cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Venetoclax in Subjects With Hematological Malignancies

This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. Participants with other lymphoproliferative diseases can be considered in consultation with the AbbVie medical monitor
* Relapsed or refractory multiple myeloma participants must have been previously treated with at least one prior line of therapy and have measurable disease
* Chronic lymphocytic leukemia/small lymphocytic lymphoma participants must have relapsed or be refractory to standard treatments such as fludarabine based regimens or alkylator based regimens
* Untreated AML subjects or Relapsed or refractory AML subjects must have been previously treated with at least one prior line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1; adequate bone marrow independent of growth factor support per local laboratory reference range; and adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening
* Participants with a history of autologous or allogenic stem cell transplantation must have adequate blood counts independent of growth factor support and have recovered from any transplant-related toxicity(s) and be at least 100 days post-autologous transplant (multiple myeloma) or 6 month post-autologous transplant (NHL) prior to first dose of study drug or at least 6 months post-allogenic transplant (multiple myeloma) prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment

Exclusion Criteria:

* NHL participants who have undergone an allogeneic stem cell transplant or were diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia
* Participant tested positive for HIV
* Participant has a cardiovascular disability status of New York Heart Association Class greater or equal to 2
* Participant has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
* Participant received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
Correlation of Ultrasonographic Lesion Type Characterization With Angioplasty Outcomes in Failing Dialysis AVFs

The continuous increase in the incidence of end stage renal disease and hemodialysis patients, has raised the interest of the vascular access scientific community and many researchers are currently investigating the potential mechanisms of arteriovenous fistulas (AVF) dysfunction. Roy-Chaudhury et al. were the first to suggest neointimal hyperplasia (NIH) as the main reason of AVF dysfunction and vessel negative remodeling as another important factor. First, Yamamoto et al. described 3 stenotic lesions categories of arteriovenous grafts (AVG) observed by ultrasonography: 1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type (constriction and neointimal hyperplastic type).

The main goals of this prospective observetional study are:

* The characterization of AVF stenotic lesions by ultrasonography
* The correlation of the stenotic lesion type with the outcomes of percutaneous transluminal angioplasty and the rate of reintervention.

This is a prospective, observetional study designed to investigate the correlation of stenotic lesion type characterization (1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type eg. constriction and neointimal hyperplastic type) using Duplex ultrasound, with the outcomes of high pressure plain balloon angioplasty. In total 200 patients with failing dialysis arteriovenoyus fistula (AVF) scheduled to undergo angioplasty of stenotic lesion(s) will be included. The study's primary endpoint will be the correlation between stenotic lesion type and target lesion re-intervention due to clinical recurrence at 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patiens with failing AVF scheduled to undergo fluoroscopically-guided high-pressure balloon angioplasty
* Signed study concent form

Exclusion Criteria:

* Patients undergoing dialysis via arteriovenous graft (AVG)
* Contraindications to angioplasty
* Immature AVF
National Survey on Hypertension in General Practitioner (GP) Consultation

To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in general practitioner consultation.


Eligibility Criteria:
Inclusion Criteria:

* male or female \> or = 18 years old
* Known hypertension
* agree to take part in this study

Exclusion Criteria:

* none
Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys During Liver Transplant by Measuring Some Physiological Substances in Blood and Urines

The purpose of this study is to verify any existing relationship between urinary parameters (such as excretion of sodium, chlorine, urinary partial CO2 pressure \[PuCO2\]) and general volemic indicators (such as PiCCO, ScvO2, O2 delivery) during liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* surgery for liver transplantation
* age 18-75
* ASA class I-III

Exclusion Criteria:

* age above 75 or under 18
* ASA class IV
* pre-existing renal failure
* pregnant patients
* patients unable to give written consent
Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention

1. To evaluate clinical safety of the device in terms of Deaths, any stroke and Myocardial Infarction up to 1 year in both study groups to prove non inferiority of biomime stent
2. To evaluate presence of Target lesion and target vessel revascularization in in both study groups prove non inferiority of biomime stent
3. To evaluate target vessel non-target lesion revasularization in both study groups prove non inferiority of biomime stent

• Drug-eluting stents (DES) represent a key advance in percutaneous coronary interventions (PCI) owing to their ability to inhibit neointimal proliferation, which lowers the need for repeat revascularisation However, older-generation DES have been shown to increase the risk of late restenosis and stent thrombosis. Efforts to reduce these risks include improvements in stent platforms, polymer carriers, and drug selection. Thinner struts reduce vessel wall injury, decrease inflammation and promote fast endothelialisation.The second-generation thin-strut DES have been shown to reduce the risk of restenosis, stent thrombosis and myocardial infarction (MI) or possibly death when compared with older-generation DES or bare metal stents. Moreover, the newer generation of biodegradable polymer stents has the potential to reduce the inflammatory reaction of the arterial wall and minimise the risk of late restenosis and thrombus formation More recently, ultra-thin (\<70 μm) DES have been shown to improve outcomes further compared with second-generation DES.The BioMime™ (Meril Life Sciences Pvt. Ltd., Vapi, India) is an ultra-thin sirolimus-eluting coronary stent (SES) with an established preliminary safety and efficacy record in the previous meriT-1, meriT-2, meriT-3 and meriT-4 trials in treating single de novo and complex lesions.The BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges which lead to Lesser Edge Dissections during expansion and Adequate Side Branch Access, coated with biocompatible and bioabsorbable polymers, PLLA (poly-L-lactic acid) and PLGA (poly-lactic-co-glycolic acid) for Faster Healing

Eligibility Criteria:
Inclusion criteria:

•All patients with ST-segment elevation myocardial infarction and diagnosed according to the last guidelines.

Exclusion Criteria:

* Left ventricular ejection fraction ≤30%.
* Killip class III or IV at presentation.
* Extreme vessel tortuosity or lesion angulation (˂45˚).
* Severe calcification proximal to or within the target lesion.
* Bifurcation lesions with side branch diameter \>2 mm.
* Mechanical complication of STEMI.
* Severe comorbidity such as malignancy
Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis

The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. With a hypothesis that the Circaid group will present a quicker and more marked reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in the frequency of postthrombotic syndrome within six months from the time of diagnosis of the acute deep vein thrombosis episode.

The pain-relief and edema reduction associated with compressive therapy in patients with acute deep vein thrombosis (DVT) have been poorly documented in randomized controlled trials (RCTs). Compressive therapy is controversial in that it is currently unclear whether or not it might reduce the risk of postthrombotic syndrome (PTS), a chronic disorder identified in 25-50% of patients with a previous diagnosis of deep venous thrombosis. With the recent SOX trial deeming elastic compression stockings to be ineffective in preventing postthrombotic syndrome and with criticisms focused on the difficulty concerning patients' compliance with these devices, alternative methods such as non-elastic compression garments have been considered. Unfortunately, to our knowledge, no trials have investigated these devices applied with a greater pressure than compression stockings in the context of preventing pain and swelling in the acute DVT phase and of late complications (postthrombotic syndrome).

The experimental literature evaluating non-elastic compression garments is primarily focused on venous insufficiency rather than deep vein thrombosis. For example, previous randomized trial patients allocated to non-elastic compression garments presented faster healing rates/week for venous leg ulcers than a group receiving four-layered compression garments. Although this evidence is related to venous insufficiency, there are currently no RCTs exploring the effect of non-elastic compression in preventing postthrombotic syndrome.

Given this gap in the literature, study aimed at conducting a Bayesian randomized trial to assess a non-elastic compression garment (Circaid) versus a control group in patients with acute DVT.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Outpatients with acute deep venous thrombosis of lower extremity
* Symptomatic patients
* Involving femoro-popliteal and / or ilofemoral segment
* Symptoms less than two weeks
* Provoked or unprovoked TVP

Exclusion Criteria:

* History of TVP
* Any allergy to the use of compression material
* Severe arterial occlusive disease
* Patients in whom thrombus removal is planned
* Ankle index \<0.5
* Inability to walk
* A life expectancy of less than six months
* Geographic inaccessibility that prevents adequate follow-up with or without assistance
* Thrombolytic therapy outside of this study for the initial treatment of acute DVT.
Subarachnoid Administration of Levobupivacaine for Cesarean Section

The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in doses achieving approximately an ED 50.

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date .

Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Parturients scheduled for elective c section
* Stillborn
* Normal cardiotocogram

Exclusion Criteria:

* BMI\>35kg/m2
* Height \<150cm or \>185cm
* Age (\<18, \>40)
* ASA \> II
* Multiple gestation
* Pregnancy complications (eclampsia, GDP, placenta previa, \>2 previous c section)
* Contraindication to spinal anaesthesia
* Failure to educate the patient, language barrier
* Patient preferred GA
Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

The purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT).

Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.

Purpose of the study: To characterize epithelial and stromal thickness distribution in keratoconic eyes and to develop epithelial and stromal thickness-based variables for keratoconus detection.

Methodology: SD-OCT corneal scans of 20 eyes with keratoconus (group 1) and 20 healthy eyes with \> 2 diopters (D) of corneal astigmatism as controls (group 2) are studied. Keratoconus patients referred to the Eye Dpt. of the University Hospital North Norway for CXL (Corneal collagen cross-linking)- treatment and healthy subjects seeking preoperative evaluation for refractive surgery at SynsLaser® Kirurgi AS Tromsø clinic are examined by corneal SD-OCT as a part of their routine examination. Analysis of their SD-OCT corneal scans is used for the purpose of this study.Two cross-sectional meridional corneal profiles (along steepest and flattest meridians, located by a Scheimpflug-based corneal topography) for each individual are obtained by using a RTVue100® (Optovue Inc. Fremont, California, USA), 26000-Hz SD-OCT across the central 6mm diameter of the cornea.

Eligibility Criteria:
Inclusion Criteria:

* Keratoconus group: Confirmed diagnosis of keratoconus
* Astigmatism group: Healthy eyes with astigmatism of \>2.0 D

Exclusion Criteria:

* Keratoconus group: Keratoconus \> stage 3 on Krumeich scale
* Astigmatism group: No signs of keratoconus
Combined Adductor&Sciatic Nerve Block vs Femoral&Sciatic Nerve Block in Total Knee Replacement Surgery

Knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. In patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for surgical treatment. Total knee replacement (TKR) surgery is aimed to eliminate the existing pain, restore and carry the movements, to protect the characteristics of the deformities and the quality of life.

Pain can be very severe after TKR surgery, which is very common in the middle and elderly patient population today. In the postoperative period, untreated pain prevents early physical therapy practices and restricts postoperative knee rehabilitation and recovery, but it also has negative effects on the respiratory, gastrointestinal, renal, and central nervous systems. Effective management of postoperative acute pain can reduce these complications and the risk of developing chronic pain.

In this study, investigators hypothesized that combined adductor canal and sciatic nerve block, applied with postoperative ultrasound guidance to patients who will undergo TKR surgery under general anesthesia, will provide effective analgesia, less opioid consumption, and faster ambulation time, similar to combined femoral and sciatic nerve block.

As a result of the power analysis investigators conducted for this study, the minimum sample size was calculated as 34 people for each group, 68 people in total, at the 95% confidence interval.

68 patients who meet the inclusion criteria will be included in our study. Patients will be randomized and divided into 2 groups. Accordingly, femoral and sciatic nerve blocks will be applied to 34 patients, and adductor canal and sciatic nerve blocks will be applied to 34 patients.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 40-85
* ASA I-III
* Patients who will undergo total knee replacement surgery under general anesthesia

Exclusion Criteria:

* Patients with deformity and pathology in the thigh region
* Clinically known local anesthetic allergy
* Clinically diagnosis of opioid, alcohol and substance dependence
* Patients who cannot perceive and evaluate pain such as psychiatric illness, mental retardation, dementia
* Morbid obesity (body mass index\> 40 kg m2)
Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma

This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination

This study is designed to investigate the potential effect of benralizumab on the antibody response to the seasonal influenza virus vaccine in patients 12-21 years of age with asthma. Benralizumab will be given subcutaneously (SC) at Weeks 0, 4, and 8 weeks, at which time benralizumab levels will reach steady state. Patients will then receive 1 dose of intramuscular (IM) seasonal influenza virus vaccine at Week 8 and samples drawn at Week 8 and Week 12 to measure the antibody response to the influenza virus

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1
* Weight of ≥40 kg
* Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA)
* Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of \>50% predicted at Visit 1 or Visit 2.
* Airway reversibility (FEV1 \>12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR
* Airway reversibility documented in the previous 12 months prior to Visit 1
* An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR
* Any condition assessed by patient recall over the previous 2-4 weeks

Exclusion Criteria:

* Clinically important pulmonary disease other than asthma
* Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine
* Receipt of an influenza vaccine within 90 days prior to randomization
* Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma
* Acute illness or evidence of significant active infection or known influenza infection during the current flu season
Acute Effect of Osteopathic Visceral Mobilization Techniques

Multiple Sclerosis (MS), caused by lesions in the white matter of the central nervous system, is an autoimmune inflammatory demyelinating chronic disease.

The disease may present with many findings from fatigue, spasticity, balance and gait disturbances to bladder-bowel dysfunction (Ferreira, A.P.S., et al., 2019). When the rehabilitation methods for incontinence were examined, pelvic floor muscle training, tibial nerve stimulation and sacral neuromodulation were frequently encountered (Rahnama'I, MS., 2020). Pelvic floor muscle training should create an effective result in MS patients, and the training should be done for a long time, such as 8-12 weeks. No study has been found examining the effects of manual therapy techniques and diaphragmatic breathing exercise in the acute phase in functional or neurogenic bladder-intestinal dysfunctions.

The study was planned as a randomized controlled trial. MS patients included in the study will be divided into two groups according to inclusion and exclusion criteria. Diaphragmatic breathing exercises and sacral relaxation, bladder mobilization, which are osteopathic manual therapy techniques, will be applied to the study group. On the other hand, only diaphragmatic breathing exercises will be applied to the control group.

Individuals will be treated in a single session. The acute effect of intervention will be examined by making a total of 3 evaluations, pre-intervention, post-intervention, and 1 week after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* The age of 18 years and the older
* Individuals with stable medical condition
* Having complaints of urinary dysfunction for at least 6 months,
* Mini Mental test score \> 24 points
* EDDS less than 6.5 (0-6.5 points will be)
* Volunteering to participate in the study

Exclusion Criteria:

* Having cognitive problems
* Presence of pelvic organ prolapse or prostate
* Pregnancy
* Abdominal surgery history
* Presence of urinary system infection
* Continuing drug use for overactive bladder
* Having received pelvic floor muscle training
* Concomitant other neurological or kidney disease
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis

The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.


Eligibility Criteria:
Key Inclusion Criteria:

* Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
* Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:

  * Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
  * ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria
  * ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria
* No evidence of active tuberculosis (TB) or untreated latent TB

Key Exclusion Criteria:

* Participants with elevated intraocular pressures and/or severe glaucoma
* Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.