cyrilzakka/clinical-trials huggingface dataset:
Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine

The purpose of this study is to evaluate and compare the changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated with and without white matter changes after rivastigmine patch therapy.

Acetylcholinesterase inhibitors (AChEIs) increase the amount acetylcholine at ACh receptors within the brain, and are the primary medications used to treat AD. Alzheimer's disease patients are frequently associated with mild or moderate white matter changes on MR imaging. The impact of whiter matter changes on the efficacy of cognition, functional abilities, behavioral and psychiatric symptoms and caregiver burden for probable Alzheimer's disease is not well known. There are very few studies for the efficacy of rivastigmine between the patients with mild to moderate Alzheimer's disease associated with or without vascular risk factors.

Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes. Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimer's and vascular pathologies contributing to dementia, providing additive treatment effects in patients suffering from both conditions concurrently. To our Knowledge, there was no study or clinical trial to compare the changes of cognitive function, ADL, BPSD and caregiver burden in two groups of patient with Alzheimer's disease associated with or without white matter changes after rivastigmine transdermal patch therapy.

Eligibility Criteria:
Inclusion Criteria:

* AD in NINCDS-ADRDA criteria, mild to moderate
* probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
* MMSE score : 10 to 26 at screening
* Hachinski scores ≤ 4
* No clinically significant laboratory abnormalities, such as thyroid disease, vitamine B12 deficiency or folic acid deficiency

Exclusion Criteria:

* Current evidence of history of neurological, psychiatric and other illness that could contribute to dementia
* Subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months
* History of cancer within the last 5 years
* Subjects with evidence or history of clinically significant allergic reaction to AchEI or drugs
* Subjects who had significant visual or hearing difficulties
Clinical Characteristics and Outcomes of Patients Requiring Mechanical Ventilation in an ICU- a Registry Based Study

Rationale: Patients admitted to the Intensive Care Unit (ICU) often require respiratory support in terms of mechanical ventilation (either non-invasive or invasive). Though these patients may be diverse in clinical characteristics, the need of respiratory support in itself is in many conditions a factor relating poorer outcomes. The exact association of the requirement of respiratory support in our patient population is missing in the current literature. This study will look at 5-year data of patients admitted to the ICUs of Tribhuvan University Teaching Hospital and try to characterize these patients according to their clinical profile. Further, this study will also help to generate data regarding the outcomes of such patients.

Study Objective: To characterize the patients requiring respiratory support in the ICUs of TUTH and find their outcomes in terms of ICU mortality.

Design: A registry based, retrospective, descriptive, cohort study. Sample size: Convenience sampling of all the patients who are admitted to the ICU.

Duration: Retrospective data from the 5-year period between November 1, 2019 to December 31, 2024.

Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH).

Interventions: Not applicable Expected results: The study will help determine the clinical characteristics of patients admitted to the ICUs of TUTH requiring respiratory support and their associated outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Admission to the ICU

Exclusion Criteria:

None
Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) will be divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures will be pre-and postoperative uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry


Eligibility Criteria:
Inclusion criteria for the study focused on patients over 34 (range from 34 to 41) with stable corneal topography and refraction for at least six months and an estimated residual bed thickness of \>410 µm.

exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.
Calculating the Volume of the Paravertebral Space

Volume of the paravertebral spaces of the tharic and lumbar regions will be measured.

Paravertebral block is an effective regional anesthesia method and a golden standart technique for various operations. In addition, paravertebral block is a volume dependent technique. However, there are few cadaveric studies that investigates the volume of the paravertebral space.

This study aims to calculate the volume of the paravertebral spaces of the lumbar and thoracic regions in the patients who had 3D computerized scan in Kocaeli University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had a CT scan of the spine in our hospital

Exclusion Criteria:

* Patients with scoliosis or known vertebral abnormalities
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity

The goal of this study is to determine how well LB54640 works and how safe it is in patients with Hypothalamic Obesity (HO). The study will evaluate the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older with HO. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo through Week 14. Eligible patients who consent to continue in the study after Week 14 will take an oral daily dose of LB54640 through Week 56.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented evidence of acquired hypothalamic obesity (HO)
* Age 12 years and older
* Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients \<18 years of age
* Male and female participants agree to follow study contraception requirements and use a highly effective form of contraception throughout the study and for 90 days after the study

Key Exclusion Criteria:

* Weight loss \>2% in the previous 3 months for patients ≥18 years of age or \>2% reduction in BMI for patients \<18 years of age
* History of major surgical procedure within 30 days
* HbA1c \>10.9%
* Fasting glucose level \>270 mg/dL
* Previous use of MC4R agonists
* Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET).
* Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
* History or close family history of skin cancer or melanoma
* Current clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results

Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Immune Response in Obesity and Type 2 Diabetes

There is a link between activation of the immune response inducing chronic inflammation and both obesity and type 2 diabetes. To date, however, the cause(s) of this inflammation, the mechanisms of the inflammatory cascade and the type of cells involved are not completely known. The aim of our project is to study the principal cell types involved in the immune response from a quantitative and functional point of view in obese diabetic patients versus obese non-diabetic patients and healthy subjects who are neither diabetic nor obese.

Despite possible inter-individual heterogeneity of immune cells, the fact that this work will be carried out by an accredited team with considerable expertise in the study of almost all the different types of immune cells will probably make it possible to know whether cell dysfunction and inflammation are associated with obesity or rather linked to insulin resistance. This study will be completed later by a second study on cell infiltration in adipose tissues in the 3 groups defined above. Better understanding of the physiopathology and especially the mechanisms and type of cells involved in obesity-related inflammation could quickly lead to the development of appropriate therapies that could act specifically on the cells involved and thus preclude the onset of complications.


Eligibility Criteria:
Inclusion Criteria:

* Patient-control who have given written informed consent Patient-control who are covered by the National Health Insurance Agency Patient-control \> 18 years old

The criteria to classify patients into groups will be as follows:

Group 1- Obese diabetics BMI \> 30 Kg /m2 AND fasting glycemia \> 1.26 g/L AND Triglycerides \>1.5g/L AND HDL \<0.4g/L (men), \<0.5g/L (women) Group 2- Obese non-diabetics without metabolic syndrome BMI \> 30 Kg /m2 AND fasting glycemia \< 1.10 g/L AND Triglycerides \<1.5g/L AND HDL \>0.4g/L (men), \>0.5g/L (women) Group 3- Healthy Subjects BMI \< 25 Kg/m² AND fasting glycemia \< 1.10g/L AND Triglycerides \<1.5g/L

Exclusion Criteria:

* Persons not covered by the National Health Insurance Agency Patients who presented a recent infection, or cancer or patients treated with corticosteroids or anti-inflammatory drugs. Patients with diabetes following an overload disease (hemochromatosis) or due to a disease of the pancreas Chronic infection Pregnant women Patients on the following treatments (glitazone: Actos, Avendia; GLP1 Agonist: Byetta, Victoza; Fibrates) Patients presenting severe renal insufficiency with clearance\<30ml/min
Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

This cross-over clinical trial is being conducted to evaluate the difference in urinary messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a low-sodium diet, as compared to a high-sodium diet. The study team will collect urine and blood samples from each participant to study mineralocorticoid receptor-regulated mRNA biomarkers following the consumption of each diet.

The study team will instruct the participants to consume 8 days each of high- (300 mmol/day) and low- (10 mmol/day) sodium meals. The order in which the participants will eat the two study diets will be randomly determined. In between the high- and low-sodium diets, the participants will have a wash-out period of 6 days, during which they will be encouraged to consume their usual diet. Participants will be asked to provide the study team with 24-hour urine samples, random urine samples, and blood samples throughout their participation in this clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Normotensive, as defined by:

  * Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg
  * Never prescribed an antihypertensive medication
* Willingness to refrain from intense exercise (for example, swimming, biking, running)

Exclusion Criteria:

* Hypertension (history of blood pressure ≥ 140/90 mmHg)
* History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension
* History of chronic kidney disease
* History of heart failure
* Current food allergy
* Pregnancy
* Known hyperaldosteronism
* Current mineralocorticoid antagonist use
* Current treatment for diabetes mellitus
* Known adrenal insufficiency
* Current glucocorticoid use
* Electrolyte abnormality on baseline laboratory assessment
* Current potassium supplementation
* Urinary tract infection (UTI)
* Significant renal insufficiency or any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study
Optimizing Dosing Strategies in Oral Iron Supplementation

The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency.

The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose.

Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* ≥18 years of age
* Iron deficiency: Ferritin \<30 µg/l
* hemoglobin ≥ 80 g/l
* CRP \< 5 mg/l

Exclusion Criteria:

* Refusal of study participation,
* Regular administration of Erythropoietin
* Oral or intravenous iron supplementation \<12 weeks prior to investigation
* Contraindications to intervention medication (Tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate
* Blood transfusion or donation \<12 weeks prior to investigation
* Active chemotherapy
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.

Note

Due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):

Anemia (as defined by the WHO): Hemoglobin \<130 g/L for men, Hemoglobin \<120 g/l for women, Hemoglobin \<110 g/l for pregnant women
A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the requirements of the study and provide consent
* Medical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* Female of child-bearing potential to use adequate birth control

Exclusion Criteria:

* Diagnosis of asthma
* Other significant disease than COPD
* Has donated a unit of blood within 30 days of study, or intends to donate
* QTc greater than 0.460 seconds
* Subjects who had radiation or chemotherapy in the previous 12 months
* Subjects who had lung resection
* History of illegal drug abuse or alcohol abuse within the past 5 years
Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* Stages of Reproductive Aging Workshop (STRAW+10) peak or late reproductive stage (-4, -3b or -3a)
* Healthy based on medical history, physical examination and standard blood chemistries
* Normotensive (resting blood pressure \<140/90 mmHg)
* Normoglycemia (fasting glucose \<110mg/dl and hemoglobin A1c\<6.5%)
* Non-smoker (for at least 12 months)

Exclusion Criteria:

* Serum Follical Stimulating Hormone (FSH) \>25mIU/mL measured during the first 5 days of the menstrual cycle
* Use of hormonal therapy within the past 3 months
* Use of antihypertensive or lipid-lowering medications
* Pregnant or lactating, or planning to become pregnant during the study period
* Known hypersensitivity to any of the study medications
* Abnormal vaginal bleeding
* History of venous thromboembolism or hormone-sensitive cancer
* History of neurologic disease or major psychiatric illness
* History of diagnosed learning disability or less than high-school education
* Contraindication to Magnetic Resonance Imaging (MRI) scanning
* Depression (Center for Epidemiological Studies - Depression (CESD) score \>16)
* Significant cognitive impairment (Mini Mental State Examination (MMSE) score \<27)
* Severe osteopenia or osteoporosis (proximal femur or lumbar spine T-score \< -2.0)
* Body Mass Index (BMI) \>40kg/m2
Epidemiology of Acute Phase Protein and CHD

To use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality.

BACKGROUND:

The use of stored serum from the MRFIT cohort contributed additional information on how various lipid fractions and other serum constituents interact to produce atherosclerotic disease. The cost of performing such studies on a new cohort would be many times greater.

DESIGN NARRATIVE:

The case-control study evaluated: 1) the relationship between acute phase reactants, albumin, alpha 1 glycoprotein c-reactive protein and sialic acid; 2) oxidized low density lipoprotein cholesterol (LDLC) measured by thiobarbituric acid reactive substances (TBARS), and risk of myocardial infarction or coronary heart disease death; 3) Lp(a); 4) antioxidized vitamin E and carotene. The study was done in one year because of the need to analyze the specimens shortly after they were thawed. The statistical analysis was done in collaboration with University of Minnesota Coordinating Center.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:

\< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including

  * 9-12 weeks of age at the time of first vaccination for the \<6 Mo group.
  * 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
  * 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
  * 24 months to 5 years at the time of first vaccination for the \>= 24 Mo group.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Born after a gestation period between 36 and 42 weeks.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
* Previous vaccination against S. pneumoniae.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
* Acute disease at the time of enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.
ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization

This is a prospective, multi-center, non-randomized, un-blinded, observational trial.

This prospective, multicenter observational study will examine the ability of ECGi mapping to

1. Effect of Ibutilide on the number and size of the driver domains
2. Effect of ablation of Ibutilide-organized driver domains
3. Effect of PV isolation on driver domains

The researchers hypothesize that this approach will lead to successful arrhythmia control .

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* ° Symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication Persistent AF - defined as Persistent: AF that is sustained \> 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.

  * Planned to undergo first catheter ablation procedure ( prior atrial flutter typical is allowed)
* Ability to understand the requirements of the study and sign the informed consent form.
* Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
* Projected lifespan greater than 1 year

Exclusion Criteria:

* They have baseline prolonged QT or renal failure precluding safe used of ibutilide
* Rheumatic heart disease,
* Current intra-cardiac thrombus,
* History of MI or CABG within 6 weeks;
* Class IV HF,
* Unable to sign consent
* Projected lifespan of \< 1 year
* Women known to be pregnant or to have positive beta-HCG.
* Participation in another study that would interfere with this study.
* Unstable Angina
* Recent cerebral ischemic events
* Contraindication to anticoagulation
* Prior history of polymorphic ventricular tachycardia or torsades de pointes