cyrilzakka/clinical-trials huggingface dataset:
Interactive Educational Website for Women With Ovarian Cancer & Caregivers

Ovarian cancer accounts for more deaths than any other gynecologic malignancy. The majority of patients are diagnosed with Stage III-IV disease. Nearly 80% of these patients will recur resulting in 5-year survival rates of 14-32%. Although enrollment is increasing in hospice, hospice programs have been challenged to reach eligible patients. Several factors limit the number of people who enroll in hospice and the length of their hospice stay. Prognostication challenges and the increasing availability of cancer therapies for people with cancer set the stage for a mismatch between certification of a 6 month prognosis and contemporary medical care. Additionally patients often are not aware of hospice and the services they can provide.

In this study, we will pilot-test a technology-based approach for women with Stage III/IV or recurrent ovarian cancer, their caregiver, and their providers to assist in and study the decision-making process that surrounds end-of-life decisions, specifically, opting for palliative care and/or entry into hospice care. We will randomize the women and their caregivers into either our intervention or control websites. All subjects will complete a battery of demographic, psychosocial, health status and outcomes, health information, and decision making measures at baseline and 60-day post-baseline.

Once the participant has completed the baseline survey, he/she will be automatically brought to their assigned website. Both the patient and their caregiver will be assigned the same group (intervention or control). All participants will have open access to their respective study websites for a minimum of 60 days. During enrollment, participants will agree to access their respective websites at least 2-3 times per week. Both patients and caregivers assigned to the control arm will view a website containing documents generally provided as part of the usual care. They will be requested to log in with the same frequency as the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Women with Stage III, IV or recurrent ovarian, primary peritoneal or fallopian tube cancer or a nominated caregiver or such women
* 18 years old or older
* At least a 5th grade education
* Able to read and write in English
* Access to computer and internet
* Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
* No known major psychiatric or neurological diagnosis (schizophrenia or active chemical dependency)

Exclusion Criteria:

* Borderline ovarian cancer
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered

To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 55 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m\^2, inclusive. BMI = weight (kg)/ \[height (m)\]\^2

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to a dipeptidyl peptidase-IV (DPP4) inhibitor or related compound
* History of allergy or intolerance to metformin or other similar acting agents
* Prior exposure to saxagliptin
* Prior exposure to metformin within 3 months of study drug administration
* Estimated creatinine clearance (Clcr) of \< 80 mL/min using the Cockcroft Gault formula
Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP

This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.

Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones (diameter \< 5mm) located in the head/body of the pancreas by using basket and/or balloon catheter.

In the clinical work of investigators' center, the ERCP treatment of pancreatic duct stones also mainly adopts basket and balloon, but whether to try basket or balloon first is mainly determined by the subjective decision of the on-site endoscopist. More than 70% of patients use the above two tools in one ERCP operation, which aims to achieve better effect, but the order of the two tools is uncertain.

However, there is no relevant research on whether the first choice for the treatment of pancreatic duct stones is the basket or the balloon, or the combination of the two tools. This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP, including the difference of stone clearance rate, abdominal pain score (Izbicki Pain Score), postoperative complications and medical expenses.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
* stones (≤5 mm in diameter) are located in the main pancreatic duct of the pancreatic head/body with dilation of the proximal pancreatic duct.

Exclusion Criteria:

* suspected to have malignant tumors;
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* bile duct stricture secondary to cholangitis or chronic pancreatitis;
* acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
* there is a stent in the main pancreatic duct;
* coagulation dysfunction (INR≥1.5 or platelet count≤50×10\^9/L);
* pregnant or breastfeeding women;
* patients who refused to participate in the study.
Familial Myeloproliferative Disorders

Myeloproliferative disorders occur in families, thus giving rise to the theory that it is a genetic disease that may be caused by an abnormal gene in the DNA that can be passed from one generation of family members to another. DNA can be gathered from family members through blood samples and the investigators will investigate (through DNA testing) to see if there are abnormal genes that may be responsible for causing the MPDs. Understanding which genes are responsible for causing MPDs can help develop ways to identify people who may be at risk for developing an MPD, allow for the development of better treatments, possibly a cure, or even prevent the development of MPDs.


Eligibility Criteria:
Inclusion Criteria:

* Families with 2 or more members diagnosed with polycythemia vera (PV), essential thrombocythemia (ET), PV and ET related myelofibrosis (PV-MF and ET-MF), idiopathic myelofibrosis (IM) or chronic myelogenous leukemia (CML).
* Healthy family members of subjects diagnosed with a myeloproliferative neoplasm (MPN).
* Participating subjects must be 7 years of age or older
* A written assent, parental permission or consent must be obtained prior to any study procedures being performed.

Exclusion Criteria:

* Subjects who have a known acquired cause of polycythemia (increased hemoglobin/hematocrit), such as people living in high altitudes (in excess of 14,000 feet), subjects with heart disease, left to right heart shunt, severe hypoxia, cyanotic congenital heart disease, or severe pulmonary disease, will be excluded from this study, secondary forms of thrombocytosis and secondary forms of myelofibrosis.
Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive Habits

To evaluate Brazilian gynecologists, through structured online questionnaires, with questions directed to their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online.

There are few Brazilian population studies on the opinion of Brazilian gynecologists about the hormonal therapy of menopause in climacteric women, their prescriptive habits and their views on the availability of treatments offered, demanding better evaluation and justifying efforts to analyze the perception of professionals in this area in our country.

Methods: To assess gynecologists across the country, through structured online questionnaires, with questions aimed at knowing their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online. Doctors will be invited to participate by e-mail messages and by social media.

Eligibility Criteria:
Inclusion Criteria:

* Brazilian licensed gynecologist doctors

Exclusion Criteria:

* Retired doctors
* Health professionals other than medicine doctor
* Medical specialties other than Gynecology
* Medical employees of the pharmaceutical industry
Gut Microbiota, "Spark and Flame" of COVID-19 Disease

Elderly, hypertension, diabetes and cardiovascular diseases are risk factors for COVID-19 morbility and mortality. However, the real reason for this is not yet understood. It is well documented that gut microbiota has a critical role in health, particularly in the immune system and therefore, we propose that gut microbiota composition could affect vulnerability and disease outcomes of COVID-19.

In order to explore this hypothesis, we will analyse the gut microbiota of SARSCoV-2 infected patients categorized according to location: \[1\] ambulatory (self-isolation at home), \[2\] ward and \[1\] ICU; and severity.

Eligibility Criteria:
Inclusion Criteria:

* Adults of 18 years and above.
* COVID-19 patients.

Exclusion Criteria:

* None.
A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor

This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Confirmed diagnosis of advanced renal cell cancer
* Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
* Written informed consent

Exclusion Criteria:

None

Other protocol-defined inclusion/exclusion criteria may apply
Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures;
* Men and women 18 years and older;.
* Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
* Native coronary lesion suitable for drug-eluting stent placement;
* True bifurcation lesions (Medina 0,1,1/1,1,1);
* Reference vessel diameter in side branch ≥2.5mm by visual estimation;
* Complex bifurcation lesions based on DEFINITION study.

Exclusion Criteria:

* Pregnancy and breast feeding mother;
* Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
* Scheduled major surgery in the next 12 months;
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
* Unable to provide written informed consent, or fail to follow the protocol;
* Previous enrolment in coronary intervention device investigation during the study period;
* Patient with STEMI within 24-hour from the onset of chest pain to admission;
* Restenosis bifurcation lesions.
Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy

This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF).


Eligibility Criteria:
Inclusion Criteria:

* Patients under 10 years of age with confirmed mutation for STXBP1. In cases where the diagnostic technique for the mutation is not optimal, a trio exome will be performed to confirm the mutation.

Exclusion Criteria:

* Presence of functional disability that prevents the neuropsychological study from being carried out and absence of a reliable informant for the patient.
Effect of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery

Postoperative pulmonary complications(PPCs) including, but not limited to ,hypoxemia, pneumonia, ventilator-induced lung injury, and acute respiratory distress syndrome (ARDS),atelectasis,pleural effusion .PPCs may result in increased resources utilization, delayed mobilization, prolonged need of supplemental oxygen or mechanical ventilation,and a longer hospital stay.postoperative pulmonary complications are common after cardiac surgery, often increasing postoperative morbidity and mortality.The extracorporeal circulation,increased oxygen concentration inhaled and the development of massive atelectasis after open-chest surgery commonly activate lung inflammation, amplifying the harm Injury of pulmonary .Currently, plenty of interventions have been studied to prevent PPCs after surgery. Most of the recent research has focused on physical therapy such as lung-protective modes during intraoperative mechanical ventilation, Alveolar Recruitment, and respiratory muscle training.These therapies have a certain effect, but still not satisfactory.Ascorbic acid is an important cofactor in multiple enzymatic reactions where its main function is as a reducing agent.Studies have shown that ascorbic acid can reduce both ischemia-reperfusion injury and oxidative stress. Unfortunately, no studies examined whether Ascorbic acid can reduce PPCs.

The possible mechanisms of ascorbic acid to alleviate ischemia-reperfusion injury are as follows: 1 Ascorbic acid as a first-line antioxidant in plasma can reduce stress by eliminating excess Reactive oxygen species and reduce damage. 2 provides rapid electron transfer to react with superoxide and hydroxyl group to scavenge reactive oxygen released into the circulation. 3 Ascorbic acid can reduce lipid peroxidation and reduce lung injury caused by ischemia-reperfusion by scavenging oxygen free radicals. 4 Vitamin C can promote the production of cytokines by immune cells to reduce local inflammatory reactions and improve tissue microcirculation.The study aims to explore whether daily used Ascorbic acid in the perioperative period has a preventive effect on PPCs in patients undergoing cardiac surgery, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization Prognosis .

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-60 years old
2. Selective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

1. Emergency surgery
2. Previous cardiac surgery
3. Severe lung disease
4. BMI\<18 or \>30
5. Mean pulmonary arterial pressure \>40 mmHg
6. were allergic to ascorbic acid
Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD

This is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of KL002 in the treatment of advanced primary Parkinson's disease.

Condition or disease: Parkinson's Disease Intervention/treatment: Drug: KL002 Phase: NA

9 patients will be enrolled to this open-label dose escalation study to evaluate up to three dose levels of KL002 of three patients each. All patients will receive bilateral intraputaminal injections of KL002 through stereotactic brain surgery. The safety and potential clinical responses to KL002 will be assessed by clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and neuroimaging.

Eligibility Criteria:
Inclusion Criteria:

1. Males/females between 40 and 70 years (inclusive)
2. Diagnosed with idiopathic Parkinson's disease, Hoehn and Yahr stage 4 and 5
3. Disease duration at least 5 years
4. MDS UPDRS Part III (total motor) score ≥ 25 and a maximum of 60 in the OFF state
5. Good compliance and can complete all follow-up in accordance with the protocol requirements

Exclusion Criteria:

1. Prior brain surgery including deep brain stimulation or abnormal brain imaging.
2. Presence of depression as measured by Hamilton Depression Scale ≥20
3. History of brain injury or central nervous system infection.
4. Cognitive impairment score\<26 on MoCA and ≤ 20 on MMSE dementia scale
5. Evidence of significant medical or psychosis, such as dementia, psychosis, and a history of drug abuse
6. Atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins.
7. Prior gene therapy.
8. Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy
9. Any other conditions that the investigator believed unsuitable for participation in this study.
Using Lignocaine Spray and Gel to Reduce the Pain Associated With Nasogastric Tube Insertion in Children

Nasogastric tube insertion is one of the most common invasive procedures performed in children's hospitals, and has long been recognised as one of the most traumatic and painful. As a once off procedure, a nasogastric tube insertion is extremely distressing but the repeated procedures that many children endure as a necessary part of treatment for a chronic disease can be so traumatic that psychological damage may occur. There have been a limited number of studies carried out which have looked at methods to reduce the pain and trauma associated with this procedure, but most of these have been carried out in the adult population.

The investigators propose to carry out a research project in a paediatric setting to definitively investigate the use of local anaesthetic spray, in combination with local anaesthetic gel, to numb the nasal passages and the back of the throat, with the aim of reducing or removing the unpleasant sensation of the nasogastric tube placement. If the study shows a benefit from the use of local anaesthetics, it would be an inexpensive and easily incorporated intervention that could be inserted into the routine procedure for nasogastric tube insertion.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent from parent of guardian
2. Signed assent from subject
3. Subject must have insertion of a nasogastric tube ordered as part of his/her current treatment
4. Must be 6 years of age or older
5. Must be able to complete visual analogue scale (VAS)

Exclusion Criteria:

1. Congenital abnormalities of the naso/oropharyngeal area
2. Any surgical alterations in the naso/oropharyngeal area
3. Mucositis
4. Known history of hypersensitivity to xylocaine or other local anaesthetics
5. Known history of hypersensitivity to other components of the xylocaine solutions such as methyl or propyl hydroxybenzoate, ethanol, polyethylene glycol 400, banana flavour PHL-131980, menthol, saccharin
6. Allergy to food colouring
7. Presence of tracheotomy / tracheostomy
8. Presence of tumour in the nasopharyngeal/oropharyngeal area
9. Impaired gag reflex
10. Impaired swallow
11. Any cardiac condition
12. Diabetes
13. Hypertension
14. Current use of antidepressant medication
15. Current use of cimetidine or propranolol
16. Significantly impaired liver function
17. Significantly impaired renal function
18. Current use of anti-arrhythmic medication