythmic drug
5. NIHSS score ≤12

Exclusion Criteria:

1. Hemorrhagic transformation
2. Large cerebral lesion or cerebellar lesion (more than 1/3 of MCA area and 1/2 of ACA area, 1/2 of PCA area, 1/2 of cerebellar area)
3. active internal bleeding
4. Impossible to anticoagulation or anti arrhythmic drug
5. Valvular AF (MA\> GII, Mechanical valve, Mitral valve replacement)
6. LV ejection fraction \< 30%
7. Structural cardiac disease
8. Catheter ablation history for AF, Cardiac surgery
9. Already prescribed anti arrhythmic drugs
10. With severe medical disease
11. Expected survival \< 1year
12. Severe alcoholics, drug addiction

14. Contraindication to MRI 15. Pregnancy
Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm companies with the BCR-ABL fusion gene encoded by the Philadelphia (Ph) chromosome. The BCR-ABL fusion protein(the formation of the chimeric gene BCR/ABL on chromosome 22 and a reciprocal ABL/BCR on chromosome 9,it has no expanded name) plays key role on CML leukemogenesis by activating its downstream signaling pathway of survival and proliferation. Imatinib, a targeted competitive inhibitor of a BCR-ABL tyrosine kinase, changed the clinical treatment and prognosis of CML. As its optimized generation, other tyrosine kinase inhibitors (TKIs), dasatinib and nilotinib have more potent anti-leukemic activity and less side-effect. However, acquired resistance to TKIs is one of the main obstacles to effective CML treatment and is involved in gene amplication of ABL tyrosine kinase point mutations. The outcomes of patients with these ABL tyrosine kinase point mutations have linked to worse prognosis and higher mortality generally. Metabolic adaptations are common in cancer cells, and cancer cells become more dependent on mitochondrial biogenesis. Tigecycline, as a broad-spectrum antibiotics, inhibits mitochondrial biogenesis as its an interesting "side-effect".In recent study,researchers indicated that tigecycline can eradicate cancer stem cells by targeting mitochondrial.Here, the investigators test tigecycline's anti-leukemic activity to chronic myeloid leukemia in vitro.

In this study, the investigators collected bone marrow(BM) or/and peripheral blood(PB) mononuclear cells from patients with chronic myeloid leukemia.Patients could be in different stages of chronic myeloid leukemia pre-treatment.Additionally, the investigators also selected some healthy volunteers as comparison.Firstly, the investigators analyzed mitochondrial biogenesis and basal metabolic characteristic of mononuclear cells from patients and healthy volunteers.Secondly, the investigators tested the cell viability and apoptosis after tigecycline treatment.Thirdly,the investigators detected the changes of cell mitochondrial biogenesis and metabolic characteristic in the same study sample after tigecycline stimulation. Finally,the investigators analyzed the correlation between sensitivities of mononuclear cells to tigecycline and patients' clinical parameters and survival outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
* Age \>18 years.
* Eligibility of patients receiving any medications or substances known to affect or determined following review of their case by the Principal Investigator

Exclusion Criteria:

* Patients may not receive any other antibiotics.
* Patients may not have received prior treatment with TKIs or hydroxyurea.
* Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
* No prior malignancies or any other cancer from which patient has been disease free for 5 years.
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 16-26

Exclusion Criteria:

* Significant Neurological Disease other than Alzheimer's disease
* Major psychiatric disorder
* Clinically significant systemic illness