cyrilzakka/clinical-trials huggingface dataset:
Reducing Lung Cancer-Related Anxiety (RELAX)

The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.

OBJECTIVES

1. To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety.
2. To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors.
3. To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Past History of any lung cancer
* For Stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease.
* For Stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease.
* After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible.
* Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
* Age ≥ 18 years
* Must have telephone

Exclusion Criteria:

* Patient does not understand English
* Active lung infection
* Progressive cancer (must be considered no evidence of disease or stable)
* Any change in psychotropic medications in past 30 days
* Hearing loss that would preclude participating in interventions. Adequate hearing to participate will be determined via: (1) Response of "no" to the question \["Do you have a hearing problem now?"\] Participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. If necessary, potential study participants will receive a brief test trial with the RESPeRATE device. If they indicate inability to hear the guiding tones, they will not be enrolled in the study.

Cortisol Exclusion

- Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted).
Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

This study is being done to find the effect of Dibenzyl Trisulphide (active ingredient in Guinea Hen Weed in combination in patients with stage four cancer of the breast, prostate, cervix and colon.

There have been many claims of the value of Guinea Hen weed in the treatment of different cancers. The preparation is readily available and used locally. The team proposes to validate the studies done on cancer cell lines by conducting a clinical trial to determine the clinical benefit in advanced and metastatic cancers.

Eligibility Criteria:
Inclusion Criteria:

* Age: Greater than 12 years.
* Documented histologic evidence of cancer
* Staged as stage IV
* World Health Organization (WHO) Performance Status of between 0 and 2
* Radiological confirmation of metastases with bone scan or X ray, CT and/or MRI scan Exclusion Criteria

  * Cancer stages less than stage 4
  * Pregnant women
  * Children 0 - 12 years
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study

Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.


Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren
* Aged 9 to 11 years

Exclusion Criteria:

- no exclusion criteria
Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)

CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia.

CREHA project is a multicenter, randomized, controlled efficacity and safety study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia

Eligibility Criteria:
Inclusion Criteria:

* men or women
* women post-menpausal or with ongoing contraception
* 18 years old or more
* diagnosis of acquired hemophilia
* patient must be insured
* patient has provided written informed consent prior to enrolment
* patient compliant

Exclusion Criteria:

* constitutional hemophilia
* chemotherapy
* ongoing treatment with prednisone \> 20mg further more 1 month
* ongoing treatment with prednisone \>0.7 mg/d further more 10 days
* thrombocytopenia
* leukopenia
* chronic disease
An Open-Label Study of DCCR Tablet in Patients With PWS

The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of clinical study C602, Visit 15
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
* Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.

Exclusion Criteria:

* Positive urine pregnancy test (in females of childbearing potential)
* Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
* Any new disease, condition, or circumstance, which may significantly impact subject safety
Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria

The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. The cross-sectional longitudinal study design used, 209 patients with pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random urine samples were taken before the 24 hour urine collection for spot urine analysis for evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in all patients as the gold standard of the urine total proteinuria.

Group 1 consisted of mild preeclampsia and gestational preeclamptic patients and group 2 consisted of severe preeclamptic patients. The predictive values of the spot urinary dipstick proteinuria and protein/creatinin ratio were determinant and the correlations of the diagnostic test of 24 hour total proteinuria were evaluated. The correlations of the severity of the disease and the tests of the proteinuria were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 16-50 years old, \> 20 gestational week pregnant women pre-diagnosed preeclampsia.
* Diagnosis and follow-up performed in inpatients clinic.

Exclusion Criteria:

* The history of chronic hypertension
* The history of systemic illness such as pre-gestational diabetes, systemic lupus erythematosis , malignancies, renal disease.
* Pre-existing urinary tract infections
* Premature rupture of membranes
* Patients who have previously been enrolled in the study
Study " COFLORES "

Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. This technique is radiation-free, but it is difficult to repeat measurements during a single exam. Also, a number of patients suffering from cardiac disease cannot receive contrast agent injections. The investigators have developed a totally non-invasive approach for quantifying myocardial perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the capillaries (Arterial spin labeling, ASL).

Goal : The major goal of this research protocol is to validate a totally non-invasive method of myocardial blood flow quantification using MRI without contrast agent injection


Eligibility Criteria:
Inclusion Criteria:

* People having no heart disease or treatment referred to cardiology
* People having no cons -indications to MRI
* People having no cons -indications to gadolinium ;
* People not wearing implantable devices
* People not wearing metallic foreign bodies or risk (eg . Business of steel, etc .. )
* People having no cardiovascular risk factor
* Person subject to the social security scheme
* Nobody agreeing to participate in the study and who signed the informed consent

Exclusion Criteria:

* Refusal to go spontaneous or MRI because of claustrophobia important
* Trouble rhythm making MRI uninterpretable
Lung Cancer Rehabilitation Study

Patients suffering from non small cell lung cancer(NSCLC), depend upon lung removal to increase their chances of survival. But, this type of surgery cannot be advised to patients with significant heart disease, limited lung fuction or reduced physical fitness. Intensive physical training has been shown to increase aerobic fitness in healthy subjects.

The purpose of this study is to determine the effect of a short term rehabilitation prior to surgery on the post-operative and physiological outcomes for patients undergoing this type of surgery.

For patients with non small cell lung cancer (NSCLC), lung resection surgery is the only treatment option which increases survival. However, surgery can not be offered to those with significant heart disease, limited lung function or lacking physical fitness. These are all major risk factors for operative outcome. Cardio-pulmonary exercise testing (CPET) allows direct measurement of aerobic physical fitness through maximal oxygen consumption (VO2 max). A recent update of professional guidelines (ERS/ESTS) has emphasized the importance of CPET in preoperative risk stratification of patients with NSCLC. Interestingly, intensive physical training has been shown to increase aerobic fitness in animals and healthy subjects whereas improvement of VO2 max has been observed in preliminary pilot studies conducted in patients undergoing surgery for NSCLC. However, the net effect of short-term, intensive, outpatient rehabilitation on clinically relevant outcomes, such as major post-operative cardio-pulmonary complications, as well as physiological outcomes is unknown.

Objectives:

1. To assess the physiological effect of 3 weeks of intensive physical training in patients eligible for NSCLC surgery.
2. To assess the effect of physical training on post-operative outcomes.
3. To identify the clinical variables, laboratory tests and specific gene polymorphisms (SNPs) associated with these outcomes.

Eligibility Criteria:
Inclusion Criteria:

Proven or suspected lung cancer, stage III A or less (eligible for surgical cure), documented by CT-scan or Positron Emission Tomography CT scan (PET-CT)

Exclusion Criteria:

* Contra-indication to perform cardio-pulmonary exercise test (uncontrolled cardiac disease, severe pulmonary hypertension, osteo-articular limitations impeding cycling)
* Inability to adhere to rehabilitation program (because of clinically limiting comorbidity, psychiatric condition or osteoarthritis)
* Clinically limiting or untreated heart disease
Retrospective Analyses of TrakStar Database

In this study, real-world data will be used to better understand the effects patient characteristics, symptoms and TMS protocol parameters have on clinical outcomes with NeuroStar TMS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female reported in database and not an invalid entry
* Age reported and not an invalid entry
* Treatment date of November 01, 2008 or later.

Exclusion Criteria:

• Incomplete information on treatment parameters
Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty

Single-celled sequencing for evaluating differences in gene expression patterns in different cell types of the dynamics of a means of this research as a starting point, to study the postoperative delirium and chronic pain at the cellular level changes the contents of a cell, reveal its occurrence and development of the role of gene regulation, find targets and biomarkers, and to provide new ideas for its pathogenesis, To provide theoretical basis support for its prevention, clinical diagnosis and treatment.

The aim of this study was to investigate leukocyte heterogeneity in patients undergoing total knee arthroplasty with POD, paired non-POD patients, and cognitively normal healthy subjects by single cell sequencing, and to investigate leukocyte heterogeneity in patients with chronic pain and patients with pain relief after surgery through postoperative pain follow-up. Moreover, multi-omics single cell technology is used to analyze various cellular contents in a single cell simultaneously, which can capture molecular footprints with higher resolution. Comprehensive analysis of multiple omics datasets reveals the relationships between cellular patterns, establishes complex regulatory networks, and provides a holistic view of cellular state. From a single cell level analysis of POD and occurred in patients with chronic pain in patients with the characteristics of the white blood cells, looking for the peripheral immune system in the pathogenesis of the POD and the potential role of chronic pain occurs, may provide POD pathogenesis and chronic pain occurred an important visual Angle, may also help to provide POD biomarkers and therapeutic targets, To provide a possible solution for the prevention and treatment of postoperative delirium and postoperative chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years old, regardless of gender.
* total knee arthroplasty for the first time.
* The ASA classification is I-Ⅲ.

Exclusion Criteria:

* severe neurological or psychiatric disorders
* drug and alcohol abuse
* patients on antidepressants
* failure and decompensation of vital organs
* chronic pain from previous surgery or trauma
Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes

The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune diabetes.

Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Regulatory T cells expanded from umbilical cord blood (UCB-Treg) ex-vivo have shown strong capacity to control immune responses in autoimmune diseases, offering a hopeful therapeutic way for AIDM. Glucagon-like peptide (GLP-1) analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in Type 2 diabetes and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide with UCB-Treg infusion in AIDM and examine the safety and efficacy of this new therapy.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes according to ADA criteria \<3 years.
* Age≥ 18 years.
* Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
* Fasting or postprandial plasma C-peptide more than 100 pmol/L
* Written informed consent from the patient or family representative.

Exclusion Criteria:

* History or family history of medullary thyroid carcinoma or MEN 2 syndrome;
* History of chronic or acute pancreatitis;
* Allergic to liraglutide or any components in Victoza®;
* Hepatic abnormalities (transaminase \> 2 times normal);
* Renal impairments (serum creatinine \>133 umol/L);
* Cardiovascular diseases (hypertension, coronary heart disease, etc.);
* Presence of anemia (Hb ≤100g/L), leukopenia (\<3.5×109/L);
* Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets \<100×109/L);
* Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30;
* Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis, etc.;
* Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months;
* Any history of malignancy;
* Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years after recruitment;
* Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory tract infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion;
* Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
Benefit of Assistive Listening Device for Lateralization

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.


Eligibility Criteria:
Inclusion Criteria:

* Experienced hearing aid users, age 18 or older
* Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
* Good understanding of the English language
* Health outer ear as confirmed by otoscopy
* Informed consent as documented by signature

Exclusion Criteria:

* Contraindications to the medical device noted upon otoscopy
* Known hypersensitivity or allergies to materials of the investigations device or comparator
* Inability to produce reliable test results
* Known psychological problems
* Self reported symptoms of vertigo or dizziness
Real-time Quantitative Optical Perfusion Imaging in Surgery

Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in real-time during surgery. Complications due to vascular compromise are a major problem, especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue necrosis. If, however, perfusion and ischemia could be monitored during surgery, then surgeons could change their reconstructive design and the anaesthesiologists could improve perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a tool that is able to image in high resolution (microvascularisation), direct, intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying vessels) and that produces quantitative data to objectify image interpretation.

Optical techniques, based on the interaction of light with tissue, are able to image tissue at high resolution and in real-time. These techniques are FDA-approved and have emerged as powerful diagnostic tools in different departments of medicine, such as ophthalmology for visualizing retina vascularisation and dermatology for skin diagnostics.

In this study, investigators hypothesize that four novel optical technologies: Fluorescence Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.

Primary objective - Perfusion will be measured with all the techniques focussed on 4 areas; from 'good' to 'decreased' perfusion (biologically)

Fluorescence Imaging (FI): Time to intensity measurements at four sides Laser Speckle Contrast Imaging (LSCI): Perfusion Units Optical Coherence Tomography (OCT): Vessel density \& decorrelation time Sidestream Darkfield Microscopy (SDF): Total vessel density, proportion of perfused vessels, perfused vessel density, max flow index, De Backer score, perfusion in mm/sec.

Differences in parameters between the four sites will be statistically be compared.

Secondary objectives

- Relation of parameters to patient outcome in terms of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years - Scheduled for reconstructive surgery with free flap reconstruction or laparoscopic transhiatal and 3-stage transthoracic gastric tube surgery.

Exclusion Criteria:

* Allergic to iodide (indocyanine green)
* Hyper-thyroidism
* Breastfeeding
* No informed consent
* Allergic to ephedrine
* Ischaemic heart disease
* Thyrotoxicosis
* Autonomic thyroid adenomas
* Intraoperative hypertension or tachycardia
Perioperative Heart Rate Variability Analysis in Realtime

This study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non-cardiac surgery under general anesthesia
* Patients aged 18-80 years
* Patients who are capable of giving informed consent

Exclusion Criteria:

* Patients \<18 or \>80 years of age
* Patients with an active cardiac pace maker
* Patients with an absent sinus rhythm in ECG
* Patients presenting with a preexisting arrhythmia
* Patients requiring postoperative ICU therapy
* Patients with pheochromocytoma