cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Facilitate Analgesia

Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.

Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.

Eligibility Criteria:
Inclusion Criteria:

* aged from 18 to 80 years old
* American Association of anesthesiologists (ASA) grade Ⅱ \~ IV
* body mass index (BMI) 18.5-40
* planning undergoing peripheral nerve block

Exclusion Criteria:

* incomplete effect of nerve block
* Alzheimer's disease
* implanted cardiac pacemakers
* mental illness
* epilepsy
* autonomic nervous system diseases
* projected the duration of the operation was more than 3 hours
Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication

Exclusion Criteria:

* Due to the non-interventional observational character of the study, there are no exclusion criteria.
Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities

Background: Games using motion capture from webcam have become increasingly popular. A population that lacks much stimulus in the teaching-learning process has under-explored the benefits of this kind of games: The Intellectually Disabled. The aim of this study is to analyse the effectiveness of games with virtual reality in the total reaction time. Method: A convenience sample of 165 Intellectually Disabled participants will have their performance measured using a virtual reality game. The intervention is to play two different games twice, in two sessions with an interval of, at least, seven days between the sessions. Participants will be randomized between two raters, both master students.


Eligibility Criteria:
Inclusion Criteria:

* All the children that uses to go the institution where the data collection will be realised (APAE).

Exclusion Criteria:

* Those who decline to participate
* Those who are not present in the two days of evaluation.
Risankizumab in Children With Crohn's Disease (RisaKids)

The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.

This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.


Eligibility Criteria:
Inclusion Criteria:

* Children under the age of 18 years,
* Patients diagnosed with CD.
* Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.

Exclusion Criteria:

\* There will be no exclusion criteria to this study.
A Sunscreen Based on Bioadhesive Nanoparticles

The initial focus of the study will be on safety, sun protection factor (SPF) characterization, and substantivity (duration of protection) studies. The primary outcome of the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles (BNP) formulation in 20-25 healthy volunteers with fair skin.

The purpose of this study will be to evaluate the duration of protection and efficacy of a novel bioadhesive nanoparticle sunscreen in 20-25 human volunteers.This technology makes sunscreens safer and longer-lasting by encapsulating UV sunscreen active agents in non-toxic nanoparticles. Strong preclinical data exists demonstrating the potential for improved safety, long-duration of retention, and increased effectiveness of this product.

This innovative solution focuses on preventing damage caused by UV exposure through the use of a nanoparticle delivery vehicle. The bioadhesive feature of this technology enables longer protection. In addition, encapsulation of the UV filter in a bioadhesive nanoparticle (BNP) improves filter photo-stability, delays filter photo-degradation, and prevents reactive oxygen species (ROS) escape, thereby reducing the risk of cell damage and epidermal toxicity from UV filters.

Furthermore, the bioadhesive feature of our technology eliminates penetration into deeper skin layers or into the blood, minimizing the potential side-effects of UV filters. It is believed that the translation of this technology will provide a longer-lasting, safer, more protective UV sunscreen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be in good health with minimal skin irregularities, as evaluated by a physical examination.
* The physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. Excess hair on the back is acceptable if the hair is clipped or shaved.
* Subjects must fall into one of the following 3 Fitzpatrick Skin Scale categories:

  1. Always burns easily; never tans (sensitive)
  2. Always burns easily; tans minimally (sensitive)
  3. Burns moderately; tans gradually (light brown) (normal)

Exclusion Criteria:

* Volunteers cannot have a history of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or melanoma).
* Volunteers cannot have a history of skin disease (such as psoriasis, exema, or vitiligo).
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery

The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.

The work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (NIRS) and consumption of hypotensives.

Null hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.

This study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.

Study type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic rhinosinusitis undergoing pansinusoperation
* Age over 18 years
* Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
* Concrete anaesthetist (Michal Parma, MD)

Exclusion Criteria:

* Coagulopathy
* Thrombocytopathies
* Vascular wall disorders
* Thrombophlebitis
* Anticoagulation or anti-aggregation therapy
* History of malignancy
* Pregnancy
The Effect of Smartphone Addiction and Mental Fatigue on Working Memory in University Students

The aim of this study is to investigate the effects of smartphone addiction and mental fatigue on working memory in university students.

University students who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the Turkish version of "Smartphone Addiction Scale", ''Mental Fatigue Scale'' and "Working Memory Questionnaire" tests, respectively. 120 university students will included in the study. To evaluate between correlation of tests will used to correlation analysis tests. In addition, it will be investigated whether there is a difference between 1.2.3 and 4th grades in terms of Smartphone Addiction, Mental Fatigue Scale and Working Memory Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Being a university student
* Be between the ages of 18-25
* Using a smartphone for at least one hour a day

Exclusion Criteria:

* Having musculoskeletal pain
* Having had surgery in the last 6 months
* Decline to participate in the study
Nurses' Practice of Safe Blood Transfusion in Surgical and Critical Care Units

Blood transfusions are an important part of nursing procedure. Nurses play a key role in safely administering blood products to patients in surgical and critical care unit

The aim of the study was to evaluate nurses' employment conditions as contributing factors affecting nurses' practice of safe blood transfusion in surgical and critical care units in Alexandria Main University Hospital.

Eligibility Criteria:
Inclusion Criteria:

Nurses

* willing to participate in the study
* work in surgical and critical care units
* Sign a consent

Exclusion Criteria:

* Nurses

  * Work in outpatient units and other units
  * Did not sign a consent
Does Statin Therapy Reduce Sympathoexcitation in Hypertension?

A number of patients with hypertension have increased central sympathetic activity. Statins seem to inhibit central sympathetic output. This study assesses the effect of statins on central sympathetic activity in hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* (Known) hypertension
* stable drug therapy for at least 2 months
* age 18-70 jaar
* BMI 18-35 kg/m2
* Sinusrhythm

Exclusion Criteria:

* Recent cardiovascular event \<6 mnd
* Plasma Creatinin:
* female: \>120 mmol/L
* male: \>133 mmol/L
* use of:
* tricyclic antidepressants
* alpha-1 -and/or alpha-2 blockers
* disease of the autonomic nervous system (Parkinsons disease, Shy- Drager syndrome, etc)
* Albuminuria \>300 mg/dag
Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC

Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.

This prospective single arm study aims to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients. Patients will be given two cycles of TP regimen + Sintilimab, followed by concurrent chemoraiotherapy, and consolidative 6 cycles of Sintilimab.

Eligibility Criteria:
Inclusion Criteria:

* (1)Age between 18 and 75; (2)Untreated patients with pathologically proven squamous carcinoma; (3)T3-4N1-2M0 cervical cancer; (4)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; (5)Adequate hematological, renal and hepatic functions: (6)Hemoglobin \> 8.0 g/dl ; Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L; Platelets \> 100 × 109/L; Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL); Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL); Serum ALT/AST ≤ 2.5× UNL; Serum Total bilirubin ≤ 1.5× UNL; (7)Life expectancy \> 6 months; (8)Eligible for concurrent chemoradiotherapy assessed by principle investigator; (9)No obvious active bleeding; (10)Written informed consent must be available before study registration.

Exclusion Criteria:

* (1)Recurrent or distant metastatic disease; (2)Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; (3)Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; (4)Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; (5)Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; (6)Previous organ transplantation or HIV patients; (7)Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; (8)Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 10\^3 copies/ml.
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial

This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA in the maternal blood.

First trimester screening is the current standard of care for pregnant women in the United States. Women with a high screening risk for trisomy then have invasive testing, which carries a risk of miscarriage, to definitively determine if the fetus has trisomy. Because of the high false negative rate of the first trimester screening, an unacceptable number of trisomic fetuses are not detected. Moreover, because of the high false positive rate, an unacceptable number of women undergo invasive follow up testing. Additional screening tests are needed that combine a high sensitivity, a low false positive rate, and minimal or no risk to the fetus.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy
2. Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
3. Mother has a high or moderate risk for trisomy
4. Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure

Exclusion Criteria:

1. Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
2. Egg donor used
3. Mother or father have known chromosomal abnormalities (including known balanced translocations)
4. Participation in the study in a previous pregnancy
5. Pregnancy is a result of IVF with pre-implantation genetic diagnosis
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).


Eligibility Criteria:
Inclusion Criteria:

1. AML as defined by the WHO diagnostic criteria
2. Age \< 19 years at time of diagnosis
3. Written informed consent

Exclusion Criteria:

1. Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
2. AML secondary to previous bone marrow failure syndrome.
3. Down syndrome (DS)
4. Acute promyelocytic leukaemia (APL)
5. Myelodysplastic syndrome (MDS)
6. Juvenile Myelomonocytic Leukaemia (JMML)
7. Known intolerance to any of the chemotherapeutic drugs in the protocol.
8. Fanconi anaemia
9. Major organ failure precluding administration of planned chemotherapy.
10. Positive pregnancy test
11. Lactating female or female of childbearing potential not using adequate contraception
MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition

The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa). The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash. This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province. One arm will receive the intervention and one will be a control arm. The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be analyzed. Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.

At international level, the WHO formulated guidelines for the treatment of severe acute malnutrition (or wasting) (WHO 1999, and more recently ACF 2011), and guidelines for moderate acute malnutrition (or wasting) are in the process of formulation. In contrast, surprisingly little is known on preventive schemes for acute malnutrition. In Haiti, Ruel et al (2008) found that targeting nutrition interventions to prevent children from becoming malnourished might be more effective than curative treatment to reduce child wasting. In addition, recent preventive trials in humanitarian settings focused on the use of food-based strategies, especially ready-to-use food (Isanaka, 2009; Hendricks, 2010; Parikh, 2010; Imbad, 2011; Huybregts, 2012). However, it is well known that the causes of under-nutrition are numerous and also relate to inadequate health and care practices, lack of food diversification, food insecurity... Therefore, the MAM'Out research project aims at assessing a context-adapted preventive approach, which is likely to influence several underlying causes of under-nutrition and not based primarily on food supplementation. The objective is to provide an evidence base for this alternative approach, in order that proven intervention be taken into account for scale-up at policy-making levels.

Eligibility Criteria:
Inclusion Criteria:

* Poor or very poor household (HEA criteria)
* Having at least one children under 1 year old at the time of inclusion

Exclusion Criteria:

* Medium or rich economic status (HEA criteria)
* no child under one year old at the time of inclusion
* not living in one of the 32 selected villages in the Tapoa province
Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.

Phase 2 study in approximately sixty subjects previously diagnosed with Polycythemia Vera who require phlebotomy on a routine basis. There is a 28 week dose finding phase to identify a dose that maintains hematocrit \<45%. Subjects who successfully complete the dose finding phase will be entered into a 12 week randomized withdrawal phase to confirm the response. Subsequently patients will enter into an up to 3 year open label extension to investigate long term safety.

Eligibility Criteria:
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled.

1. Male and female subjects aged 18 years or older.
2. Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera.
3. Records of all phlebotomies performed for at least 28 weeks (preferably up to 52 weeks) before dosing are available.
4. Subjects who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy.
5. Subjects receiving cytoreductive therapy with hydroxyurea, interferon, or ruxolitinib must have received cytoreductive therapy for at least 24 weeks and be on a stable dose or have a decreasing dose (Medical Monitor approval required) for at least 8 weeks before dosing and with no planned change in dose.

Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled:

1. Active or chronic bleeding within 4 weeks of screening.
2. Meets the criteria for post-PCV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
3. Known primary or secondary immunodeficiency.
4. Any surgical procedure requiring general anesthesia within 1 month prior to screening or planned elective surgery during the study.
CLBP Single-Arm Long-Term Follow-up Study

This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.


Eligibility Criteria:
Inclusion Criteria:

- Patient received the Intracept procedure while participating in "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Long-Term Study)"

Exclusion Criteria:

- None