cyrilzakka/clinical-trials huggingface dataset:
Examination of the Relationship Between Home Affordances With Development

Babies with a history of premature birth and low birth weight are at risk for developmental disorders. These infants may have motor, cognitive and behavioral problems compared to their term peers. Although advances in technology lead to an increase in survival rate, 50% of these infants may have developmental delays in motor, cognitive and behavioral areas. Premature birth does not accelerate any of the early sensory development processes, but exposure to intense, unusual stimuli of unusual character may delay or inhibit sensory development. Therefore, children born prematurely may be at risk in terms of sensory processing. The physical, sensory and social environment of the infant and young child is critical in supporting the healthy and appropriate development of the brain and nerve-sensory systems.

A newborn baby reacts involuntarily or reflexively to its environment. During the first few years of life, through physical growth and learning experiences, the child learns to participate actively in the world. Motor skills and sensory experiences begin to develop after birth, and development continues as children grow. Having good motor control also helps children explore the world around them, which can help many other areas of development. There are many environmental and biological factors that affect motor development. Especially the home environment where the child spends most of his time is one of the key factors affecting motor development. The home environment is known to be a very important factor for motor development in infants. At the same time, the variety of equipment and environmental conditions help children provide different sensory experiences. Exploring the home environment can have important developmental implications, as it is common practice for physiotherapists to advise patients on home activities. Environmental factors can affect the motor development of preterm children as well as other developmental areas. The number of studies examining the effects of environmental factors on motor and sensory development in preterm infants is limited in the literature. This study was planned to examine whether there is a relationship between the environmental conditions and equipment variety and the motor and sensory development of the preterm child.

Eligibility Criteria:
Inclusion Criteria: Fifty infants between 4-18 months with a history of premature birth and with the consent of their parents will be included in the study.

Exclusion Criteria:

Babies with chromosomal anomaly, serious congenital problems and whose parents are not willing to work will not be included in the study.
Healthy Eating in Women at Risk of Gestational Diabetes

Healthy eating during pregnancy has favorable effects on markers related to diabetes (glucose tolerance) and is associated with lower gestational diabetes mellitus (GDM) risk. The cornerstone of GDM treatment is nutrition therapy but the latter often starts late in pregnancy and thus may not have the expected effects on glucose tolerance. What if an intervention promoting healthy eating was initiated at the beginning of pregnancy in all women at risk, would it improve glucose homeostasis? To answer this important question, the investigators will perform a randomized controlled trial in 150 pregnant women. Women receiving the nutritional intervention will be compared to a control group receiving standard care. The nutritional intervention, which will start in the first trimester, is based on the 2019 Canada's Food Guide and is composed of 4 individual sessions with a registered dietitian (12, 18, 24 and 30 weeks). Between those follow-ups, informative nutritional web capsules and phone calls with the registered dietitian will be provided. To ensure that the women remain motivated and receive social support, a private Facebook group will be used. The investigators hypothesize that the nutritional intervention will be effective at improving glucose homeostasis. The investigators expect the results will show the importance of nutritional care starting early in pregnancy in women at risk of GDM.

Individuals will participate in three on-site research visits during which a 2-hour oral glucose tolerance test will be performed. At each of these trimesters and 3 months after the delivery, participants will also complete three validated web-based 24-h recalls from which diet quality will be assessed. Subjects will be randomized to two arms after the first oral glucose tolerance test at the first visit. For all participants, on-site follow-ups by the research team will occur at each trimester and 1 virtual follow-up will be done 3 months after delivery for both groups. The total duration of participation for all is approximately 9 months.

Eligibility Criteria:
Inclusion Criteria:

* ≤ 14 gestational weeks;
* Singleton pregnancy;
* At risk of GDM According to Diabetes Canada (being 35 years of age or older or from a high-risk group (African, Arab, Asian, Hispanic, Indigenous, or South Asian) or having a BMI ≥ 30 kg/m2, prediabetes, GDM in a previous pregnancy, given birth to a baby that weighed more than 4 kg, a parent, brother or sister with type 2 diabetes, polycystic ovary syndrome or acanthosis nigricans (darkened patches of skin).

Exclusion Criteria:

* Having a diabetes diagnosis in the 1st trimester;
* Pre-existing diabetes mellitus;
* Diseases requiring active nutritional treatment or influencing glucose metabolism (including previous bariatric surgery);
* Taking part in a nutritional intervention program;
* Corticosteroid use;
* Previous or current diagnosis of an eating disorder;
* Inability to give informed consent;
* Inability to communicate in French.
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II

There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colon or rectal adenocarcinoma
* Expected to receive at least 12 weeks of chemotherapy
* Able to speak and read English
* Access to a mobile phone with Internet and text messaging capabilities
* ≥4 weeks since last major surgery and fully recovered
* ≥18 years old
* Physician consent to participate in unsupervised moderate intensity physical activity
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Engaging in 150 minutes/week or more of moderate physical activity, 75 minutes/week or more of vigorous physical activity, or an equivalent combination
* Hypertension that is not well-controlled (≥160/90) on anti-hypertensive therapy
* Any contraindications to exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or nonhealing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3; advanced Chronic Obstructive Pulmonary Disease (COPD) on oxygen
* Serious cardiovascular event within 6 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI)
* Has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity
Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women

This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.

Eligibility Criteria:
Inclusion Criteria

* Male and female subjects aged 40 to 65 years old, inclusive, at Screening;
* Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 32 kg/m\^2;
* Laboratory test results within the normal range
* Serum 25-hydroxyvitamin D values must be \> 20 ng/mL.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study;
* Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
* History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
* History of allergy to abaloparatide or drugs in a similar pharmacological class;.
Biometric Characteristics of the Eye With Microcornea/Microphthalmia and Congenital Cataract Before And After Cataract Extraction

Early cataract surgery in microcornea/microphthalmia eyes is essential to prevent amblyopia and improve visual outcomes, including stereopsis. However, despite recent advances in pediatric cataract microsurgical techniques, this surgery remains challenging owing to several intraoperative difficulties attributable to the crowded anterior segment in these small, soft, and poorly developed eyes with shallow anterior chambers, and poor pupillary dilation.

In this study the investigator aim to report on the changes in the anterior segment biometric characteristics after cataract extraction in eyes with microcornea/microphthalmia with congenital cataract.

Eyes with congenital cataract have usually small cornea due to developmental delay of the globe. Recognition of microcornea/microphthalmia may be important as a potential contributor to the development of aphakic glaucoma after cataract surgery. Biometrics characteristics of eyes with m/m before and after removal of the cataractous lens can justify the occurrence of postoperative complications, including glaucoma.

Aim of the study: to report on the changes in the anterior segment biometric characteristics after cataract extraction in eyes with microcornea/microphthalmia with congenital cataract.

Methods:

The study will be a prospective cohorte. Biometry of eligible eyes with congenital cataract in one or both eyes with horizontal cornea diameter less than 11mm and/or axial length less than 2standard deviation for age will be compare to otherwise normal eyes with congenital cataract before and after cataract extraction. The anterior segment biometric characteristics using ultrasound biomicroscopy to measure anterior chamber depth and angle.Cataract surgery will be conducted with or without intraocular lens implantation.Postoperative follow up will be scheduled at the first week and first month, third and sixth months

Eligibility Criteria:
Inclusion Criteria:

1. Children presenting with congenital cataract in one or both eyes and with a horizontal corneal diameter less than 11 mm and/or an axial length less than 2 standard deviations for age of the child, less than 18mm in children under one year and less than 20mm in those less than 1year (cases).
2. Children presenting with congenital cataract in one or both eyes with otherwise normal ocular biometric characteristics (controls).

Exclusion Criteria:

1.Children presenting with congenital cataract associated with other ocular anomalies other than microcornea/microphthalmia
Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer

The scope of the PICASSO project is to apply an innovative patient-based pan-omic approach to immune-assays, that will include multi-omics tumour characterization (genome, proteome, transcriptome), blood immune-cells and cytokine profiling, serological screening for paraneoplastic autoantibodies, clinical and metabolic measurements.

The PICASSO project is aimed to validate in real world population the predictive role of SCLC transcriptomic classification (particularly, I-SCLC subtype) and to explore correlations with dynamic changes in peripheral blood immunity. Additionally, investigators expected to validate the predictive/prognostic role of emerging new variables, including metabolic-induced meta-inflammation alterations and subclinical auto-immunity.


Eligibility Criteria:
Inclusion Criteria:

1. histologically- or cytologically-documented extensive-stage SCLC
2. to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors
3. No evidence of brain metastases at diagnosis
4. ECOG PS 0-2
5. adult patients (aged ≥ 18 years) at diagnosis;
6. signing of informed consent approved by the local Ethic Committee

Exclusion Criteria:

* none
Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?

Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Eligibility Criteria:
Inclusion criteria

* AO/OTA (Orthopedic Trauma Association) fracture classification 31B
* Surgically treated with either hemiarthroplasty or total hip arthroplasty
* Acute fracture treated within 72 hours of injury
* Low energy isolated injury
* Age greater than 18 years old

Exclusion Criteria

* Transfusion received during admission, prior to surgery
* Creatinine clearance less than 30 mL/min
* History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE
* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
* Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
* History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days
* Coronary stent placement within the previous 6 months
* Disseminated intravascular coagulation
* Subarachnoid hemorrhage
Screening Patients With Sickle Cell Disease for Kidney Damage

This study aims to study the temporal course of sickle nephropathy and assess novel biomarkers that can predict patients prone to nephropathy.

Sickle cell disease causes kidney damage that gets worse with increasing age, leading to chronic kidney disease and kidney failure in nearly one third of patients with sickle cell disease. Some patients develop kidney damage at a young age and others show mild kidney damage at older ages. We do not know the natural progression of kidney damage in sickle cell disease patients, nor do we know who is more prone to develop severe kidney damage. Therefore, currently, there are no preventative measures or treatments for sickle cell related kidney disease. The purpose of this research study is to collect data that will help in assessing the progression of kidney damage in sickle cell disease, develop novel urine and blood tests that can predict kidney damage early, and developing treatment ideas for intervention and prevention of kidney damage that eventually leads to kidney failure.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease (i.e. Hgb SS, Hgb SC, Sβ-Thalassemia)
* Individuals at baseline/steady state (absence of fever or acute sickle event, defined as vaso-occlusive pain crises, acute chest syndrome, splenic sequestration, stroke, priapism) for three weeks.
* Adult Subjects \> 18 years of age: ability to consent to donate blood and/or urine for research purposes only.
* Newborn to \< 18 years of age: ability of parent/legal guardian to consent for peripheral blood and/or urine samples to be obtained for research purposes only.

Exclusion Criteria:

* Hematologic malignancy
* Patients that either do not have the ability to undergo the informed consent process or whose parent/legal guardian does not have the ability to undergo the informed consent process
Effect of Quadro-Iliac Plane Block on Recovery After Total Hip Arthroplasty

Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.

Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.

Recently, Tulgar et al. introduced a novel fascial plane block called the "quadro-iliac plane block". This block is performed in the quadro-iliac plane, located between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. In their study, Tulgar et al. bilaterally injected 40 mL of methylene blue into the quadro-iliac plane, observing widespread dye distribution along the posterior and anterior surfaces of the quadratus lumborum muscle, transversalis fascia, ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. Based on these findings, quadro-iliac plane block has been proposed as a potentially effective technique for managing acute or chronic pain in the lumbosacral, abdominal, and hip regions. However, apart from a few case reports involving lumbar spine surgery and kidney transplantation, evidence regarding the efficacy of quadro-iliac plane block remains limited.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral THA.
* Spinal anesthesia.
* Age 18-85 years.
* ASA classification I-IV.

Exclusion Criteria:

* Patients who declined consent.
* Contraindications to regional anesthesia.
* Coagulation disorders.
* Infections at the block site.
* Emergency surgeries.
Maraviroc Abacavir STudy - Effect on Endothelial Recovery

HIV infected patients treated with abacavir might have a higher risk for the occurrence of cardiovascular events. At time of writing of this protocol the underlying mechanism is not yet elucidated, however some studies find impaired endothelial function and elevated markers of chronic inflammation in these patients,suggesting a higher lever of chronic inflammation. Recently maraviroc (Celsentri®), a CCR5-receptor antagonist, became available for treatment of patients infected with HIV-1.

Improvement of endothelial function may be a potential beneficial side effect of treatment with maraviroc, due to the potential reduction of immune activation and chronic inflammation as a result of blocking the CCR5-coreceptor. Moreover, treatment intensification of HAART with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below the cut-off of 50 copies/ml as well.

The investigators hypothesize that maraviroc intensification therapy in patients on an abacavir-containing regimen will improve endothelial function.

The objectives of this study are: First, to assess the effect of addition of maraviroc to an abacavir-containing regimen on endothelial function; second, to assess the effect of this intervention on markers of immune activation and chronic inflammation, and on plasma HIV-RNA below 50 copies/ml.

The MASTER study is a phase IV, randomized, open label, cross-over, intervention study. Study subjects who are on stable abacavir-containing regimen will be randomized into two arms. In arm A maraviroc will be added to their regimen at baseline, while study subjects in arm B will continue their abacavir-containing regimen. After 8 weeks, cross-over of the study arms will be performed. Subjects in arm A will then stop maraviroc, while in subjects in arm B maraviroc will be added to their regimen (for 8 weeks again). The total duration of the study will be 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* HIV-1 infection
* Treatment with antiretroviral regimen containing abacavir for at least the previous 3 months
* Undetectable plasma HIV RNA (50 cp/ml) for at least 6 months (one 'blip' allowed, which is defined as a detectable plasma HIV-RNA level between 50 and 400 copies/ml, preceded and followed by undetectable (\<50 copies/ml) plasma HIV-RNA measurements)
* CD4+ cell count \> 200 cells/μL
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Allergy for peanuts or soya
* Hypersensitivity for maraviroc
* Treatment of underlying malignancy
* Acute infection in the preceding 30 days
* Renal insufficiency requiring hemodialysis
* Acute or decompensated chronic hepatitis
* Modification of antiretroviral regimen in the previous 3 months