cyrilzakka/clinical-trials huggingface dataset:
Once Daily Metronidazole for Perforated Appendicitis

The objective of this study is to determine whether administering once-daily doses of metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated appendicitis, is as effective in children as delivering it in the standard method of once every eight hours. Reducing the frequency of administration has the potential of decreasing personnel time and healthcare cost and increasing the lifespan of the IV line.

To determine the effectiveness once-daily administration, a randomized controlled trial (RCT) will be conducted to compare outcomes between the two treatment schedules. We will recruit 100 patients (50 per treatment) aged 5-18 being surgically treated for perforated appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such as duration of hospital stay and theoretical cost will be measured and analyzed using statistical tests.


Eligibility Criteria:
Inclusion Criteria:

* All children 5-18 years of age, presenting to CHEO with perforated appendicitis (confirmed either in the operating room or diagnosed preoperatively according to radiological criteria), and managed surgically will be assessed for eligibility to participate. These patients may participate if baseline lab values of serum AST (SGOT), AL T (SGPT), LDH, triglycerides and hexokinase glucose are normal, complete physical exam is normal, hGC test is negative for pregnancy (if the patient is a female of reproductive age) and none of the exclusion criteria are present.

Exclusion Criteria:

* Any known co-existing gastrointestinal disease
* Uncertainty about the diagnosis
* Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
* A known allergy to any of the antibiotics to be used in this trial
* An active neurological disorder
* Receiving medical treatment for a neurological disorder
* A history of blood dyscrasia, hypothyroidism or hypoadrenalism
* Hepatic disease
* Renal impairment
* Patients receiving any other oral or intravenous concomitant antimicrobial at enrollment
* Pregnancy
* Under five years of age
* Patients who have received metronidazole orally or intravenously in the last 14 days, prior to the current admission for appendicitis
* Patients already taking any of the following medications at admission (as these may interact with Metronidazole as stated in the product monograph): disulfiram, oral anticoagulant therapy (warfarin type), phenytoin or phenobarbital, vecuronium, lithium, busulfan
* The physician elects to treat the patient conservatively (non-surgically)
A New Anatomical Classification of Portal Vein Location of Pancreas Tumors

In this retrospective study, we recorded the location of pancreatic tumors and relation/proximity to the portal vein. The surgical difficulty and requirement of additional interventions were also evaluated.

Between May 2014 and October 2018, all patients who underwent PD procedure were retrospectively reviewed. This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection. Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded. The local ethical committee was approved this study.

Data collection included demographical features, tumor characteristics including the PV level of the tumor considering computed tomography results, neoadjuvant therapy, surgical data, hospital stay, morbidity and mortality.

Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location (Figure I). Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.

Eligibility Criteria:
Inclusion Criteria:

* This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection.

Exclusion Criteria:

* Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded.
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

* To determine the activity and efficacy of the schema specified as dose regimen
* To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-1
* Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
* No previous treatment with chemotherapy or radiotherapy
* Measurable lesion (uni or bidimensional)

Exclusion Criteria:

* Creatinin clearance \<50 mL/min
* Total bilirubin \>1.5\*ULN (Upper Limit of Normal)
* AST/ALT \> 2.5\*ULN
* Total White Blood Cell \<1.500.000/mL
* Platelet count \<100.000.000/mL
* symptomatic sensitive peripheral neuropathy
* pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Proteomics for Chronic Disorder of Consciousness

Following severe traumatic brain injury, patients may remain unconscious for many years. It is the first proteomic analysis comparing differentially expressed proteins between patients with chronic disorder of consciousness and controls so far. The investigators generated accurate lists of proteomes and identified differences at different disease time courses. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness.

Background: Patients who awake from severely traumatic brain injury (sTBI) may remain unconscious for many years. Although behavioral assessment and functional imaging are currently used as diagnostic tools, the molecular basis underlying chronic condition has yet to be explored.

Objective:To explore the molecular basis and identify novel biomarkers for the diagnosis and prognosis of patients with chronic disorder of consciousness.

Method: Plasma samples were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls. Potential molecular mechanisms were further discussed through bioinformatics analyses. Candidate proteins were validated by enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 14 to 65 years old;
2. Patients had a history of sTBI;
3. Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
4. Patients stay unconscious for more than 1 month.

Exclusion Criteria:

1. Patients with acute infectious diseases or liver dysfunction;
2. Patients with serious diseases such as cardiac or pulmonary problems.
Clinical Significance of Smear or Culture Positive for Candida Spp. From Sputum Three Times a Week

The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.


Eligibility Criteria:
Inclusion Criteria:

* 85ys\>age\>14ys
* APACHE II\<25
* Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever
* smear or culture positive for candida spp. from sputum

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to fluconazole
* Isolated candida was non-sensitive to fluconazole
* Severe liver or renal diseases who can not tolerate fluconazole treatment
* With at least one of the following high risk factors:organ transplantation, neutropenia\>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS
* With one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or BALF, cryptococcus isolated from sputum or CSF, galactomannan antigen positive twice for blood
* Probable or possible pulmonary aspergillosis
* Definite oral or esophageal candidiasis
Molar Intrusion in Open Bite Treatment

This experimental study will evaluate the effect of different methods for the molar intrusion (compared with the control group) in adolescent and adult patients with open bite malocclusion. The study sample will consist of 45 patients with anterior open bite. The sample will be randomly allocated into two experimental groups, in addition to a control group.

The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be used in the first treatment group, while miniscrews will be used in the second treatment group. In the control group, only OBA will be used. The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be assessed by using posteroanterior and lateral cephalometric radiographs. Pre- and post- treatment changes for each group will be evaluated, in addition to the comparison of the post-treatment skeletal and dental changes that occurs between groups.

Open bite malocclusion is considered one of the most difficult orthodontic problems to correct because it appears as a result of the interaction of numerous etiological factors (genetic, dental, skeletal, functional, soft tissue, and habit) that contribute to its development. Various therapeutic approaches have been proposed for the treatment of an anterior open bite. These approaches vary depending on the causative factors and involve myotherapy, preventive treatment, functional therapy, orthognathic surgery, and orthodontic treatment using anterior teeth extrusion or posterior teeth intrusion. Among the non-surgical orthodontic treatment methods are the temporary anchorage devices (TADs) including miniplates and miniscrew or micro-screw implants. The intrusion of posterior teeth with temporary anchorage devices was suggested to lead to decreased lower facial height by a counterclockwise rotation of the mandible; this may resemble the orthognathic surgery outcomes for any open bite patients. To the best of the investigators current knowledge, this is the first randomized controlled trial evaluating the effect of molar intrusion in adolescence and adult patients in the permanent dentition stage.

Eligibility Criteria:
Inclusion Criteria:

* Patients with skeletal open bite determined by an increased B angle (angle between the maxillary plane and mandibular plane), the Sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
* Patients between 12 and 18 years old in permanent dentition stage.
* Negative over-bite of more than a mm
* Class I or Class II skeletal anteroposterior relationship.

Exclusion Criteria:

* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Class III skeletal anteroposterior relationship.
Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with calcitriol.

This is a multi-center, prospective, open label, one arm, phase IV study designed to demonstrate paricalcitol efficacy and safety in the treatment of moderate to severe secondary hyperparathyroidism in calcitriol resistant participants on dialysis.

Following screening, participants began an 8-week controlled calcitriol therapy period. Participants whose parathyroid hormone (PTH) levels decreased were to be discontinued from the study. Those whose PTH levels did not decrease began paricalcitol therapy using a dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol was administered intravenously at anytime during the subjects' dialysis. The paricalcitol dose was to be titrated every 2 weeks until iPTH was reduced or up to 4 months, after which it was to be adjusted monthly for 1 year based on serum PTH, calcium, phosphorus, and albumin measurements.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants \> 18 years of age, with chronic kidney disease (CKD) stage V;
* Participants with diagnosis of calcitriol resistance defined as: Episodes of hypercalcemia and/or hyperphosphatemia (defined as an episode of calcium or phosphorus above Upper Limit of Normal or documented by medical history stating that the treatment with calcitriol was discontinued due to hypercalcemia and/or hyperphosphatemia) that precludes treatment continuation and/or persistent PTH above 600pg/mL during the calcitriol therapy;
* PTH value at screening visit between 600 pg/mL and 2,000 pg/mL;
* Stable clinical conditions;
* Participant has voluntarily consented to participate in the study, by signing and dating an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and all his questions about the study have been elucidated. The informed consent must be signed before any study-specific procedures are performed.

Exclusion Criteria:

* Previous parathyroidectomy;
* Presence of hypercalcemia (corrected Ca \> 10.5 mg/dL) and/or hyperphosphatemia (P \> 6.0 mg/dL) and/or Ca x P product \> 60, at screening visit (corrected Ca calculated by: \[4 - participant's serum albumin (g/dL)\] x 0.8 + participant's serum Ca value);
* Severe and/or unstable clinical conditions, e.g., congestive heart failure, advanced cancer, advanced HIV disease, severe endocrinopathies, uncompensated diabetes mellitus, life-threatening cardiac arrhythmias, etc;
* Abnormal liver tests (\> 1.5 times above upper limit of normal);
* Pregnant or breast-feeding women;
* Evidence of vitamin D toxicity;
* Known hypersensitivity to any study drug components.
Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery

To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.

Select the patients who will receive posterior lumbar surgery in the Second Hospital of Shanxi Medical University. According to the classification criteria of fat infiltration, it will be divided into three groups: mild, moderate and severe. This study will pump and titrate rocuronium bromide under the monitoring of muscle relaxation during the operation, record the dosage of rocuronium bromide and the duration of pump injection, and evaluate its clinical effect. Postoperative results include the use and clinical effect of rocuronium, which will be counted after the trial.

Eligibility Criteria:
Inclusion Criteria:

Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy.

Exclusion Criteria:

refusal to participate by the present experimenter; those with severe cardio-cerebrovascular disease, severe hepatic and renal dysfunction; taking medications affecting the neuromuscular junction; area of monitoring site for skin breakers; patients with intraoperative bleeding, anaphylactic shock, or other serious complications; patients requiring intraoperative neurophysiological monitoring (including sensory, motor evoked potentials).
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test

Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.

Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.

Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.

Exclusion Criteria:

* Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing
A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.

This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Age≧18 year, male;
* ECOG performance scale 0 to 1;
* Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ;
* Adequate hepatic, renal, heart, and hematological functions;
* Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

* Subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1;
* Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens;
* Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels ;
* Evidence of brain metastasis or primary tumors;
* Planned to initiate any other anti-tumor therapies during the study;
* Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases;
* History of seizure or certain conditions that may predispose to seizure;
* Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

The clinical study evaluates in an open-label, crossover design the comparative efficacy and safety of intranasal oxytocin and autologous umbilical cord blood for improving the functioning of children with autistic spectrum disorder

Children aged 3-7 years diagnosed with autistic spectrum disorder and who did not previously receive oxytocin or umbilical cord blood treatments, will be enrolled to receive both treatments in random order. Assessment of functioning impairment will be done with QCHAT/M-CHAT/CAST questionnaires initially, at 2 months, 6 months and 1 year after first treatments. Either oxytocin or cord blood will be administered initially and at visit 2, which will take place at 2 months. All children will receive both treatments. A total of 25-40 children are expected to enroll and complete the study.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autistic spectrum disorder

Exclusion Criteria:

* metabolic or genetic disorder (ex storage disease, Down, etc),
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Stage II/III carcinoma of the esophagus squamous cell carcinoma.
2. Completed pre-operative chemoradiotherapy followed by surgery
3. Diagnosed with residual pathologic disease after being surgically rendered free of
4. Disease with negative margins following complete resection
5. Nonresponding to initial neoadjuvant Chemoradiotherapy(TRG3 and TRG4)

Exclusion Criteria:

1. Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
2. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；
3. Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
4. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
5. Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
6. Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
7. Allergic reactions to test drugs for this application；
8. Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。