cyrilzakka/clinical-trials huggingface dataset:
A Pilot Implementation Study of GLA:D Back

GLA:D Back is a program developed in Denmark to help people with persistent low back pain. This pilot study will assist in contextualizing Danish content into an English version of the program.

GLA:D Back is a program developed in Denmark to help people with persistent low back pain. Unfortunately, all materials developed for the program are in Danish. In this pilot, the investigators will translate the Danish materials into English, then use them to conduct an English training session for community clinicians in Edmonton, Alberta, Canada. Interested clinicians will then implement the program in their communities and provide feedback to contextualize the program for use in English. Specifically, surveys, interviews and focus groups will be used to help fine-tune the printed content of the course (e.g. manuals), it's training materials (e.g. lectures) and processes related to REDCap data collection (e.g. surveys).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have persistent low back pain of at least 1 month's duration.

Exclusion Criteria:

* Participating currently in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial.
* Patients with nerve root involvement, suspected serious pathology, unstable trauma to the spine, aspects of pregnancy or other conditions that would prevent participation or disallow trial completion within the prescribed time period.
* Persons with conditions that require a specialist consult are suspected of needing a specialist consult, or have conditions that would be aggravated or worsened if treated by the interventions in this study.
Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study

This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' \< 30 weeks of gestation.


Eligibility Criteria:
Inclusion Criteria:

* postconceptional age less than 30+0 weeks
* infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3

Exclusion Criteria:

* conditions which will decrease life expectancy
* major anomalies which will decrease life expectancy
* any anomalous conditions which involve upper and lower airway
* neuromuscular disease
Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors

This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors.

SECONDARY OBJECTIVES:

I.To estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia.

II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors.

OUTLINE:

Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade \>= 2 dysphagia on Modified Barium Swallow (MBS) \>= 2 years after curative-intent radiotherapy for head and neck cancer
* Grade \>= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis
* Willing and able to return for 10 sessions over 6 weeks of therapy

Exclusion Criteria:

* Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment
* Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment
* History of subtotal or total glossectomy or total laryngectomy
* Functionally limiting cardiac, pulmonary, or neuromuscular disease
* Current tracheostomy
A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab

This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab


Eligibility Criteria:
Inclusion Criteria

* Adult male or female (≥18 years of age) patients with NSCLC
* Treated with nivolumab on the Australian PAP
* Initiated Nivolumab between May 2015 and August 2017
* Attending clinician agreeable to provide patient data
* Local institutional ethics requirements satisfied

Exclusion Criteria:

* Insufficient data available

Other protocol defined inclusion/exclusion criteria could apply
Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy

Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving CRRT. Doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. However, pharmacokinetic studies must be performed in CRRT patients to generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to differences in ultrafiltration rates and dialysis membranes. The investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.

This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.

Eligibility Criteria:
Inclusion Criteria

* Patient is hospitalized and undergoing continuous renal replacement therapy (CRRT) as a result of the clinical management of the patient (i.e. CRRT is not initiated for the purpose of this study).
* Patient is receiving peramivir for a positive rapid antigen test for influenza or on the basis of clinical suspicion with a high local epidemiological prevalence of H1N1 disease.
* Patient has a CRRT blood flow rate greater than or equal to 100 mL/min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr,
* The patient is anticipated to require CRRT and peramivir treatment for a full 24 hours (i.e. life expectancy is not less than 24 hours).

Exclusion Criteria

* The patient has received greater than 5 doses of peramivir.
* The subject has a pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
* The patient is receiving CRRT utilizing a pre-membrane dilution method.
Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)
* Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg

Exclusion Criteria:

* Patient did not sign the informed consent.
* Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg
* Age above 75 years.
* Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.
* Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).
* Acute heart failure or CHF IV in NYHA.
* Severe arrhythmias.
* Pregnancy, lactation.
* The presence of severe diseases of other organ systems that may result in death during the first year after surgery.
The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments

Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.

Syncope is a common ED problem. The three underlying causes are reflex (simple faint), orthostatic hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac dysrhythmia). Diagnosis is difficult and is not apparent in \~50% of patients after assessment. For the first time, European Society of Cardiology (ESC) guidelines incorporating ED management of patients presenting with TLOC, either undifferentiated or thought to be of syncopal origin, have been produced.

However, very little is currently known about the use of diagnostic algorithms and management of this patient group in EDs across Europe. As a result, the application of guidelines and the management of TLOC by European Society of Emergency Medicine (EUSEM) members in different countries and hospitals, cannot yet be recommended for use in settings other than those where they have been successfully validated.

This study aims to describe the prevalence, clinical presentation, current assessment, management strategies and ESC risk categories of patients presenting with TLOC (undifferentiated or thought to be of syncopal origin) to the ED, and will provide data to help identify the gaps in our knowledge and practice, and areas where further research and development work is required to fully implement European Society of Cardiology (ESC) guidelines within European EDs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin.

Exclusion Criteria:

* Inability to consent
* Patient in custody or prison
* Aged \<18 years
* TLOC thought to be due to neurological seizure (e.g., epilepsy/alcohol or drug withdrawal) or trauma
Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis

To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active women between 18 and 50 years
* Patients attending to the gynecologist with acute vulvovaginal candidiasis.
* Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study.
* Women who agree to participate in the study and has signed the informed consent sheet.

Exclusion Criteria:

* Use of any medication that may interfere significantly with study assessments.
* Pregnant or breastfeeding
* Women with signs of other genital infection
* Within 3 months after childbirth or abortion
* Patients that is expected not to attend follow-up visits
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers

In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.


Eligibility Criteria:
Inclusion Criteria:

1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
3. Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and \<28.0 kg/m2, weight of male must≥ 50.0 kg and \<90.0 kg, and female≥ 45.0 kg and \<90.0 kg;
4. The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.

Exclusion Criteria:

1. Serious infection within 3 months before screening;
2. History of food or drug allergy or atopic allergic disease (asthma, urticaria);
3. Positive blood pregnancy test;
4. Have a history of drug abuse;
5. Women who are pregnant or breastfeeding;
6. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
Medication Histories Conducted by Nurses (RNs), Pharmacy Techs (CPhTs) & Pharmacists (RPhs)

Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital setting are estimated to be related to communication issues regarding patient medications at various transition points of care from admission to discharge. The Joint Commission (TJC) requires accurate and complete medication reconciliation occur at each transition point throughout hospitalization. Evidence from NQF demonstrates pharmacists (RPh) are the most effective medication management team leaders in the implementation of medication management practices and design of medication error reduction strategies; medication reconciliation is one of the five safety objectives pharmacists are recommended to lead. In addition, the Massachusetts Coalition for the Prevention of Medical Errors states strong evidence supports the use of pharmacy technicians (CPhT) in conjunction with pharmacists in completing accurate medication histories.

WMC nurses (RN) currently are involved in the medication reconciliation process. In 2009, a Medication Use Evaluation (MUE) of Medication Reconciliation Accuracy found a 67% medication error rate on admission determined by comparing the nurse-obtained medication history to the pharmacist-obtained medication history. The number of home medications identified by the pharmacist compared to the nurse was 411 versus 312 (p\<0.0001). The total percentage of medication errors prevented by the pharmacist was 66.2. Using the VA Healthcare Failure Mode Effects Analysis - HFMEA™ Hazard Scoring Matrix, 3 independent pharmacist reviewers found that 18% of patients interviewed had a score greater than 7, and 3 patients had a score of 12 (major/probable), if the discrepancies would not have been identified and corrected by the pharmacist conducting the admission medication reconciliation audit. The same patients' discharge medication reconciliation and discharge medication lists were retrospectively reviewed for the MUE, and the total percentage of patients with medication errors on discharge was 43%.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted as inpatients from the Emergency Department

Exclusion Criteria:

* Prisoners (because the IRB does not have a prisoner representative)
* Patients not admitted as inpatients through the Emergency Department
* Patients admitted more than once during the study period
Folic Acid Supplementation in Eating Disorder

The aim of this study was to determine the effect of folic acid supplementation on homocysteine levels in a group of patients with eating disorders (ED) with low folate intake. The secondary aims were to evaluate the evolution on cognitive and depressive status after the intervention.

Some authors have identified the presence of increased levels of homocysteine in patients with eating disorders and attempts have been made to find some association between this and the high rates of depression and cognitive function impairment recorded in these patients. It is still not known what causes this increase in homocysteine levels, whether the levels return to normal after the nutritional state is normalised and what strategies must be employed to carry out this normalisation.

Eligibility Criteria:
Inclusion Criteria:

* Males and females diagnosed with eating disorders (DSM-IV criteria of the American Psychiatric Association, 2000)
* Age \> 18 years
* Low folate intake based on the recommended daily intake in terms of age (Institute of Medicine, 1998)

Exclusion Criteria:

* Patients with contraindications for folic acid supplementation due to hypersensitivity to folic acid or anaemia due to lack of B12
* Patients who routinely used drugs that interfere with folic acid absorption (analgesics, anticonvulsants, hydantoin, carbamazepine, antacids, antibiotics, cholestyramine, methotrexate, pyrimethamine, triamterene, trimethoprim and sulphonamides)
* Patients with vitamin and mineral supplements intake.
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable haemodialysis or peritoneal dialysis treatment.
* Stable phosphate control
* Stabilised phosphorus diet.
* female subjects of child-bearing potential must have a negative serum pregnancy test.
* Male subjects must agree to use appropriate contraception.
* Completed one of the MCI-196 PIII studies

Exclusion Criteria:

* Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
* Body Mass Index (BMI) \<= 16.0 kg/m2 or =\>40.0 kg/m2.
* Current or a history of significant gastrointestinal motility problems
* Positive test for HIV 1 and 2 antibodies.
* History of substance or alcohol abuse within the last year.
* Seizure disorders.
* History of drug or other allergy.
* Temporary catheter with active signs of inflammation or infection.
* The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.
Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.

Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. Gastic adenocarcinoma is diagnosed by histological and cytological examination.
2. Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
3. According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.
4. 18 \< Age \< 70 year old
5. Expected survival \> 3 months
6. Performance status: ECOG 0-1
7. Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3
8. Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN

10. Voluntary participation after getting written informed consent.

Exclusion Criteria:

1. Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
2. Extensive adhesion in peritoneal cavity
3. Previous History of other malignancies
4. Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
5. Receiving other chemotherapy, radiotherapy or immunotherapy
6. Patients who are unsuitable candidates by doctor's decision
7. Without given written informed consent
Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Present study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral stones with semi-rigid ureteroscopy (s-URS).

For this purpose patients with ureteral stones are being stratified according to ureteral stone location and prospectively randomized into two groups' according to SGW usage or not in s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr (Olympus) and laser. Chi-square and student t-test were used for comparing data.


Eligibility Criteria:
Inclusion Criteria:

* Ureteral stone disease patients who would undergo ureteroscopy procedure

Exclusion Criteria:

* Patients who have a medical condition that makes randomisation not possible
* Patients in whose operations safety guidewire is regarded as a necessity
* Patients who refuse to participate