cyrilzakka/clinical-trials huggingface dataset:
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Primary Objective:

To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks.

For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of RA, ≥3 months disease duration;
* Participant willing and able to self-inject;
* Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);
* Moderate-to-severely active RA.

Exclusion criteria:

* Participants \<18 years;
* Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;
* Treatment with tumor necrosis factor (TNF) antagonists;
* Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;
* Prior treatment with a Janus kinase inhibitor.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Use of the Pressure Right Device After Laparoscopic Surgery

The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.

The study design is a randomized, double-blinded and sham-controlled evaluation of the adjunctive Acupressure on the P6 point with Pressure Right to reduce the incidence of PONV and the need for rescue antiemetics leading to an improve quality of recovery after laparoscopic and ENT surgery. The two proposed study groups are: Group 1 (Sham-Control) 50 patients, will receive the sham Pressure Right (without acupressure button)30-45 min before induction of anesthesia and will be kept in place for 24h after discharge, and Group 2 (Pressure Right) 50 patients, will receive the Pressure Right device 30-45 min before induction of anesthesia and will be kept in place for 24h after discharge. In addition, all 100 study patients will receive a combination of antiemetics (ondansetron and dexamethasone) during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo major laparoscopic and ENT surgery procedures under genertal anesthesia.
* ASA Class I-III adults of either sex
* Willingness and ability to sign an informed consent document.

Exclusion Criteria:

* Patients with known allergy, hypersensitivity or contraindications to 5-HT3 antagonist.
* Patients experienced vomiting or retching within 24 h before surgery.
* Patients with clinically-significant medical conditions.
* Pregnant and lactating women.
Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

Acute kidney injury and chronic kidney disease usually associated with radical cystectomy operation which is the treatment of choice for invasive urinary bladders tumor. Peri-operative acute kidney injury (AKI) is common but poorly recognized and managed which is associated with increase surgical morbidity and mortality and hospital cost .Prospective human studies establishing a renal protective effect of dexmedetomidine are still questionable.

The aim of this study is to test the hypothesis that intra-operative intravenous dexmedetomidine infusion could improve early renal function after open radical cystectomy.

This randomized comparative study will be carried out on 100 patients of either sex, ASA I and II with baseline serum creatinine below 1.4 mg/dl who will be submitted for radical cystectomy. The patients will be randomly allocated into two groups according to the drug infused intra-operatively; dexmedetomidine group and fentanyl group. Dexmedetomidine group: will receive loading dose (0.8μg/kg) over 20 minutes, followed by intravenous infusion (0.4μg/kg/h) and fentanyl group: will receive loading dose (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure. Assessment of renal function through evaluation of pre-operative estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula based on baseline serum creatinine, serum cystatin C level at 24 hours post-operative, daily post-operative serum creatinine for one week post-operative and post-operative eGFR using MDRD formula.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II.
* Patients scheduled for elective radical cystectomy.

Exclusion Criteria:

* Serum creatinine level equal or greater than 1.4 mg/dl.
* Allergy to alpha-2 adrenergic agonist
* Allergy to any anesthetic drugs
* Uncontrolled hypertension.
* Uncontrolled diabetes.
* Heart block greater than first degree.
* History of alcohol abuse.
* History of drug abuse.
* Clinically significant neurologic disease.
* Clinically significant cardiovascular disease.
* Clinically significant respiratory disease.
* Clinically significant hepatic disease.
The Role of the Circadian System in Neurological Sleep-wake Disorders

The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Vigilance, attention, risk behavior as well as sleep onset latency will be observed.

Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. Advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm.

This study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants 18 years to 35 years of age
* Written informed consent by the participant after information about the research project
* Healthy controls: 7-8 hours of sleep per night
* Healthy controls: sleep satiation before start of the study
* Narcolepsy type 1: diagnosis of narcolepsy with cataplexy, drug free during study, proven excessive daytime sleepiness with increased REM (MSLT), clear-cut cataplexy present, undetectable or low cerebrospinal fluid hypocretin levels (if data is available)
* Idiopathic hypersomnia: diagnosis of idiopathic hypersomnia, drug free during study, proven excessive daytime sleepiness without increased REM (MSLT), increased sleep need (\>10h/day) on work-free days shown by 2-week actigraphy

Exclusion Criteria:

* signs of neurological, psychiatric, or other sleep-wake disorders
* signs of sleep deprivation
* shift work and time zone change of more than one hour within one month prior the study start
* extreme morning and evening types
* underweight
* obstructive gastro-intestinal disease or history of gastrointestinal surgery
* an implanted medical device or a scheduled MRI scan during the experimental period
TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure with Breast Cancer

This study examines TRPC6 in predicting and preventing chemotherapy related cardiac toxicity and heart failure in patients with breast cancer. Cardiac toxicity, changes in heart function is a well-recognized complication of certain cancer related therapies. Understanding these changes may allow early intervention against therapy-related cardiac toxicity and also identify novel therapeutic targets to protect patient long-term cardiac health. Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA), identify biomarkers related to cardiac toxicity, and prevent the development of therapy-induced cardiac toxicity in patients receiving chemotherapy.

PRIMARY OBJECTIVE:

I. Characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.

OUTLINE: This is an ancillary-correlative study.

Patients undergo collection of blood samples at time of enrollment. Patients who develop cardiac toxicity may undergo additional collection of blood samples. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Any breast cancer patient initiating doxorubicin/other anthracycline and patients receiving trastuzumab without doxorubicin/anthracycline in the neoadjuvant/adjuvant setting
* An understanding of the protocol and its requirements, risks, and discomforts
* The ability and willingness to sign an informed consent
* Diagnosed with therapy related cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment OR completed chemotherapy with no cardiotoxicity at least two years post treatment OR patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include doxorubicin chemotherapy, or trastuzumab.
* Healthy, non-pregnant, adult subjects who weigh at least 110 pounds

Exclusion Criteria:

* Inability on the part of the patient to understand the informed consent or be compliant with the protocol
* Anemia with hemoglobin less than 8
* Patients not willing to undergo a blood draw
* Patients with stage IV or distant metastatic breast cancer
SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life- threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.

Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra- compartmental pressure within 6 to 10 hours.

The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.

Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 device safe and non-invasive for the patient with only initial training required for the healthcare professionals, but it has also demonstrated high intra- and inter- observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Male or female
* Age 18 to 84 years

Exclusion Criteria:

* Previous surgery to or fracture of the leg and/or forearm
* Peripheral arterial or venous disease
* History of compartment syndrome
* Limb anomalies
* General muscle disorder
Hemithoracic Arc Radiotherapy Post Pleural Decortication

Malignant Pleural Mesothelioma is an aggressive and refractory disease , the most aggressive treatment plan offered to these patients include trimodalitiy approach with chemotherapy as the mainstay of treatment . the rationale of post operative Radiotherapy is to sterilize the post operative volume to reduce local failure meanwhile minimizing toxicities in this trial we are going to assess the safety and efficacy of Radiotherapy in Mesothelioma patients poat Pleural decortication

This study will include malignant Pleural Mesothelioma patients treated by trimodalitiy approach starting with neoadjuvant chemotherapy followed by surgery in the form of Pleural decortication then all patients will receive post operative hemithoracic radiation

Eligibility Criteria:
Inclusion Criteria:

* Evidence of metastatic disease.
* Underwent Pleural decortication.
* Able to provide informed consent.

Exclusion Criteria:

* Poor pulmonary function tests.
* Recurrent or palliative cases.
* Inability to attend full course of Radiotherapy or follow up visits.
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.

The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective \& randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.

Traditionally the duration of progesterone exposure before embryo transfer has been considered equal for day 5 and day 6 embryos but this may not be the case and warrants further study. The optimal preparation of the endometrium in frozen embryo transfer (FET) cycles is yet to be determined. Synchronization between the embryonic stage and the endometrial window of implantation (WOI) is crucial and progesterone plays a critical role in the WOI (1). Data on the optimal route of administration, the dose and duration of progesterone supplementation before blastocyst transfer are inconsistent (2,3). In view of the current lack of evidence, this study will be of importance.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years to 43 years.
* Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality.
* Endometrial trilaminar appearance on the day of progesterone start

Exclusion Criteria:

* Uterine abnormality
* Hydrosalpinx
* Asherman syndrome
* Any known contraindications or allergy to oral estradiol or progesterone.
* Intention to treat : exclusion factors :

  1. Spontaneous ovulation HRT cycle
  2. Discontinuation of HRT medication
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC.

Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression

Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment.

If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival

Eligibility Criteria:
Inclusion criteria

* HCC based on histopathological confirmation
* No prior systemic therapy for HCC
* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
* Child-Pugh Score class A
* ECOG performance status of 0 or 1 at enrollment

Exclusion criteria

* Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
* Clinically meaningful ascites
* Main portal vein tumor thrombosis
* Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
* HBV and HVC co-infection, or HBV and Hep D co-infection
Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy

The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive external oblique intercostal block after induction. Group B: will receive postoperative morphine per patient request.

General anaesthesia induction will be achieved using fentanyl 1µg/kg (IV), propofol 2mg/kg (IV), and0.5mg/kg of IV Atracurium. General anaesthesia will be maintained with mechanical ventilation with isoflurane with O2 \\ Air mixture.

During anaesthesia maintenance Intraoperatively, if BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine will be given to stabilize the patients' haemodynamics.

All patients will receive 1g intravenous paracetamol and 4mg ondansetron 8mg dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

- Eligible patients will be older than 18 years old with American society of anestheologist ASA physical status I, II and III scheduled for Trans-Abdominal ( Anterior Subcostal) Nephrectomy

Exclusion Criteria:

* Patients who are:
* Unable to cooperate.
* Patients who have allergy to any of the study drugs.
* Patients who are on opioids.
* Known abuse of alcohol or medication.
* Local infection at the site of injection or systemic infection.
* Pregnancy
* Patients with coagulation disorders or on anticoagulation therapy
Ezetrol Post-Marketing Study

To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.


Eligibility Criteria:
Inclusion Criteria:

* Men Or Women Older Than 20 And Younger Than 80 Years Of Age
* Willing To Follow An Ncep Therapeutic Lifestyle Changes (TLC) Or Similar Cholesterol-Lowering Diet For The Duration Of The Study
* Female Patients Receiving Hormone Therapy (Including Hormone Replacement Therapy, And Estrogen Antagonist/Agonist, Or Oral Contraceptives) If Maintained On A Stable Dose And Regimen For At Least 8 Weeks Prior To Visit 1 And If Willing To Continue The Same Regimen Throughout The Study
* Patient With Total Cholesterol Equal Or Greater Than 240 Mg/Dl Or Ldl-C Equal Or Greater Than 160 Mg/Dl For Primary (Heterozygous Familial And Non-Familial) Hypercholesterolemia And/Or Ldl-C Equal Or Greater Than 130 Mg/Dl For Secondary Hypercholesterolemia With Identifiable Risk Factors
* Patient Is Able To Discontinue Any Lipid Lowering Drugs For 6-8 Weeks Wash-Out Period (6 Week For Statin And 8 Week For Fibrate)
* Triglyceride (Tg) Concentrations Equal Or Less Than 400 Mg/Dl
* Liver Transaminases (Alt, Ast) Equal Or Less Than 1.5x Uln With No Active Liver Disease And Equal Or Less Than 1.5x Uln At Visit 2

Exclusion Criteria:

* Women Who Are Pregnant Or Lactating
* History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major Psychiatric Illness Not Adequately Controlled And Stable On Pharmacotherapy
* Patients Who Have Been Treated With Any Other Investigational Drug Within 3 Months Of Visit 1
* Patients Previously Randomized To A Study With Ezetimibe
* Active Liver Disease Or Impaired Liver Function Tests (Alt, Ast \> 1.5xuln)
* Impaired Renal Function ( Serum Creatinine Equal Or Greater Than 1.5 Mg/Dl Or Urine Protein Equal Or Greater Than 100 Mg/L) Or Nephritic Syndrome At Visit 1
* Unstable Angina
* Myocardial Infarction, Coronary Bypass Surgery Or Angioplasty Within The Previous Three Months Of Visit 1
* Uncontrolled Cardiac Arrhythmias
* Uncontrolled Hypertension (Treated Or Untreated) With Systolic Blood Pressure \> 160 Mmhg Or Diastolic \> 100 Mmhg At Visit 1
* Poorly Controlled Diabetes Mellitus Patient. (Hba1c\>8.0%). If The Patient Treated With Md, No Any Dm Medication Will Be Change During The Study Period)
* Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoprotein, E.G. Hyperthyroidism (Tsh \> 5.5 (Iu/Ml). However, Patients Who Are On A Stable Therapy Of Thyroid Replacement Therapy For At Least 6 Weeks Are Eligible For Enrollment
* Patients Hypersensitive To Hmg-Coa Reductase Inhibitors Or Ezetimibe
* Patient Who Is Unable To Give Informed Consent (The Patient With A Legal Representative To Sign The Informed Consent Is Eligible To Participate The Study.)
* Any Condition Or Situation Which, In The Opinion Of The Investigator, Might Pose A Risk To The Patient Or Confound The Results Of The Study
Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study

This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start initial, second-line, or third-line therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.

OUTLINE: This is an observational study.

Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.

Eligibility Criteria:
Inclusion Criteria:

* Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
* No evidence of persistent or progressive malignancy at the time of enrollment
* Agrees to be evaluated at the transplant center before initial, second-line, or third-line treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after treatment is started or if a new therapy is started before 6 months
* Signed, informed consent

Exclusion Criteria:

* Inability to comply with study procedures
* Uncontrolled psychiatric disorder
* Anticipated survival \< 6 months