cyrilzakka/clinical-trials huggingface dataset:
Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children

Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction of congenital heart defects, complicated by acute heart failure. Goal directed therapy will be implemented with the aid of transpulmonary thermodilution and based on predetermined algorithms.


Eligibility Criteria:
Inclusion Criteria:

* informed written consent signed by legal representative (parent or guardian)
* radical correction of congenital heart defect(s)
* use of cardiopulmonary bypass
* vasoactive-inotropic Score of 10 or greater during first 24 hours after surgery.

Exclusion Criteria:

* confirmed intranatal infection;
* gestational age \< 37 weeks;
* inotropic support prior to surgery;
* acute renal or hepatic failure prior to surgery;
* participation in conflicting randomised controlled studies.
Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients

The purpose of this phase III study is to assess the efficacy and safety of YW17 produced by CinnaGen Company compared to Aldurazyme® in mucopolysaccharidosis type I (MPS I) patients.

All patients receive Aldurazyme® for 12 weeks, followed by YW17 for another 12 weeks.

The primary outcome is the assessment of the maintenance of the mean uGAG levels at the end of each medication administration. The secondary outcomes are the assessment of 6-minute walking test (6MWT), predicted forced vital capacity (FVC), enzyme activity assay, and adverse events (AEs).

This is a phase III, single-sequence, cross-over study to assess the efficacy and safety of YW17 produced by CinnaGen Company in comparison with Aldurazyme® in MPS I patients.

All patients receive 0.58 mg/kg of Aldurazyme® for 12 weeks and then receive 0.58 mg/kg of YW17 for another 12 weeks.

Premedication with antipyretics and/or antihistamines is administered for all patients one hour before the infusion.

The primary outcome is to compare the mean uGAG levels at weeks 8, 10, and 12 (related to Aldurazyme®) with the mean uGAG levels at weeks 20, 22, and 24 (related to YW17).

The secondary outcomes, including 6MWT and FVC are assessed at the beginning and the end of each medication administration. Enzyme activity is assessed at the end of each medication administration. Safety assessments are performed during the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-18
* Diagnosed with MPS I
* Signing informed consent form

Exclusion Criteria:

* Prior bone marrow transplantation or being a candidate for receiving haematopoietic stem cell transplantation (HSCT)
* Prior tracheotomy
* Being naïve to laronidase
* Acute hydrocephalus
* Abnormal renal function determined by measuring serum creatinine and blood urea nitrogen (BUN) levels
* Any severe organic disease that is not associated with MPS I
* Known hypersensitivity to laronidase or components of the laronidase solution
* Presence of any medical condition or other circumstances that could significantly interfere with study compliance
* Pregnancy and lactation
* Administration of any investigational drug within 30 days before study enrollment
Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.

This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Capacity for consent
* Minimum age 18
* Presence of one of the following tumor diseases: Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain, Head and Neck Cancer, Pancreas Cancer, Sarcoma Cervix Uteri Cancer
* ECOG 0-2
* Indication for a radiotherapy or a radiochemotherapy with an intended treatment time of minimum 4 weeks (definitive/adjuvant/neoadjuvant)

Exclusion Criteria:

* Participation in any other interventional study
* Radiotherapy of Breast cancer
* Pregnancy
* Contraindication against physical activity/sport and others
* Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA \> I°)
* preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
* ECOG Status 3-4
* prior use of activity trackers
Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkin's Lymphomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.

OBJECTIVES:

* Assess the feasibility and toxicity of oral combination chemotherapy with granulocyte colony-stimulating factor in elderly patients with intermediate and high grade non-Hodgkin's lymphoma.
* Determine the objective response rate, response duration, and survival in this patient population.

OUTLINE: All patients receive one cycle of oral chemotherapy, 6 weeks in duration. Etoposide is given on days 1-3 and cyclophosphamide and procarbazine are given on days 22-31 of each cycle. Lomustine is given on day 1 of cycles 1 and 3 only. Filgrastim (granulocyte colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each cycle.

Patients who have disease progression after one cycle of therapy or at any time thereafter are taken off the study. Patients with a complete response after 1 cycle of therapy receive 2 additional cycles of chemotherapy and are observed off treatment. Patients with a partial response (PR) also receive 2 additional cycles of chemotherapy. Following the third cycle of chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive radiation therapy. All other patients with a PR are treated at investigator's discretion.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy proven stage I through IV intermediate to high grade non-Hodgkin's lymphoma of B-cell, T-cell, or indeterminate immunologic phenotype
* Measurable or evaluable
* No cytologic or radiographic evidence of CNS lymphoma

PATIENT CHARACTERISTICS:

Age:

* 60 and over

Performance status:

* ECOG 0-3

Life expectancy:

* At least 6 weeks

Hematopoietic:

* WBC at least 1500/mm3
* Platelet count at least 50,000/mm3

Hepatic:

* Bilirubin no greater than 3.0 mg/dL

Renal:

* Creatinine no greater than 3.0 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy allowed for localized stage I or II disease that has progressed beyond initial radiotherapy ports

Surgery:

* Not specified
Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)

This study will estimate the radiochemical and radiation safety and assess the efficacy of \[18F\]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses will test whether \[18F\]MK-3328 is sufficiently safe and well-tolerated, based on an assessment of clinical and laboratory evaluations and adverse experiences in healthy participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD) participants, to permit continued investigation. The study efficacy hypothesis will test whether \[18F\]MK-3328 can discriminate between AD participants and cognitively normal elderly control participants based on tracer volume of distribution, or one of its surrogates, in brain posterior cingulate gyrus.


Eligibility Criteria:
Inclusion Criteria:

Part I:

* Participant is male or female of non-reproductive potential between 50 and 65 years old.
* Participant is less than 6'5" tall
* Participant is in good health
* Participant has been a non-smoker for at least 10 years

Parts II and III:

* Male or female of non-reproductive potential at least 55 years of age
* Participant is cognitively normal (HE participants), or has probable mild-to moderate AD (AD participants)
* Participant is willing to have an arterial catheter placed in the radial artery (Part II only)

Exclusion Criteria:

Part I:

* Participant has a history of stroke, seizures, or neurological disorder
* Participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable

Parts II and III:

* Participant has a history or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with altered cognition
* Participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable
* Participant is living in a nursing home or skilled nursing facility
Improving Show Rates in Dental Care Settings Serving Underserved Populations

The goal of this study is to compare different no-show interventions in dental clinics serving underserved populations. The main question it seeks to answer is

* How do different no-show intervention methods compare in reducing no-shows?

Participants will be asked to

* Implement different interventions
* Report a limited set of data to researchers

Persistent no-show rates contribute to the oral health disparities and inadequate access to dental care that disproportionately affect underserved populations. The proposed research will test the impact of three different strategies on improving show rates using a full factorial design. Specifically, the study is designed as a 2×2×2 factorial cluster-randomized trial of reminder messaging, motivation-enhanced communication, and walk-in visit. The unit of intervention and randomization will be dental clinic sites (clusters). Forty clinics will be randomized between eight possible combinations of receiving or not receiving the three study interventions, with five clinics receiving each intervention. Findings from this study seek to provide an evidence-based approach to reducing no-shows and increasing access to dental care for underserved populations.

Eligibility Criteria:
Inclusion Criteria:

Sites must be:

* Serve at least a 51 percent self-pay and Medicaid patients
* Be willing to provide limited data sets of clinic data to the research team
* Be willing to undertake and support and organizational improvement project to improve show rates

Staff must be:

* A paid staff member at a participating clinic
* Be able and willing to provide written or verbal consent

Exclusion Criteria:

* No exclusion criteria for clinics or staff
Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females,18 years of age or older (50% with sensitive skin).
* Completed written informed consent.
* Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).

Exclusion Criteria:

* Pregnancy or lactation.
* Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
* Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
Performance Testing in Young Soccer Players

The aim of this study is to investigate physiological characteristics, body composition and performance indicators among youth soccer players of four age categories (U-12, U-14, U-16, and U-18). Participants will undergo assessment of their body weight, body height and percent of body fat as well as performance testing including flexibility, strength, vertical jump, speed, repeated sprint ability, agility, dribbling and endurance.

This study aims at investigating anthropometric, body composition and performance indicators among male youth soccer players. The study will be conducted prior to the preparation period. Initially, participants and their parents (for those under 18 years) will be informed about the benefits, risks and discomforts associated with the study and will provide a written consent. Participants will be instructed to refrain from strenuous exercise for at least 48 hours prior to testing and they will be also asked to consume their normal diet. Prior to testing all participants will be familiarized with testing procedures and specific test. Body weight will be measured on a seca beam balance. Participants' height will be measured by using a fixed stadiometer and the percent body fat will be calculated with bioelectrical impedance analysis. Flexibility will be assessed by using the sit and reach test and the lower body explosive strength will be determined through vertical jump testing (squat jump and counter movement jump without arm swing). Knee flexor and extensor strength will be assessed on an isokinetic dynamometer. Sprint performance will be assessed from a standing start over by infrared photocells with participants running 10m and 30m as fast as they can. The repeated sprint ability will be tested by using linear sprint test including 5 maximum sprints of 30 meters with a 25-second recovery period in-between. Maximal oxygen consumption (VO2max) will be determined by open-circuit spirometry via breath-by-breath analysis during a graded exercise test to exhaustion on a treadmill. Furthermore, participants will be evaluated in agility by using the short dribbling test and the ability to recover after repeated intense exercise through the YO-YO Intermittent Recovery test 1 (only for u-16 and U-18 groups).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 11 and 12 years
* Active soccer players participating in regular soccer practice and competition
* Training age ≥ 3 years
* Free of chronic diseases
* Free of musculoskeletal injury

Exclusion Criteria:

* Musculoskeletal injury
* Chronic disease
* Training age ≤ 2 years
Clinical Research Outside of Teaching Hospitals (RECHNONU)

The very most part of clinical research in France takes place in teaching hospitals. Advantages to develop it in others hospitals are numerous: access to innovative treatments, improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and reduced selection bias. The objectives of the study are to report the current situation of clinical research outside of teaching hospitals in France.

The very most part of clinical research in France takes place in teaching hospitals. Advantages to develop it in others hospitals are numerous: access to innovative treatments, improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and reduced selection bias. The objective the study is report the current situation of clinical research outside of teaching hospitals in France.

A three-stage survey was conducted between January and October 2012 in non-teaching hospitals of North-eastern France. First questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with clinical research actors of 20 selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* non-teaching hospitals
* established in north-eastern France

Exclusion Criteria:

* more than 100 beds
* for the second stage only:
* less than 300 beds
Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious cervical lesions.

This is a prospective, randomized, monocenter parallel group study on restoration of tooth with non-carious cervical restorations. Each patient receives cervical restoration(s) either with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one experienced operator. One of two independent examiners will evaluate the restorations at baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria. Reliability of examination will be assessed on a random sample of 30 restorations.

Eligibility Criteria:
Inclusion Criteria:

* indication of a restorative treatment for a sclerotic non-carious cervical lesion
* lesions should be accessible for treatment and visual-tactile re-evaluation
* sufficient moisture control should be possible
* cervical margins should be located in dentin whereas the coronal margin should be located in enamel

Exclusion Criteria:

* allergy/hypersensitivity against any of the used materials
* participants should not be systematically ill, disabled, pregnant or participating in another study
Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study

The purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.

The goal of this study is to determine whether the short-term (4 week), double-blind administration of Merck L-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. This initial, small sample size study (n=9 on L-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Male participants
* Between the ages of 18 and 50
* Meet diagnostic criteria for schizophrenia or schizoaffective disorder
* Are clinically stable for a minimum of 3 months on current dose of medication
* Are unemployed (i.e., work less than 20 hours per week at competitive employment)

Exclusion Criteria:

* Psychoactive substance dependence within the past 6 months or substance abuse within the past month
* History of head trauma or other neurological disorder
* Medical illness or medications, such as benzodiazepine treatment or HIV medications, that may be affected by study participation (the study doctor will discuss this with potential subjects)
* Mental retardation
* Seizure disorder
* History of a heart attack, arrhythmia, or other heart disease
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.


Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Has worn soft contact lenses for a minimum of 6 months;
5. Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
6. Has an acceptable fit and comfort with both study contact lenses in the powers available;
7. Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;
8. Is willing to be awake for at least 2 hours before visit 2;
9. Is willing to not wear eye makeup on the day of visit 2 and 3;
10. Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;
11. Has a wearable pair of spectacles.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to sodium fluorescein dye;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has a known sensitivity to petroleum jelly (Vaseline);
10. Has epilepsy and/or a sensitivity to flashing lights;
11. Wears toric contact lenses;
12. Has any physical impairment that would interfere with holding the evaporimeter;
13. Has taken part in another research study within the last 14 days.