cyrilzakka/clinical-trials huggingface dataset:
The Incidence of Venous Thromboembolism in Atopic Dermatitis

This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

Eligibility Criteria:
Inclusion Criteria:

* All eligible adult people (aged ≥ 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.

Exclusion Criteria:

* People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.
Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC

Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.


Eligibility Criteria:
Inclusion Criteria:

* histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;
* progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;
* received both NGS test and ddPCR from peripheral blood simultaneously.

Exclusion Criteria:

* progression from first- or second-generation EGFR-TKIs as adjuvant therapy;
* having received third-generation EGFR-TKIs prior to the gene tests;
* having received NGS test only or ddPCR test only.
Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)

This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease). Participants will continue their normal care and will not get any treatment other than those the study doctor has prescribed.


Eligibility Criteria:
Inclusion criteria:

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
2. Age 18 years or above at the time of signing the informed consent.
3. Presence of ASCVD (atherosclerotic cardiovascular disease) and/or HF (heart failure)
4. Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).

Exclusion criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Current participation (i.e., signed informed consent) in any other interventional clinical study.
3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
4. Clinical evidence, or suspicion of, active infection within the last 60 days.
5. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
A Randomized Controlled Trial of a Pre-Transplant Education Intervention

A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care.

Kidney transplantation is the best treatment for most patients with end-stage kidney disease, but it is an extremely complicated process. To become active on the transplant waitlist, patients must learn new information, navigate the healthcare system and undergo several specialized tests. After the transplant, another set of challenges emerge. Transplant recipients must commit to lifelong therapy with immunosuppressive medications and adapt to lifestyle changes. Up to half of all patients have difficulty taking the medications as prescribed, which can lead to transplant rejection, kidney loss, and death. The transplant process is challenging and confusing; however, increasing education and support to transplant candidates demands greater use of care providers' time and resources in a health care system that is already stretched.

A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement.

A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life and beliefs in medications as compared to usual care. Participants will be randomized (1:1) to the control group, or the intervention group, who will be provided access to the video series, in addition, to standard of care. Differences in changes in transplant knowledge, self-efficacy, beliefs about medicines, quality of life, and education satisfaction will be evaluated by a pre-and post-intervention survey. A thorough assessment of video-viewing habits and satisfaction with the intervention will provide insight on the feasibility of expanding home-based education to other health settings.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* can speak and understand and read English
* are being assessed or wait-listed for kidney transplantation

Exclusion Criteria:

* do not meet inclusion criteria
Macintosh and D-Blade® in Simulated Difficult Airway

In the presented study, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis.

An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK.

Therefore, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring general anesthesia for orthopedic surgery

Exclusion Criteria:

* known or expected difficult airway
* undergoing urgent or emergent surgery
* non-fasted
* American Society of Anesthesiology Class (ASA) IV-VI
* no consent for participation
The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.

Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:

1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?

The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
* normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
* Age \>18 years and \<80 years
* Estimated GFR \> 60ml/min

Exclusion Criteria:

* Chronic Kidney Disease or eGFR\<60
* Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
* Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c \>7.5%
* History of liver failure
* History of heart failure
* The use of typical or atypical antipsychotic medications or lithium.
* Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs or glucocorticoids
* The use of prescribed doses of potassium supplements.
* Illness requiring overnight hospitalization in the past 6 months
* Active tobacco or recreational drug use
* Pregnancy or current breast feeding
Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.

Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality.

Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis.

It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.

Prevention and treatment of bleeding due to general or local fibrinolysis

Eligibility Criteria:
Inclusion Criteria:

* Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture
* Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).

Exclusion Criteria:

* Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
* The refusal of the patient or their relatives/legal representative to participate in the study.
* Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients).
* Patients with a history of seizures.
* Patients with severe renal and hepatic insufficiency.
* Patients with venous thrombosis.
* Patients with active concomitant bleeding of renal origin.
Parameters of Neurological Deficit After Thoracolumbar Fractures

To detect Radiological parameters affecting neurological injury after thoracolumbar spinal fractures.

Thoracolumbar spine fractures are the most common spinal column fractures. High activity and lack of stability make it more prone to fractures.

Many studies have attempted to determine whether the neurological deficit in such fractures is related to spinal canal stenosis or other parameters observed on axial computed tomography (CT). However, this relationship remains controversial.

Few reports shed light on the relation between different imaging parameters like sagittal alignment, vertebral body compression, canal stenosis, and type of fracture according to AO classification with the severity of nerve damage.

These four radiographic parameters will be tested as expected risk factors for the neurological deficit in thoracolumbar fractures.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old with or without neurological deficit
2. In orthopaedics and trauma department of Assiut university hospital from 1st of November 2018 to 31 st of October 2019.

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients suffering from preoperative neurological diseases that hinder our examination like peripheral neuropathy or previous strokes.
* Obtuned patients who cannot be properly examined like those with low GCS score.
* Patients with old thoracolumbar fractures more than one month duration.
* Patients with pathological spine fractures like those with osteoporosis and cancer metastasis.
* Patients with fracture type A0 according to AO classification.
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.


Eligibility Criteria:
Inclusion criteria:

* Women of childbearing potential
* Established history of COPD
* Cigarette smoking history greater than 10 pack years
* FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion criteria:

* Morbidly obese patients (body mass index \>40)
* Hospitalisation or treatment for worsening of COPD in past 6 weeks
* History of increased liver function tests
* hypersensitivity to salbutamol or ipratropium bromide
* Blood pressure \> 155/95
68Ga-N188 PET/CT Imaging in Malignancy

The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.

\[68Ga\]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed or suspected cancer;
* 18F-FDG PET/CT within 1 week;
* Signed written informed consent.

Exclusion Criteria:

* Pregnant and lactating women;
* Female patients plan to become pregnant within 6 months.
Cell Free Preimplantation Genetic Testing

This study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). Genetic testing of culture media will be compared to conventional methods based on embryo biopsies.

Consenting patients will receive standard clinical IVF and PGT. Culture media from embryos will be collected for analysis. Collection of media will include laser assisted collapse of the blastocyst on day 5, 6, or 7 in order to release blastocoel fluid into the culture media. Embryos diagnosed as aneuploid or monogenic disorder affected (abnormal embryos) will be donated for additional analysis with patient consent.

Results obtained from culture media will not be provided to the patients. The information obtained from cf-PGT will be compared to results obtained from embryo biopsies obtained as part of routine PGT and evaluated for concordance and reliability. Abnormal embryos will be rebiopsied (\~3 to 4 times) to evaluate concordance with cf-PGT and the original clinical trophectoderm biopsy PGT results.

All cases will be labelled using a 5-digit barcode and embryo number or saliva source code. Because PGT will be conducted under clinical regulatory approval (CAP and CLIA), patient information will be protected under HIPAA guidelines, including sending reports in encrypted secure email per standard operating procedures. All publications and presentations will maintain de-identification of any patient data used.

Patients may withdraw from the study at any time by contacting the principal investigator of their respective recruiting site. They will continue to receive standard of care through their treating IVF center. A recruitment target of 200 patients is intended for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF electing to utilize LifeView testing (PGT) will be offered participation in this study.

Exclusion Criteria:

* None
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.

Infants were randomized to receive either a standard protein formula or a low-protein formula. The composition of the low-protein formula vs the standard formula was: energy (65 vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).

To investigate the safety of the low-protein formula without any bias, a 4-month intervention period was selected during which the infants were fed only formula.

Anthropometric parameters (weight, length, and head circumference) and body composition were assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.

The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term infants.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* singleton
* full-term infants (gestational age 37/0 to 41/6 weeks)
* birth weight adequate for gestational age (\>p10 and \<p90 for gestational age) according to the World Health Organization growth charts.

Exclusion Criteria:

* presence of congenital diseases
* presence of chromosomal abnormalities
* presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
* being born to mother affected by endocrine and/or metabolic diseases
* having a family history of allergic disease
Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis

the study was conducted on 31-patients with symptomatic primary knee osteoarthritis. The patients were randomized into intervention and control groups. The control group was kept on their medications without intervention. The intervention group received two doses of allogenic lyophilized growth factors (L-GFs); at baseline and after 2 months.

the study included 31 patients with symptomatic primary knee osteoarthritis (KOA) The study group was randomized into an intervention group and a control one. The control group patients were kept on their traditional medications without any intervention, while intervention group patients were instructed to stop using non-steroidal anti-inflammatory drugs (NSAID) at least 1 week before the assessment and throughout the study. All participants were subjected to baseline clinical, radiographic, and ultrasonography assessment. Follow up assessments was conducted after 6 months.

Patients of the intervention group received two doses of intra-articular knee injections of allogenic lyophilized growth factors (L-GFs); one dose at the baseline and the other was after 2 months.

Lyophilized GFs were prepared at the Cairo Medical Centre Blood Bank from allogenic platelet rich plasma to according a previously published patented method.

Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.

The injection was done under complete guidance of ultrasonography through lateral supra-patellar short axis in-plane approach under sterile aseptic conditions. After injection, local ice application and oral paracetamol were allowed if the patient felt pain. NSAIDs were completely avoided as they may inhibit the desired post-injection inflammatory process. Patients were encouraged to restrict vigorous knee activities for 48 hours.

Eligibility Criteria:
Inclusion Criteria

* Clinical and radiographic diagnosis of primary knee osteoarthritis
* Patients must be symptomatic

Exclusion Criteria:

* Patients with secondary knee osteoarthritis
* previous intra-articular steroid, or hyaluronic knee injection in last year
* Patients with other disabling lower limb osteoarthropathy or myopathy
Changes in Motor Cortex Following Exercises for Chronic Low Back Pain

The motor cortex of the brain changes following chronic pain and injury, and this is linked to pain-associated changes in motor behaviour. This study aimed to investigate whether therapeutic exercises in patients with chronic pain can induce reorganisation of the motor cortex and restore normal motor behaviour. The investigators hypothesised that motor training can induce reorganisation of the motor cortex and that these changes are related to improved motor behaviour.

The sensory and motor systems can reorganize following injury and learning of new motor skills. Recently we observed adaptive changes in motor cortical organization in patients with chronic back pain, which are closely linked to changes in motor behavior. Although pain-related alterations in behavior can be trained and are associated with improved symptoms, it remains unclear whether these meaningful functional outcomes are related to motor cortical reorganization. Here we investigate the effects of two interventions in people with chronic back pain: skilled motor training and a control intervention of self-paced walking exercise. We measured motor cortical excitability (motor threshold (MT)) and organization (center of gravity (CoG) and map volume) of the deep abdominal muscle, transversus abdominis (TrA), using transcranial magnetic stimulation (TMS). In addition, motor behavior of TrA was assessed during single rapid arm movements. The study helps to elucidate the mechanisms of specific motor exercises in chronic back pain management.

Eligibility Criteria:
Inclusion Criteria:

* Sustained or episodic non-specific low back pain lasting longer than 3 months

Exclusion Criteria:

* Orthopaedic, neurological, circulatory or respiratory conditions
* History or family history of epilepsy
* Recent or current pregnancies
* Previous surgery to the abdomen or back
* Abdominal or back exercises in the preceding 12 months