cyrilzakka/clinical-trials huggingface dataset:
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer

For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.

it is a placebo controlled phase III trial. Investigators plan to enroll 240 patients with 1:1 to A arm and B arm

Eligibility Criteria:
Inclusion Criteria:

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
2. age \>18 years old;
3. diagnosis metastatic colorectal cancer with histology;
4. Did not received first-line chemotherapy
5. Karnofsky Performance scores should be 60,70,or80
6. should have target lesions or non-target lesions
7. For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
8. For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C\<7.0%
9. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

1. patients who is receiving chemotherapy;
2. WBC\<4.0×109/L，ANC\<1.5×109/L,PLT\<100×109/L，Hb\<90g/L,TBIL\>1.5Limitation;BUN）\>1.5Limitation；Cr）\>1.5Limitation；ALT or AST\>2.5Limitation（without liver metastasis）；ALT or AST）\>5Limitation（with liver metastasis）;
3. heart dysfunction;
4. brain metastasis;
5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
6. patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days
Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

Patients with chronic liver disease due to hepatitis B or C viruses, Non-alcoholic fatty liver disease, autoimmune hepatitis, wilson disease, cryptogenic hepatitis etc are prone to develop complications. Hepatic encephalopathy is one of such complications. It is graded into four types depending on severity of clinical features, which range through altered sleep pattern to coma. The current study aims to compare the effectiveness of lactulose enema with oral lactulose in time to recovery from higher grade of encephalopathy to lower grade of encephalopathy.

Hepatic encephalopathy (HE) is defined as neuropsychiatric disorder due to liver failure. It is characterized by mild cognitive impairment, stupor and coma. The most common reasons for pathogenesis include the role of neurotoxins, impaired neurotransmission due to metabolic changes in liver failure, changes in brain energy metabolism, systemic inflammatory response and alterations of the blood brain barrier. Neurotoxin ammonia is related to precipitating HE, for which the gastrointestinal tract is the primary source. Colonic bacteria catabolise the nitrogenous sources into ammonia.

Lactulose is the initial treatment for HE. It produces diarrhea by osmosis and reduces pH of colonic contents, which leads to reduced absorption of ammonia by converting it to ammonium ion (NH4). Understandingly, it does not cure the underlying liver disease however, it does prevent deterioration of the mental status in HE.

Initial oral dose of lactulose is 30 ml once a day or twice daily. For retention enema the dose is 300 ml lactulose plus 700 ml water, administered every 4 hours. It can be increased as tolerated. At least, 2-4 loose stools per day should be passed by the patient.

Lactulose is also effective as primary prophylaxis against the development of HE.

Constipation is one very common precipitating factor for hepatic encephalopathy which is routinely managed with oral lactulose or kleen enema (21.4g (18.1% w/v) Sodium Dihydrogen Phosphate Dihydrate and 9.4g (8.0% w/v) Disodium Phosphate Dodecahydrate). Lactulose enema is also given to patients in hepatic encephalopathy either alone or in combination with oral lactulose. However it is not clear whether there is any difference in the efficacy of oral or enema lactulose in patients with hepatic encephalopathy in terms of improvement of encephalopathy grade and time to improvement. This study aims to determine the efficacy of oral versus enema lactulose in the achievement of these goals.

Eligibility Criteria:
Inclusion Criteria:

* Male and female cirrhotic patients in grades 3 or 4 of hepatic encephalopathy
* Patient with constipation as the precipitating factor will be included in the study

Exclusion Criteria:

* Patients with dehydration
* Electrolyte abnormalities
* Spontaneous bacterial peritonitis (SBP),
* Fever
* Using sedative / hypnotic medications as predisposing factors for hepatic encephalopathy
Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve replacement.

STUDY DESIGN

Prospective randomized double blind study including patients diagnosed with severe symptomatic aortic stenosis and anemia undergoing aortic valve replacement. The patients will be identified in the cardiac surgery / aortic stenosis outpatient clinic or in the hospitalization department of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec.

SAMPLE SIZE

100 patients (50 patients per group).

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥60-year old
2. Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention
3. Anemia defined according to the World Health Organization (WHO) definition 69:

   1. Men: Hemoglobin\<130 g/L
   2. Women: \<120 g/L

Exclusion Criteria:

1. Contraindication for transcatheter aortic valve replacement.
2. Erythropoietin treatment within last 30 days before Aortic Valve Replacement
3. Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
4. Ferritin\>800 µg/L
5. Uncontrolled hypertension (Blood pressure\>175/95 )
6. Platelet count\>450,000/L
7. Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
8. Dialysis patients
9. Hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure
10. Active cancer or very high risk of thromboembolic events
11. Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
12. No written consent
A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning

Increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. The computer vision and machine learning based solution used in this project (Nelli) is an automatic seizure detection and reporting method that has a CE mark for this specific use.

The present study will provide data to expand the utility and detection capability of NELLI and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

This is a prospective, blind comparison to the clinical gold standard for seizure characterization. This study is intended to compare the Nelli Software's ability to identify seizure events to vEEG review in adults with suspected nighttime seizures. Simultaneously, Nelli will continuously record audio and video while video-electroencephalography (vEEG) is recorded per typical standard of care. Events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical vEEG data. Nelli Software will review the audio and video data and independently identify events with positive motor manifestations. The outcomes of event identification will be compared between Epileptologists and the Nelli Software. For each category of event captured the positive percent agreement will be calculated using the exact binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to identify seizures that have a positive motor component with a sensitivity of \> 70%.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing video-EEG monitoring for clinical purposes who are suspected of having seizures.

Exclusion Criteria:

-
Future Mental Projections in Schizophrenia

The aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. Patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. Then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. The investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. The investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.


Eligibility Criteria:
Inclusion Criteria:

* for patients only
* male or female
* age limits : 18-55 years old
* under the protection of health insurance
* who have signed up the consent form
* schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).
* clinically stable for at least 2 months
* patients under guardianship or curatorship need agreement of their legal representative
* informed of the results of prior medical examination for controls only
* male or female
* age limits : 18-55 years old
* under the protection of health insurance
* who have sign up the consent form
* recruited from the general population and matched on gender, age years of schooling
* no psychiatric history (DSM-5)

Exclusion Criteria:

* for both patients and controls
* current severe or unstable somatic illness
* neurological history (brain injury \> 15 minutes loss of consciousness , epilepsia, brain surgery...)
* current substance use disorder (DSM-5)
* current major depressive disorder (CDSS,BDI, HDRS)
* mental retardation (IQ \< 70, WAIS-4, f-NART)
* history of general anesthesia 3 months prior to the experiment
* pregnancy declared by the subject
* breast feeding
* current legal control
* in emergency situation
* included during exclusion period in another experiment
* for controls only
* taking of antipsychotic drugs for the 3 weeks prior to inclusion
* under guardianship or curatorship
Cross-Sectional Survey on the Use of Tobacco Products - Italy

The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Italy.

The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Italy and in adult IQOS users registered in the IQOS user database of Philip Morris Italia S.r.l. (Italy IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:

1. Estimate the prevalence of current tobacco use status in the study population.
2. Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).
3. Explore the association between self-reported health status and use of tobacco products in the study population.
4. Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Italy registered in the Italy IQOS User Database.

Eligibility Criteria:
Inclusion Criteria (all participants, including IQOS users):

* Legally permitted to buy tobacco products in Italy (≥18 years of age).
* Currently residing in Italy.
* Able to read, write and understand Italian.
* Consent to participate in the survey

Inclusion Criteria (IQOS users only):

* Has used more than 100 HEETS tobacco sticks in his or her lifetime.
* Is currently using IQOS.
* Has access to the internet.
* Is not currently employed by Philip Morris International or any of its affiliates

Exclusion Criteria:

* Not meeting the inclusion criteria.
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.


Eligibility Criteria:
Inclusion criteria:

* Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016 classification.
* MDS patients must have Intermediate (\>3 to 4.5 points), High Risk (\>4.5 - 6) or Very High Risk (\>6 points) disease according to the Revised International Prognostic Scoring System 2012 (IPSS-R).
* Clinical indication for treatment with azacitidine for MDS or AML.

Exclusion criteria:

* Patients with AML who are candidates for standard induction chemotherapy as first line treatment.
* Patients with known active CNS leukemia.
* Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
Walking the Isobole of Drug Interaction

The investigators study whether four equipotent combinations of propofol and remifentanil (as predicted by interaction models for "tolerance of laryngoscopy") result in identical haemodynamic conditions, independent of their relative different balance between the concentration of propofol and remifentanil.

In anesthesia, the synergistic interaction between hypnotics and opioids is applied daily to give adequate anesthesia and analgesia at significantly lower doses compared with the ones needed if only one drug was given to reach the same effect. A lot of research has been done to quantify these interactions with a focus on the desired effects (Tolerance of laryngoscopy, tolerance of shake and shout etc...), but the simultaneous interaction on the unwanted side effects is less well described. The response surface model of Bouillon et al. and other models predict combinations of propofol and remifentanil effect-site concentrations that lead to an equipotent desired effect. Due to the availability of the models, the anesthesiologists now could use the knowledge on interactions to target specific effects more accurately, using predefined equipotent combinations of drugs: for instance, a desirable 90% probability of tolerance of laryngoscopy (TOL90) in the population can be reached through either a high propofol/low remifentanil combination, but equally well through a low propofol-high remifentanil combination.

However, at this time it is not known whether some of the combinations of propofol and remifentanil have a favorable hemodynamic stability compared to other equipotent combinations. The researcher in this study want to determine whether equipotent combinations of remifentanil and propofol (all deliberately selected to evoke 90% probability of "tolerance to laryngoscopy"), result in different effects on the undesired side effects of anesthetics, such as hemodynamic instability (hypotension, changes in heart rate or cardiac output), decreases in cerebral or tissue oxygenation (both measured with near infrared spectroscopy).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* General anesthesia required for the procedure
* Age: 18 years and older
* American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria:

* Refusal to participate in this study
* Contra-indications for the use of propofol or remifentanil
* BMI \> 35 kg/m2
* Central nervous system disorders (i.e. cerebrovascular accident, dementia, seizures, psychiatric disorders)
* Relevant hepatic disease (Child B or higher)
* Regular use of medication that affects the central nervous system (i.e. benzodiazepines, antidepressants, antipsychotics, antiepileptic drugs)
* Use of alpha-agonists or beta-blockers
* Overt signs of alcohol abuse
* Use of preoperative benzodiazepines (on the day of the study)
* Beta blockers eye drips
* Overt signs of Drugs abuse
The Impact of a Technology-enabled Decision Aid, for Patients With Hip and Knee Osteoarthritis on Decision Quality, Level of Shared Decision-making, Patient Satisfaction and Magnitude of Limitations

This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question \& answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. The study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience \& limitations of patients in this setting is relatively unknown.


Eligibility Criteria:
Inclusion Criteria:

* All patients with a presumptive diagnosis of knee OA aged between 45 and 89 (in-line with the decision aid algorithm)
* Radiographic evidence of moderate to severe osteoarthritis (Kellgren and Lawrence grade 3-4)
* KOOS Jr scores between 0-85 (in-line with the decision-aid algorithm)
* Participant able to give informed consent for participation in the study

Exclusion Criteria:

* Kellgren and Lawrence scale for classification of osteoarthritis grade 0-2
* Patients with a prior experience of total joint replacement
* Patient with experience with the pilot form of the decision aid
* Patients undergoing consideration for revision joint replacement
* Patients seeking care for trauma condition or psoriatic/rheumatoid arthritis
* Non-English or Non-Spanish speakers
* Patients with BMI below 20 or above 46 (in-line with the decision-aid algorithm)
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).

To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes:

Primary outcome: Daily opioid consumption

Secondary outcomes:

Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays.

Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection.

When results were entered, the detailed description was updated to reflect the outcome measures used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral primary THA
* All surgical approaches
* American Society of Anesthesiologist (ASA) status I, II and III.

Exclusion Criteria:

* Patient refusal;
* Age less than 18 years
* Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team;
* Coagulopathy;
G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease

Study Design

50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B)

Investigations:

Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection ( blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2 staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous pressure gradient ( HVPG)


Eligibility Criteria:
Inclusion Criteria:

* All patients who were known to have cirrhosis of liver with portal hypertension, now decompensated with ascites/ jaundice/ bleed/ HE/ HRS

Exclusion Criteria:

* Age \<12 or \> 75 years

  * Autoimmune disorders
  * HCC
  * Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP)
  * Multi organ failure
  * Grade 4 HE
  * HIV seropositivity / pregnancy
  * Essential Hypertension
  * Patients being taken up for transplant
  * Refusal to participate in the study
Longitudinal Study of Empathy Levels in Physiotherapy Students

'Empathy' is a core term of occupations related to health sciences like physiotherapy. In physiotherapy education programs, empathy is necessary to have a successful cooperation with the clients. This study was planned to follow the changes of empathy levels in physiotherapy students of a four-year bachelor program and therefore enhance the curriculum related to the results. To the best of our knowledge, this research is the first longitudinal study about empathy levels of students in Turkey. Hypotheses: Empathy levels of the students increase year by year (1). Female students are more empathetic than male ones (2).

Totally 120 physiotherapy students at a non-governmental university in Istanbul participated in this study. The Turkish reworded student version of the Jefferson scale of physician empathy was used. Empathy scores were compared related to study years and gender. Empathy scores relevant to gender were compared using Mann-Whitney U test. The Kruskal-Wallis one-way analysis of variance was used for differences among the four study years.

Eligibility Criteria:
Inclusion Criteria:

* attending the first through fourth year of physiotherapy department
* being willing to participate in the study

Exclusion Criteria:

do not continue in physiotherapy department