cyrilzakka/clinical-trials huggingface dataset:
Precision Dosing of Busulfan in Children Undergoing HSCT

The objective of this clinical trial is to evaluate the personalization the conditioning regimen prior to the hematopoietic stem cell transplant (HSCT) in children and adolescents, to improve HSCT efficacy while reducing conditioning-related toxicities. Namely, we are going to compare the accuracy of two methods for determining the first dose of busulfan, one of the medicines used during the conditioning regimen. First doses will be determined based either only on anthropometric information such as age and weight or by adding a genetic factor that influences the individual ability of busulfan metabolization.

Participants will be randomly assigned (1:1 ratio, stratified by conditioning regimen - the presence of fludarabine) to receive their first dose of busulfan according to:

1. the most performing method based on age and weight - McCune's model (control arm)
2. a method that also considers a pharmacogenetic factor (variants occurring in the promoter region of the GSTA1 gene) in association with the co-administered chemotherapeutic agent fludarabine in the dose personalization (experimental arm)

This is an international study being carried out in five countries (Canada, Italy, Switzerland, France, and Denmark).

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged from 0-18 years old on entry to the study;
* Clinical indication of allogeneic or autologous hematopoietic stem cell transplantation;
* The conditioning protocol must include IV Bu formulations, Busulfex® (Otsuka Pharmaceutical), Busilvex® (Pierre Fabre Pharma) or other European Medicines Agency (EMA) or Food and Drugs Administration (FDA) approved generic formulations regardless of the administration schedule (q6h, q12h, or q24h)
* The expected length of time from recruitment to starting the conditioning regimen must be superior to 10 days;
* Informed written consent to participate in the study signed by the participant/parent

Exclusion Criteria:

• At least one of the drugs listed below scheduled to be administered in the Bu administration days up to 24h after the last dose of Bu, whenever a washout is not possible:

* Metronidazol (required washout: 7 days)
* Nalidixic acid (required washout: 7 days)
* Phenytoin (required washout: 21 days)
* Itraconazole (required washout: 14 days)
* Ketoconazole (required washout: 7 days)
* Voriconazole (required washout: 7 days)
* Deferasirox (required washout: 7 days)
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort

The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
2. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
3. Is correctable to a visual acuity of 6/6 or better with their habitual correction.
4. Is willing and able to follow product usage instructions and maintain the visit schedule.
5. Is at least 18 years of age and has full legal capacity to volunteer.
6. Can be successfully fitted with study lens type.
7. Has read, understood and signed an Information Consent Letter.
8. Has a distance contact lens prescription is between -0.50 D and -9.00 D
9. Has astigmatism of ≤ 1.00 D Cyl
10. Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
11. Has no systemic disease affecting ocular health.
12. Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
13. Has clear corneas and no active ocular disease.
14. Has no known ocular or systemic allergies, which could interfere with contact lens wear.
15. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.
16. Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
17. Has not worn extended wear contact lenses in the last 30 days.
18. Has had an oculo-visual examination in the last two years

Exclusion Criteria:

1. Has any active ocular disease.
2. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
3. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
4. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
5. Is using topical ocular prescription or any topical over-the-counter medication.
6. Is actively involved in any other research/clinical study.
7. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
8. Has had corneal refractive surgery.
9. Has known sensitivity to any of the study solutions.
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D\&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.


Eligibility Criteria:
Inclusion Criteria:

* Women presents with spontaneous fetal death
* Gestational age of fetus between 14-28 weeks

Exclusion Criteria:

* Transmural uterine scar;
* Allergies or other contraindications to use of misoprostol;
* Placental abruption with active hemorrhage;
* Complete placenta previa;
* Extreme uterine structural anomalies;
* Or other contraindications to vaginal delivery of the fetus;
* Presentation in active labor (moderate to severe contractions every 10 minutes); or
* Four or more previous deliveries
Gene-guided Warfarin for Anticoagulation Therapy

This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism patients)
* Clinicians judge that long-term oral anticoagulation with warfarin is required
* No anticoagulation treatment in the past 10 days
* Agree to participate in this project

Exclusion Criteria:

* Patients who had a tendency to bleed when taking warfarin
* High-risk groups using warfarin anticoagulation
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease

The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test.

The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants.

Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least four (4) years old
* Cognitively normal (no developmental delay or syndrome)
* Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
* Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
* Do not have any ocular diseases that could interfere with the visual field testing

Exclusion Criteria:

* Developmental delay
* Inability to obtain consent
* Inability to understand English
Can mCPN Intervention Improve Injection Site Rotation

The current research study has accordingly been designed to determine if a "pharmacist-dispensed montméd Coloured Pen Needle (mCPN) intervention" will improve injection site rotation relative to the standard dispensing of non-mCPN insulin pen needles.

Study Design and Conduct This is a 30-day, two-arm, randomized, controlled study.

Enrolled participants will be randomly assigned to one of the following study arms:

* Control group: participating pharmacists will dispense boxes of standard insulin pen needles to the patient participants
* mCPN group: participating pharmacists will dispense boxes of montméd Coloured Pen Needles to the patient participants

Study Sites and Participating Pharmacists All pharmacies in Canada that provide services to individuals with diabetes who use injectable insulin therapy will be eligible to participate in this study. All participating pharmacists who will play an active role in participant enrollment and the follow-up visits will be required to complete a participation consent form and 2 surveys. The first (Pre-study survey) should be completed after they have been fully trained on the study protocol and their study obligations, and before commencement of study enrollment. The second (Post-study survey) should be completed after the last patient has completed the 30-day follow-up visit. (Refer to Section 11 for the Study Flow).

Randomization Process Participating pharmacists will dispense one of the two study pen needles according to a computer-generated list that will be provided to the participating pharmacy upon site activation

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus or type 2 diabetes mellitus who have been using daily insulin therapy for 1 year or more
* Able to read the English text on the boxes of the pen needles

Exclusion Criteria:

* Individuals currently treated with a glucagon-like peptide 1 receptor agonist (GLP-1RA)
* Current or previous user of mCPN
* Individuals who are unable to understand or communicate in English
* Pregnant women
* Individuals with serious mental illnesses eg. dementia, schizophrenia disorders, bipolar disorders, major depression, etc.
High-Speed Yoga and Executive Function

The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease.

The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease. Subjects will be randomly assigned to either the high-speed yoga group or an inactive control group. All subjects will be tested before and after the 16 week training period using tests of balance, cognition and functional movement. The high-speed yoga group will receive yoga sequences lead by a certified yoga instructor during each of the 32 visits to the yoga studio. Each session will last one hour and be conducted two times per week. The program will consist of several different balance poses and movements where participants are encouraged to move quickly. Participants will also be asked to move in different directions based on colored lines placed on the yoga mat. To ensure a safe environment, several assistants will be present to help participants move into each pose. In addition, several assistive devices such as chairs and yoga blocks will be available if participants chose to use them.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between 50 and 85 years of age (inclusive);
2. Diagnosis of Parkinson's Disease (Hoehn and Yahr scale I-III);
3. Ability to ambulate with or without an assistive device for at least 50 ft;
4. Ability to get up and down from the floor with minimal assistance;
5. Ability to provide informed consent;
6. No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.);
7. A score of 23 or above on the Montreal Cognitive Assessment;
8. Not currently participating in yoga more than one time per week;
9. Can understand and communicate in English.
10. Willing and bale to provide consent.

Exclusion Criteria:

1. Existing musculoskeletal injury.
2. Severe freezing of gait.
3. Enrolled in another yoga or research program.
4. Unstable or active major medical illness.
5. Answer "Yes" to any questions on the PAR-Q or Elder PAR-Q.
6. Pregnancy
The Importance of Glucagon-Like Peptide-2 (GLP-2)in Mesenteric Bloodflow in Humans

The purpose of this study is to study the effect of GLP-2 on mesenteric bloodflow in healthy adults by the use of ultrasound., it is the hypothesis that GLP-2 vil increase the bloodflow.

The investigation will include 10 testpersons.

It will be a 2 fase study over 2 days.

day 1: The testperson will meet fasting, and take in a standard liquid meal, after this the bloodflow in a mesenteric artery will be measured by use of ultrasonic technique. Bloodsamples will be taken regular in a total wolumne of 200 ml.

day 2:The testperson will meet fasting, there wil be administered intraveneous GLP-2 in 3 increasing doses over 3 x 45 min.and one subcutaneous dose. During this the bloodflow in a mesenteric artery will be measured by use of ultrasonic technique. Bloodsamples will be taken regular in a total wolumne of 200 ml.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* use of drugs
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria


Eligibility Criteria:
Inclusion Criteria:

* Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care
* Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines

Exclusion Criteria:

* Urticaria with a clear underlying etiology other than CSU
* Urticaria with a clearly defined or sole trigger (chronic inducible urticaria)
* Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)

This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.
* Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
* Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
* Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.

Exclusion Criteria:

* Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
* Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function
* Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
* More than two prior lines of chemotherapy.
* Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.
* Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy
Molecular Heterogeneity in Multilobar Low-grade Gliomas

Low-grade diffuse glioma (GDBG) are rare tumors of young adults, whose ontogenesis is poorly understood. Patient management is based on the molecular profile defined by two molecular markers : mutations of the IDH genes and chromosomal 1p19q co-deletion. To date, the IDH and 1p19q statuses are determined on a single fragment collected from the tumor. In the case of GDBGs infiltrating several brain lobes, the sampling is done randomly on only one of the infiltrated lobes. An intra-tumoral heterogeneity of genetic alterations has been suggested and would impact management.

Phylogenetic analysis of genetic alterations found, by high throughput sequencing, in each lobe invaded by the same GDBG will make it possible to assess intra-tumoral heterogeneity and to discuss, at a fundamental level, the hypothesis of a single tumor site with secondary diffusion or that of the convergent progression of two or three distinct tumor sites. Clinically, understanding the ontogenesis of GDBGs will improve their management because of the known link between brain location, dominant molecular profile, and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old.
* Subject not opposed to participating in the study
* Be scheduled in the operating room for the first surgery of a low-grade diffuse glioma presupposition on the basis of clinical and imaging criteria.
* Confirmation, after histopathological analysis of the resected tumor fragments, of the diagnosis of grade II glioma according to the 2016 WHO classification of brain tumors.

Exclusion Criteria:

* Patient minor, or major under legal protection, or unable to give consent.
* Refusal to participate in the study.
* Pathology diagnosis of grade III glioma according to WHO 2016 classification
* Have received oncology treatment (chemotherapy and or chemotherapy) before the first surgery.
Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS

Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Upper limb amputation;
* Stable clinical condition;
* Skin integrity of the stump;
* Age between 18 and 65 years;
* High level of motivation to participate in the study and acceptance of the purpose of the study;
* Signed informed consent document.

Exclusion Criteria:

* Clinical instability;
* Dehiscence of the amputation wound;
* Failure to complete the informed consent;
* State of pregnancy;
* Implanted devices that can interfere with TENS stimulation (e.g. pacemakers);
Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars

The goal of this clinical trial was to evaluate cryotherapy versus dexamethasone on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

* Does controlled irrigation with cold saline in root canal treatment reduce the severity of postoperative pain?
* Does controlled irrigation with dexamethasone in root canal treatment reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone group, the root canals were irrigated with 2 °C salin solution in final irrigation.

In the dexamethasone group, unlike the control and cryotherapy group, the root canals were irrigated with 1 mL dexamethasone solution in final irrigation.


Eligibility Criteria:
Inclusion Criteria:

* Vital mandibular first and second molars with 3 root canals that responded positively to the cold test and electric pulp test
* Patients who had not taken analgesics or antibiotics in the last 24 hours before the procedure were included in the study.

Exclusion Criteria:

* Devital mandibular first and second molars that responded negatively to cold tests and electric pulp tests
* Mandibular first and second molars with poor periodontal status (pocket depth \> 4 mm),
* Mandibular first and second molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity were excluded from the study.