cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments

Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.

To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.

Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.

Medical devices studied :

* Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in Germany
* Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in Germany
* VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by Asahi Kasei Medical in Japan
* Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in Italia

These hemodialyzers are EC marked and are used in their own indications.

Schema

Details of the cross-over plan :

8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated with the dialyzer "test" for the two first sessions of the week. During the last dialysis session of each week, only their usual dialyzer will be used as wash-out. A randomization will define the order of use of the dialyzers in the 4 centers. This order will be identical in a center.

Number of patients :

32 (8 patients per center (4 centers))

Duration :

One week per dialyzer

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test
* Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum)
* Patient treated before with high permeability membrane
* Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min
* Patient treated with a high surface area dialyzer ≥ 1,8 m²
* Patient covered by the social French health organism
* Patient informed of the study goals and having signed the informed consent

Exclusion Criteria:

* Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min
* Patient with a fast progressive chronic disease
* Patient with an uncontrolled anemia
* Patient refusing to sign the informed consent
* Pregnant or nursing patient
* Pediatric patient
* Patient under tutorship
Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults

This is a randomized crossover intervention designed to evaluate effects of daily intake of beverages containing orange or apple Pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health and self-reported GI symptoms and dietary intake as well as analysis of gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females 18-60 years old
* Willing and able to consume 16 oz. of orange or apple beverage per day for 4 week periods
* Willing to maintain usual diet, smoking status, physical activity pattern, supplements and meds

Exclusion Criteria:

* Food allergies or sensitivities to ingredients in study beverages
* Presence or history of GI condition, endocrine (including diabetes), cardiovascular disease or other disease or condition that could interfere in the interpretation of the study results in the opinion of the Investigator.
* Extreme dietary habits including vegetarian, vegan or Atkins diet
* Females or are pregnant, planning to become pregnant or breast feeding during the study period.
Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers

To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2
* All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\>= 100 ml within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial

Following exclusion criteria are of special interest for this study:

* History of haemorrhagic diathesis
* History of gastro-intestinal ulcer, perforation or bleeding
* Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency
Social Cognitive Development in Young Children With Autism

Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 24 to 42 months old
* Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team
* Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing.
* The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period.
* The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing).
* Parents must be between the ages of 18 and 65 years old
* It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)

Exclusion Criteria:

* \<34 weeks or \>42 weeks gestational age
* \<2500 grams birth weight, severe birth trauma
* Head or serious bodily injury sustained before or during the study
* Illicit drug or excessive alcohol exposure (defined in our telephone screening interview)
* Major hearing or visual impairment
* Non-febrile seizures
* Any known genetic syndrome
* Mitochondrial disorders
* Severe birth defects
* No foster children may participate
* The child must not be adopted
* The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs.
* Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements)
* Has a sibling participating in this study
Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet

Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.

Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week. With a follow up period of 6 months, we are planning to enroll 55 children in each arm. Adverse effect profile in each arm will also be monitored during the study. Also the effect of the dietary therapy on behavior and cognition in each arm will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 1-15 years with drug resistant epilepsy
2. Willing to come for regular follow up

Exclusion Criteria:

1. Surgically remediable cause for drug resistant epilepsy
2. Proven in born error of metabolism except in which dietary therapy for epilepsy is indicated(i.e. pyruvate carboxylase deficiency and GLUT 1 deficiency)
3. Previously received KD, MAD or LGIT
4. Known case of

   * Chronic kidney disease
   * Chronic liver disease/GI illness
   * Chronic heart disease(congenital and acquired)
   * Chronic respiratory illness
Comfort Level After Transfemoral Coronary Angiography

With the increase in the number of cardiovascular diseases, the safety of the angiography method used in diagnosis and treatment becomes important. The transfemoral approach is often preferred during angiography. It is recommended to have bed rest for 6-12 hours after transfemoral angiography (TFA) to prevent possible complications. In order to reduce the complications arising from angiography, it is predicted from the studies that giving the patient a therapeutic position, elevating the head of the bed and gradual early mobilization will reduce the patients' groin pain, prevent urinary retention and increase patient comfort. In this study, the effect of gradual mobilization after transfemoral angiography on the vital signs, complications and comfort level of the patients. It is planned to be done to determine the


Eligibility Criteria:
Inclusion Criteria:

* Individuals who can be contacted at a level that can answer research questions
* Individuals with transfemoral angiography

Exclusion Criteria:

* Those with hypertension
* Individuals with psychological and neurological disorders
* Patients with communication problems
* Patients with deterioration in hemodynamics after angiography
Quality Control of CE-Certified Phonak Hearing Aids - 2016_06

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems and to equivalent competitor devices.

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders
Randomized Controlled Trial Comparing Embryonic Quality in rFSH Versus hMG in IVF Protocol With GnRH Antagonist

rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF. However, there is a debate in the literature which one is better to induce ovulation in patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.

The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.

To compare embryonic quality and other clinical outcomes when using human menopause gonadotropin (hMG) or recombinant follicle stimulating hormone (rFSH) to the ovarian stimulation in IVF cycles with the GnRH antagonist protocol.

Design: open randomized single center study with infertile patients submitted to IVF comparing IVF outcomes between hMG and rFSH when controlled with GnRH antagonist.

Setting: A single private center of reproductive medicine in association with Universidade Federal do Rio Grande do Sul.

Patients: Infertile women with normal ovarian reserve with IVF indication. Intervention: The patients were randomized in two groups, 85 received rFSH and 83 received hMG to ovulation induction, both groups used GnRH antagonist to prevent ovulation.

Main Outcome Measure: Total embryonic score and best embryonic score. Secondary outcomes: Total dose of gonadotropins, number and size of follicles in the end of the stimulation, number of mature oocytes, number of embryos, pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* 25 to 40 y
* infertile
* submitted to IVF
* no hormonal disease
* normal FSH (\< 10)
* anti-mullerian hormone (AMH) \> 1 ng and \< 10 ng
* both ovaries
* only first or second IVF

Exclusion Criteria:

* thyroid-stimulating hormone (TSH), prolactin (PRL) altered
* endometrioma
* ovarian tumor or cysts
* previous Ovarian Hyperstimulation Syndrome (OHSS)
* severe male factor
Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis

This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.

The general approach of the statistical methodology is the following:

* The qualitative variables are described with number and percent of each level.
* The quantitative variables are described with mean and standard deviation.
* All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
* Given the large sample size, no normality assessment will be done.
* Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)\*100.
* Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
* Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
* Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
* Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.

Eligibility Criteria:
Inclusion Criteria:

• atopic dermatitis or other skin disease with dryness or severe xerosis

Exclusion Criteria:

• patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis
Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review

Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one of the available treatments is the injection of Botulinum Toxin. This study aims to review the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the controlled randomized clinical trials were chosen to review with the CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.


Eligibility Criteria:
Inclusion Criteria:

* Controlled randomized clinical trials
* Adult patients diagnosed with idiopathic overactive bladder
* Language of the study: english

Exclusion Criteria:

* Diagnosis of neurogenic overactive bladder
* Patients under 18 years old
* Use of Type-B Botulinum Toxin as the intervention
* Other types of studies
Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance

Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form voluntarily and follow the plan requirements;
* Age from 18 to 75 years old (including 18 and 75 years old), regardless of gender;
* Patients who received non-invasive mechanical ventilation after cardiac surgery and were intolerant of non-invasive ventilation.

Exclusion Criteria:

* A history of allergy to any component of the study drug;
* Visual analogue scale of pain (VAS) score \>4；
* Who had taken dexmedetomidine within 8 hours prior to the study;
* Who had used remifentanil within 2 hours before the study began;
* Expectoration difficulties;
* Women who are pregnant or lactating;
* Coma or uncontrollable convulsions;
* Have a history of mental illness or cognitive impairment;
* Delirium before the study began;
* Patients with severe liver dysfunction (CTP grade C);
* Patients with renal insufficiency (patients receiving renal replacement therapy);
* Preoperative left ventricular ejection fraction (LVEF) \< 30%;
* History of drug and alcohol abuse;
* Other conditions that the investigator deems inappropriate for participation in this clinical trial.
R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers

The long-term goal of our research program is to reduce the high incidence of musculoskeletal injury associated with person-handling tasks performed by EMS providers/responders (NORA Public Safety Industry Sector). The literature shows the significant burden of these injuries, many of which affect the back and are debilitating. There is a need for effective ergonomic tools that can assist EMS providers in the patient handling tasks encountered in patient homes, particularly those patient handling situations that include restricted or tight spaces. To address this need, our prior work identified a set of potential ergonomic solutions, using a participatory process with EMS providers, for physically challenging and frequently occurring patient handling tasks that occur in patient homes. A final product of this prior work was the development of the LiftKit, which is a collection of seven tools that were shown in biomechanical validation studies with EMS providers to effectively reduce physical demands during simulated patient handling tasks in a laboratory setting. The overall objective of this proposed research-to-practice application is to evaluate the LiftKit's seven patient handling tools (interventions) in the field to assess their usability, usefulness, and desirability, as well as their impact with regards to preventing musculoskeletal injuries incurred during EMS patient handling tasks. In this field study, 30 LiftKits will be placed on EMS vehicles that service urban, suburban, and rural communities. Given the three-shift operation used by fire-service based EMS departments, there is the potential to recruit between 180 and 270 EMS providers for the study. Immediately following the training on how to use the tools and at 4, 8, and 12 months following the training, participants will be interviewed and questioned about each tools' usability, usefulness, and desirability. Frequency of each tool's use will be assessed with a questionnaire at the time of the interview and a daily Run-Use survey tool. Musculoskeletal injury data due to patient handling tasks during the 12 month follow-up period will be compared with injury data from the three-year period prior to study initiation. The final product of this work will provide the important evidence needed to widely promote the adoption of the ergonomic tools within the LiftKit, in order to reduce MSD injury risk to EMS providers associated with common patient handling tasks.


Eligibility Criteria:
Inclusion Criteria:

* Working EMS providers

Exclusion Criteria:

* None