cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in participants receiving chemotherapy treatment for cancer.

This study consists of three periods:

1. Screening Period up to 28 days
2. Treatment Period of up to16 weeks
3. A Follow-up period of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of non-myeloid malignancy
2. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 grams (g)/deciliter (dL) at screening
3. Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks
4. Estimated life expectancy ≥ 6 months at enrollment (Day 1)

Exclusion Criteria:

1. Participants with cancer receiving chemotherapy when the anticipated outcome is cure
2. Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer
3. History of leukemia
4. Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
5. Use of any investigational drug within 8-weeks prior to treatment with roxadustat
6. Clinically significant anemia due to other etiologies
7. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (for example, deep vein thrombosis \[DVT\] or pulmonary embolism) within previous 6 months of screening
8. Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients with body mass index ≥ 30 kg/m2

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion exclusion criteria also apply.
Induction and Recognition of Emotions

This study evaluates the differences in cognitive function between healthy older adults, older adults with mild Alzheimer's type dementia and older adults with Parkinson's disease and if there are differences in valence assessment and activation that produce them a mood induction task. Subjects are assessed using neuropsychological tests and then a mood induction task based on movie clips is applied.

Different neuropsychological tests will be used to assess the differences in cognitive function in the different groups, whose scores are expected to be lower in the group of older adults with Alzheimer's disease (AD) and older adults with Parkinson's disease (PD).

After studying the cognitive function in the different groups, we proceed to check through a task based on movie clips if there are also differences in the valence assessment (liking/disliking depending on the emotion induced by scenes from different films) and activation (excitement caused by each one of the movie scenes), hoping to find differences for the negative emotions taking into account the cognitive difficulties that both (the EA group and the EP group) may have for processing this type of cognitively more demanding information; instead, it is possible that the positivity effect continues to affect these patients so that for positive emotions there are no differences between the different groups.

Eligibility Criteria:
Inclusion Criteria:

For the group of healthy older adults:

* MEC score greater than 26 points.
* GDS between 1 and 3.

For the mild EA group:

* MEC score between 18 and 23 points.
* GDS between 3 and 4.

For the EP group:

* MEC score greater than 23 points.
* GDS between 1 and 3.
* FAB score equal to or less than 11 points.

General Exclusion Criteria:

Participants cannot have:

* Significant asymptomatic neurovascular disease
* History of previous symptomatic stroke
* Alcohol or drug abuse/dependence
* Severe psychiatric symptoms
* Depressive symptoms higher than mild
DBS Virtual Learning Experience

The success of Deep Brain Stimulation (DBS) is more correlated to fulfillment of patients' expectations, than merely improvement of motor status1. Therefore, it is of utmost importance to inform the DBS candidates as good as possible to set realistic expectations. Currently, the patient - most of the time accompanied by a family member - is informed about the surgery and its benefits and risks during the outpatient consultation of the neurologist, and later on during the consultation of the neurosurgeon. Written information is provided in the form of a booklet that the patients take home.

Due to the large amount of information, not all of it can be captured by the patient. Therefore, we would like to investigate whether an additional online immersive educational session on DBS would better educate the patient. The online session is a 1-hour video call with a small group of DBS candidates and their caregivers, lead by DBS experts, where testimonials of other patients are shown, together with multiple infographics. Two weeks later their will be a second online session summarizing the information and providing the opportunity for Q\&A.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of any age over 18 who are capable of understanding and granting informed consent.
2. Consecutive enrollment of Parkinson's disease patients, eligible for DBS surgery who will be operated in Toronto Western Hospital.
3. Targets of surgery (STN or GPi) equally in each study arm.
4. Patients must be able to follow the assessment procedure.

Exclusion Criteria:

1. people with limited digital skills (to the discretion of the PI).
Priming and Patient Reported Outcome Measures

The objective of the study is to assess which health-related questionnaire is the most accurate and reliable.

The hypothesis is that some health-related questionnaires are more reliable than others.

The objective of the study is to test the reliability of patient reported outcome measures, and their robustness to patient-related factors.

Patients will be randomly assigned to complete 1 of 6 patient reported outcome measures. Patients will either be asked to reflect on health-related experiences or not prior to completion of the questionnaire. Basic non-identifiable demographic information, and a brief medical questionnaire will follow completion of the patient reported outcome measure.

Results from each individual patient reported outcome measure will be compared.

Eligibility Criteria:
Inclusion Criteria:

18 years of age and older, living in the US, fluent written and spoken English, able to consent

Exclusion Criteria:

Any criteria that does not meet the inclusion criteria
FLNA in HCC Patients

The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high. Having a predictive marker of early recurrence (ER) would be desirable to personalize the follow-up and possibly develop new targeted therapy. The aim of this study was to test the expression of Filamin A (FLNA) in a cohort of patients operated for HCC.

A consecutive cohort of resected HCC patients will be analyzed. Several different prognostic factors, including FLNA expression, will be tested against the risk of ER. FLNA expression will be analyzed with immunohistochemistry in the intra-tumoral and extra-tumoral tissue compartments using a dedicated tissue microarray.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were represented by the histological positivity for HCC with complete clinical, surgical, pathological, and follow-up data.

Exclusion Criteria:

* Patients preoperatively treated with chemotherapy or trans-arterial therapy were excluded.
* Similarly, patients operated for recurrent HCC or with non-radical surgery or with missing data were excluded.
A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of sporadic or familial ALS
* ≤ 4 years since ALS symptom onset
* Stable doses of approved ALS treatments (riluzole and/or edaravone) for at least 2 months prior to screening
* Participants must be able to swallow the study intervention
* Vital capacity \>50% predicted at screening
* Women must have been surgically sterilized, be postmenopausal, or for participants of childbearing potential, must not be pregnant, and both the participant and the male partner must use highly effective contraception
* Men, and sex partner if a woman of childbearing potential, must use highly effective contraception

Key Exclusion Criteria:

* Any history of unstable or poorly controlled psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* Positive serum pregnancy test or currently lactating or breastfeeding
* History of malignancy within 5 years
* History of clinically significant neurologic disorders other than ALS
Biochemical Predictors of Delirium in Cardiac Surgery

Delirium is a common neurologic complication after cardiac surgery occuring in 30-50% of patients. The occurence of this complication is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality. Considering great clinical significance of this complication, the search for early predictors of postoperative delirium remains an urgent task. The purpose of this prospective observational study is to test the hypothesis that metabolomic changes before and after cardiac surgery could be served as early predictors of this complication.


Eligibility Criteria:
Inclusion Criteria:

* surgery under cardiopulmonary bypass
* Age \> 60 years
* CABG surgery or valve surgery (repair/replacement)

Exclusion Criteria:

* urgent surgery
* surgery on aorta
* combined procedures (CABG+valves)
* significant stenosis of carotid arteries
* Parkinson's disease
* liver cirrhosis
* use of anticholinergic drugs, antidepressants, antiepileptic or chemotherapy drugs
Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates \[UAE\], Qatar, Bahrain, Kuwait and Oman).


Eligibility Criteria:
Inclusion Criteria:

* More than or equal to 18 years of age
* Clinician diagnosed LN participants.
* At least one visit to the investigational center during 12 months prior to the baseline visit, recorded in medical documentation.
* Literacy in English or Arabic allowing to fully comprehend the written informed consent and study-specific patient reported questionnaires.

Exclusion Criteria:

* Incomplete medical records to be able to assess the disease severity or absence of any of the following renal laboratory results from the medical record within the last twelve months: a. Urinary protein to creatinine ratio (UPCR) or 24-hour proteinuria or urine sediment (activity). b. Serum creatinine or estimated glomerular filtration rate (eGFR); or measured glomerular filtration rate (GFR), if eGFR is not available.
* Current or medical history of: a. Congenital or acquired immunodeficiency. b. Malignancy in active treatment phase. c. Acute viral infection, such as human immunodeficiency virus (HIV) infection, requiring hospitalization.
Accuracy of Intraocular Lens Power in High Myopia

evaluation of the accuracy of iol power in high myopia using different biometry formula \& iol master

High myopia or pathological myopia is associated with elongation of axial length longer than 26 mm or refractive error at least-6 diopter.

High myopia is one of the most prevalent refractive condition globally with a higher risk of other eye conditions Moreover in high myopic eyes the incidence of cataract is significantly higher than in non myopic eyes and the progression is also faster.

Calculation of IOL in high myopic eyes remains a challenge often leading to unexpected postoperative hyperopia the main potential sources of errors in IOL calculation for high myopic eyes include AL measurement \& IOL constants used \&IOL power calculation formula used.

investigators suspect that the SRK I1 formula is inaccurate for myopic eyes, and that new formulas are needed, taking into account all those factors that make up the dioptric power of an eye.

Formulas for IOL power calculation had past four generations, first generation formulas were theoretical and based on the same fundamental constant with no respect to anterior chamber depth. Since then, Binkhorst, Holladay, Hoffer and Shammas had refined the existing theoretical formulas where each of them developed his regression formula based on analysis of their previous IOL cases .

This work was amalgamated in 1980 and yielded the Sanders Retzlaff Kraff I (SRKI) formula The second generation was designed by combining linear regression analysis and stepwise adjustment for long and short eyes according to anterior chamber depth .

The third and fourth generation formulas, started by Holladay in 1988, all aimed at better calculation of the IOL power in eyes with extreme axial length where another term had appeared which is IOL specific anterior chamber depth .

The accuracy of third and fourth generation formulas for IOL calculation in patients with high axial myopia had not been fully evaluated For that, the need for more studies conducted to evaluate such accuracy is crucial.

This study will be conducted to evaluate the accuracy of different formulas used for IOL power calculation in patients with high axial myopia undergoing cataract surgery

Eligibility Criteria:
Inclusion Criteria:

- 1- patients with clear lense extraction or cataract \& high myope with{ AL more than 26 mm.

2-their IOLpower is less than 15 diopter or their refraction before operation is more than -6.

Exclusion Criteria:

1. Keratoconus patients or those with irregular cornea
2. Patients with post operative complications like posterior capsule injury or vitrous loss.
3. patients who had undergone previous intraocular surgery at anterior segment or posterior segment.
Treatment of Fibromyalgia With Recovery Factors

Treatment of Fibromyalgia and CFS with Recovery Factors

Use of a unique oral porcine peptide nutritional supplement in those meeting ACR 2010(amended) diagnostic criteria for Fibromyalgia or CDC Criteria for CFS

Eligibility Criteria:
Inclusion Criteria:

* Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS

Exclusion Criteria:

Under 18 Pregnant Other severe complicating conditions

-
Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers

This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* A male or female between, and including, 12 and 24 months of age at the time of vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.
* History of any neurological disorders or seizures.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
Stress and Gingival Inflammation in Non-pregnant and Pregnant Women

Background: The purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on salivary stress-related hormones.

Methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the study inclusion criteria were chosen. The participants with moderate/severe gingivitis were included. Clinical data and samples of GCF and salivary were collected at baseline and after periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked immunosorbent assay kits.

Periodontal clinical measurements and periodontal treatment were applied by a previously trained and calibrated examiner. Clinical parameters measurements including; probing pocket depths (PPD; the distance from the gingival margin to the base of the gingival sulcus), clinical attachment level (CAL), full mouth gingival index (GI)21 and plaque index (PI)20 scores using a periodontal probe were registered following saliva and GCF sample collection. Then, non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction was applied. Clinical measurements, recruitment of GCF, and saliva samples were repeated after three weeks.

Gingival Crevicular Fluid and Saliva Sample Collection Selected anterior teeth for GCF sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted parallel to the root surface for 5 to 10 seconds to dry the area.

The periopaper strips were gently inserted into the gingival crevice until resistance was felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in the anterior region of each patient (two samples per patient and per visit). The samples containing blood were discarded and were placed in sterile Eppendorf tubes and were stored at -20°C until the assay procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Must be systemically healthy;
2. Must be at least twenty teeth in the mouth;
3. Clinical diagnosis of gingivitis;
4. Must be the probing pocket depth (PPD)≤3 mm in all four quadrants.

Exclusion Criteria:

* the use of anti-inflammatory,
* antimicrobial and hormone therapy within the preceding 6 months,
* having psychiatric disorders,
* a systemic disease,
* smoking cigarettes and
* for the control group breastfeeding, pregnancy and menstrual periods.
Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (singleton)
* Gestational diabetes not requiring medical therapy
* Between 18 and 50 years of age
* Able to give written informed consent

Exclusion Criteria:

* Women in the first trimester of pregnancy
* Hematocrit less than 30%
* Current or past treatment with any hypoglycemic agent
* Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.
* Women with high triglyceride levels, history of gallbladder or pancreatic disease.
* Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)