cyrilzakka/clinical-trials huggingface dataset:
Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia

The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic trioxide in the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APML). In addition, correlation between pharmacokinetic data and both therapeutic response and therapy-related toxicities will be sought.

OUTLINE: This is a dose-escalation study.

Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period. Patients may receive up to 3 courses of treatment.

Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) or minimum effective dose (MED) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. After the MTD or MED is determined, an additional 20 patients are enrolled at this dose level.

Patients are followed monthly for 6 months and every three months for an additional 1.5 years.

Eligibility Criteria:
INCLUSION CRITERIA

1. APML diagnosis based upon morphological, histochemical, and/or flow cytometric criteria, confirmed upon review by a central, study-designated hematologic pathologist;

   OR

   any relapsed acute leukemia bearing a t(15:17) translocation or variant APML translocations involving the retinoic acid receptor alpha gene on chromosome 15q22, based on cytogenetics or PCR.
2. disease in first or subsequent relapse, following standard induction and consolidation chemotherapy (with all-trans retinoic acid) and/or allogeneic bone marrow/stem cell transplantation;

OR

failure to achieve initial complete remission with ATRA and standard chemotherapy.

EXCLUSION CRITERIA

1. Availability of a fully HLA-matched sibling donor for patients otherwise felt to be candidates for allogeneic bone marrow/stem cell transplantation; patients with only a partially HLA-matched sibling or matched unrelated donor will remain eligible for study entry.
2. pregnancy.
3. Patients with significantly impaired left ventricular ejection fraction (\<40%) will be ineligible for the study.

Patients with renal failure and a creatinine clearance of less than 25 ml/min or requiring hemodialysis will be ineligible for the study. Otherwise, there are no rigid exclusion criteria based upon age, performance status, or co-morbidity. Decisions regarding enrollment of patients for whom these factors may be relevant will be individualized and left to the discretion of the investigators. Central venous access will be required for all patients. Patients of child-bearing potential must agree to use contraception during sexual intercourse while undergoing treatment with arsenic trioxide.
Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy in our locality of conservative management and delayed cholecystectomy. However, evidence to support early cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients with mild biliary pancreatitis.

Inclusion criteria

1. Patient diagnosed with a first attack of mild biliary pancreatitis
2. Age ≥ 18 years
3. American Society of Anesthesiologists (ASA) grade I, II or III
4. a serum C-reactive protein (CRP) concentration less than 100 mg/L,
5. no need for opioid analgesics,
6. normal oral diet tolerance Exclusion criteria

1. chronic pancreatitis 2. alcohol abuse 3. pregnancy The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, we found that 53 patients should be present in each group. Eligible patients will be randomly divided into two equal groups (Group 1: early cholecystectomy, Group 2: delayed cholecystectomy) according to a computer-generated random numbers.

Procedure Early cholecystectomy was done within 48 after admission. Delayed cholecystectomy was done after 30 days after randomization. All cholecystectomies were done by, or under the direct supervision of, a surgeon who had undertaken at least 100 cholecystectomies in the past 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with a first attack of mild biliary pancreatitis
2. Age ≥ 18 years
3. American Society of Anesthesiologists (ASA) grade I, II or III
4. a serum C-reactive protein (CRP) concentration less than 100 mg/L,
5. no need for opioid analgesics,
6. normal oral diet tolerance

Exclusion Criteria:

* 1. chronic pancreatitis 2. alcohol abuse 3. pregnancy
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis

The purpose of this study is to determine whether the daily inhalation of nebulised hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase the quality of life for people with non cystic fibrosis bronchiectasis.

Bronchiectasis is a disabling, chronic respiratory condition which significantly impacts on the quality of life of patients who present with chronic sputum production and respiratory infections. The occurrence of pulmonary infections is a strong predictor of morbidity and mortality in this group of people so the primary goal of treatment is to prevent infections caused by the presence of sputum in their lungs.

Physiotherapy is a major aspect of their management and focuses on teaching appropriate airways clearance techniques. Traditionally, the physiotherapy management of sputum retention due to bronchiectasis has included the active cycle of breathing technique which has been demonstrated to enhance airways clearance. For some patients, this treatment is not adequate. The use of nebulised hypertonic saline has been used for patients with cystic fibrosis and has been demonstrated to improve sputum removal and lung function.

The aim of this project is to determine the long term effect of the daily inhalation of hypertonic saline on respiratory infections, quality of life, lung function and hospital admissions in patients with non cystic fibrosis bronchiectasis. Hypertonic saline has been shown to be beneficial as a once only treatment in this patient group, but its' long term effects have not been studied.

Participants will be randomised to two groups - those receiving hypertonic saline (6%) and those receiving isotonic saline (0.9%) - and will be blinded to the treatment that they are receiving. They will be given nebuliser equipment and will be instructed how and when to inhale their medication.

Objective measures will be taken by a blinded assessor before the commencement of the project and then at 3 months, 6 months and 12 months post commencement.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bronchiectasis on high resolution computer tomography
* at least 2 respiratory exacerbations per year over the past 2 years
* producing sputum daily
* in a stable clinical state
* over 18 years of age.

Exclusion Criteria:

* cystic fibrosis
* Positive response to hypertonic saline challenge - FEV 1 decreased by ≥ 15%
* FEV 1 ≤ 1L
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Primary Objective:

To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.

Secondary Objectives:

To assess in male and female lupus patients:

* The pharmacokinetics of SAR113244.
* The pharmacodynamics of SAR113244 for the following disease-related parameters:

  * Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive protein.
  * Peripheral blood B and T cells subsets.

The total duration of screening to end of study per subject is 20 weeks with post-study observation on Day 226 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).

Eligibility Criteria:
Inclusion criteria:

* Male or female patients, between 18 and 75 years of age, inclusive.
* Clinical diagnosis of systemic lupus erythematosus (SLE) by American College Rheumatology criteria.
* Autoantibody-posititve.
* On active and stable SLE disease.

Exclusion criteria:

* Pregnant and nursing.
* Have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, whichever is longer.
* Have received intravenous or oral cyclophosphamide within 180 days of Day 0. Severe active lupus nephritis or chronic renal insufficiency.
* Active or chronic, severe neuropsychiatric lupus.
* Acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test or test postitive at screening for HIV, hepatitis B, or hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs

1. Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents
2. The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment

Patients and methods:

This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.

Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response

Method:

Patients presenting in this study will be subjected to the following:

1. Full history and clinical evaluation.
2. Body weight (kg) and height (m).
3. BMI will calculate as weight divided by squared height (kg/m2).
4. Waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together.
5. Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest and taken an average.

Laboratory investigations will include:

* Complete blood count (CBC)
* Liver function test
* HCV Ab and HCV RNA by PCR
* HBs Ag
* Alpha fetoprotein
* Lipid profile
* Serum urea and creatinine
* Fasting blood sugar (FBG)and Serum fasting insulin level
* Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) ----------------------------------------------------------------- 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)
* Vitamin D level:

Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level \< 20 ng/mL, vitaminD insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30 ng/mL (Holick MF et al.,2011)

* Abdominal Ultrasound
* Electrocardiogram (ECG)

Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV will receive DAAs for treatment

Exclusion Criteria:

1. Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
2. Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
3. Extra-hepatic malignancy except after two years of disease free interval.
4. Patients with diabetes mellitus.
5. Patients with Chronic kidney disease.
6. Pregnancy or in ability to use effective contraception.
7. Patients with history of using lipid lowering therapy
8. relapser or failure of previous HCV treatment
"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation

Thanks to using VR googles and the phenomenon of total immersion "VR Tier One" allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the game, it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.

The goals of the project:

1. The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of the patients undergoing post-stroke rehabilitation.
2. The evaluation of the influence of virtual therapeutic game on the acceptance of the illness and self-efficacy assessment of the patients undergoing post-stroke rehabilitation.
3. The evaluation of the influence of virtual therapeutic game on the effectiveness of post-stroke rehabilitation process in relation to locomotive function as well as basic and instrumental activities of daily living.
4. The analysis of possible side effects appearing while using virtual reality therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* depression symptoms scored 10 and more in Geriatric Depression Scale (GDS-30)

Exclusion Criteria:

* cognitive functions (MMSE\<24)
* epilepsy,
* vertigo,
* aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE,
* presence at the time of the examination or in the medical data: mental retardation, disturbances of consciousness or other serious mental disorders,
* patient's refusal at any stage of the research project
Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Mortality Risk Prediction Tool in Hospitalized Dementia Patients

The objective of this study is to develop and validate a clinical prediction tool to estimate 1-year mortality among hospitalized patients with dementia.

Patients with dementia are frequently hospitalized. Despite having specialist palliative care needs, they have infrequent and late access to corresponding services. Accurate and personalized predictions of mortality risk among hospitalized patients with dementia could inform clinical care decisions made during admission and upon discharge, including whether or not to engage specialist palliative care services. Existing prognostic tools have limitations. We seek to develop and validate a clinical prediction tool to estimate 1-year mortality in this patient population.

The derivation cohort will comprise about 235,000 patients with dementia, who were admitted to a hospital in Ontario from April 1st, 2009 to December 31st, 2017. Predictor variables have been fully prespecified based on a literature review and on subject-matter expertise, and were categorized as follows: sociodemographic factors, comorbidities, previous interventions, cognitive status, functional status, nutritional status, admission information, and previous health care utilization. The outcome variable will be mortality within 1 year of admission, which will be modelled as a binary variable, such that a logistic regression model will be estimated. Predictor and outcome variables will be derived from linked population-based administrative databases. The validation cohort will comprise about 63,000 dementia patients, who were admitted to a hospital in Ontario from January 1st, 2018 to March 31st, 2019. Model performance, measured by predictive ability, discrimination, and calibration, will be assessed in the validation cohort. The final model will be based on the full cohort.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia using a validated algorithm to identify cases based on a combination of hospital codes, physician claims, and prescribed medications that are specific to dementia
* Hospitalization at least once from March 31st, 2009, to April 1st, 2019

Exclusion Criteria:

* Age \<65 years at the time of index admission
* Ineligibility for universal health insurance at the time of admission
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes

The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days


Eligibility Criteria:
Inclusion criteria:

1. Male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent
2. Antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (GLP-1) analogues or dipeptidyl-peptidase 4 (DPP-4) inhibitors.
3. Antidiabetic treatment unchanged for 12 weeks prior to informed consent
4. Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5% at screening
5. Age ≥ 20 and age ≤ 70 years
6. BMI ≥ 25 and BMI ≤ 40 kg/m2 (Body Mass Index)
7. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
2. Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
4. Gastrointestinal tract surgery that might affect absorption and elimination of drugs
5. Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
6. Chronic or relevant acute infections (e.g. HIV, hepatitis)
7. History of allergy/hypersensitivity (including allergy to drug or its excipients) that are deemed relevant to subject's safety or the trial by the investigator
8. Intake of drugs with a long half-life (\> 24 hours) within one month prior to administration of the trial drug except for allowed co-medication
9. Treatment with glitazones, GLP-1 analogues, insulin, DPP-4 inhibitors, systemic or inhaled glucocorticoids, or anti-obesity drugs (e.g. orlistat) within 12 weeks prior to informed consent
10. Sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin, verapamil, budesonide, buspirone, eplerenone , eletriptan, felodipine, fluticasone, midazolam, saquinavir, sildenafil, vardenafil) or CYP3A4 substrates with narrow therapeutic range (e.g. cyclosporine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) or drugs that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to first administration of the trial drug
11. other exclusion criteria apply.
Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea

A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea

Eligibility Criteria:
Inclusion Criteria:

1. Age≥19
2. Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab.
3. Not diagnosed with diabetes
4. Subject who can written informed consent voluntarily
5. Subject can continue to participate for 12 months on Study

Exclusion Criteria:

1. Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin)
2. A pregnant or nursing woman