cyrilzakka/clinical-trials huggingface dataset:
The Effect of Art Therapy on Pain, Emesis, Anxiety and Quality of Life, Breast Cancer

The research sample consisted of 60 individuals, including the intervention group (n=30) and the control group (n=30), who received treatment at the Oncology Center of Sivas Cumhuriyet University Practice and Research Hospital. Personal Information Form, Pain Intensity Measurement-Visual Analog Scale, Rhodes nausea, vomiting and retching index, Beck Anxiety Inventory, FACT-G Quality of Life Scale were applied to the research data. Toxicity Rating Scale total score was recorded from the patient file. Within the scope of the research, a chemotherapy session for 10 weeks (5 sessions) with an interval of two weeks was made by the art expert of the art of marbling, accompanied by a ney concert. No intervention was made in the control group. Within the scope of the research, scale forms will be applied to both groups in the first interview, in the 3rd and 5th chemotherapy sessions of the patients. The data obtained from the study were uploaded to the SPSS (22.0) program and statistical evaluation was made.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received at least one course of chemotherapy, who have undergone breast surgery, who have not been given art therapy, who have no communication difficulties and no mental problems, who are 18 years of age or older, and who agreed to participate in the study.

Exclusion Criteria:

* Those with cancer stage IV, visual, hearing and communication difficulties, those under the age of 18 and those who wanted to leave the study were not included in the study.
Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer

The purpose of this study is to evaluate the association between wearable biosensor data, performance status and patient-reported outcomes in cancer patients. Participants in this study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires that will assess patient reported outcome measures including physical function, emotional distress, pain interference, sleep disturbance and fatigue.

Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18 years of age and be English speaking due to the questionnaires that will be administered during the study. Patients must also be ambulatory (use of walking aids, such as cane and rollator, is acceptable) and have access to a smartphone with internet access (IOS or Android). It is also necessary for patients to have scheduled oncology clinic visits at least once every 2 weeks.

This study aims to measure association between biosensor data, performance status and patient-reported outcomes. This study will also evaluate the feasibility of using Fitbit activity monitors in a cancer population to capture objective activity data. The study will be recruiting patients with advanced cancer diagnoses (stage 3 or 4) and will be referred by the treating oncologist. This is an exploratory study that will follow patients with stage 3-4 cancer for a period of 15 days. Subjects will be provided with a Fitbt Charge HR® activity monitor. They will be requested to wear the Fitbit Charge HR® at all times, except for while bathing or performing other activities where the activity monitor can become submerged in water. Subjects will be asked to wear the Fitbit Charge HR® for two weeks. They will be seen in the clinic at baseline, at the end of week 1 (day 8) and at end of 2 weeks (day 15) for physical exam, evaluation of performance status by both treating oncologist and practice nurse using standardized scales and administration of PROMIS® questionnaires. Patients will be followed up to 6 months after the last clinic visit for adverse events, hospitalization and survival. Thirty subjects will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced solid malignancy (Stage 3 or 4) with measurable disease, who are being followed by an oncologist
* 18 years or older
* English speaking
* Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
* Access to IOS or Android smartphone with internet access
* Expected to have oncology clinic visits at least once every 2 weeks
* Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
* Ability to consent

Exclusion Criteria:

* Allergy to surgical steel or elastomer/rubber
* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment
Safety and Local Tolerability of Prevenar in Indian Children

This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.

Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.

Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.

This is an observational study and the protocol for the study has been approved by the Board of Health.


Eligibility Criteria:
INCLUSION CRITERIA

Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:

For Primary Immunization Schedule:

* Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
* For Catch-up Immunization Schedule:
* Healthy male or female subjects 12-23 months of age

EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.

* A known or suspected history of Streptococcus pneumoniae disease.
* A previous anaphylactic or other severe vaccine-associated adverse event.
* A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents.
* A major congenital, developmental or serious chronic disorder.
* A confirmed or suspected underlying evolving neurological disorder or history of seizures.
* A history of thrombocytopenia or any coagulation disorder.
* Any acute illness at the time of vaccine administration
An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury

This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old
2. Initial ESTOP AKI score ≥0.01 within the last 8 hours.

Exclusion Criteria:

1. Voluntary refusal or missing written consent of the patient / legal representative.
2. Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
3. Patients without a measured serum creatinine value during their inpatient stay.
4. Patients with a creatinine \>4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
5. Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
6. Patients with prior renal consultation during their admission.
The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.

The goal of this randomised study is to learn about, the effect of hypnotherapeutic sound-files on the sleep of parents of infants in the neonatal unit. The main questions it aims to answer are:

* Can hypnotherapeutic sound-files make parents of infants in the neonatal unit sleep longer and better?
* Does hypnotherapeutic sound-files effect the state anxiety score of parents of infants in the neonatal unit?

Participants will have access to sound-files and:

* wear actigraphy sleep registration
* complete state-trait anxiety score


Eligibility Criteria:
Inclusion Criteria:

* Parents of a newborn in the neonatal unit at Randers Regional Hospital

Exclusion Criteria:

* Age under 18
* Hearing disability to an extend where sound-files cannot be used
* Psychotic diagnosis, including schizophrenia and personality disorder
* Already using hypnotherapeutic sound-files
* The use of sleep medication.
Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)

The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.

Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.

Eligibility Criteria:
Inclusion Criteria:

* Apnea and hypopnea index of more than 20 /hr, and treated with CPAP
* Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg

Exclusion Criteria:

* Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months
* Uncontrolled arrhythmia
* Severe hepatic or renal disorders
* Having poor prognosis disorders such as malignant disorders
Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor
* Proteinuria \>=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening
* Body weight ≥ 40 kg at Screening

Exclusion Criteria:

* Kidney transplant
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 during Screening
* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
* Treatment with complement inhibitors at any time.
* Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1.
* Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients

To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 21, who will get catarct surgeyr
* Patients whose visual acuity anticipated better than 20/25 after surgery
* Patients with informed consent
* Patients with meibomian gland dysfunction

Exclusion Criteria:

* ocular injury, active injection
* uncontrolled systemic disease
* Contact lens wear within 1 month
* Allergic to fluorescein sodium or topical anesthetics
* ocular surgery or trauma within 6 months
* disorder of lid anatomy
* other reason for decreased vision other than cataract
* anticipated visual acuity less than 20/25
* Patients less than 20 years.
A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)

A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Chinese Paediatric and Adult Subjects with Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN).

Paediatric and adult patients with Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN) will be evaluated in the screening visit to confirm eligibility. Approximately 16 paediatric and 16 adult qualified patients will receive oral selumetinib 25 mg/m\^2 twice a day (approximately every 12 hours) continuously until disease progression or unacceptable drug-related toxicity, whichever occurs first. Once a patient has discontinued the study treatment then the patient will be followed for specified period for safety assessment

Eligibility Criteria:
Inclusion Criteria:

* Paediatric cohort: Chinese subjects ≥3 years and \<18 years of age
* Adult cohort: Chinese subjects ≥18 years of age at the time of study enrollment
* Subjects must be diagnosed with (i) NF1 as per NIH Consensus Development Conference Statement and（ii) PN is defined as a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches. (iii) inoperable PN
* Subjects must have at least one measurable typical or nodular PN
* Absolute neutrophil count ≥1.5×10\^9/L, haemoglobin ≥9g/dL, and platelet count ≥100×10\^9/L. Subject must be without growth factor support and platelet transfusion support 7 days before the screening assessment.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2×upper limit of normal (ULN), total bilirubin ≤1.5×ULN except in the case of subjects with documented Gilbert's disease (≤2.5×ULN).

Exclusion Criteria:

* Evidence of malignant peripheral nerve sheath tumour.
* Clinically significant cardiovascular disease
* Prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject had been disease free for ≥2 years or which would not have limited survival to \<2 years) or other cancer requiring treatment with chemotherapy or radiation therapy.
* Subjects with the following ophthalmological findings/conditions:

Current or past history of retinal pigment epithelial detachment/central serous retinopathy or retinal vein occlusion; Intraocular pressure \>21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of IOP); Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study physician; Any other significant abnormality on ophthalmic examination that would make the subject unsuitable for enrolment into the study, as assessed by the investigator.
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

The purpose of this study is to evaluate the safety, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. Measurable disease by CT scan PATIENTS CHARACTERISTICS

1. ECOG performance status 0-2
2. Life expectancy \> 3 months
3. Laboratory values as follows 2,000/mm3 \< WBC \< 15000/mm3 Platelet count ≥ 750,000/mm³ Total Bilirubin ≤ 1.5 x Aspartate transaminase \< 150 IU/L Alanine transaminase \< 150 IU/L Creatinine ≤ 3.0 mg/dl
4. HLA-A\*2402
5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breast-feeder
3. Active or uncontrolled infection
4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
5. Serious or aggravated wound
6. Active or uncontrolled other malignancy
7. Steroids or immunosuppressing agent dependant status
8. Interstitial pneumonia
9. Ileus
10. Decision of unsuitableness by principal investigator or physician-in-charge
Pharmacological Postconditioning During the Aortic Valvular Surgery

Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or females, scheduled for an aortic valvular surgery;
* 18 years of age or older.

Exclusion Criteria:

* Combined valvular and coronary surgery;
* Significant coronary artery stenosis (upper than 70%);
* Left ventricular dysfunction (ejection fraction \< 40%);
* Emergency surgery and/or infectious endocarditis;
* Known cyclosporin hypersensitivity;
* History of known recent immunosuppression (\< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis;
* Renal insufficiency (creatininaemia \> 150 µmol/l);
* Hepatic insufficiency (prothrombin time \< 50%);
* Uncontrolled arterial hypertension defined by a systolic arterial pressure \> 180 mm Hg;
* Women of child bearing potential, who are pregnant or not under efficient contraception;
* Patients treated with nicorandil, sulfonylurea or rosuvastatine;
* Patients under judicial control.
Gentamicin in Cardiac Surgery

Surgical site infection (SSI) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's health and survival. This study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI with monitoring to the effective therapeutic level.

Gentamicin is an aminoglycoside antibiotic that exhibits a wide range of antibacterial effects, mostly targeting Gram-negative bacteria, while its effectiveness against Gram-positive organisms is comparatively weaker. Gentamicin has significant efficacy against multidrug-resistant bacteria as well. Gentamicin is often used in conjunction with beta-lactam antibiotics to provide enhanced therapeutic efficacy via a synergistic effect, particularly in cases of Gram-positive and multidrug-resistant bacterial infections.

This study aims to evaluate the efficacy of administering gentamicin in combination with flucloxacillin as a pre-medication and for 48 hours after surgery in reducing the incidence of surgical site infections in patients undergoing cardiac surgeries, as compared to using a combination of ceftriaxone and flucloxacillin. Additionally, the study aimed to observes the therapeutic level of gentamicin required to achieve an effective concentration of the drug.

A prospective comparative study was conducted using an appropriate sample of 50 Iraqi patients undergone several types of cardiac surgeries.

A total of 50 patients (34 males and 16 females) between the ages of 18 and 75 were included in this study. These patients were admitted to the Surgical Department of the Iraqi Center for Heart Disease over a one-year period from January 2020 to January 2021. All patients underwent various types of cardiac surgery, such as coronary artery bypass graft (CABG), valve replacement, or device placement. The same surgical and anesthesia teams conducted the procedures.

A computerized randomization method was used to allocate patients into two groups in a randomized manner. Following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program Research Randomizer

Eligibility Criteria:
Inclusion Criteria:

* The research included individuals of both genders.
* Patients aged 18 and above.
* Patients had undergone any type of cardiac surgery.

Exclusion Criteria:

* Patients having a prior diagnosis of organ failure.
* Patients already on antibiotics.
* Patients with elevated baseline renal function test before operation.
* Patients with contraindications to any of the prescribed medications were excluded from this study.
Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris

Acne vulgaris is a chronic skin disease of the pilosebaceous unit characterized by formation of papules, pustules, comedones, nodules and cysts. It can have a major psychological burden on the patients. It develops due to blockage of the hair follicles. This is thought to occur as a result of the following four abnormal processes: a higher than normal amount of sebum production, excessive deposition of keratin leading to comedo formation, hair follicles' colonization by Propionibacterium acnes (P. acnes) and the local release of pro-inflammatory mediators. Androgens also play a role in pathogenesis either from elevated levels or exacerbated response

In 2015, acne was estimated to affect 633 million people globally, making it the 8th most common disease worldwide. Acne commonly occurs in adolescence and affects an estimated 80-90% of teenagers. Children and adults may also be affected before and after puberty Many treatment options for acne are available, including lifestyle changes; such as eating healthy, medications (topical and systemic) and medical procedure.Despite of the availability of many therapeutic modalities, none of them has proved to be ideal. Recently, Vitamin D was proved to be an exciting option for treating many chronic inflammatory dermatological diseases. It appears to have systemic antimicrobial and other effects that may be crucial in a variety of both acute and chronic illnesses. Vitamin D regulates the immune system, Furthermore, it has antioxidant and anti-comedogenic properties. So, Vitamin D deficiency maybe involved in the pathogenesis of Acne Vulgaris . Thus,Vitamin D use could potentially reduce inappropriate antibiotic prescription and boost therapeutic response, either as a monotherapy or in combination with other anti-acne medications. High glycemic food intake and excessive consumption of dairy products as well as of saturated fatty acids were all suggested to have an influence on AV course. In addition, obesity has been reported to be associated with acne. Interestingly, genetic studies found out that obesity can drive down vitamin D levels So, there seems to be a theoretical background about the association between Acne Vulgaris, Vitamin D and obesity

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Acne of any grade.
2. Patients between 18 and 45 years old.

Exclusion Criteria:

1. Patients below 18 and above 45years.
2. Patients with any concomitant Dermatologic or systemic illness
3. Patients on any topical or systemic medication within 4 weeks before enrollment.
4. Pregnancy.