cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients

This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of impaired renal function.

The primary objective of this study is to evaluate the plasma and urine PK of Levetiracetam (ucb L059) and its metabolite (ucb L057) after a single dose of LEV 250 mg or LEV 500 mg in Japanese subjects with normal renal function and in Japanese subjects with various degrees of renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with normal renal function
* Subject is Japanese
* Subjects with creatinine clearance within 1 of 3 Groups (CLcr\[mL/min/1.73 cm\^2\]: Group B: 50 - \<80, Group C: 30 - \<50, Group D: \<30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

* Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's disease
* Age 50-85
* Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Exclusion Criteria:

* Significant Neurological Disease
* Major psychiatric disorder
* Clinically significant systemic illness Other exclusion criteria apply.
Assessment of Corneal Endothelial Function Following Hypoxic Stress

The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.

Clarity of the cornea is essential for optimal vision. The endothelium is a layer within the cornea that controls its clarity. Fuchs endothelial corneal dystrophy (FECD) is a progressive disease that affects both eyes in which the endothelium is dysfunctional, causing the cornea to swell and lose its clarity. Because of the vision loss associated with this swelling, corneal transplantation is needed for patients with advanced FECD.

Currently, there is no method to directly measure how well endothelium cells are functioning in patients with FECD. Such a measurement, if it were possible, would allow physicians to identify patients who are at a higher risk of corneal swelling. The goal of this study is to establish a tool to measure and compare the amounts of corneal swelling between normal and FECD patients after a stress test is performed (the wearing of an FDA-approved contact lens.) Data will also be collected regarding how quickly and how well a cornea recovers from swelling in patients with healthy eyes compared to those with FECD.

Eligibility Criteria:
Inclusion Criteria:

Subjects in the Fuch's Dystrophy arm of the study must meet following criteria:

* Have a clinical diagnosis of Fuchs endothelial corneal dystrophy
* Be scheduled for corneal transplantation in the next 6 months
* Have no history of prior ocular surgery in study eye
* Have no history of contact lens intolerance
* Be motivated and willing to complete ocular imaging tests

Subjects in the healthy eyes arm of the study must meet following criteria:

* Have no prior history of ocular disease including ocular surface disease or glaucoma
* Have no history of prior ocular surgery in study eye
* Have no history of contact lens intolerance
* Be motivated and willing to complete ocular imaging tests

Exclusion Criteria: Pregnant women

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Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.

Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. \< 36°C) and shivering will be assessed postoperatively.

Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.

The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.

The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. \< 36°C) and shivering will be assessed postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for minor surgery (planned duration approximately \<1h).
* Age 18-75yrs,
* ASA I-II physical status

Exclusion Criteria:

* Emergency surgery,
* pregnant patients,
* patients not able to give informed consent,
* duration of surgery \>2h,
* necessary postoperative mechanical ventilation
APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.

The National Institutes of Health (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.

Eligibility Criteria:
Inclusion Criteria for Living Donors:

* Living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African) will be eligible for inclusion.

Exclusion Criteria for Living Donors:

* Participants who are unable or unwilling to provide informed consent.

Enrollment and bio sample collection from deceased donors at OPOs ended on May 31, 2023 and recruiting kidney transplant recipients ended on June 15, 2023.

Phase II started on 9/1/2023 and only Living Donors will be recruited for an additional 2 years.
Randomized Controlled Trial of a Self-help Book for Insomnia in Patients With Co-morbid OSA and Insomnia

Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. This project evaluates the effects of a self-help book for insomnia in patients being treated with CPAP for OSA.

This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia in patients with obstructive sleep apnea (OSA) and co-morbid insomnia. 180 patients are randomized to either receive the self-help book (90 patients) or sleep hygiene advice (90 patients). Patients fill out questionnaires about sleep and health both at baseline and after three months. Furthermore, CPAP compliance and OSA severity will be evaluated after three months of CPAP use. The aim is to evaluate whether the self-help book will improve sleep parameters and CPAP compliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with OSA and scheduled for CPAP treatment.
* Having co-morbid insomnia.

Exclusion Criteria:

* Less than 18 years of age
* Not fluent in Norwegian
Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.

Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* primary intermediate risk AML in molecular complete remission;
* primary high risk AML in molecular complete remission awaiting unrelated HSCT;
* Karnofsky or Lansky performance scale greater or equal to 70;
* written informed consent.

Donors:

* haploidentical family donor;
* donor suitable for cell donation and apheresis according to standard criteria;
* written informed consent.

Exclusion Criteria:

Patients:

* uncontrolled infection;
* severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age;
* positive serology for human immunodeficiency virus (HIV).

Donors:

* pregnancy;
* positive serology for HIV, hepatitis B or C.
Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease

This single-center, randomized, quadruple-blinded, double-crossover comparative efficacy trial will study the effects of unilateral 50% voltage reduction in axial motor dysfunction for patients with Parkinson's disease that develop treatment-resistant postural stability gait dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease (PD) (previously diagnosed according to the UK brain bank criteria) who develop treatment-resistant postural instability gait dysfunction (PIGD) more than 6 months but less than 5 years after bilateral subthalamic nucleus deep brain stimulation (STN-DBS).
* Treatment-resistant PIGD will be defined as freezing of gait and UPDRS or MDS-UPDRS PIGD subscales of more than 6 points despite optimization of medications and bilateral STN-DBS programming.

Exclusion Criteria:

* Treatment-resistant PIGD less than 6 months or more than 5 years after STN-DBS surgery.
* PIGD responsive to optimization of medications and/or bilateral STN-DBS programming.
* Cognitive impairment or psychiatric comorbidities (including substance abuse) that would interfere with the informed consent process, study adherence or outcome assessments.
* Advanced PD or any other neurological, cardiovascular or musculoskeletal co-morbidities that would preclude or require assistance to complete the 10-meter walking test.
* Patients not able to comply with 4-week interval evaluations following their potential enrollment due to personal reasons.
* Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically-stable on therapy, in the opinion of the site investigator, for at least 30 days prior to study entry.
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®

The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the generic GPO saquinavir shows bioequivalence when boosted with Norvir®. If the generic formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.

The primary objective is to establish bioequivalence of "ritonavir boosted generic GPO saquinavir", with Invirase® and Norvir® as the reference drug.

The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthy male 18-45 years old
* Documented negative test for HIV-1 infection \< 1 wk prior to start of study and with no risk of HIV exposure in the last 6 months
* BMI 18-25
* Normal physical examination
* Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV infection

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the study and the procedures required.
* Participation in a drug study within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose.
* Use of concomitant medication
* Smoke cigarettes not more than 10 cigarettes a day.
* Drink alcohol not more than 2 units a day.
* Discontinue smoking and alcohol for at least 1 month before enrollment.
* Take other medication regularly
* Involvement in any drug addiction.
* Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs
The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care

This study will determine whether an intervention aimed at reducing sedentary time in patients admitted to acute care will result in decreased frailty levels at hospital discharge, compared to the current standard of care. All patients will be fitted with accelerometers then randomised to the control or intervention group. The control group will receive only standard of care while in hospital. Participants in the intervention group will engage in daily goal setting for time out-of-bed and have access to real-time feedback on a bedside monitor. Participants in the intervention group will also received assisted mobilization if they have not met their daily goal by the late afternoon. The main outcome is frailty, assessed by a frailty index.

The objective of this study is to determine if an intervention designed to reduce sedentary time during a patient's stay in acute care will reduce patient's frailty levels more so than current standard of care. This study will be conducted at a single-centre, but will be a stratified, block randomised control trial. Fifty participants will be recruited within 24 hours of admission to a geriatric acute care unit. Both groups will be fitted with a device that measures sedentary and active time (accelerometer). Participants in the intervention group will have a daily goal for activity and will be provided with real-time feedback on attainment of that goal displayed on a bedside tablet. Participants in the intervention group who do not independently achieve their goal will be assisted in reducing their sedentary time in the afternoon and/or early evening to the maximum level of their ability; this level will be determined in consultation with the healthcare team. The primary outcome is a change in frailty during hospitalization, measured using a 30-item frailty index. The data collection phase is approximately 10 months. Data analysis will take an additional six months (16 months total). Knowledge-users will be involved during all stages of the project. The data generated from this study will enable us to scale up this intervention nationally and internationally. If the intervention is successful, it will warrant a study to implement the intervention as part of standard care. Ultimately, this study will inform guidelines to limit patients' sedentary behaviors in acute care.

Eligibility Criteria:
Inclusion Criteria:

* Anticipated hospital length of stay \>1 day
* Patient or care partner able to communicate in English

Exclusion Criteria:

* Patient unable to provide informed consent and care partner not available to provide consent
* Bedridden prior to hospital admission
* Previous participation in our study (i.e. readmission during data collection phase)
* End-of-life or waiting for long-term care facility
* Patient is admitted to a shared room with a current study participant.
Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia - Results From Real-life Clinical Studies

Quercetin, a natural flavonoid found in various fruits and vegetables, has gained attention for its potential role in managing hyperuricemia. Emerging evidence suggests that quercetin may reduce plasma uric acid levels by inhibiting xanthine oxidase, an enzyme responsible for uric acid production. Additionally, its anti-inflammatory and antioxidant properties could help mitigate the oxidative stress and inflammation associated with hyperuricemia. As a result, quercetin supplementation offers a promising avenue for therapeutic intervention in conditions like gout and other uric acid-related disorders.

In the present retrospective cross-sectional observational study, the investigators assessed the potential pharmacological effect of supplemental quercetin on the plasma uric acid levels of health adults. These participants visited nutritional clinics in Italy during the Coronavirus disease (COVID-19) pandemic for general health check-up in real-life to enhance their immune system with supplements aimed at providing additional protection against COVID-19 infection. The supplements, either quercetin or probiotic Streptococcus salivarius K12 (BLIS K12), were advised randomly to the participants for 90 days, tailored to individual needs and in the absence of any pre-defined criteria.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* BMI between 18.5 and 29.9 kg/m²
* Non-smoker
* Consumtion of less than 3 units of alcohol per day

Exclusion Criteria:

* - Plasma uric acid concentrations above 7 mg/dL
* Diagnosis of endocrinological, metabolic, oncological, neurological, or bowel inflammatory disease diseases, gout, kidney stones
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)

The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.

The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.

Referring to animal data, empirical studies, and pilot human trials, exercise should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with impaired glucose tolerance during a short term exercise program.

Eligibility Criteria:
Inclusion Criteria:

* subjects with impaired glucose tolerance
* 50-65 years old
* moderate to heavy weight (BMI 25-35)
* must be able to do exercise intervention

Exclusion Criteria:

* diabetes
* younger than 50 years
* BMI \< 25
* psychiatric medication
* severe disease
* MMSE \< 26
* severe cardiovascular disorders
Clinical Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Miglustat in Patients With Stable Type 1 Gaucher Disease

Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy, safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18 years or older
2. Type 1 Gaucher disease, diagnosed by glucocerebrosidase assay or molecular analysis of the glucocerebrosidase gene.
3. Treatment with ERT for at least 3 years, with a stable dose regimen for at least the last 6 months.
4. Clinically and biologically stable disease for the previous 2 years, with at least 2 time points assessments (including baseline as one potential time point), defined as:

   * Stable organomegaly (assessed by magnetic resonance imaging (MRI) or computed tomography (CT)):

     * Liver volume within 10% of the mean.
     * Spleen volume within 10% of the mean.
   * Free of progressive symptomatic documented bone disease.
   * Hemoglobin levels \> 11g/dl
   * Mean platelet count \> 100x10\^9 /l.
   * Chitotriosidase activity within 20% of the mean.

     * If chitotriosidase is not available (in the case of chitotriosidase deficiency, or if it was not determined), other relevant biomarkers (e.g., angiotensin converting enzyme (ACE), tartrate resistant acid phosphatase (TRAP) and ferritin) could be considered.
5. Written informed consent.

Exclusion Criteria:

1. History or evidence of oculomotor gaze palsy, ataxia or other clinical manifestations typically associated with neuronopathic type 3 Gaucher disease.
2. Not ambulant patients, or with progressive symptomatic documented bone disease.
3. Splenectomy before 18 years of age for splenomegaly and/or thrombocytopenia.
4. Peripheral polyneuropathy (not mononeuropathy) documented with both clinical signs and symptoms, and electrodiagnostic (EDX).
5. Patients (males and females) who do not agree to use reliable contraception throughout the study and for 3 months after cessation of miglustat treatment.
6. Female patients who are pregnant or breast feeding, or without pregnancy test prior to Day 1.
7. History of significant lactose intolerance.
8. Clinically significant diarrhea (\>3 liquid stools per day for \>7 days) without definable cause within 6 months prior to Day 1, or a history of clinically relevant gastrointestinal disorders.
9. History of cataracts or known increased risk of cataract formation.
10. Severe renal impairment i.e., with a creatinine clearance \<30 ml/min/1.73m\^2
11. Concomitant active medical condition such as human immunodeficiency virus (HIV) or hepatitis B/C that would render patients unsuitable for study.
12. Previous treatment with miglustat.