cyrilzakka/clinical-trials huggingface dataset:
Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders

Several epidemiological studies in large cohorts suggest a strong association between sleep duration, complaint of insomnia and risk of hypertension.These findings suggest an important role of sleep quality in development of hypertension. Principal limitations of these studies are the cross-sectional study design, self-report sleep duration and poor measurement of blood pressure. The investigators propose to study an insomniac population with complete evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement of hypertension.

Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with chronic complain of insomnia. In our study, sleep duration is evaluated by complete evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement.

The primary objective of this epidemiological study is to show an increase risk of hypertension when sleep duration is less than 7 hours, with objective measurement of sleep duration and hypertension.

Secondary objectives are to evaluate role of complain of insomnia in the risk of hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.

Eligibility Criteria:
Inclusion Criteria:

* adult with insomnia (6 months or more)

Exclusion Criteria:

* sleep disorders with obstructive apnea
Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

There is a clear need for improved therapy in ANCA associated vasculitis where current treatments are toxic and contribute to poor outcomes. Conventional therapy combines cyclophosphamide with prednisolone but is associated with severe adverse events in 35%, early mortality, malignancy and infertility. Mycophenolate mofetil (MMF) is a newer immunosuppressive drug which has superior efficacy to azathioprine in solid organ transplantation. MMF is an effective alternative to cyclophosphamide in lupus nephritis. Open label studies and retrospective surveys point to the efficacy and low toxicity of MMF in vasculitis.

We hypothesise that MMF not be less effective than cyclophosphamide for remission induction in AASV. 140 new patients will be randomised to MMF 3g/day or a European consensus intravenous cyclophosphamide regimen, with the same prednisolone dosing. Following a six month induction course all patients will receive consensus remission maintenance treatment with azathioprine and prednisolone. The primary end-point will be remission rate by six months, secondary end-points include relapse rate at 18 months and safety. The trial will be conducted in 10 countries by members of the European Vasculitis Study Group (EUVAS). The trial duration will be 42 months (24 months recruitment, 18 months follow up).

Eligibility Criteria:
Inclusion Criteria:

Inclusion (requires all):

* New diagnosis of AASV (WG or MPA) (within the previous six months)
* Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1)
* ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix )
* Written informed consent

Exclusion Criteria:

* Previous treatment with:

  * MMF: more than two weeks ever.
  * Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC (15mg/kg)
  * Rituximab or high dose intravenous immunoglobulin within the last twelve months
* Active infection (including hepatitis B, C, HIV and tuberculosis).
* Known hypersensitivity to MMF, AZA or CYC.
* Cancer or an individual history of cancer (other than resected basal cell skin carcinoma).
* Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
* Any condition judged by the investigator that would cause the study to be detrimental to the patient.
* Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia.
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)

This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Healthy male volunteers 18 to 45 years of age
* Part 1: Left ventricular ejection fraction (LVEF) at least 55 percent (%)
* Part 1: Body mass index (BMI) 18 to 32 kilograms per meter-squared (kg/m\^2)
* Part 1: Normal, intact skin without tattoos or lesions in the injection area
* Part 2: Females at least 18 years of age
* Part 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0
* Part 2: Previously treated, non-metastatic carcinoma of the breast
* Part 2: Baseline LVEF at least 55%
* Part 2: Negative pregnancy test and use of adequate contraceptive measures among women of childbearing potential

Exclusion Criteria:

* Part 1: Positive urine test for drugs of abuse
* Part 1: History of exposure or active viral infection of Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Part 1: Cardiac disease including hypertension or hypotension
* Part 1: Lower extremity edema
* Part 1: Any clinically relevant history of systemic disease
* Part 1: History of breast cancer
* Part 1: Chronic corticosteroid use
* Part 1: Receipt of IV antibiotics within 7 days prior to enrollment
* Part 2: Concurrent malignancy requiring therapy that may interfere with pharmacokinetic investigations, or history of other malignancy within 5 years prior to Screening
* Part 2: Significant cumulative exposure to anthracyclines
* Part 2: Serious cardiac disease including uncontrolled hypertension
* Part 2: Poor hematologic, renal, or hepatic function
* Part 2: Pregnant or lactating women
* Part 2: History of exposure or active viral infection of Hepatitis B, hepatitis C, or HIV
* Part 2: Chronic corticosteroid use
* Part 2: Receipt of IV antibiotics within 7 days prior to enrollment
VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients

This is a prospective randomized study to compare the influence of area under the curve (AUC)-monitored dual treatment with steroids in combination with either a calcineurin inhibitor (CNI) or mycophenolate mofetil (MMF) on the progression of subclinical cardiovascular disease in renal transplant recipients.

Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers' hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease.

Stable renal transplant patients on maintenance immunosuppressive therapy with steroids, a calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF) will be randomized for AUC-monitored withdrawal of either CNI or MMF.

The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness, Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups.

The duration of the study will be 3 years and the target sample size is 100 patients per arm

Eligibility Criteria:
Inclusion Criteria:

* Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
* Informed consent

Exclusion Criteria:

* Calculated creatinine clearance \< 30 ml/min
* Multi-organ recipients
* Patients with a (historic) panel reactive antibody (PRA) \>60%
* Third renal transplant or more.
* Patients receiving investigational drugs other than MMF in combination with cyclosporine or tacrolimus
* Solid malignancy, post-transplant lymphoproliferative disease.
Diffuse Type In-Stent Restenosis After Drug-Eluting Stent

To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.

Despite a significant reduction of angiographic restenosis and the need for repeat revascularization after introduction of DES, post-DES restenosis still occur and the treatment for DES failure is challenging. However, there have been little data for therapeutic strategy for post-DES restenosis, especially diffuse type ISR. Therefore, we need the well-designed randomized trial to achieve the best therapeutic option for the treatment of diffuse type post-DES restenosis.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 18 years of age.
2. Restenosis after drug-eluting stents (\>50% by visual estimate)
3. Lesion length ≥ 10 mm (diffuse type ISR)
4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications:

   * Heparin
   * Aspirin
   * Both Clopidogrel and TIclopidine
   * Sirolimus eluting stent
   * Stainless steel and/or
   * Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
2. Systemic (intravenous) Sirolimus use within 12 months.
3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
6. Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
7. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
9. Patients with EF\<30%.
10. Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
11. Creatinine level 3.0mg/dL or dependence on dialysis.
12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
13. Patients with left main stem stenosis and left main in-stent restenosis created by DES(\>50% by visual estimate)
Long Term Outcomes of Coronavirus Disease-19 (COVID-19)

The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.

Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. The disease mostly infects the lower respiratory tract. Typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. There is a close relationship between tomography findings and clinical severity. It is not known whether there will be complete recovery in the lungs.

Investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least 6 months after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were ≥18 years
* COVID-19 confirmed by Real-Time PCR
* At least 6 months after discharge

Exclusion Criteria:

* Patients who were \< 18 years
* Pregnancy
* Become bedridden after discharge
Pilates Physical Activity in Sickle Cell Disease

Sickle cell anemia (SCA) is a life-threatening hereditary hemoglobinopathy characterized by hemoglobin (Hb) polymerization that affects many people worldwide.Reduced physical capacity is common in people with SCA. Pilates is a form of physical activity that recently used in clinicial practice

SCA patients (40 patients) with ages more than 18 years will join randomly the pilates group (20 patients) or control non exercised group (20 patients). Pilates will be trained 30 minutes (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months

Eligibility Criteria:
Inclusion Criteria:

* sedentary sickle disease patients from both both sexes in medical stable condition

Exclusion Criteria:

* cardiac complaints, pregnant women, patients who smoke or drink alchols
Peripheral Artery Disease and Sepsis Outcomes

The peripheral artery disease (PAD) prevalence is high in the elderly, the diabetic patients, and the patients receiving hemodialysis. To date, there is no guideline recommendation on the screening of PAD in patients admitted to the medical intensive care unit (MICU) for sepsis.

We conducted a prospective cohort study focusing on patients admitted to the MICU with the main diagnosis of sepsis. The ankle-brachial indexes are performed within 24 hours after admission. Invasive arterial line monitoring and standard non-invasive measurements are collected. After confirmation of PAD, standard anti-platelet treatments (aspirin and cilostazol) are initiated. The survival before and after the conduction of this trial is compared to historical records. The outcomes including all-cause mortality, stroke, myocardial infarction, minor amputation, major amputation, and prolonged ventilator dependent are to be collected.

This is a prospective observational study focusing on peripheral artery disease (PAD) in patients admitting to intensive care units with a diagnosis of sepsis. The sepsis is defined by the quick SOFA score. The primary outcome is all-cause mortality. The secondary outcomes included stroke, myocardial infarction, amputation, and prolonged mechanical ventilation.

We plan to enroll 150 patients. Patients will be grouped into patients with PAD and patients without PAD. We then compare them in the following parameters: clinical data, laboratory data, survival and other outcome data. Two-sample student's t-tests will be used for the comparisons of continuous variables. Chi-square test will be used to detect the difference between categorical variables. The difference is considered statistically significant if P \< 0.05. All statistics works were analyzed using the SPSS 17.0 software (Chicago, IL, USA), R software (Gimc packages).

Eligibility Criteria:
Inclusion Criteria:

* sepsis patients admitted to the MICU meeting quick SOFA score \>= 2 points

Exclusion Criteria:

* NA
A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers. Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy males and females, 18 to 55 years of age inclusive
* Caucasian, Japanese, or non-Japanese subjects. Caucasian or non-Japanese subjects will have no parents or grandparents of Japanese descent; Japanese subjects must be first, second or third generation
* Body weight between 45 and 105 kg, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory evaluations
* Fertile males and women of childbearing potential must use appropriate form of contraception from screening until 60 days after study completion
* Negative for hepatitis B, hepatitis C, and HIV infection
* Negative for selected drugs of abuse at screening (not including alcohol) and at check-in (including alcohol)

Exclusion Criteria:

* Pregnant and lactating women
* History of clinically significant drug allergy and/or a known hypersensitivity to the study drug or formulation components
* History of helminthic infection or travel within the past 3 months to areas of high risk for parasitic exposure
* Use of prescription drugs including inhaled, oral, or parenteral corticosteroids and/or beta agonists, within 7 days prior to dosing or during the study
* Use of tobacco- or nicotine-containing products from 7 days prior to check-in, resulting in urinary cotinine \>500 ng/mL. Minimal/intermittent smoking will be permitted during the study
* Participation in any other investigational drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (Day -1)
* History of significant, chronic, or recurrent infections requiring treatment
Acupoint Stimulation Improves Sleep on the Plateau

Sleep disorder is common in people going to plateau. Acupuncture and related techniques could be used for treatment of sleep disorder. In this trial the effect of transcutaneous electrical acupoint stimulation on sleep disorder in people going to plateau will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 40 years
* first time to the plateau (altitude ≥3000 meters)

Exclusion Criteria:

* those who live in area with altitude ≥2000 meters, or travel to plateau in the last half year
* history of insomnia
* patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
* difficulty in verbal communication
* history of taking medicine to improve sleep during the last 3 months
* regular daily intake of large dose of tea or coffee (\>400 mg of caffeine)
* suspected or existed abuse of drug or alcohol
* disease that influence sleep such as chronic pain
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (\>=) 6
* Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
* Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
* A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
* Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment
* The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
* The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations
* Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
* Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
* Known allergies, hypersensitivity, or intolerance to milvexian or its excipients
Mortality, Morbidity and Risk Factors of Liver Retransplantation

This study aims to compare the short and long term outcomes of living donor and deceased donor liver retransplantation. Bearing that in mind, the investigators will retrospectively analyze the files of patients whom underwent a liver retransplantation in Memorial Bahcelievler Hospital Organ Transplantation Center.


Eligibility Criteria:
Inclusion Criteria:

* Having a liver retransplantation

Exclusion Criteria:

* N/A