cyrilzakka/clinical-trials huggingface dataset:
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.

Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.

Iron overload in hereditary hemochromatosis is treated by phlebotomy. In Switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range.

Individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation.

It is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards.

The study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-75 years
* Body weight \> 50 Kg
* Haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)
* In subjects of the HH and non-HH group: ferritin values \>500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the Blood Donation service or elsewhere), not followed by a blood donation or a phlebotomy
* In subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutation
* In subjects of the control group: ferritin values \< 300 ng/ml (males) or \< 200 ng/ml (females)
* Written informed consent to the participation in the study

Exclusion Criteria:

* Inadequate vein access for whole blood collection
* Body weight \< 50 kg
* Chronic viral infection (hepatitis B or C, HIV)
* Previous acute coronary heart disease
* Previous or current history of epilepsy
* Other severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluation
* No informed consent
* Pregnancy (according to the information on the standard blood donor questionnaire)
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
* Serum IgE level must be equal to or greater than 30 IU/mL at screening.

Exclusion Criteria:

* Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
* Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
* Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
* Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
* Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
* Prior use of Xolair® or other anti-IgE antibodies
* Concomitant use of allergy vaccination therapy

Other protocol-defined inclusion/exclusion criteria may apply.
Geranylgeraniol Supplementation in Patients With Mevalonate Kinase Deficiency

Mevalonate kinase deficiency (HyperIgD syndrome, HIDS) is an inborn error of immunity caused by a block in the mevalonate pathway. The subsequent lack of isoprenoids with antiinflammatory properties might contribute to the autoinflammatory nature of the disease.

A pilot study aims to verify the safety and efficacy of the dietary supplement Geranylgeraniol, aiming at a mitigation of isoprenoids deficiency caused by the above-mentioned block in the MVK pathway.

Mevalonate kinase (MVK) deficiency, a rare autosomal recessive disease, significantly impacts metabolism and immunity, leading to mevalonic aciduria in severe cases and hyper-IgD syndrome (HIDS) in partial deficiency. These conditions arise due to disruptions in the mevalonate pathway, which is an essential metabolic pathway responsible for the synthesis of non-sterol isoprenoids and other molecules. The resulting metabolic blockade triggers autoinflammatory responses, primarily due to deficient isoprenoid intermediates such as geranylgeranyl pyrophosphate (GGPP).

This study evaluates the safety and efficacy of dietary geranylgeraniol (GG) supplementation in patients with genetically confirmed mevalonate kinase deficiency.

The pilot study consists of a month of a pre-supplementation period to monitor the level of inflammation and clinical status in patients with MVK deficiency(HIDS).

This period is followed by 3 months of supplementation of 150mg of GeranylGraniol (GG Pure (Extendlife Natural Products) containing GG gold®30 Annatto Extract, 500 mg capsule (30% geranylgeraniol, 150 mg per capsule).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 12 years with genetically confirmed MVK deficiency
* Overall good clinical status apart from the clinical presentation of the MVK deficiency
* Normal liver tests
* Compliance with the study protocol

Exclusion Criteria:

• Children below 12 years
Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone

The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery.

The study was prospective, randomized, controlled and blinded. Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF. In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

Eligibility Criteria:
Inclusion Criteria:

* degenerative disc disease or degenerative spondylolisthesis

Exclusion Criteria:

* vertebral fractures,
* infections or spinal neoplasms,
* non-rigid instrumentations,
* medication affecting bone mineralization (e.g., corticosteroids),
* body mass index higher than 35,
* systemic diseases,
* blood disease and/or immunosuppressant treatment and/or dicoumarol therapy;
* immunosuppressant and/or neoplastic and/or infectious diseases.
Evaluation of Adolescent Smoking Cessation Programs

The purpose of this study was to determine if a school-based multi-session group smoking cessation program is more effective than a single session group program.

The investigators reformatted two group smoking cessation programs (the NOT program of the American Lung Association and Kicking Butts), both of which involve 50 minute sessions delivered once weekly, into a program that could be delivered during school lunch periods (25-30 minutes) twice weekly. Smoking status was subsequently assessed over the 12 month period following the intervention,

Eligibility Criteria:
Inclusion Criteria:

* Students who indicated they smoked cigarettes and wanted to quit

Exclusion Criteria:

* Students referred as part of a disciplinary requirement to stop smoking
Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)

Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need alternative treatment option. Cord blood transplantation (CBT) has become an alternative treatment means in various diseases, but it has not been proved to be good for severe aplastic anemia. Double units CBT is proposed to have better engraftment potential and and we reported successful double units UCBT after engraftment failure with single unit with promising result. To increase the engraftment potential, fludarabine, cyclophosphamide plus TBI conditioning regimen for double units cord blood transplantation was proposed for the patient with severe aplastic anemia without HLA-matched donor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion.
* Peripheral blood

  * Neutrophils \< 0.5 x 109/l
  * Platelets \< 20 x 109/l
  * Corrected reticulocytes \< 1%
* Bone marrow

  * Severe hypocellularity (\< 25%)
  * Moderate hypocellularity (25-30%) with hematopoietic cells representing \< 30% of residual cells
* No prior hematopoietic stem cell transplantation.
* Age: no limits.
* Performance status: ECOG 0-2.
* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

  * Heart: a shortening fraction \> 30%, ejection fraction \> 45%.
  * Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
  * Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
* Patients must lack any active viral infections or active fungal infection.
* No appropriate donor
* Appropriate cord blood is available: matched at least in 4/6 of A, B, DR loci.
* Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

* Pregnant or nursing women.
* Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
* Psychiatric disorder that would preclude compliance.
* Congenital aplastic anemia including Fanconi anemia.
Preparing the Personal Physician for Practice (P4)

We would like to better understand how different educational strategies may influence the practice of family medicine. More specifically, we are interested in participant satisfaction with the educational program, participant retainment in this career, and to see if the curricular change better prepares participants for contemporary clinical practice.

In 2004, the Future of Family Medicine report called for implementation of innovative strategies in residency education, allowing translational key insights from the national demonstration project toward new approaches to family medicine training. Taking full advantage of the P4 Project will require careful evaluation planning and implementation. A comprehensive evaluation plan for the P4 Project will be implemented by a core evaluation team that will interact with site-specific evaluators.

The P4 evaluation program represents an observational case series assessment of selected residency programs. It is not an intervention trial; rather each residency program will systematically enroll cohorts of learners who will be exposed to curricular content and learning approaches that will likely be innovative and unique. In the absence of a rigorous study design, core data elements should be obtained from each program including: learner characteristics, program characteristics, and both nationally available data and targeted validated instruments that can link specific educational interventions to learners knowledge, attitudes and skills.

Eligibility Criteria:
Inclusion Criteria:

* Medical Residents at Christiana Care's Residency Program
Power of Peanuts School Feeding

This will be a two-phase protocol. Phase 1 will include the development of the peanut-based school food, and a small formative research study on the acceptability and consumption of the school food study intervention. This will occur among children 5-12 yr in the Mion district, 60 school aged children between 6-12 years old will be recruited to participate in a 3 week consumption and acceptability study. An integral part of the food development process is acceptability testing. A child must like and want to eat a new food if it is to be consumed as prescribed and effective in potential improving linear growth and cognitive performance. This study will confirm that food developed for the school feeding clinical trial will be consumed as dosed and what additional snack food offerings may be useful in encouraging consumption.

Phase 2 will be a individually randomized, investigator blinded, controlled clinical effectiveness trial of a peanut-based school meal with and without milk powder compared to a control meal for linear growth and cognitive performance. 880 children 5 to 12 years old, healthy, enrolled in primary school, including kindergarten at 6 selected schools in the Mion district will be randomized to receive one of three school foods, a peanut-based food with milk, a peanut-based food without milk and a control group composed of commonly available tuber/cereal. The sample size accounts for up to 15% attrition for a final sample size of 750 with a total 250 eligible children enrolled in each group. Enrolled children will receive the meal daily during the school lunch period for an entire school year. At enrollment and upon completion, anthropometric measurements and body composition data will be collected and a tablet- based, language independent cognitive test battery will be administered. Basic demographic information and school attendance information will be collected as well.


Eligibility Criteria:
Inclusion Criteria:

* Healthy school children

Exclusion Criteria:

* severe malnutrition
* chronic debilitation disease
* peanut or milk allergy
* not attending school
Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation

The general objective of the study is to assess whether the implementation of the antibiotic essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Bacterial infections, with microbiological isolation, in one of the following tissues: skin, soft tissue or surgical wound infections

Exclusion Criteria:

* Age \< 18 years
* Inability to sign informed consent
Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

This pilot clinical trial studies cognitive assessments in patients with cancer undergoing chemotherapy. Questionnaires that measure cognitive changes during chemotherapy may help identify the side effects of chemotherapy.

PRIMARY OBJECTIVES:

I. To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.

SECONDARY OBJECTIVES:

I. To estimate the variability of the various cognitive tests and to assess changes in cognitive performance based on the results of cognitive assessments obtained prior to chemotherapy and at 6 to 8 weeks and 12 to 16 weeks after the initiation of chemotherapy.

II. To explore the association of cognitive performance with the Eastern Cooperative Oncology Group (ECOG) performance status as evaluated by the patient's oncology team.

III. To assess the association between cognitive performance and the occurrence of a serious adverse event during chemotherapy.

OUTLINE:

Patients complete cognitive assessments, comprising Hopkins Verbal Learning Test-Revised (HVLT-R), Trail Making Test Parts A \& B (TMT-A, TMT-B), Digit Symbol Coding Test (DSC), Category Fluency Test (Animals), Montreal Cognitive Assessment (MoCA), and Digit Span Test (DST). Patients also complete the Beck Depression Inventory. Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed cancer
* Patients are candidates for systemic chemotherapy for their cancer diagnosis
* Life expectancy must be greater than 6 months
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have had prior systemic chemotherapy in their lifetime
* Patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* Patients may not be participating on any other study investigating cognitive function
* Patients who are non-English speaking are ineligible
* Patients with hematologic malignancies are ineligible
* Patients with primary central nervous system malignancies are ineligible
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.

This is a clinical pharmacology study with 2 cohorts (subjects with severe HI by Child-Pugh criteria and matched healthy control subjects) to evaluate the PK, safety, and tolerability of a single oral dose of 30 mg quizartinib in otherwise healthy subjects with severe HI (as defined by Child-Pugh criteria). This study is planned to be conducted at up to 3 sites in the US, which use Child-Pugh criteria.

Eligibility Criteria:
Key Inclusion Criteria:

1. Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
2. Male and female subjects 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg/m2 to 37 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.
3. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum and estradiol \<40 pg/mL \[\<147 pmol/L\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the means of contraception from Screening until 7 months after the dose of quizartinib 4. In females, agreement to not retrieve eggs/ova via assisted reproductive technology (ART) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later.

5. In males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from Screening until 4 months after the dose of quizartinib 6. In males, agreement to avoid sperm donation for 4 months after the dose of quizartinib

Key Exclusion:

1. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
3. Subjects with primary biliary cirrhosis or primary sclerosing cholangitis.
4. Subjects with history of Gilbert's syndrome.
5. Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib.
6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy).
HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria

This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 19 years
2. Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
3. Diagnosed with hypertension
4. Written informed consent
5. Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization

Exclusion Criteria:

1. Type I diabetes
2. Uncontrolled diabetic patients with HbA1c \> 10% at screening
3. Hypertensive patients whose mean blood pressure was not controlled at 160/90 mmHg or more in triplicate despite the use of antihypertensive agents at the time of randomization
4. Calculated LDL-C ≥ 160 mg/dL at randomization
5. Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
6. Heart failure patients with NYHA class IV
7. Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
8. Patients with a history of cerebral blood cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, and percutaneous coronary intervention)
9. Patients taking immunosuppressive drugs
10. Patients undergoing eGFR \<30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
11. Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
12. Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
13. Patients who are pregnant or planning to become pregnant
14. Contraindications stated in the SPC of telmisartan or rosuvastatin
15. Those participating in other clinical trials for investigational products at screening
16. Patients deemed to be ineligible to participate in the trial by investigator