cyrilzakka/clinical-trials huggingface dataset:
Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload. Phlebotomy is currently the standard therapy. More recently Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.In the proposed clinical trial the investigators will examine whether TE can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the number of treatment procedures when compared to current standard therapy by P.

The research population exists of patients with HH ( by genetic analysis confirmed as homozygous for C282Y) living in south-east of the Netherlands and currently treated with phlebotomy as maintenance treatment to keep their serum ferritin levels \< 50 ug/l. Ferritin level at start of the inclusion between 30-50ug/l. Exclusion criteria are: patient receiving other therapies such as chelating therapy or forced dietary regimen, further patients with excessive overweight (BMI\>35). After enrollment the patients will be randomized to start either with TE or continue with P. After a year of treatment and being at a serum ferritin level \<50ug/l, patients will continue the study but then being treated with the other of the two treatments. Randomization will be done by blocked randomization.

Eligibility Criteria:
Inclusion Criteria:

* homozygous for C282Y
* currently treated with phlebotomy as maintenance therapy for at least 6 month
* ferritin level between 30-50 micog/L
* age 18 years an older
* weight more than 50 kg
* signed informed consent
* willingness to fill out additional questionnaires at three points in time

Exclusion Criteria:

* chelating therapy
* forced dietary regime
* aged below 18 years
* excessive overweight ( BMI more than 35)
* pregnancy
A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.

  * Primary tumor has been resected \> 3 months prior to randomization.
* At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
* Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
* Adequate hematologic, renal and hepatic function.

Exclusion Criteria:

* Any prior therapy with irinotecan
* Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) =\> Grade 2
* Clinically significant conditions that increase the risk for antiangiogenic therapy.
* History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

To evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. Secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.

Patients and methods:

We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital, and will recruit 150 female patients with overactive bladder syndrome. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the King's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. In addition, measurement of heart rate variability and bladder blood perfusion will be performed.

Expected results:

We will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.

Eligibility Criteria:
Inclusion Criteria:

* \>20 years old .
* female patients with overactive bladder syndrome

Exclusion Criteria:

* Cases of hypersensitivity to mirabegron or tolterodine.
* Betanley is contraindicated in the following patients: uncontrolled severe hypertension.
* Dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie Inulin clearance rate (GFR\<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong CYP3A4 inhibitors such as ketoconazole.
* Patients with myasthenia gravis.
* The patient is taking drugs that interact with tolterodine or mirabegron.
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Eligibility Criteria:
Key Inclusion Criteria:

1. Complaint of chronic pain of the trunk and/or limbs
2. Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
3. Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

1. Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
2. Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
Efficacy of New Alcohol Free Mouthrinses

Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.

Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* participants between 18 and 65 years
* no severe periodontitis
* informed consent

Exclusion Criteria:

* handicapped participants
* allergies against mouth rinses
Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers

Description: To investigate bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use.

Interventions: 12 healthy volunteers will receive in a cross-over design two formulations i.e. the commercially available tablet formulation and the trial formulation. Blood samples (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs from both formulations and will be compared.

Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 55 years, extremes included. Males and females.
* Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection.
* Normal weight as defined by a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
* Healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out less than 3 weeks before the first dose.

Exclusion Criteria:

* Subjects presenting anaemia, neutropenia or platelets deficits
* Subjects with kidney failure or renal dysfunction
* Pregnant, lactating females
* History of allergy or hypersensitivity to Zidovudine or Lamivudine.
* History of clinically cardiovascular disease or liver disorder
Computed Tomography Laser Mammography Breast Imaging Device

The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 21 and over
* Heterogeneously or extremely dense breast
* Schedule for biopsy
* Gave informed consent

Exclusion Criteria:

* Mammogram not performed within the last 60 days
* Open lesions on the breast
* Previous breast biopsy within 60 days of the CTLM scan
* Surgical deformity of breasts
* Commercial Tattoos
* Protoporphyria
* Lactating
Polyethylene Body Bags as an Alternative to Radiant Heat Lamp During the Neonatal Adaptation in Infants Older Than 29 Weeks

INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in the basic technology for neonatal adaptation may not be available. Polyethylene bags may be an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the differences between babies undergoing body bag with polyethylene or conventional drying during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá, Colombia, 2013.

MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag body and / or radiant heat lamp was removed. Environment temperature and humidity, temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of the outcome. The study was approved by the hospital ethics committee of victory.


Eligibility Criteria:
Inclusion Criteria:

* Inborn neonates with both a gestational age \>29 weeks

Exclusion Criteria:

* Abdominal wall defect, myelomeningocele, major congenital anomaly, or blistering skin disorder
Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.

Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.

We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.


Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 18 ans
* Acute kidney injury with continuous renal replacement therapy
* Fluid overload \> 5%
* Equivalent Norepinephrine dose \< 0,5 µg/kg/min

Exclusion Criteria:

* - Chronic intermittent haemodialysis
* Active bleeding
* Stroke with coma
* Pregnancy
* advanced directives to withhold or withdraw life-sustaining treatment
* patient's opposition to the use of his/her personal health data."
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo setting.


Eligibility Criteria:
Inclusion Criteria:

* supported on ECMO
* receive piperacillin-tazobactam or cefazolin as part of routine care or infection management

Exclusion Criteria:

* \>= 18 years
* No Consent provided
Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

The purpose of this study is to determine if pharmacokinetics of docetaxel is modified by the body composition (assessed by the BMI but also by CT-scan) in patients treated by docetaxel as adjuvant treatment of a localized breast cancer

Half of the patients treated for a localized breast cancer are obese or overweighted. Recently published post-hoc analyses of a large randomised trial (BIG-2-98) revealed that BMI could impact the benefit of a docetaxel based chemotherapy, but not of an anthracyclin based chemotherapy.

One of the hypothesis is that the distribution volume of hydrophobic drugs, such as docetaxel, may be influenced by the BMI, and more precisely by the amount of total fat.

In that context, we aim to assess the docetaxel pharmacokinetics during its first exposure for localized breast cancer, and compare these results according to 3 groups of patients (lean, overweight and obese).

Eligibility Criteria:
Inclusion Criteria:

* Woman older than
* Early breast cancer
* CT-scan of less than 3 months, including L3 level
* Indication of docetaxel at 100 mg/m² as adjuvant CT

Exclusion Criteria:

* HER2 amplified or triple negative tumors
* Pregnant or breastfeeding women
* Patients under guardianship or curatorship
* Concomitant administration of another cytotoxic drug or targeted therapy
* Psychosocial disorder
* Administration of another cytotoxic drug or targeted therapy within 20 days prior to blood collection
Expanded Access for ATB200/AT2221 for the Treatment of IOPD

This is an expanded access program (EAP) for eligible participants designed to provide access to ATB200/AT2221.

This program is being offered on a patient by patient basis.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is male or female and 0 to \< 18 years old.
2. Patient has a diagnosis of Pompe disease, based on documentation of GAA genotyping demonstrating variants associated with IOPD.
3. Patient does not currently qualify for or is unable to enroll (eg, due to location, etc) in any commercial drug-sponsored ongoing clinical trial.
4. Patient is currently being treated with an approved ERT and is declining (eg, worsening in motor function, respiratory function/parameters, cardiac function, etc) based on treating physician's clinical judgement.
5. The patient's legal guardian or representative has given informed consent (and assent when age appropriate for regional requirements) to treatment prior to administering ATB200/AT2221 in a manner consistent with all national requirements.
6. If of reproductive potential and sexually active, female subjects agree to use a highly effective method of contraception throughout the duration of the treatment and for up to 90 days after their last dose of ATB200/AT2221.

Exclusion Criteria:

1. Patient has a hypersensitivity to any of the excipients in ATB200, alglucosidase alfa, or AT2221
2. Patient has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator and/or Amicus, pose an undue safety risk to the patient.
3. Concomitant use of miglitol (eg, Glyset), non-AT2221 form of miglustat (eg, Zavesca), acarbose (eg, Precose or Glucobay), voglibose (eg, Volix, Vocarb,or Volibo)
Efficacy of Training in Manual Preparation of Platelet Rich Plasma

This is a device study in some respects, in that specialized centrifuges are commonly used to make platelet rich plasma, and we are studying the use of standard laboratory equipment to do so. However, it is primarily interventional in that we will evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method.


Eligibility Criteria:
Inclusion Criteria:

* English speaking medical practitioners(N.D., D.O. or M.D.)or their office staff

Exclusion Criteria:

* History of difficult blood draws
* Platelet count \< 150,000

  * Hb \< 37%
* History of blood disorder
* History of altered platelet function
* History of chemotherapy or radiation therapy.
Phase II Pilot Study of Aminoimidazole Carboxamide Riboside (AICAR), a Precursor of Purine Synthesis, for Lesch-Nyhan Disease

OBJECTIVES: I. Determine the effects of aminoimidazole carboxamide riboside (AICAR) on hematologic manifestations of Lesch-Nyhan disease.

II. Assess the behavioral and neurological benefits of AICAR in patients with Lesch-Nyhan disease.

III. Examine the effect of AICAR on purine production.

PROTOCOL OUTLINE:

After a 3-day baseline, patients are treated with aminoimidazole carboxamide riboside (AICAR) by continuous infusion for 12 days. Concurrent allopurinol and folate are allowed.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Men with Lesch-Nyhan syndrome Moderate erythrocyte macrocytosis No active urinary tract disease or impaired renal function
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients

The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).

ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.

Eligibility Criteria:
Inclusion Criteria:Age:

* 30 to 50 years,
* Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria:

* Receiving vitamin D or calcium or omega-3 supplements within the last three months,
* On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,
* Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.
* Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications
Turkish Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)

Environment which children live and grown is very important for the all development stages. In Turkey there is no measurement for home environment evaluation so our aim is to investigate the Psychometric Properties of the Turkish version of Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) in a sample of Turkısh children.

With the advances in technology and medical fields, the rate of cerebral palsy is increasing worldwide with the increase in the survival rate of preterm, low birth weight babies and neurodevelopmentally risky babies living in neonatal intensive care units.

The International Classification of Health, Function and Disability - Child and Youth version (ICF-CY), developed by the World Health Organization, provides a common language to record problems involving functions and structures of the body, restrictions of activity and participation that occur in childhood and adolescence, and related environmental factors; and It was developed to use terminology and consists of four main components: "Body Functions", "Body Structures", "Activity and Participation", "Environmental Factors". According to ICF-CY, environmental factors that have an effect on activity and participation are changeable factors. Therefore, it is stated that environmental conditions should be changed, redesigned and the child-supportive environment should be increased in order to increase the level of activity and participation in children.

Preschool children spend most of their time at home and playing games. Toys in the game environment, playmates, parental participation and attitude play a major role in the development of the child's motor and cognitive skills and social participation (6, 7). In recent years, the importance and positive effects of the enriched environment on the motor and cognitive development of babies have been emphasized in studies. Regular neuromotor evaluations and follow-up of risky babies are guiding in establishing an early intervention program. The "Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)" scale, developed to evaluate the characteristics of the environment in which babies live, is a valid and reliable scale that is frequently used in the literature in many different areas such as hearing loss, motor developmental delay, sensory impairment, and typical development. is a scale (8-11). Translation has been done in many different languages so far. Turkish infants at risk on a scale to evaluate the home environment in Turkey within our existing information is not yet available. It is thought that the introduction of the AHEMD-IS scale into the Turkish language will give clinicians and academicians a different perspective in the evaluation of risky babies and children.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer parents who have;
* 3-18 months child/children
* All children as typically developing children, genetic disorders, metabolic disorders, neuromotor disorders etc.

Exclusion Criteria:

* Parents who refuse to participate in the study