cyrilzakka/clinical-trials huggingface dataset:
Fetal 3D Study (Fetal Body Composition and Volumes Study)

Normal fetal growth is a critical component for a healthy pregnancy and for ensuring the health and well-being of infants throughout childhood and adolescence. One promising area of research suggests that changes in fetal soft tissue may be the earliest changes that occur in pathologic growth. Three-dimensional volume assessments may be used to detect changes in fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than conventional 2D measures. This knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.

The NICHD Fetal Growth Study was a multi-site, prospective cohort study designed to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population. For the singleton study, 2,334 low-risk, non-obese gravidas were recruited from each of 4 self-identified race/ethnicity backgrounds. An additional 468 obese women and 171 dichorionic twin gestations were recruited. After an initial sonogram in the first trimester, women were randomized to serial ultrasonology schedules. Each schedule comprised five additional sonograms for fetal biometry (six in twins) plus additional image and 3D volume acquisition for later analysis.

Ultrasound measurements at each follow-up visit included standard fetal biometrics ((BPD, HC, AC, FL) and the following volumes in the singleton study if they were able to be obtained: 1st trimester: fetus and gestational sac; 2nd and 3rd trimesters: head, cerebellum, face, chest, heart, abdomen, pelvis, arm and thigh. In twins, the volumes collected were 1st trimester: fetus and gestational sac and in the 2nd and 3rd trimesters the thigh. In addition to ultrasound, this study recorded maternal anthropometrics and a brief interview to capture changes in health status, stress and depression, and physical activity at each follow-up visit. Blood draws at baseline and at targeted gestational ages were obtained for the eventual identification of biomarkers indicative of fetal growth were collected. After delivery, neonatal anthropometric measures were assessed, placental biospecimens were collected, and select information about the obstetrical course and newborn status were abstracted from medical charts.

The Fetal 3D Study is being conducted to catalog and perform 2 Dimensional (2D) and 3 Dimensional (3D) measurement of the obstetrical ultrasound images in the existing bank of singleton and twin gestations collected from the NICHD Fetal Growth Studies. The research study aims to understand the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat, lean mass) and organ measurements (in singletons) over the course of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women with ultrasound data collected from the NICHD Fetal Growth Studies-Singletons and Twin Gestations

Exclusion Criteria:

* None
Treatment of Splenic Trauma: a Retrospective Cohort Study

In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most frequent source of bleeding in the abdomen.

Historically, splenectomy was the treatment of choice for splenic bleeding. For exsanguinating patients, open splenectomy is still the proper choice of treatment if the spleen is a significant source of bleeding. However, for hemodynamic stable patients with splenic injury, non-operative management (NOM) is an alternative, assuming they have no other indication for surgery (peritonitis).

Non-operative management includes observation and/or splenic artery embolisation (SAE), but the indications for observation and SAE varies between trauma centers. The greatest advantage of NOM is the preservation of splenic function.

In the investigators hospital splenic artery embolisation was introduced in 2007. The investigators want to describe the treatment of splenic injuries in their hospital, to see if the number of splenectomies has been recduced after 2007, and to see if SAE has also been used in transferred trauma patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted at UNN Tromsø in the period of 01.01.2000 - 31.12.2013 and with the discharge diagnosis S36.0 Splenic injury (ICD-10)

Exclusion Criteria:

* no injury/coding error
* iatrogenic injury
* transfer \>7 days after injury
* \>10 days between injury and first hospital admission
Polyester Patch in Massive Rotator Cuff Repair Improves Healing

The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.

Exclusion Criteria:

* We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.
Vitamin D Nasal Drops in Post COVID-19 Parosmia

The current study will be a pilot study for a randomized controlled trial conducted on patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine To evaluate the effect of vitamin D nasal drops in the treatment of post COVID 19 parosmia

The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study.

To be included in the study, patients should be more than 18 years old, have a history of COVID 19 infection more than three months ago as confirmed by PCR test, have a post COVID parosmia, and have no history of systemic steroid administration over the last one month. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Ivermectin were the exclusion criteria for this study.

Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. The case group will receive a 4 week course using Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drop. The patients will receive two drops per nostril twice daily. The Control group will receive a 4 weeks course of local steroids in the form of budesonide (64 µg per puff in a dose of 1 puff for each nostril twice daily.

Assessment protocol:

Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria. Endoscopic examination of the nasal cavity will be performed to exclude any other intranasal pathology. The degree of parosmia will be assessed using a visual analog scale before and four weeks after treatment.

Outcome measures:

Primary outcome measures will include a comparison between the pre and post treatment values of visual analog scales of parosmia, and a comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement. Secondary outcome measures will include assessment of the side effects of Ivermectin nasal drops among the case group.

Eligibility Criteria:
nclusion Criteria:

* Patients should be more than 18 years old,
* Patients having a history of COVID 19 infection more than three months ago as confirmed by PCR test,
* Patients having a post COVID parosmia,
* Patients having no history of systemic steroid administration over the last one month.

Exclusion Criteria:

* History of previous nasal surgery,
* Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
* Hypersensitivity to vitamin D3.
HPV Vaccination Health-promotion Programme on Vaccine Acceptance and Uptake Among Female Adolescents

The MDL-SHPVP will be developed and a clustered randomised controlled trial will be conducted to evaluate the effects of the MDL-SHPVP and to examine whether the effect of the MDL-SHPVP on the rate of HPV vaccine uptake 1 year after intervention is mediated by parents'/guardians' and female adolescents' HPV knowledge, attitudes and beliefs, adolescents' intention to receive HPV vaccination and vaccine acceptance among their parents/guardians.

2520 adolescents and their parents or guardians from 18 local secondary day schools will be recruited. Multicomponent interventions will be offered to the intervention schools. To build and strengthen the community capacity in health promotion, a team of volunteers will be established to raise awareness of HPV, cervical cancer and HPV vaccine.

Data will be collected at baseline, 1 month and 1 year after intervention. The mixed-effects model will be used to compare the differential changes for each of the primary and secondary outcomes across time between the two groups.

The project is expected to instil a more accurate understanding of HPV and HPV vaccination and support the decision to undergo vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Female;
* Age 14-17 years;

Exclusion Criteria:

* Have received the HPV vaccination before
SugarFACT - Sugar Requirements For African Children Trial

The purpose of this study is to evaluate the impact of dextrose administration in severely sick children admitted to hospital with low-glycaemia.

The problem: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a mortality rate of up to 42%. An increased mortality has also been reported among acutely ill children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason for increased mortality rates is not fully understood.

Study objective: To determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.

Methodology: Severely ill children admitted to two central Malawian hospitals; Queen Elisabeth Central Hospital, Blantyre and Zomba Central Hospital, with low-glycaemia (2.5-5.0mmol/l) will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5ml/kg followed by a dextrose infusion in addition to standard care while the control group will receive standard care only. Children will be followed until discharge from hospital or death. Primary end-point is in-hospital mortality.

Enrolment started at Queen Elisabeth Central Hospital on Dec 5th 2016. Due to a slow enrolment rate a second site at Zomba Central Hospital has been opened to start enrolment on October 17th, 2017 in order for the project to be completed in December 2019.

Eligibility Criteria:
Inclusion Criteria:

* Age between one month to 5 years (5 to 12 years for outcome measure no 3)
* Parent/carer willing and able to give consent
* Presence of one or several emergency signs (as defined in WHO pocket book of hospital care for children)

  * Obstructed or absent breathing
  * Central cyanosis
  * Severe respiratory distress
  * Shock/impaired perfusion
  * Coma/reduced consciousness
  * Convulsions
  * Severe dehydration
* Clinical concern that the child is in an emergency state
* Blood glucose 2.5-5.0mmol/l at arrival to the emergency department (3.0-5.0mmol/l for severely malnourished children). For outcome measure no 4 children with \<2.5 mmol/l on arrival who then have 2.5-5.0 mmol/l on the repeat test 30 minutes later are also included

Exclusion Criteria:

* Children with a known diagnosis of diabetes
* Refusal to participate by the child or guardians
The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction

The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients

Cardiovascular disease (CVD) remains the first cause of mortality worldwide. More than 30% of CVD-connected fatalities are ascribed to ST-segment Elevation myocardial infarction (STEMI). There is strong and consistent evidence that aerobic exercise after a STEMI improves overall and cardiovascular-related mortality. Aerobic exercise (AE) acts in key mechanisms of cardiac remodeling and function improvement after STEMI, thus contributing both to prevent or postpone harmful adaptations, and even to recover from negative alterations caused by cardiac ischemia. However, the time of day to exercise for STEMI patients' optimal cardiac benefits is currently unknown.

The circadian clock endows the host with temporal precision and robust adaptation to the surrounding environment. Almost all physiologic, metabolic and endocrine processes, including glycolysis, lipid and carbohydrate metabolism as well as cardiovascular function (heart rate, blood pressure) are influenced by the circadian clock. Recent investigations in rodents utilizing gain-of-function/loss-of-function models and in humans have identified Adverse cardiovascular events have day/night patterns is related to endogenous circadian clock control of platelet activation events. Several studies have also demonstrated the effect of AE at different times on blood pressure. Indeed, timing is critical in amplifying the beneficial impact of AE. However, these studies did not address cardiac structural remodeling or other CVD-related metabolic markers, it difficult to determine the physiological and structural effects of different time AE on cardiovascular health.

Thus, In this trial our aim is to assess, in patients who have had an STEMI, AE in which time of a day can give the best benefits to cardiac remodeling and function improvement.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 75-years-old;
* Typical symptoms of acute myocardial infarction within 24 hours, with ST segment elevation of ≥1mm in two consecutive leads on electrocardiogram
* After receiving complete revascularization treatment
* Cardiac function grading I to II without any other serious complications
* Left ventricular ejection fraction \>30%
* Compliant with the guidelines of the American College of Cardiology/American Heart Association for participating in cardiac rehabilitation standards
* Signed written informed consent.

Exclusion Criteria:

* Patients with unstable angina
* severe symptomatic congestive heart failure detectable myocardial ischemia
* valvular disease requiring surgery
* severe ventricular arrhythmias
* severe concomitant life-threatening diseases such as cancer, and rheumatoid disease
* osteoarticular diseases that may affect the exercise process
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.

This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.

At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, 30 to 60 years of age
* Bilateral lateral canthal lines rated as moderate or severe
* Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study
* Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Muscle weakness or paralysis in the area receiving study treatment -Active skin disease or irritation at the treatment areas
* Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
* Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
* Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure.
* Previous treatment with Botulinum Toxin Type A in the face area
Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations

TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations. Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30 minutes before their surgery and will be followed up until 6 months after their surgery. The purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide measurements in the legs of patients undergoing lower limb amputation to predict wound healing complications and to determine an optimum cutoff value for both oxygen and carbon dioxide levels beyond which healing complications are likely to occur and a closer amputation level is indicated.

Lower limb amputation is a serious and unfortunate outcome for many patients with vascular disease, especially those with diabetes. It results in significant decreases in all aspects of quality of life. The need for further surgery to revise the amputation to a more proximal level leads to increased potential for serious and life-threatening complications, as well as a decrease in patient morale. From surveys and background literature, it can be estimated that there are approximately 8600 vascular disease-related lower limb amputations in Canada each year. As the epidemic of diabetes continues to unfold and the mean age of the population increases, this number is expected to increase. The results of this study may significantly assist in the surgical and clinical care of this patient population by providing clinicians with a means to assess appropriate lower limb amputation levels.

Further, the modalities of transcutaneous measures may assist in guiding further intervention studies in higher risk patients to improve clinically important outcomes. This study will act in part as a feasibility trial for a randomized controlled trial assessing the efficacy of supplemental oxygen therapy, including hyperbaric oxygen therapy, as a therapeutic tool to increase rates of healing after lower limb amputation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Requires a lower limb amputation between the ankle and knee due to vascular complications
3. Provides written informed consent

Exclusion Criteria:

1. Requires a lower limb amputation for non-vascular reasons, including trauma and cancer
2. Requires primary amputation below the level of the ankle or above the knee
Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)

KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (\<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment.

Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.

CNRK center is working on an eye rubbing questionnaire since 2017 in order to quantify that pejorative factor. Patient education can limit in a certain amount the Keratoconus progression. Thus, our objective will be to evaluate the therapeutic impact on Keratoconus progression of patient's education against eye rubbing according to an eye rubbing Questionnaire.

The validation of a dedicated questionnaire is an important act that will allow the scientific evaluation of this factor with both environmental and behavioral traits. It can thus be integrated into our care activity for its intrinsic educational and therapeutic virtues and for its decision-making aid for certain treatments. It will be useful first of all for the refinement of the correct prescription of corneal collagen crosslinking for evolving KC or KC with a high risk of progression.

Eligibility Criteria:
Inclusion Criteria:

* Coming for the first time for expert advice on KC
* Having a suspected or known KC
* Being over 13 years old (or from 13 years old)
* Possess computer connection equipment (computer, tablet or smartphone) and access to the network, for the completion of the questionnaire at home.
* Being affiliated to or beneficiary of health insurance
* Have signed the informed consent form from the patient and from legal representatives for minor patient

Exclusion Criteria:

* Being incapacitated or unable to follow study procedures
* Patient under legal protection
* Previous ocular surgery