cyrilzakka/clinical-trials huggingface dataset:
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.


Eligibility Criteria:
Inclusion Criteria:

- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries

Exclusion Criteria:

- Not applicable as this is a study collecting third-party data from registries
Video Telehealth Gait Retraining for Running-Related Knee Pain

In this randomized control trial, participants with running-related knee pain will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a telehealth gait retraining intervention, an at-home exercise program, a return to running protocol, and standard physical therapy. Participants in the control group will receive an at-home exercise program, a return to running protocol, and standard physical therapy. Data will be collected before intervention, at 10-weeks, and at 14-weeks to determine efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Active Duty Soldier or Cadet between the ages of 18 to 60 years old
* Knee pain that occurs during and/or after running that was not due to a recent acute trauma (such as an accident or a fall) and that is a pain intensity of at least a '3' and no greater than a '7' on a numeric pain rating scale with '0' meaning "no pain" and '10' meaning the "worst possible pain"
* Fluent in speaking and reading English

Exclusion Criteria:

* Currently on an Army running limiting profile for something other than knee pain
* Presence of rheumatoid or neurological diseases
* Plans to deploy or permanent change of station (PCS) within 4 months
* Current lower extremity injury other than knee pain
* History of traumatic knee injury (such as a surgery, ligament tear, or meniscal tear)
* Current pregnancy
* Inability to perform 20 unassisted single leg heel raises on each leg
* A non-rearfoot strike pattern during running
* Showing signs of ligamentous instability, meniscus pathology, or knee effusion
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or equal 10 years and \< 65 years
* Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye \>0.4 logMAR
* No explanation for visual loss besides LHON

Exclusion Criteria:

* Any previous use of idebenone
* Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
* Previous participation in Study SNT-II-003 (RHODOS) for idebenone.
Old Red Blood Cell In Renal Transplantation

Kidney transplantation is the treatment of choice for ESRD. However, the life expectancy of kidney transplant patients is lower than that of the general population. Deaths recipients are due mainly to cardiovascular diseases related to a chronic inflammatory state. In addition, renal transplant patients frequently have anemia, identified as an independent cardiovascular risk factor that can be corrected by blood transfusion.

But the relationship between transfusion and inflammatory condition are bidirectional. The patient's inflammatory condition will sound on the effectiveness of transfusion and transfusion could trigger an inflammatory condition. This has been reported with the said blood components "aged", especially with packed red cells in patients hospitalized in intensive care after heavy heart surgery.The main objective of this study is to evaluate the impact of early transfusions on the evolution of renal transplantation (ie death, anti-HLA immunization, acute rejection, graft loss, delayed graft function, cardiovascular events ) taking into account in the analysis: patient age at the time of transplantation, the number of incompatibility (s) (HLA class I and / or II) between the graft and the patient and sex of the recipient.

This is a multicenter retrospective observational study (descriptive epidemiological study).The impact of early transfusions is determined retrospectively over a period of 6 years from 01 January 2002 to 31 December 2008, in renal transplant patients of all centers of France met the criteria for inclusion. This cohort represents about 12 000-14 000 patients


Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged over 18 years
* patients who received a first kidney transplant

Exclusion Criteria:

* Patients who received multiple transplants.
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI.

SPECIFIC AIM 1

2 urine samples (sampling at least 2 weeks apart) for urinalysis, urine culture, uNGAL, and NGS (16S rRNA and shotgun) under the same conditions. In addition to completing the USQNB-IC prior to urine collection, participants will complete the USQNB-IC 3 days after urine collection

SPECIFIC AIM 2 Intravesical LGG dose (group: high or low) will be obtained, USQNB-IC, urine collection for urinalysis, culture, NGAL and next generation sequencing as described above. And patient satisfaction questions.

Eligibility Criteria:
Inclusion Criteria:

* SCI at least 1-year duration;
* Neurogenic bladder;
* Utilizing intermittent catheterization for bladder management;
* Women must be premenopausal and not currently menstruating;
* Community dwelling

Exclusion Criteria:

* Use of prophylactic antibiotics;
* Instillation of intravesical antimicrobials to prevent UTI;
* Psychologic or psychiatric conditions influencing the ability to follow instructions;
* Use of oral or IV antibiotics within the past 2 weeks;
* Sexual activity within the previous 72 hours;
* Participation in another study with which results could be confounded.
Air Tamponade in Macular Holes < 400 μm

Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.


Eligibility Criteria:
Inclusion Criteria:

* Primary macular hole less than 400 μm in diameter
* Duration of symptoms less than 36 months
* Informed consent

Exclusion Criteria:

* Previous vitreomacular surgery
* Myopia more than 6 diopters
* Ocular trauma
* Disease affecting visual function
PAthwAy of Dyspneic patIent in Emergency in the North-east Region (North-East PArADIsE)

This is an observational retrospective multi-center study in patients managed for acute dyspnea by Emergency department medical team.

The main aim of the study is to evaluate factors associated with mortality risks in patients managed for acute dyspnea by an Emergency department medical team, overall, as well as in subgroups of interest (male/female, age categories, mode of admission and comorbidities).


Eligibility Criteria:
Inclusion Criteria:

* Man or women ≥ 18 years
* Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy, CHR Metz-Thionville and CH d'Epinal.

Exclusion Criteria:

* Cardiorespiratory arrest before medical management by the Emergency Department team
* Adults under legal protection
To Evaluate Pharmacokinetics of LFF269 in Healthy Volunteers and Patients With Hypertension

This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.


Eligibility Criteria:
Inclusion Criteria:

Part 1

- Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

Part 2

* Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive.
* Patients with mild-to-moderate uncomplicated essential hypertension

Exclusion Criteria:

Part 1

* History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
* A history of clinically significant ECG abnormalities.
* Known history or current clinically significant arrhythmias.
* History of hypertension, adrenal or endocrine disease.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Smokers (use of tobacco products in the previous 3 months).
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen or Hepatitis C test result.

Part 2

* Pregnant or nursing (lactating) women.
* Women of child-bearing potential.
* Known history or evidence of a secondary form of hypertension
* Type 1 or type 2 diabetes mellitus.
* History of heart diseases
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Other protocol defined inclusion/exclusion criteria may apply
Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.

Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.

Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.

Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV


Eligibility Criteria:
Inclusion Criteria:

* Medically free pregnant Female from 18 to 30 yrs old.
* Undergoing elective LSCS.
* Body mass index less than 40.
* Consenting for sub arachnoid anesthesia.
* Coagulation profile is within normal ranges.

Exclusion Criteria:

* Emergency LSCS.
* Patient refusal enrollment in the study.
* Allergy to the medications.
* Coagulopathy or anticoagulation drugs.
* Fetal or Maternal comorbidities.
Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics

The investigators aimed to evaluate whether they can be improved by an AI-based personalized prescription of scalp cosmetics.


Eligibility Criteria:
Inclusion Criteria:

1. healthy adults aged \>19 years
2. presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple)

Exclusion Criteria:

1. presence of active infectious scalp diseases
2. history of treatment with topical or systemic steroids, oral immunosuppressants, topical or systemic antibiotics, or antifungal agents that could affect the scalp conditions, within 4 weeks prior to the baseline
3. difficulty understanding or following the protocol
Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants

This study will investigate pharmacological interventions between fluconazole and ibuprofen when they are given to premature newborn babys. This in order to find out if the drugs are influencing each other when they are given at the same time. The study is meant to find out if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.

To evaluate the effect of fluconazole and/or ibuprofen on the urinary excretion of two vasoactive arachidonic acid products, thromboxane A2 (TXA2) and prostacycline (PGI2), in newborn infants treated with one or both of these drugs because of fungal infection prophylaxis and/or patent ductus arteriosis (PDA), respectively, as measurement of the possible interactions between these drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Newborn infants in need of prophylaxis with fluconazole according to clinical routines and/or clinical indication for treatment of Patent Ductus Arteriosis (PDA), or newborn infants who are not treated with either fluconazole or ibuprofen according to the following study groups:

   1.1 Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole.

   1.2 Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen.

   1.3 Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen.

   1.4 Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen.
2. Parents that are in command of the Swedish language and capable of understanding the study plan
3. Informed written parental consent

Exclusion Criteria:

1. Infants who need treatment with other drugs that are metabolised by enzyme Cytochrome (CYP2C9) (such as phenytoin, sulphamethoxazole, fluvastatin, sildenafil, losartan, irbesartan, torsemide, tienilic acid), or any other enzyme involved in the metabolism of fluconazole and or NSAIDs, or treatment with drugs that interact with NSAIDs at the cyclooxygenase level, or interact with the vasal effects of the metabolic products of the cyclooxygenase.
2. Infants without possibility to conceive the objectives and implications of the study in the opinion of the investigator.
The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women

Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2".

Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. The aim of this study, which was conducted to determine the effects of mindfulness practices and deep relaxation exercises on the level of pregnancy-related anxiety, is to create intervention programs compatible with the prenatal period and to contribute to the improvement of pregnancy outcomes. First of all, a total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. However, we recalculated the power analysis with a reference study after obtaining approval and before starting the study. With the calculation we made with the reference study, we determined our final sample number as 102 pregnant women (34 individuals for the mindfulness meditation group, 34 individuals for the deep relaxation exercises group, and 34 individuals for the control group). Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2". Mindfulness and deep relaxation practices was applied by midwives who are experts in their fields who are certified in these fields.

Eligibility Criteria:
Inclusion Criteria:

* Having internet access,
* Without any diagnosed psychiatric health problem,
* At 12-24 weeks of gestation,
* There is no risk factor in pregnancy,
* Literate,
* Using smart phone,
* Having a headset accessory for phone calls,
* Pregnant women who voluntarily agreed to participate in the study

Exclusion Criteria:

-Mental disabilities
Consumer Motivation for Disease Prevention 2 (Clear Labels)

The purpose of this study is to examine (1) how the causal structure of a disease influences people's disease prevention decisions; and (2) how the causal structure of a disease interacts with people's regret anticipation in determining their disease prevention decisions.

People sometimes have to deliberate on whether or not to remove a risk factor that may potentially cause a disease in the future. When a modifiable risk factor (say, X) is the only factor that causes a disease, the decision to remove it may simply depend on the probabilistic relationship between X and an outcome, as well as the cost of removing X. However, little is known when other factors that are out of the decision-maker's control are also present. The main question being asked here is how does the presence of such non-modifiable factors change people's decision to remove X.

Specifically, the investigators consider two cases: a disease caused by a single modifiable risk factor (say X) and a disease caused by two risk factors -- a modifiable factor (X) and a non-modifiable factor (Y). In both cases, the removal of X can result in a meaningful reduction in overall disease risk. It is hypothesized that even when the magnitude of overall risk reduction brought by the removal of X is the same in the two cases, people would have a lower motivation to remove X in the latter case.

The investigators also examine how the presence of a non-modifiable risk factor interacts with the respondents' regret anticipation to influence their decision to remove X. In the context of the current research, regret anticipation could take one of the following forms: (a) feel regretful if one decides not to remove X and later develops the disease (b) feel regretful if one decides to remove X but still develops the disease. The investigators expect (a) to moderate the effect of non-modifiable risk factor on motivation to remove X.

Eligibility Criteria:
Inclusion Criteria:

* students currently studying at the Chinese University of Hong Kong

Exclusion Criteria:

* None
Problem Specific Templates for Electronic Hospital Documentation

The emergence of electronic documentation has led to multiple new challenges for physicians. Despite positive expectations, many physicians have received electronic health systems with mixed results. Review of current literature has identified the following reasons for concern: increased time required for documentation, deteriorating quality of notes, mindless use of copy-and-paste functions, and fragmentation of clinical work from poorly designed computing workflows. The study of template use has not been done in a large scale or with clear outcome measurements. The purpose of this study is to examine the effects of Problem Specific Templates on quality, accuracy, and efficiency of physician documentation practices.

This is a prospective cohort study, which will examine the effects of Problem Specific Templates on quality, accuracy, and efficiency of physician documentation practices. The Hospitalist physicians will be the subjects. All physicians of the Hospital Medicine Service will be invited to participate. For the intervention, participating Hospitalists will be trained on the use of templates for 20 common hospital problems. Once trained, the Hospitalists will be asked to use these templates for a one-month period. Pre-intervention and post-intervention medical records will be compared using chart reviews, validated document assessment instruments, physician surveys, and electronic medical record time auditing.

Eligibility Criteria:
Inclusion Criteria:

* Physicians: All physicians of the Hospital Medicine Service will be invited to participate

Exclusion Criteria:

* Any invited physicians who refuse to consent
Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study

The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.

There are 7 different averaging time settings available with PRICO (Acutronic Medical Systems AG, Hirzel, Switzerland), but after over a year of experience there is no clear clinical impression of the best setting. Therefore, a small systematic study is needed to determine the optimal guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after parental informed consent is obtained.

Exclusion Criteria:

* Parental informed consent is not obtained
* Recording device for automated control of FiO2 is not available