cyrilzakka/clinical-trials huggingface dataset:
Predictive Value of Drug Elimination Gene Polymorphisms on Clearance and Dose Adjustment of Sunitinib in Cancer Patients

Sunitinib is an anticancer drug, but like most drugs, the effect varies from person to person. This is partly due to a variation in how well each person eradicates the drug from the body. This can lead to toxicity if the drug is eliminated slowly. Just as important is inadvertent underdosing in people who eliminate the drug quickly which may lead to a reduced anti-cancer effect. The investigators group has developed a battery of tests that may measure how an individual clears a drug from their body. The investigators intend to apply these tests to a group of patients taking sunitinib to see whether any test will help predict the level of sunitinib in the body and also the side effects. If a test seems to be promising from this study it may be possible to do a simple test on patients before they receive sunitinib so the best dose is chosen. The tests involve identifying the genes that are involved with drug elimination (CYP3A, ABCB1, ABCG2, OCT1, OATP) as well as directly measuring elimination using marker drugs (midazolam clearance and sestamibi liver clearance).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* A malignancy treated with single agent sunitinib
* ECOG 0, 1 or 2 at time of study accruement
* Any stable dose of therapy with sunitinib (defined as no dose change within 3 weeks prior to blood collection for pharmacokinetics)
* Adequate liver and renal function defined as serum bilirubin concentration less than 2 x ULN, AST and ALT less than 2.5 x ULN, serum creatinine concentration less than 2 x ULN
* No known primary liver disease and no other severe or uncontrolled concurrent medical condition within the first 3 months of treatment with sunitinib.
* Patients who have participated on other clinical studies of sunitinib will be suitable for this study.
* Signed informed consent
* Patients must not have Class ¾ cardiac problems as defined by the New York Heart Association criteria or any other severe or uncontrolled concurrent medical disease.
* Patients must not be pregnant or nursing and must be using an effective contraception method

Exclusion Criteria:

* Patients who are unable to sign informed consent
* Patients unable to give blood
* Patients with known midazolam allergies will not be included
* Patients must not be pregnant or nursing and must be using an effective contraception method
* Patients who had a bone-marrow-transplantation prior to sunitinib treatment
* Patients must not be taking routine systemic corticoid therapy
* Patients must not be taking therapeutic warfarin or warfarin derivates doses as anticoagulation at the time of study tests with an at least 2 weeks warfarin free period of time prior. Patients requiring anticoagulation may use low-molecular weight heparin
The Effect of Father-Sensitive Childbirth Education on Prenatal Paternal Attachment Level

This study was planned as a randomised controlled trial to examine the effects of a "Father-Sensitive Childbirth Preparation Class" on the level of prenatal attachment. The main question it aims to answer is:

1- How does a father-sensitive birth preparation class affect fathers' prenatal attachment levels?

It was conducted between February 1, 2024, and October 1, 2024, with expectant fathers living in Mersin province, whose spouses were experiencing their first pregnancy, who were between 20-32 weeks' gestation, and who were going to become fathers for the first time.

A total of 99 expectant fathers were included in the study - 50 in the intervention group and 49 in the control group. The intervention group was given a "Father-Sensitive Childbirth Preparation Training" consisting of four sessions, while the control group received a standard "Childbirth Preparation Training", also consisting of four sessions.

The "Descriptive Data Collection Tool" and the "Prenatal Father Attachment Scale" were used to collect the research data.


Eligibility Criteria:
Inclusion Criteria:

Participants were:

* Over 19 years of age,
* At least literate,
* Whose spouse was between 20 and 32 weeks pregnant,
* Whose spouse was primigravida,
* Whose spouse had a singleton pregnancy,
* With no prior experience of pregnancy, childbirth, or parenting,
* With no history of miscarriage, curettage, or perinatal loss,
* Whose spouse had no pregnancy-related complications or risk factors,
* Who had not previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.

Exclusion Criteria:

Participants were excluded if they:

* Had a spouse whose pregnancy was outside the 20-32 week gestation range,
* Had a spouse with a multiple pregnancy,
* Had any pregnancy-related complications or risk factors (high risk),
* Had prior experience of pregnancy, birth, or parenting,
* Had experienced miscarriage, curettage, or perinatal loss,
* Had previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.
Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Current use of an artificial tear product at least twice daily for at least 3 months, on average
* Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Exclusion Criteria:

* Anticipated contact lens wear during study or contact lens use within 6 months
* Active ocular infection or allergy
* Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
* Use of any topical cyclosporine products within 3 months
Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

Aortic valve stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, pathophysiology of AS remains poorly understood and preliminary data suggest that genetic factors may be involved. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with AS and 1500 controls with no evidence of valve disease). For all patients and controls, blood samples including DNA and echocardiography will be performed.

Eligibility Criteria:
Patients:

Inclusion criteria :

* Age \>=18 years
* Pure isolated degenerative aortic valve stenosis

Exclusion criteria :

* Rheumatic, congenital or post-radiation aortic stenosis
* Severe renal insufficiency (clearance \< 30 ml/min)
* Aortic insufficiency \> or = grade 2/4
* Other valve disease \> or = grade 2/4

Controls

Inclusion criteria :

- Age \>=18 years

Exclusion criteria :

* Known first degree relative with aortic valve stenosis
* Severe renal insufficiency (clearance \< 30 ml/min)
* Any valve disease \> or = grade 2/4
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa

The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung disease.

This study was terminated prematurely. The reason for trial termination was challenge with enrollment and patient recruitment. A significant decrease in the eligible patient population had been identified as main driver.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* Patients with elevated LCI of ≥ 7.5 at screening
* Patients with FEV1 of ≥ 50% predicted at screening
* Use of inhaled Tobramycin in a 28 days on / off regimen in the past 3 months before screening
* chronic lung Infection with Pseudomonas aeruginosa

Exclusion Criteria:

* Patients who are regularly receiving more than one class of inhaled anti-pseudomonal antibiotic
* Patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days prior to on-phase of study drug
* Pregnant or nursing (lactating) women
* Change in dose, formulation or strength of the study drug in the past treatment cycle before screening
* History of hearing loss or chronic tinnitus
* Infection with Burkholderia cenocepacia complex

Other protocol-defined inclusion/exclusion criteria may apply
ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip

In the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. Therefor we want to assess which technique is the most successful in the placing of a PICC.

This is a randomised prospective single blinded study. All adult patients with an indication for PICC placement can be included. Patients will be randomised into two groups, one with ECG-guided placement followed by ultrasound control and the other with only ultrasound guided placement. After placement, in both groups, control radiography of the chest will be done which will be interpreted by an independent radiologist. For the ECG-guided group the ultrasound control of the tip position will be done by an independent, blind operator, after placement. For the only ultrasound guided placement group, the ultrasound will be done by a second operator during placement.

Eligibility Criteria:
Inclusion Criteria:

* All adults with indication for PICC

Exclusion Criteria:

* Age \<18y
* Pregnant women
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants \< 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 1000 gm. birth weight
* Less than or equal to 30 weeks gestational age
* Day 7-14 of life
* Intubated and mechanically ventilated at any time days 7-14 of life

Exclusion Criteria:

* Serious congenital malformations
* Life expectancy less than 7 days from enrollment
* Previous treatment with iNO
* Active pulmonary hemorrhage at time of enrollment
* Active air leak syndrome at time of enrollment
* Bilateral grade IV intracranial hemorrhage prior to enrollment
* Less than 48 hours from last clinical dose of early surfactant.
Dehydration, Rehydration, and Blood Viscosity

The purpose of this study is to examine and compare the rehydration effect of Essentia Water, an electrolyzed high-pH bottled water, with industry-standard bottled water purified by reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3) bioelectrical impedance analysis, and (4) body mass change, using serial measurements in apparently healthy adults following exercise-induced dehydration in a controlled environment.


Eligibility Criteria:
Inclusion Criteria:

* Free from any medication for at least 1 week prior to the study

Exclusion Criteria:

* Any chronic condition requiring regular treatment or medical follow-up
* Bleeding disorder or susceptible to prolonged or uncontrolled bleeding
* Active infection
* Current smoker
* Subject has a BMI equal or greater than 30
* Use of oral contraceptives in the previous 3 months
* Subject is pregnant or breast-feeding
* Currently menstruating
Treatment of Patients With Idiopathic Membranous Nephropathy

Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.

Inclusion Criteria:

* patients with idiopathic membranous nephropathy
* nephrotic syndrome
* normal renal function (serum creatinine \[Screat\] \< 1.5 mg/dl)
* elevated urinary beta2-microglobulin and IgG

Immunosuppressive therapy consisting of:

* cyclophosphamide 1.5 mg/kg/day for 12 months
* prednisone orally, 0.5 mg/kg on alternate days for 6 months
* i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122

Study Groups:

* early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk
* late: start of therapy after deterioration of renal function (increase of Screat \> 25% and Screat \> 1.5 mg/dl)

Main Outcome Parameters:

* serum creatinine
* remission of proteinuria
* period of nephrotic proteinuria
* major side effects: hospitalisations, infections

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic membranous nephropathy
* Serum creatinine \< 1.5 mg/dl
* Nephrotic syndrome

Exclusion Criteria:

* Infection
* Instable angina
* Systemic disease
* Pregnancy
* Renal vein thrombosis
* Prior therapy with immunosuppressant agents
* Liver dysfunction
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Proellex Pharmacokinetics Bridging Study

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Eligibility Criteria:
Inclusion Criteria:

* Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
* Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion Criteria:

* Post-menopausal women,
* Subject with documented endometriosis
* Subject with known uterine fibroids or vaginal polyps
Study of Cytokines in Children With Opsoclonus-Myoclonus Syndrome

The purpose of this study is to determine if cytokines, inflammatory mediators, are increased in spinal fluid and blood, correlate with disease activity, and could serve as biomarkers or therapeutic targets in children with opsoclonus-myoclonus syndrome (OMS), an autoimmune complication of the tumor neuroblastoma.

In this translational research, immunological mechanisms that underlie the assault of the immune system on the brain in paraneoplastic opsoclonus-myoclonus syndrome (OMS) are under evaluation. To test our principal hypothesis that there is an imbalance of pro-inflammatory (Th1) and anti-inflammatory (Th2) cytokines in OMS, a comprehensive cytokine panel will be measured by enzyme-linked immunosorbent assay (ELISA) and multiplexed fluorescent bead-based immunoassay detection (LUMINEX 100 Lab MAP system)in blood and cerebrospinal fluid (CSF) of 400 children. To test the second hypothesis that cytokines could serve as biomarkers of disease activity in OMS, cytokine concentrations will be correlated with clinical variables, such as disease severity, OMS duration, prior relapses, and remissions, as well as immunological variables, such as lymphocyte subset analysis. The cytokine 'biomarker profile' could aid decision making for early intervention by identifying children at high risk for relapse and poor outcome and allow targeting of the most implicated inflammatory cytokines by cytokine therapies. To test our third hypothesis that lack of response to immunotherapy is due in part to failure to increase the expression of anti-inflammatory Th2 cytokines, we will make paired pre/post comparisons of the impact of immunotherapies given in the course of clinical care \[steroids, adrenocorticotropin (ACTH), intravenous immunoglobulins (IVIg), rituximab, chemotherapy, other drugs, combinations\] on the cytokine and clinical profile. This research could lead to the application of commercially-available cytokines and cytokine blockers or to the development of new ones for OMS.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of OMS

Exclusion Criteria:

* Equivocal diagnosis
* Contraindications to lumbar puncture
* Treatment with agents outside the scope of the study
Effect of Maolactin on Gastrointestinal Tract (GIT) Health

This is a randomized, double-blind, placebo-controlled, 3 arm parallel group study of 12 weeks duration, with a 4-week run-in period as the control phase and an 8-week intervention period, to investigate the effectiveness of the treatment on upper GI disturbance.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and over
* Generally healthy
* BMI \<35kg/m2
* Able to provide informed consent
* Agree to not participate in another clinical trial while enrolled in this trial
* Females using a prescribed form of birth control (e.g. oral contraceptive)
* Experiencing moderate GI disturbances of the upper GI tract - 1 or multiple symptoms (reflux, heartburn, regurgitation, nausea, bloating, abdominal pain) at least once a week for at least 3 months.
* Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2-month period of self-reported dietary stability.
* Agree to not change current diet and/or exercise frequency or intensity during entire study period
* Agree to not use any dietary supplements for gut health or digestive enzymes during the study period

Exclusion Criteria:

* Unstable(1) or serious illness (e.g. serious mood disorders such as depression or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)
* People with a past or current history of GIT conditions e.g. inflammatory bowel disease, celiac disease or cystic fibrosis as well as gastrointestinal tract surgery
* Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking any proton pump inhibitors \[e.g., pantoprazole (Somac), rabeprazole (Pariet), omeprazole (Losec) or any anticoagulation or antiplatelet medications \[e.g. Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin, dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), betrixaban (Bevyxxa), clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), cilostazol (Pletal) and dipyridamole (Attia, Ofcram, Persantin, Persantin Retard, Trolactin)\] including low dose aspirin (acetylsalicylic acid)
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Allergic to any of the ingredients in active or placebo formula
* Pregnant or lactating woman or women trying to conceive
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion (including hypercholesterolemia)
* Currently participating in any other clinical trial

Footnote

(1)An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain

The purpose of this study is to assess the benefit of adding stretching exercises to cervical mobilization and cervical range of motion exercises on cervical range of motion, pain, pain threshold, level of disability and patient satisfaction for patient with non-specific mechanical neck pain

All recruited participants will sign a statement of informed consent. Subjects were randomly divided into two groups (combined intervention group and standard intervention group). The following questionnaires were completed in the following order: Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), and Global Rating of Change Scale (GROC). Next, Cervical Range of Motion (ROM) and Pain threshold were measured for both groups. The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise). The standard intervention group received cervical mobilization and home program (ROM exercises).

Eligibility Criteria:
Inclusion Criteria:

* The participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks

Exclusion Criteria:

* Participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years or older
2. Documented diagnosis of FCD
3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Exclusion Criteria:

1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)
IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

To evaluate the effect of concomitant late course accelerated hyperfractionation radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent; 2.Acquired pathological diagnosis; 3.Life expectancy≥6 months; 4.Age:18-75 years, male or female; 5.General state of health: ECOG 0-1 grade; 6.Without any chemotherapy or radiotherapy; 7.Subjects meet the following criteria for the clinical laboratory:HG≥100g/L, WBC≥3.5X109 /L, neutrophilic leukocyte≥1.5X109,PLT100X109 /L。CR≤1.5 x N，TB≤2.5XN，AST and ALT≤2.5xN，AKP≤2.5XN.

Exclusion Criteria:

* 1.Serious infection; 2.Uncontrollable diabetes; 3.Other serious diseases, such as myocardial infarction in 6 months; 4. Participated other clinical trials in 4 weeks or at present