cyrilzakka/clinical-trials huggingface dataset:
To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension following 12 weeks of daily intake.


Eligibility Criteria:
Main Inclusion Criteria:

* Office Systolic Blood Pressure between 130 and 159 mmHg and Diastolic Blood Pressure \< 100 mmHg
* Body Mass Index (BMI) between 18.5 and 35 kg/m²
* Weight stable within ± 5 % in the last three months
* No significant change in food habits or in physical activity in the 3 months prior to randomization and agreeing to keep them unchanged throughout the study

Main Exclusion Criteria:

* Known or suspected secondary hypertension
* Known hypertensive retinopathy and/or hypertensive encephalopathy;
* History of spontaneous or drug-induced angioedema;
* Clinically significant valvular heart disease or severe aortic stenosis
* History of acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to screening
* Suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.


Eligibility Criteria:
Inclusion Criteria:

* Girls and boys ≥5 years to ≤12 years (Cohort 1); and ≥6 to ≤59 months of age (Cohort 2) with uncomplicated, symptomatic malaria as indicated by the presence of the following:
* Blood smears positive for monoinfection with P. falciparum and asexual parasitemia between 1000 -100,000 parasites/µL;
* Documented fever (38.0°C/100.4°F rectal or tympanic; 37.2°C/99.0°F axillary or 37.5°C/99.5°F oral) or history of fever (as reported by the legally acceptable representative) within the prior 24 hours;
* Appropriate for outpatient treatment;
* Blood glucose ≥60 mg/dL;
* Hemoglobin ≥6 g/dl or hematocrit ≥18% without signs of anemia-induced Congestive Heart Failure (CHF);
* Negative urine pregnancy test for females ≥10 years of age (and of child bearing potential)

Exclusion Criteria:

* Peripheral blood smear positive for mixed infection with multiple Plasmodium spp.
* Severe or complicated malaria including subjects with any of the following:
* Impaired consciousness (eg, obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria;
* Known hemoglobinuria;
* Jaundice;
* Respiratory distress;
* Persistent vomiting;
* Gross hematuria, as reported by the subject's legally acceptable representative;
* Recent history of convulsions;
* Inability to drink or breastfeed;
* Unable to sit or stand as appropriate for age;
* Known pregnancy or breast-feeding or positive urine pregnancy test (females ≥10 years of age and of child bearing potential);
* History of allergy to or hypersensitivity to azithromycin, any macrolide, chloroquine, artemether, any artemisinin derivative, lumefantrine;
* Any contraindication to any study drug including AZ, CQ and AL;
* History of treatment with any antimalarial drug (such as halofantrine, chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment of a subject (and/or of the mother of a subject who is being breastfed) into the study;
* Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the investigator would place the subject at increased risk to participate in the study.
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.

Lymphatic malformations (LMs) are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and might present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells. With an estimated incidence of approximately 1/4000-1/2000, LMs can occur at any site in the lymphatic system, in which head, neck and axilla were mostly detected and have been reported to account for over 75%. Based on the location and size of the lesion and the extent of involvement, LMs may be asymptomatic with incidental detection, or chronic abdominal pain and distension due to their compression of surrounding structures, or critical and even fatal secondary to their volvulus, hemorrhage, infection and rupture. Surgical excision is a definitive treatment for LMs, while it may be difficult at times because of the infiltrative nature of the lesions, leading to a high incidence of complications like vital organ injuries, nerve injuries, bleeding, infection scar formation, and recurrences. Sclerotherapy is a simpler alternative to tedious surgical excision treatment for LMs and avoids the complications related to surgery. As an anticancer drug extracted from Streptomyces verticillus, Bleomycin has been more and more widely used in the sclerotherapy of LMs for pediatric patients, which has been proven to be primarily dose dependent. However, the optimum concentration of Bleomycin in the sclerotherapy of LMs for pediatric patients has not been strictly validated, due to the lack of high-quality RCT studies. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants less than 14 years of age at the time of informed consent/assent form was signed.
* Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them.
* Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy.

Exclusion Criteria:

* Penicillin allergy.
* Vascular tumors or combined vascular malformations.
* Participants who may have had surgical or sclerotherapy treatment by other hardeners.
* LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely.
Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine

Covid-19 vaccines offered a good opportunity to counteract the spread of Sars-Cov-2 infection among the general population, reducing significantly both morbidity and mortality.

Nevertheless, after the first and second doses of vaccination (regardless of the type of vaccine used) several women required gynaecological visits claiming menstrual Irregularities or abnormal uterine bleeding. Considering this anecdotal evidence, a questionnaire was designed to investigate systematically whether menstrual Irregularities or abnormal uterine bleeding occurred in a significant percentage of women undergoing first and second doses of covid-19 vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

Exclusion Criteria:

* Women undergoing any kind of hormonal therapy, including combined oral contraceptives, oral/vaginal progestins, intrauterine devices, GnRH-analogues, aromatase inhibitors, hormonal replacement therapy in menopause;
* Surgical menopause (hysterectomy and/or bilateral oophorectomy);
* Breastfeeding.
Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures

to assess the success of wide-awake local anaesthesia In fixation of ankle fractures

The wide-awake local anesthesia with no tourniquet provides an alternative method for the existing anesthesia methods including general anesthesia, intrathecal, epidural anesthesia, peripheral nerve block and local anesthesia with intravenous sedation. Each method of them has its inherent risks and costs.

The wide-awake local anesthesia has few risks for the patient and can be used in satisfaction where other types of anesthesia particularly general anesthesia are contraindicated.

This method is safe, effective and provides satisfactory pain and anxiety scores. Patients don't have to stay for a long time after surgery. It allows the surgery to be done without tourniquet due to the use of epinephrine and this avoids the complication of tourniquet and allows the surgery to be done safely in cases of limb vascular insufficiency and in diabetic patients where tourniquet usage is not favorable.

Wide awake local anesthesia method for ankle fracture management is not a novel idea; it was previously investigated in one study but the limitation of this study that it was retrospective study with small sample size and without control group treated with other anesthetic modalities.

There is concern that the use of lidocaine in hematoma block is harmful for joint cartilage. Excess use of epinephrine may cause excessive vasoconstriction and cyanosis of fingers . Neuropathic complication are notably high during the early postsurgical period .

Wide-awake anesthesia is delivered by the surgeon . The role of anesthetic team, if needed, is monitoring the vital signs and in case of failure of wide-awake and prolonged time of surgery .

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with unstable ankle fracture who need fixation presenting to the Trauma Unit of Assiut University Hospital with the following criteria:

  1. Age ≥ 18 years.
  2. Isolated ankle fracture in one or both lower limbs.

Exclusion Criteria:

1. patients\< 18 years.
2. Patients with uncontrolled diabetes mellitus.
3. open fractures.
4. Associated fractures in the lower limbs(Spinal anaesthesia will be more suitable in multiple fractures)
5. Fractures managed by closed contact casting.
6. Patients with dementia and psychological disease.
Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine

Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general population. It is characterized by chronic headache occurring for at least 15 days a month, by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month (for simple analgesics). The chronic headache must have occurred during the period of antimigraine drug abuse and the headache must have returned to its episodical pattern after withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the first year following the antimigraine drugs withdrawal.

The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse in the transformation from migraine through MOH is not fully understood.

We recently explored cerebral metabolism in these MOH patients using (18F)FDG-PET (Fluoro Dexoxy Glucose Positon Emission Tomography) comparing them with controls. Results showed a hypometabolism in the OFC, which persist immediately after the antimigraine drugs withdrawal. A similar pattern is observed in varied substance related disorders and should be a marker of addictive behaviour. It can be linked with difficulties in the decision-making process, which can be explored by the Iowa Gambling Task (IGT) test.

Several questions are still unanswered. What will this abnormality become in the long term ? Is it predictive of susceptibility for relapse? Can it be linked to a specific psychological profile (addictive behaviour)?

Eligibility Criteria:
Inclusion Criteria for patients :

* older than eighteen years
* suffering from MOH (ICHD-II criteria)
* French speaking
* who wish to go on a withdrawal procedure

Exclusion Criteria :

* pregnant women or women of child bearing age who are not using contraception
* post traumatic headaches
* illnesses interfering with the central nervous system functionning
* psychotic disorder or current major depressive episode
* contraindication for PET or MRI (Magnetic Resonnance Imaging)
* contraindication for all prophylactic treatment for migraine
Effect of Smoking on the Expression of Gelatinases in Chronic Periodontitis

This study comparatively evaluate the expressions of MMP-2 and MMP-9 in smoker vs non-smoker chronic periodontitis patients as well as periodontally healthy subjects. the hypothesis of this study was that smoking may interfere with periodontal disease by effecting MMP-2 and MMP-9 expressions.

Smokers have greater risk for developing periodontal disease and smoking is highly correlated with greater marginal bone loss. Matrix metalloproteinases (MMP) play a major role in periodontal tissue destruction. MMP-2 and MMP-9, called gelatinases, are one of the major MMPs that plays important roles in periodontitis. To date, several studies showed the increased levels of gelatinases in periodontal disease and only a limited number of study investigated the effect of smoking on gelatinases. However, no previous study has directly investigated the possible relationship between smoking and gingival tissue gelatinases expressions (MMP-2 and MMP-9) in chronic periodontitis (CP) patients relative to periodontally healthy subjects.

Therefore this study is conducted to comparatively evaluate the expressions of MMP-2 and MMP-9 in smoker vs non-smoker chronic periodontitis patients as well as periodontally healthy subjects. the of this study hypothesis was that smoking may interfere with periodontal disease by effecting MMP-2 and MMP-9 expressions.

Eligibility Criteria:
Inclusion Criteria:

* A total of 80 subjects (35 females, 45 males, with an age range of 16-62 years) were included in this study from those patients seeking dental treatment at the Baskent University School of Dentistry between February 2010 and December 2012.

Exclusion Criteria:

* Patients with systemic disease;
* pregnant and/or lactating women;
* patients taking any medications that may influence the study.
Online Survey on Computer Password Usage.

Researchers at Towson University are conducting a study of computer password behaviors among users who have difficulty using their hands and arms (e.g., individuals with carpal tunnel syndrome, high level spinal cord injuries, etc.). Volunteers are needed to take a short 5-10 minute online survey.

The survey is completely confidential and anonymous. If you would like to participate, please visit the URL below. Thank you.

http://pages.towson.edu/jdarcy/securitysurvey.htm

Two researchers from the Department of Computer \& Information Sciences at Towson University are seeking individuals who have difficulty using their hands and arms (e.g., as result of carpal tunnel syndrome, high level spinal cord injuries, etc.) to participate in a survey. The survey should take approximately 10 minutes to complete and all responses will remain completely confidential and anonymous.

The purpose of the survey is to gain insight into the computing behaviors of individuals with upper-body motor impairments. We expect that the results will help researchers and system developers create more effective access control techniques to meet the special needs of this user population. The results should also assist employers in providing improved technical and procedural support to computer users that have difficulties using standard input devices.

If you would like to take the online survey, please go to the following link:

http://www.towson.edu/cosc/securitysurvey

If you prefer a paper version of the survey, please send us an e-mail that contains your mailing address and we will send the survey to you.

Contact information:

John D'Arcy, Ph.D. (jdarcy@towson.edu) Jinjuan Feng, Ph.D. (jfeng@towson.edu) Department of Computer \& Information Sciences Towson University 7800 York Road Towson, MD 21252 U.S.A.

Eligibility Criteria:
Inclusion Criteria:

* Users who have difficulty using their hands or arms

Exclusion Criteria:

-
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening with Momentum SpineTM

The goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. The main question it aims to answer \[is/are\]:

* Based on previous data it is hypothesize that Momentum SpineTM imaging software will be able to accurately detect scoliosis progression (\>= 7 degrees), including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs.
* Based on the above hypothesis that Momentum SpineTM is able to accurately detect scoliosis and curve progression (\>= 7 degrees).
* It is hypothesized there will be indications for accelerated clinical visits based on at home detection of progression, and that these visits will be accurate and necessary.
* It is hypothesized that there will be a proportion of standard care visits that are deemed unnecessary, and that the application is able to accurately predict these visits.

Participants will:

* Use Momentum SpineTM assessment from home to perform body scans at 1-month intervals on personal device and during the clinical visit.
* Received monthly scans that will be evaluated by the provider using the application.
* Receive additional scans as warranted.
* Complete net promoter score (NPS) within the application following completion of a body scan.
* Complete a patient satisfaction survey following 6 months of application usage.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 8-18 years of age
* Confirmed radiographic diagnosis of adolescent idiopathic scoliosis
* No history of spinal/ chest surgery.
* Participants who have had spine x-rays ±1 week as baseline visit at CHLA will be included in the study.
* Participants who have identifiable markings such as tattoos or birthmarks can be included in the study, though their markings will be covered with tape.

Exclusion Criteria:

* Participants who have had x-rays in a brace will not be included.
* Participants who have had an x-ray from another institution will not be included in the study. X-rays from out of community are typically done with a different and lower quality machine then the one at our institution. Additionally, we do not have consent from outside institutions to use their x-rays for research purposes.
* Participants with a confirmed pregnancy will not be included. Pregnancy status will be self-reported by participants.
* Participants with the existence of a second deformity which may affect topographic assessment will be excluded (e.g. Limb length discrepancy greater than 2cm).
* Families who do not speak English and Spanish will be unable to participate as the application is only available in English and Spanish at this time.
* Families who do not have access to their own compatible personal smart phone device will be unable to participate in the study.
MEasurement by a Numerical Approach of BREAst Volume

Breast asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic.

In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. It is recommended to do this surgery after a slimming treatment if the woman is overweight or after pregnancy that causes a change in the structure and volume of the chest. In fact, the weight variations deteriorate the long-term result.

However, this surgical management remains difficult. In fact, the volume to be removed (unilateral breast reduction) to be symmetrized is a function of the volume of the contralateral breast and the preoperative drawings are made while standing. Currently, the evaluation of the volume to be removed remains subjective and is based on the experience of the surgeon. In addition, intraoperatively, this evaluation is also subjective because the patient is lying down which changes the position of the anatomical landmarks: the optimization of the symmetrization is only possible by the eye and the touch.

No measuring device is currently used to assess the difference in volume between the 2 breasts and guide the surgeon in the volume (or weight) to remove. It is therefore sometimes necessary to perform a second intervention in case of residual postoperative asymmetry.

Primary objective :

To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).

Second objective : To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for uni / bilateral breast reduction as part of an indication of surgical management.
* Major patients.
* Patients affiliated or beneficiaries of a social security scheme
* Patients who have signed prior informed consent.

Exclusion Criteria:

* Protected patients (pregnant, parturient and lactating women, persons deprived of their liberty by an administrative or judicial decision, persons undergoing psychiatric care under duress, minors, adults over the age of 18) legal protection measure or unable to express their consent).
* Patients unfit to understand the objectives or instructions of the study.
* Patients in an exclusion period relative to another interventional study.