cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Doxorubicin in Children With Cancer

Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .

* Paediatric patients up to the age of 17 years will be included. Number and time points of PK sampling will depend on age and tumour type.
* PK samples will be collected from two doxorubicin administrations. Analyzing samples from two doxorubicin administrations will allow distinguishing between interindividual, intraindividual and residual variability.
* Doxorubicin and its major metabolite doxorubicinol will be measured in plasma using HPLC
* In addition, the natriuretic peptide BNP and the precursors NT-pro ANP and NT-proBNP as well as troponin T will be measured in plasma up to 28 days after doxorubicin administration to evaluate their use as clinical markers for cardiotoxicity.
* A data set of max 5 samples (3 +2 (in the 1st + 2nd Doxorubicin sampling periods)) will be collected in the younger children (\< 3 years) and a data set of max. 8 samples ( 5 + 3) will be collected in the older children. Samples will be taken at predefined time points/ time intervals.
* An additional DNA sample will be taken and analyzed for genetic polymorphisms. The influence of genotype on pharmacokinetics and metabolism will be investigated by appropriate statistical methods, including population pharmacokinetic analyses. Genes to study would include MDR1 and SLC22A16, both involved in the transport of doxorubicin and AKR1A1 and CBR1, both involved in the reduction of doxorubicin to doxorubicinol. Selected genotypes will be incorporated as covariates into the population pharmacokinetic models developed. The potential impact of genetic variation will be evaluated in the context of other sources of variability such as age, weight, gender etc

Eligibility Criteria:
Inclusion Criteria:

* patients ≤ 17 years of age
* plan to receive at least two cycles of doxorubicin
* must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients \< 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
* Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
* Life expectancy of at least 3 month
* Karnofsky performance status of ≥ 70%
* Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator

Exclusion Criteria:

* prior cardiac problems
Beijing Percutaneous Coronary Intervention Registry

The registry study is to obtain the state of the art of the percutaneous coronary intervention state treatment for coronary heart disease in Beijing area of P.R.China in a real world. The data are collected from 48 hospitals in Beijing area using an uploading system through internet.


Eligibility Criteria:
Inclusion Criteria:

* Patients from selected 48 hospitals of Beijing, P.R.China
* Patients receiving coronal artery angiography or percutaneous coronary intervention therapy

Exclusion Criteria:

* none
Study of Endostar Subcutaneous Injection in NSCLC

This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Histological/cytological confirmed unresectable stage ⅢB～Ⅳ non-squamous NSCLC
* ECOG performance status 0-1
* Life expectancy≥3 months
* Adequate hematologic function: WBC≥3.0×109/L ,ANC≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L;
* Adequate hepatic and renal function: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, creatinine≤1×ULN, creatinine clearance≥50ml/min;
* Normal coagulation function (PT, APTT, TT, Fbg) ;
* Patients signed informed consent form;
* Willingness and capability to comply with protocol requirement and well communicate with investigators.

Exclusion Criteria:

* With uncontrolled ascites or pleural effusion;
* Patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study;
* History of ischemic or TIA within 6 months before enrollment;
* Uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy;
* Arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure NYHA class ≥ II；
* Serious active infections;
* History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
* Symptomatic brain or meningeal metastasis;
* Epileptic seizure need to be treated;
* HCV, HBV or HIV positive;
* History of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma);
* Known allergies to any excipient in the study drug;
* Any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study;
* Any conditions that may endanger patient safety or interfere with the patient's compliance;
* Pregnant and lactating women;
* The investigators consider the patients unsuitable for this trial
Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans

Acanthosis nigricans (AN) is a dermatosis with aesthetic implications and is characterized by the focal or diffuse development of a velvety, hyperpigmented cutaneous thickening in intertriginous areas. Trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.

Acanthosis nigricans is common, although exact prevalence depends upon the racial makeup of the population studied. Exact pathogenesis is unknown, elevated insulin concentrations result in direct and indirect activation of IGF-1 receptors on keratinocytes and fibroblasts, leading to proliferation. This hyperpigmentation, which has poorly defined borders, usually occurs in skin fold areas symmetrically, such as the back of the neck, axilla and groin, and may rarely involve oral mucosa. The lesions may be related to a wide range of benign conditions and may occur as a paraneoplastic manifestation of various potentially fatal malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will present with acanthosis nigricans as per operational definition will be included in the study.

  * Either gender.
  * Age 20-50 years.

Exclusion Criteria:

Pregnancy.

* Breastfeeding.
* Patients with history of skin resurfacing by dermabrasion, chemical peels and facial laser within the preceding 9 months.
* Patients with history of hypersensitivity.
* Malignant Acanthosis Nigricans.
* Drug Induced Acanthosis Nigricans.
Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients with Advanced Parkinson's Disease

This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia).

Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing.

In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.

Study design:

Non-interventional study, primary data collection.

No visits or measurements will be made mandatory by the observational plan. The assignment of patients to Lecigon® not decided in advance by the study's observational plan but falls within current practice. Prescription of Lecigon® occurred before and independently of the decision to include the patient in the study.

The participating centres will offer participation in the ELEGANCE study to all patients who receive treatment with Lecigon® part of routine clinical practice. From patients, who switched to treatment with Lecigon® prior to signing of informed consent, baseline data will be collected retrospectively.

The planned non-interventional study aims to collect real-world data on the effectiveness and safety of Lecigon® as a therapy for advanced Parkinson´s Disease in routine care in Germany and Austria. The study will be expanded to additional European countries as soon as marketing authorisation in these countries and commercial stock will be available.

Primary Objectives:

* Long-term effectiveness of Lecigon®
* Long-term safety of Lecigon®

Secondary Objectives:

* Patient non-motor symptoms and quality of life
* Healthcare resource utilisation by patients

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients (18 years old and over) with Advanced Parkinson Disease already under treatment with Lecigon® (for up to 3 months before giving informed consent) in accordance with the Summary of Product Characteristics (SmPC)
* Patients or legal representative must have signed informed consent to participate in the study
* Patients are not taking part in another clinical (interventional) study at the same time

Exclusion Criteria:

* Patients with contraindications as defined in the current version of the SmPC for Lecigon®
* Patients who will not be seen again for their follow up care at the investigator's site after commencement of Lecigon® therapy
* Patients with pump placement or pump use issues, e.g. patients with acute severe illness, patients unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse
Yoga in Treatment of Eating Disorders

Purpose: to examine effects of hatha yoga in treatment of eating disorders.

Methods:

Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not Otherwise Specified will be invited to participate in this study. Exclusion criteria will be age under 18, serious medical complications, psychosis or increased risk of suicide.

Design: randomized controlled single-blinded trial. Intervention: 2 x 90 min weekly group sessions for 12 weeks with hatha yoga. Main outcome measure: reduction in Eating Disorders Examination score. Secondary outcome measures: reduction in body dissatisfaction, depression and anxiety

For the last years, yoga has become a popular "body-mind" form of exercise in western countries (Daubenmier, 2005). Yoga has shown good effects on increasing muscle strength, flexibility and stability, in addition studies have found reduced stress level, improved mood and breathing (Astin et al., 2003; Gimbel, 1998b; Granath et al., 2006; Lavey et al., 2005; Manjunatha et al., 2005b; Netz \& Lidor, 2003a; Telles \& Naveen, 1997b; Yadav et al., 2005b). Previous research have shown a tendency for persons practicing yoga improving body awareness and body sensitivity, and reduction of body dissatisfaction (Daubenmier, 2005). In addition, two studies have examined yoga in treatment of binge eating disorder (Daubenmier, 2005; Gimbel, 1998a). Results showed reduction in number of binge eating episodes in the intervention group compared to the control group. No available studies have examined effect of yoga in treatment of the eating disorders types Anorexia Nervosa or Bulimia Nervosa.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or above
* DSM-IV Anorexia nervosa, Bulimia nervosa or Eating disorders not otherwise specified

Exclusion Criteria:

* serious medical complications
* psychosis
* suicidal behavior
A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).


Eligibility Criteria:
Inclusion Criteria:

* Mild-to-Moderate Alzheimer's disease
* MMSE score 10-24 inclusive

Exclusion Criteria:

* Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
* Complication of other causes of dementia
Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

Background: Smoking counselling during hospitalisation with post-discharge follow-up increases quitting. However, provision of cessation care for hospitalised patients is suboptimal. Students are potentially an untapped resource for providing cessation advice, but no studies have investigated this.

Aim: To determine if medical students can encourage motivation to stop smoking (MTSS; primary outcome) in hospitalised smokers .

Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital (www.hse.ie/eng/services/list/3/hospitals/Connolly/).

Participants: Inpatient smokers. Intervention and procedures: 60 graduate medical students will receive standardised motivational interviewing training in the provision of cessation advice. Each student will be randomly assigned to counsel \~1-3 smokers each, including an individual in-hospital, face-to-face session and post-discharge phone counselling. Training and implementation will cover Sept-2015-May-2016. Smokers will be randomised to 'usual care' (n\~90), or intervention (n\~90, student-delivered motivational interviewing). A researcher will enable recruitment and follow-up, and conduct a qualitative evaluation of programme participants.


Eligibility Criteria:
Inclusion Criteria:

* All identified inpatient smokers at Connolly Hospital.

Exclusion Criteria:

* Advised by ward manager that patient is too unwell or cognitively impaired, or otherwise unsuitable;
* Death during hospitalisation;
* Receiving palliative care;
* Under 18 years of age;
* To be transferred to another hospital;
* Not English speaking;
* Refusal to participate;
* Inpatient in psychiatric ward
Plyometric Training Versus Strengthening Exercise On Children With Hemiplegia

The aim of the study is to evaluate the effect of plyometric training versus strengthening exercise on quadriceps and hamstring muscles and quality of life and selective motor control of lower limb of children with hemiplegia.

The aim of the study is to evaluate the effect of plyometric training versus strengthening exercise on quadriceps and hamstring muscles and quality of life and selective motor control of lower limb of children with hemiplegia.

Hand-Held dynamometer is used to assess the muscle strength of quadriceps and hamstring Selective control assessment of lower extremity scale is used to assess selective motor control of lower limb.

Peds Ql scale is used to assess quality of life of the children. The methods of assessment are valid and reliable.

Eligibility Criteria:
Inclusion Criteria:

* Their age will be ranging from 8 to 10 years.
* They will be on level (1 : 1+) according to Modified Ashworth scale
* They will be on level I according to Gross Motor Functional Classification System
* They can understand and follow instructions.

Exclusion Criteria:

* Child undergoes orthopedic surgery past one year.
* Visual or auditory problems that interfere with rehabilitation programs.
* Botox injection past 6 months.
* Cardiac problems or uncontrolled seizures.
The Effect of Progressive Muscle Relaxation Exercises on Fatigue Severity and Sleep Quality in Emergency Department Nurses

Emergency departments are critical units where patients with life-threatening conditions and acute illnesses receive rapid interventions. Nurses working in these units aim to provide the best possible healthcare by intervening with patients at high risk of life-threatening situations. However, long working hours, inadequate working conditions, high stress, and critical patient care often lead to physiological issues among nurses. Fatigue and insomnia, which are commonly linked to burnout, are among the most frequent physiological problems.

Insomnia is a condition characterized by poor and irregular sleep patterns occurring within a 24-hour period due to disruption of the circadian rhythm. Chronic insomnia, if persistent, triggers fatigue. Fatigue is a subjective condition that, when prolonged, negatively affects nurses' daily activities and reduces job performance. Moreover, increasing fatigue has significant adverse effects on alertness, attention, judgment, and mood. These effects can lead to accidents, errors in practice, and injuries.

Progressive relaxation exercises reduce blood levels of epinephrine and norepinephrine, oxygen consumption, blood pressure, metabolic rate, heart rate, muscle tension, lactic acid levels, pain and fatigue. On the other hand, concentration increases endorphin release, reduces insomnia and provides mental well-being. When the literature was examined, progressive relaxation exercise practices were performed on patients with rheumatoid arthritis and it was determined that there were positive effects on insomnia and fatigue levels in patients at the end of a six-week period. In another study evaluating the effectiveness of progressive relaxation exercise in dialysis patients, it was found that the fatigue level of the patients decreased. Again, when the literature was examined, two studies evaluating the effectiveness of progressive relaxation exercise on intensive care nurses were found in our country. In these studies conducted with intensive care nurses, it was reported that progressive relaxation exercises had a positive effect on fatigue.

In line with our research, no study was found to examine the effect of progressive relaxation exercises applied to nurses working in the emergency department on fatigue severity and sleep quality.

Translated with www.DeepL.com/Translator (free version)

Eligibility Criteria:
Inclusion Criteria:

* Working in the emergency service unit,
* No psychiatric disorder,
* Can do progressive relaxation exercises,
* Apply progressive relaxation exercises for one month,
* No disease that prevents progressive relaxation exercise,

Exclusion Criteria:

* Nurses who do not meet the inclusion criteria will be excluded from the study.
Pharmacokinetic Study of Fluconazole in Premature Infants

The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.


Eligibility Criteria:
Inclusion Criteria:

* very low birth weight infant (birth weight \< 1,500 g) who were admitted to the NICU before day 3 of life
* Informed consent from the parents

Exclusion Criteria:

* Major congenital anomaly
* Expired within 72 hours of life
* Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)
* Proven congenital or intrauterine fungal infection
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures.
* The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
* Outpatient status at enrollment and randomization.

Exclusion Criteria:

* Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
* Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
* Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)

This clinical trial aims to assess the effect of nutrition and exercise on muscle and adiposity in adults with Philadelphia Chromosome (Ph) Negative B-ALL undergoing inpatient induction therapy.

Participants will take part in 2 different interventions:

* Nutrition Intervention
* Physical Exercise Intervention

All subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.


Eligibility Criteria:
Inclusion Criteria:

* New Diagnosis of Philadelphia Chromosome Negative B-ALL
* Receiving intensive pediatric-inspired induction chemotherapy

Exclusion Criteria:

* BMI ≤18.5 kg/m2 at time of diagnosis
* Unable to comply with both the recommended diet and exercise regimen as deemed by the research or treatment team
* Pregnant
Cognitive Anxiety Sensitivity Treatment for Suicide

The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder.

CAST is a newly developed computerized treatment targeting specific risk factors associated with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to one of two conditions. In both conditions, participants will complete various self-report questionnaires and a computerized presentation. Additionally, all participants will be asked to complete a one month follow-up appointment.

Eligibility Criteria:
Inclusion Criteria:

* At or above the community sample mean on the ASI
* English speakers
* 18 years of age or older

Exclusion Criteria:

* Significant medical illness
* Current substance dependence
* Current or past psychotic-spectrum disorders
* Uncontrolled bipolar disorder
* Serious suicidal intent that warranted immediate medical treatment