cyrilzakka/clinical-trials huggingface dataset:
Respiratory Mechanics and Pleural Effusion

The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.

In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.

Eligibility Criteria:
Inclusion Criteria:

* ALI/ARDS patients underwent invasive mechanical ventilation

Exclusion Criteria:

* Haemodynamic instability
* Chronic obstructive pulmonary disease (COPD) patients
The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients

The purpose of this study is to assess the impact of text message reminders on adherence to medications and exercise in patients recently discharged from the hospital after a myocardial infarction (MI).

The Impact of Text Messaging on Medication Adherence and Exercise Regimen among Post-Myocardial Infarction Patients includes two single-center randomized control trials to assess the impact of text message reminds on adherence to medications and exercise regimen in patients recently discharged from the hospital after MI.

Recruitment conducted at Cambridge Cardiac Rehabilitation in Ontario, Canada for both the medication adherence and exercise trial. Potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either intervention or usual care (control).

Patients randomized to the intervention arm in the medication adherence trial receive an automated text message once per day at the time they are prescribed to take their medication. The text message does not contain any personal or pharmacological information.

Patients randomized to the intervention arm in the exercise adherence trial receive four text messages per day at 7:30 am, 12:00 pm, 6:00 pm, and 9:00 pm, reminding them to exercise for 30 minutes per day as per their health care provider.

Eligibility Criteria:
Inclusion Criteria:

* Post-MI hospital discharge within 2 weeks
* Enrolled in cardiac rehabilitation
* Prescribed anti-platelets, beta-blockers, ACE-inhibitors or ARBs, and/or statins on 1x/day regimen (for medication adherence trial)
* Prescribed exercise regimen (for exercise trial)
* Ability to read and write English
* Possession of a cell phone with text messaging capability

Exclusion Criteria:

* Age \< 18
* Incarcerated individuals
* Unable to read and write English
* Not in possession of a cell phone
* Patients prescribed medication regimen \> 1x/day
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.

The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).

This was an open label, single arm, multi-center, Phase IV Post-Approval Commitment (PAC) study with once daily oral dose of 10 mg everolimus in participants with renal AML associated with TSC. There were three separate phases in this study: a Screening phase, an Open-label treatment phase where participants received everolimus for 48 weeks or until disease progression, and a Treatment discontinuation follow-up phase for patients who discontinue study drug for reasons other than disease progression. Every participant had an End of Treatment visit within 28 days after last dose and a safety follow-up visit 30 days after last dose.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for treatment with everolimus as per the locally approved label.
* Presence of at least one AML ≥ 3 cm in its longest diameter using CT or MRI.

Exclusion Criteria:

* AML related bleeding or embolization during the 6 months prior to enrollment.
* History of myocardial infarction, angina or stroke related to atherosclerosis.
* Impaired lung function.
* Significant hematological or hepatic abnormality.
* Any severe and/or uncontrolled medical conditions.
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: a Prospective Cohort Study

Brief Summary

The goal of this observational study is to evaluate the long-term outcomes of different surgical techniques for sacral Tarlov cysts in adult patients aged 18-75 years diagnosed with symptomatic sacral Tarlov cysts. The main questions it aims to answer are:

* Does one surgical technique result in better pain relief (measured by VAS score) and functional recovery (measured by JOA score) compared to others?
* How do different surgical techniques impact the long-term recurrence rate and complication rate?

Researchers will compare three surgical techniques:

1. Partial cyst wall resection with nerve root sleeve plasty.
2. Partial cyst wall resection with nerve root sleeve reinforcement and reconstruction.
3. Autologous fat/muscle with fibrin glue microscopic cyst filling.

Participants will:

* Undergo one of the three surgical procedures based on clinical indications.
* Complete preoperative and postoperative assessments, including pain and functional scoring, as well as MRI evaluations at baseline and during follow-up.
* Participate in a follow-up program for up to 2 years to monitor outcomes and recurrence.


Eligibility Criteria:
Inclusion Criteria

1. Age 18-75 years.
2. Diagnosed with symptomatic sacral Tarlov cysts confirmed by MRI.
3. Presence of at least one of the following symptoms:

   * Persistent sacral or lower back pain (VAS score ≥ 4).
   * Neurological deficits such as lower extremity numbness or weakness.
   * Bowel, bladder, or sexual dysfunction attributable to the cyst.
4. Eligible for surgical intervention based on clinical evaluation.
5. Willing and able to provide written informed consent.

Exclusion Criteria

1. History of prior sacral Tarlov cyst surgery.
2. Concurrent spinal conditions requiring separate surgical intervention.
3. Active infection or systemic inflammatory disease.
4. Severe comorbidities that increase surgical risk (e.g., advanced cardiac or pulmonary disease).
5. Pregnancy or lactation.
6. Inability to comply with follow-up requirements.
7. Known allergy or contraindication to surgical materials (e.g., fibrin glue).
A Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Bictégravir, Emtricitabine and Ténofovir Alafénamide

The main objective of the study is to evaluate the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

ANRS EP69 BICTEVOIR is an interventional pilot study, multicenter, involving the use of human biological samples.

34 HIV-1 infected male subjects, from Bicetre, La Pitié Salpêtriere, Antoine-Béclère, Necker, Hôtel-Dieu and Saint-Antoine Hospitals will be recruited.

Different samples will be performed during one single day:

* blood samples
* rectal biopsies
* nodes biopsies
* cutaneous fat tissues biopsies
* semen sample (at home)

Eligibility Criteria:
Inclusion Criteria:

* Male HIV-1 infected subjects
* Age \> or = 18 years old
* Currently receiving as first line a stable ARV regimen containing bictegravir (at 50 mg once a day) and two nucleoside reverse transcriptase inhibitors, tenofovir alafenamide/emtricitabine (Biktarvy)
* HIV RNA \<50 Cp/mL, undetectable 6 months after treatment initiation and confirmed and 12 months after treatment initiation.
* Normal laboratory value of TP and TCA and platelets numbers at screening
* Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the research / study / trial) (article L1122-1-1 of the Public Health Code)
* Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme)

Exclusion Criteria:

* Single HIV-2 infection
* Biopsies contraindication, taking anticoagulant and antiplatelet drugs are not allowed
* Haemophilia
* Symptomatic sexually transmitted infection
* Being under guardianship or trusteeship mandate for future protection
* Participate to another research involving human person, categories 1 or 2,
* Associated treatments : carbamazepine, oxcarbazepine, phenytoin, phenobarbital, rifampicin, St. John's Wort.
SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY

The aim of this study is to test whether it is possible in principle to determine defective vision using light field technology. The measurements with this first prototype will be compared with the results of the conventional method for subjective refraction determination and those using a phoropter (Vision R-800 phoropter).


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Best corrected visual acuity ≥ 0.8 (logMAR ≤ 0.1).
* Dioptric range for hypermetropia: ≤ +4.50 D.
* Dioptric range for myopia: ≥ -6.50 D.
* Dioptric range for cylinder: ≤ -2.00 D.
* Good general health, i.e.no systemic disease such as diabetes or rheumatism which could influence ocular health
* No ocular pathology or history of (intra)ocular surgery except for cataract surgery

Exclusion Criteria:

* • Contact lens wear during the days of visit

  * Binocular vision problems (e.g. amblyopia, strabismus).
  * Inability to follow the procedures of the investigation, such as language problems, psychological disorders and dementia
Genetic Variants Associated With the Risk of Gall Stones and Cirrhosis.

Gall stone disease is more common in patients with cirrhosis. This association has been well established in different studies. Among the various factors which predispose a patient with gall stone disease to have associated liver cirrhosis, genetics also plays an important role.

This study aims to do a genetic panel-based analysis of genes which are involved in cholestasis to find any association between liver cirrhosis and gall stone disease.

Patients with history of gall stone or history of cholecystectomy done for gall stone disease will be evaluated for the presence of liver cirrhosis by fibroscan and ultrasonography. Those patients with cirrhosis and without cirrhosis will undergo a panel based genetic test for the common cholestasis genes and multivariate analysis will be done for variants associated with lithogenesis and cirrhosis.

Study population:

* Patients \> 18 years of age.
* Who have either gall stone disease or cirrhosis. Study design: All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion.

Study period: 1 year. Intervention: Blood sample from included patients will be subject to panel based NGS.

Monitoring and assessment: History of all patients including family history will be taken. Screening for cirrhosis will be done by fibroscan or ultrasound scanning. Gall stone diagnosis is made by USG. History about patients' parents, siblings, spouse, children will be taken with respect to gall stone and cirrhosis. NGS of cholecystitis will be send for the subject and the results will be collected as the fastQ file for analysis.

Statistical Analysis: MVA will be done to identify gene variants independently associated with lithogenesis and cirrhosis, along with demographic and environmental risk factors for these conditions. \* From this data, overlapping risk-variants in common associated genes will be identified. A risk estimate (OR with 95% CI) will be calculated for each of the above identified genetic risk variant for the phenotype of cirrhosis with GS.

Adverse effects:

There are no adverse outcomes with respect to this study. Stopping rule of study: There are no stopping rules for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years of age.
2. Who has a GSD diagnosed by USG or have history of cholecystectomy for gall stone disease.
3. Who is a diagnosed case of cirrhosis by Fibroscan or USG (Cirrhosis including alcohol related cirrhosis, Hepatitis B, Hepatitis C, Wilsons disease, Hemochromatosis are excluded.

Exclusion Criteria:

1. Patients who have haemolytic anaemia
2. Patients who do not consent for genetic study
3. Patients who has a diagnosed cause for liver disease, including alcohol related cirrhosis, Hepatitis B, Hepatitis C, Wilsons disease, Hemochromatosis.
4. Inability to provide informed consent.
5. Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue

Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Male and female subjects aged 20 years or older at informed consent
* Essential hypertension who had never received angiotensin II receptor antagonists and calcium channel blockers

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus
* History or evidence of a stroke
* Hepatic or hematologic abnormality
* Mild Cognitive Impairment or Dementia
* Serum potassium level ≥ 5.5 mEq/L
* Serum creatinine level ≥ 3.0 mg/dL
* Acute or chronic disease
* Allergy to any drugs
* Pregnancy
Impact of Image-defined Risk Factors on the Outcome of Patients With Neuroblastoma: A Retrospective Study

The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with neuroblastoma, at the time of their initial presentation, as a prognostic factor for prediction of subsequent outcome \& complications related to surgery, in the accordance with the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in Upper Egypt.

Background:

Neuroblastoma is the third most common childhood cancer, after leukemia and brain tumors, and is the most common solid extracranial tumor in children.

The concept of surgical risk factors in neuroblastoma surgery was introduced with the European multicenter study (LNESG1) study.

In 2005 the International Neuroblastoma Risk Group (INRG) Task Force, representing all major co-operative pediatric cancer groups, adopted the principle of surgical risk factors and incorporated it in the INRG Staging System. The INRG Task Force preferred the term Image-Defined Risk Factors (IDRF) to surgical risk factors, and agreed upon a list of IDRF.

Patients \& Methods:

This retrospective study will be carried out by reviewing the medical records of patients with neuroblastoma seen at the pediatric oncology department, in the period from 2001 January till 2015 December.

Data from Patients' medical records will be gathered, Pathologic diagnosis of neuroblastoma will be verified before the enrollment into the study. As an initial imaging was done for all patients at presentation, as a routine for diagnosis \& staging, the reports of the computed tomography scans will be reviewed for verification of the presence or absence of the IDRF. This historical cohort will be followed forward with time for ascertainment of the role of surgery in treatment, and treatment outcomes of these patients. Any complications occurred due to surgery will be reported, as collected from surgical reports of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than 19 years.
* Patients diagnosed with non-metastatic neruoblastoma.

Exclusion Criteria:

* Patients whose age more than 18 years.
Effects of Melatonin in Untreated Obstructive Sleep Apnea

The investigators have previously shown that 1 week of 10mg Melatonin improves sleep consolidation in untreated obstructive sleep apnea (OSA) patients. This study aims to extend on those findings to determine if longer treatment of Melatonin improves other outcomes in untreated OSA patients.

Intermittent hypoxia (low oxygen), sleep fragmentation and restriction are characteristic of obstructive sleep apnea (OSA) and cause mental deficits and cardiovascular disease (CVD). Melatonin (MLT) is a hormone with sleep promoting properties and the investigators have found 7 days 10mg MLT treatment significantly increases sleep consolidation in untreated OSA. Thus, melatonin could improve mental function. MLT also has potent antioxidant, anti-inflammatory and anti-hypertensive properties. In humans with CVD and metabolic disorder exogenous MLT improves a wide range of cardio-metabolic outcomes. In rat models of OSA, MLT completely blocks intermittent hypoxia induced cardiovascular damage and brain cell death. Intermittent hypoxia also induces lasting changes in the neural control of breathing, which worsens OSA. Experimentally antioxidants block the induction of changes to neural control of breathing. Thus MLT may also normalize the control of breathing and reduce the severity of OSA. Given these findings, the hypothesis is that MLT will improve mental function, cardiovascular outcomes and control of breathing in untreated OSA.

Eligibility Criteria:
Inclusion Criteria:

* moderate-severe OSA (AHI ≥15/hr)

Exclusion Criteria:

* non-English speakers (due to necessity to complete neurocognitive testing)
* other sleep disorders
* history of driving or other accidents due to sleepiness or an Epworth score (ESS)\> 18
* pregnant
* smokers (quit ≥ 1 year ago acceptable)
* diabetes
* cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease
* Substantial alcohol (\>3oz/day) or use of illicit drugs
* psychiatric disorders (other than depression or anxiety)
* current MLT use or use within last 6 months
* beta blockers, central nervous system depressants or stimulants, anti-inflammatories, anticoagulants, immunosuppressants, vitamins, antioxidants.
A Contralateral Dispensing Clinical Trial of Study Test Silicone Hydrogel Lens Against Enfilcon A Silicone Hydrogel Lens

This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.

Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction or the assigned study lenses
* Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

* Is participating in any concurrent clinical or research study
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable\^
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). Rationale is that systemic changes over time due to pregnancy/lactating may adversely affect contact lens wear e.g. ocular dryness may increase.
* Is aphakic
* Has undergone corneal refractive surgery.

For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).

\^ For the purposes of this study, participants will be excluded, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
GlucoFriend-evaluation the Effectiveness of Glucobay When Combined With a Basal Insulin

To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life treatment conditions in a large sample of Korean patients.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Age ≥ 18 years
* Diagnosed of type 2 diabetes for at least 6 months prior to enrollment
* Patients treated with stable dose of a basal insulin (insulin glargine or insulin detemir) at least 2 months
* HbA1C≥7.5 and ≤10.0%

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information
Studies on the Expression and Functions of RLIP76 in Blood Samples of Healthy Human Subjects

RLIP76 (Ral binding protein1) is a 76 kDa splice variant protein encoded by the human gene (RALBP1, 18p11.22). It is a multifunctional modular protein found ubiquitously from Drosophila to humans, in cells ranging from red blood cells to endothelial cells of the brain. Its expression more predominant in breast, heart, liver and less so in colon and brain parenchyma.

RLIP76 is shown to be over expressed in a variety of cancer cells. However, no study has yet been done on its expression on normal cells. The studies proposed in this project will study the expression of RLIP76 in blood cells of healthy human subjects in the population of North Texas region.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as defined by lack of serious health conditions or diseases

Exclusion Criteria:

* Children, pregnant women, prisoners, persons with any medical condition that precludes phlebotomy and persons unwilling or unable to provide consent will be excluded.