cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

OBJECTIVES:

* To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
* To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
* To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
* To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.

OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia

  * Matched patients non-tumor and blast DNA samples
  * Enrolled on COG-P9906 or COG-AALL0232 protocols
* Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri

PATIENT CHARACTERISTICS:

* Newborn infants from the state of Missouri

PRIOR CONCURRENT THERAPY:

* Not specified
Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery

Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.


Eligibility Criteria:
Inclusion Criteria:

* Elite level youth soccer players, competing in the highest portuguese division

Exclusion Criteria:

* Older adults
* none elite soccer player
* Play less than 70 minutes of match
Black Cohosh Extract in Postmenopausal Breast Health

The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.

As in Brief Summary

Eligibility Criteria:
* Postmenopausal females
* 20 months since any breastfeeding
* Active postmenopausal symptoms, i.e., hot flashes
* At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed
* Able to make 4 visits during the trial to the study clinic in Columbia, Missouri
Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectomy Surgery and Controls

Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.

Approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. Scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.

Eligibility Criteria:
Inclusion Criteria:

* phakic eyes of patients that are scheduled to undergo pars plana vitrectomy,
* controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery,
* age 18 and older

Exclusion Criteria:

* any eye that is pseudophakic,
* has had previous vitreoretinal surgery,
* has had previous intravitreal injection,
* previous intraocular inflammatory condition such as uveitis,
* previous irradiation,
* any patient with a history of ocular malignancy,
* history of infectious intraocular condition
Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.

Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in regulation of inflammatory responses, vascular permeability, blood coagulation. It can be easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly, the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases such as diabetes mellitus, atherosclerosis, malignancy has been researched.

In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion, oxidative stress which can damage endothelial glycocalyx. In this research, the investigators would like to discover the impact of perioperative shedding of the endothelial glycocalyx on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.

Syndecan-1, Heparan sulfate serve as biomarkers of glycocalyx degradation. Both biomarkers will be measured 2 times, before the anesthetic induction, and immediately after weaning from cardiopulmonary bypass, during the valvular heart surgery.

Postoperative acute kidney injury up to postoperative 48 hours, Composite morbidity and mortality up to postoperative 30 days will be checked.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing valvular heart surgery (\>20 years old)

Exclusion Criteria:

* Emergency operation
* Aorta surgery (Graft replacement of Total arch or Descending thoracic aorta)
* Minimal invasive surgery
* Chronic kidney disease (eGFR\<30mL/min/1.73m2) / Dialysis history
* Infective endocarditis
* Malignancy
* Patients who cannot give Informed consent (e.g. Illiterate, Foreigners)
* Patients who are already enrolled to another study than can affect the results
Innovation in Food Production Techniques to Improve Bioactive Content

The purpose of this study is to establish to what extent innovations in food production techniques may facilitate retention of bioactive compounds in healthy individuals.

The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma concentration and urinary excretion levels of a range of bioactive compounds will be assessed over a 24 hour period following intake of either a vegetable based convenience food, or a minimally processed meal containing the same vegetable materials.

To do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment at +24hr) and will provide blood and urine samples, which will be collected at biologically relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on separate days, with a wash-out period of at least 1 week between assessments.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* ≥ 18 years old
* Successful biochemical, haematological and urinalysis assessment at screening

Exclusion Criteria:

* Current smokers, or ex-smokers ceasing \< 3 months ago
* Pregnant women, or those currently breast feeding
* Subjects with existing or significant past medical history of medical conditions likely to affect the study measures i.e. diabetes, hepatic, renal, digestive or cancer (excluding Basal-cell carcinoma) - to be judged by the study clinical advisor.
* Those unprepared to adhere to dietary restrictions for 3d preceding and during each assessment day.
* Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material.
* Those on therapeutic diets or having experienced substantial weight loss (to be judged by clinical advisor) within 3 month of screening
* Taking dietary supplements containing flavonoids, isothiocyanates or carotenes (including multivitamins) (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
* Prescribed medications likely to affect ADME (absorption, distribution, metabolism, and excretion); medications to be assessed for suitability by the clinical advisor.
* Clinical advisor judged: abnormal biochemical, haematological or urinary results or measurements considered to be counter indicative for the study: including kidney and liver function, fasting glucose (especially if indicative of diabetes), lipid abnormalities, full blood count.
A Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder arthroplasty
* Osteoarthritis
* Consent

Exclusion Criteria:

* Previous surgery in the same shoulder
Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery.

The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery.

The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery.

Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Parenteral opioids are generally preferred in the management of acute postoperative pain. However opioids have undesired adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events). Regional anesthesia techniques may be preferred as the use of ultrasound (US) increases in daily anesthesia practice.

The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The erector spina plane block can be performed by administering local anesthetic solution between the transverse process and the erector spina muscle.

The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* 2 or 3 levels of posterior lumbar spinal fusion surgery under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis
* receiving anticoagulant treatment
* known local anesthetics and opioid allergy
* infection of the skin at the site of the needle puncture
* pregnancy or lactation
* patients who do not accept the procedure
Long-Acting Growth Hormone in Children Compared to Daily rhGH

The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

This study is designed as a pivotal study to compare the safety and efficacy of a selected dose regimen of somavaratan to daily rhGH. The study is a randomized, multi-center, open label study of 12 months duration. The primary endpoint is height velocity at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Chronological Age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys).
* Pre-pubertal status: Absent breast development in girls, testicular volume \< 4.0 mL in boys.
* Diagnosis of growth hormone deficiency (GHD) as documented by two or more growth hormone (GH) stimulation test results ≤ 10.0 ng/mL.
* Height standard deviation score (SDS) ≤ -2.0 at screening.
* Weight for Stature ≥ 10th percentile.
* Insulin-like growth factor-I (IGF-I) SDS ≤ -1.0 at screening.
* Delayed bone age (≥ 6 months).

Exclusion Criteria:

* Prior treatment with any growth promoting agent
* History of, or concurrent significant disease (for example, diabetes, cystic fibrosis, renal insufficiency).
* Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome.
* A diagnosis of Attention Deficit Hyperactivity Disorder.
* Daily use of anti-inflammatory doses of glucocorticoid.
* Prior history of leukemia, lymphoma, sarcoma or cancer.
* Treatment with an investigational drug in the 30 days prior to screening.
* Known allergy to constituents of the study drug formulation.
* Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening.
* Significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants.
* Significant abnormality in screening laboratory studies
The Effect of Hand Massage on Pain, Anxiety, and Comfort Levels of Intensive Care Patients

This study titled "Evaluation of the Effect of Hand Massage on Patients' Pain, Anxiety and Comfort Levels" aims to determine the effect of hand massage on patients in intensive care units. Our study is single-center and will continue until May 30, 2023. The study is designed to create an experimental and control group. Your patient is in the control group of the study. During the application period of the study, patients in the control group will be provided with routine nursing care and no additional nursing intervention will be applied. Patients in the intervention group of the study will be applied a total of 12 sessions of hand massage, 6 sessions per week (15 minutes each session).

The study sample consisted of patients who were receiving treatment at the Neurology Intensive Care Unit of Sakarya University Training and Research Hospital between April and May 2023, who met the inclusion criteria and agreed to participate in the study. The patients were divided into an intervention group (n=32) that received 15-minute hand massage and a control group (n=32) that received routine nursing care. The Sociodemographic Data Form, Visual Pain Scale (VAS), General Comfort Scale-Short Form and Spielberger State-Trait Anxiety Inventory (STAI) were used to collect data. Inclusion Criteria

* Being 18 years of age or older
* Agreeing to participate in the study and having written permission
* Not having any cognitive, sensory or mental disorders
* Being able to speak and communicate in Turkish
* Being fully oriented to place, time and person
* Individuals to be included should not have conditions such as masses, loss of sensation, fractures or ingrown toenails in their hands

Exclusion Criteria

* Patients who do not agree to participate in the study
* Patients who want to leave the study during the research process will not be included.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years and over who agreed to participate in the study
* whose written consent was obtained
* who had no communication problems (hearing, vision, speech, and perception) were included in the study.

Exclusion Criteria:

* Patients who did not agree to participate in the study, who had conditions such as mass in the hand area, sensory loss, previous surgical operation, allergy or skin disease, fracture, and ingrown nail, and who could not complete 12 sessions were excluded.
Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation

Patients with NAFLD indicated for ursodeoxycholic acid treatment ("by SPC: cholestatic hepatitis") will be offered an observational study. Examinations will be performed before the treatment and after 6month period. Laboratory parameters, non-invasive indices, liver elastography, cardiovascular parameters and liver MR spectroscopy will be performed.

Patients with NAFLD newly indicated for ursodeoxycholic acid treatment will be offered an observational study. Clinical examinations, blood sampling, ultrasound examinations of the liver and liver elastography will be performed. Non-invasive indices evaluating liver fibrosis and steatosis based on common anthropometric and laboratory parameters (FLI, NAFLD fibrosis score, BARD score, APRI, FIB-4) will also be evaluated. The examinations will be repeated after 6 months of treatment (all as part of regular routine check-ups performed in patients with NAFLD). Before and after the follow-up, patients will be offered examinations as part of cardiovascular disease (ultrasound examination of the carotid artery and endothelial dysfunction) and examinations for quantification of hepatic steatosis by MR spectroscopy.

Statistical processing: individual parameters will be evaluated before the start of monitoring and after 6-month monitoring. A difference of p≤0.05 will be considered a statistically significant change.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with NAFLD with ALT elevation and cholestatic features who are indicated for standard treatment with ursodeoxycholic acid according to SPC ("Hepatitis of various etiologies with cholestatic syndrome").

Exclusion Criteria:

* Previous treatment with ursodeoxycholic acid.
* Diagnosis of cirrhosis at the start of the study.
* Etiology of liver disease other than NAFLD.
* Presence of malignant disease.
* Cardiovascular comorbidity: CHD / CHD on pharmacological therapy, history of myocardial infarction, stroke and coronary / carotid intervention.
* Pregnancy.
Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation

The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

Ivacaftor is the first CFTR modulator to show an improvement in CFTR function and clinical benefit in subjects with CF. Results from Phase 3 studies (VX08-770-102 \[Study 102\] \[NCT00909532\] and VX08-770-103 \[Study 103\] \[NCT00909727\]) showed that ivacaftor is effective in the treatment of subjects with CF who have the G551D-CFTR mutation, as evidenced by sustained improvements in CFTR channel function (measured by reduction in sweat chloride concentration) and corresponding substantial, durable improvements in lung function, pulmonary exacerbations, respiratory symptoms, and weight gain. Ivacaftor was also well tolerated, as evidenced by the rates and reasons for premature discontinuation and results of safety assessments.

Ivacaftor (Trade Name Kalydeco; 150 mg tablets) was initially approved in the United States for the treatment of CF in subjects 6 years of age and older who have a G551D mutation in the CFTR gene.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF
* At least 1 allele of the following CFTR gating mutations: G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D
* Percent predicted forced expiratory volume in 1 second (FEV1) greater than or equal to (\>=) 40 percent (%) predicted normal for age, sex, and height
* 6 years of age or older
* Minimum weight of 15 kilogram (kg) at screening
* Females of childbearing potential must not be pregnant
* Willing to comply with contraception requirements

Exclusion Criteria:

* G551D-CFTR mutation on at least 1 allele
* History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the subject
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before the first dose of study drug
* History of solid organ or hematological transplantation
* History of alcohol, medication or illicit drug abuse within 1 year before the first dose of study drug
* Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days before screening
* Use of inhaled hypertonic saline treatment
* Use of any inhibitors or inducers of cytochrome (CYP) P450 3A
* Evidence of cataract or lens opacity at screening