cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Chronic plaque PSO for at least 6 months prior to the Screening Visit
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
* Subject is a candidate for systemic PSO therapy and/or phototherapy
* Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

* Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab
* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Subject has had previous exposure to adalimumab
* Presence of active suicidal ideation or positive suicide behavior
* Presence of moderately severe major depression or severe major depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed CD19+ haematological malignancies.

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) γδT-cells (CD19 CAR γδT-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR γδT-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR γδT-cells in patients with high risk relapsed CD19+ malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 70 years.
5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to infusion.

Exclusion Criteria:

1. KPS\<50.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.

This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.

Participants will be invited to participate to this research study by their oncologist within 1 to 2 weeks before starting bevacizumab treatment, as part of standard treatment. They will finish the research at the end of the third infusion of bevacizumab.

Patients will perform a home blood pressure self-measurement over three days and will collect urine over 24 hours prior to the start of each bevacizumab infusion at cycles 1, 2 and 3. Blood pressure measurements will also be performed during each bevacizumab infusion and blood tests will be performed before each infusion to measure the following biomarkers:

* Salt consumption as estimated by 24-hour natriuresis measured before each of the first 3 infusions
* 24 hours aldosterone excretion measured before the first and third infusions
* plasma methoxylated derivatives measured before the first and third infusions
* NTproBNP measured before the first and third infusions
* 24 hours urinary free cortisol measured before the first and third infusions
* bevacizumab trough concentration measured before the first three bevacizumab infusion

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization

Exclusion Criteria:

* Renal cancer
* Recent changes in antihypertensive treatment(s) in the last month, with the exception for diuretics where treatment stability of at least 3 months will be required
* Patients who do not wish to participate to the study
Effect of the Position of the Patient's Head

The position of the head of the patient influences the cerebral venous return and cerebral perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC. Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected by changes of position of the head of the patient. But the whole of the literature on this subject has significant bias.

Registration of blood flow changes induced when the patient's head will be tilted at 0 ° (that is to say flat), 15 ° and 30 ° (the order of actions will be determined by randomization). The patient will remain 10 minutes in each of these positions and will also have a little extra blood sample of 1 ml (ie 9 samples). These measures will be carried out again the next day and then after five days to see if the results vary depending on the evolution of his condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years with:

  * A severe head injury
  * or subarachnoid hemorrhage before the 5th day of evolution
  * or spontaneous intracranial hematoma
  * or ischemic stroke
* Neurosurgical Patients after surgery
* Presenting intracranial hypertension

Exclusion Criteria:

* Hemodynamic and / or neurological instability. In the most unstable patients, care and mobilizations are reduced to a minimum.
* Craniectomy
Efficacy of FLAG Regimen for the Treatment of Patients With AML

The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 year old
* De novo or secondary leukemia.
* Treated with FLAG regimen

Exclusion Criteria:

* Acute promyelocytic leukemia (APL)
Optical Coherence Tomography And NEphropathy: The OCTANE Study

Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.

This project is an exploratory study, using enhanced depth imaging with the new SPECTRALIS OCT, designed to examine choroidal and microvascular retinal structure in patients with hypertension, chronic kidney disease (CKD), and in age and sex matched healthy controls. The study is non-invasive and takes only a few seconds to acquire these complex images. The Centre, where the images will be captured and where image analysis systems are located, is on the Royal Infirmary of Edinburgh (RIE) site close to the RIE outpatient clinics, making recruitment easy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-80
* Body mass index ≤35
* For those with hypertension: BP ≥140/90 or on treatment for hypertension
* For those with CKD: CKD as defined by the Kidney Diseases Quality Initiative guidelines

Exclusion Criteria:

* Subject is below the age of legal consent, or is mentally or legally incapacitated
* The subject has donated blood (450 ml) within the last 4 weeks
* Past or present drug or alcohol abuse including intravenous drug abuse at any time
* Participation in another clinical trial within 1 month
* Considered to be at high risk of HIV or hepatitis B
* Patients with known eye disease, or previous eye surgery, or refractive error greater than +/- 6 dioptres.
Diet, Exercise and Cardiovascular Health Among Ethnic Children

To document the patterns of influence or socialization from parents to children in regard to the transmission of cardiovascular disease risk related behaviors such as diet and physical activity.

BACKGROUND:

While much of the research in heart disease prevention has focused on relationships among cardiovascular disease risk factors, cardiovascular disease morbidity and mortality, there is a growing recognition of the importance of various health behaviors, such as what people eat, how much they exercise, if they smoke, their habitual approach to life including Type A behavior. Many of these risk related behaviors are correlated with the various cardiovascular disease risks. This study determined differences in social influence patterns in regard to diet and exercise between obese and non-obese families, and the impact on the obesity, dietary and exercise habits, and risk factors of children beginning at three to four years of age until seven to eight years.

DESIGN NARRATIVE:

This prospective, longitudinal study collected data on the twelve cohorts of families. Blood pressures, resting pulse, height, weight, skinfolds, plasma cholesterol fractions and Type A behavior data were collected on the children at five times over the course of five years. During the four years between each of the clinic measurements, observational data were collected on the diet and exercise habits of the children. At the time of clinic assessment, clinic data were also collected on the parents of the children and self report data on the parents' diet, exercise habits, and other psychosocial variables. Two substudies were also conducted. The first assessed energy expenditure levels of children in the three age groups of 3-4 years, 5-6 years, and 7-8 years and the three body types of lean, average, and obese in 12 different activities. The second substudy assessed the accuracy of mothers' 24-hour recall of the diet and exercise behaviors of their 3-4 year old children as compared to observational data on the same behaviors.

Eligibility Criteria:
No eligibility criteria
In-Room PET in Proton Radiation Therapy

The investigational part of this study is using a mobile PET/CT scanner to take images of the participants tumor immediately after they are treated with proton radiation. This allows the participant to be treated and imaged on the same bed. The information obtained may improve the accuracy of treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.

For all participants, right after one regular treatment fraction, NeuroPET or NeuroPET II will be wheeled into the patient room. The patient bed will be moved directly into the scan position and a PET scan will be acquired in list-mode for 15 to 20 minutes followed by a CT scan for \~5 minutes. After undergoing their first PET scan, participants will have the option to undergo 1-2 additional scans throughout radiation treatment in the same manner as the first scan.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with brain, head and neck, and skull base tumors receiving external beam proton radiotherapy at the Francis H. Burr Proton Therapy Center at MGH
* Age 18 or over
* ECOG Performance status 0, 1 or 2

Exclusion Criteria:

* Uncontrolled intercurrent illness that, in the opinion of the investigator, would limit the participant's compliance with study requirements.
A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan

The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in Taiwan.

The investigators conducted a quasi-experiment in older workers from three worksites in southern Taiwan.

* Qualified subjects were assigned to the intervention or the reference group according to their availability to take part in study activities.
* A researcher reviewed the health record and discussed with the subject about his/her health status.
* Subjects in the intervention group received lifestyle interventions. The activities included motivational presentations to increase awareness of own health problems and the role of lifestyle in the etiology of non-communicable chronic diseases.
* Subjects were organized into small groups to have biweekly meetings to share experiences, stimulate mutual encouragement and to overcome obstacles.
* Anthropometric and biochemical indicators were measured at baseline and endpoint (week 24).

Eligibility Criteria:
Inclusion Criteria:

* full-time worker
* aged 50 years or older
* willing to complete a screening questionnaire
* sign a study consent

Exclusion Criteria:
Thyroid and Adrenocortical Hormone Replacement in Organ Donors

Brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. In addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. Catecholamine vasopressors are widely used to support hemodynamics in potential organ donors, however their use has also been shown to compromise allograft function.

Trials studying the effects of thyroid hormone and corticosteroid treatment on brain dead organ donors have had mixed results with respect to improving donor hemodynamics. Further, few studies have attempted to discriminate the relative contribution of thyroid hormone vs. corticosteroids.

The specific aims of this study include:

1. To quantify hemodynamic changes during the management of cadaveric organ donors routinely receiving thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those who do not receive any hormonal therapy (controls)
2. To document number and types of organs procured in donors treated with thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those not treated with hormonal therapy (controls)
3. To quantify graft and patient outcomes in recipients of organs exposed to thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to recipients of organs not exposed to hormonal therapy (controls).


Eligibility Criteria:
Inclusion Criteria:

Cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs.

Recipients of these cadaveric organs

Exclusion Criteria:

Cadavers failing to meet inclusion criteria
A Clinical Investigation of the M2a- 38™ Hip System

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System


Eligibility Criteria:
Inclusion Criteria:

* Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis of osteoarthritis, avascular necrosis, traumatic arthritis, subcapital fracture, legg perthes, slipped capital epiphysis, fracture of the pelvis, diastrophic variant.
* Patients with full skeletal maturity
* Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously
* Patients of all races and gender
* Patients who are able to follow postoperative care instructions
* Patients who are able and willing to return for follow-up evaluations
* Patients have preoperative total Harris Hip Score less than 70 with at least moderate pain.

Exclusion Criteria:

* Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.
* Patients less than 18 years.
* Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.)in the hip joint to be operated.
* Patients with previous Girdlestone procedures.
* Patients with above the knee amputation of the contralateral and/or ipsilateral leg.
* Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.
* Patients who are pregnant.
* Patients with an active or suspected infection in or around the hip.
* Patients with Parkinson's disease.
* Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.
* Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would preclude stability of the prosthesis.
* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
* Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients with previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome, e.g., Paget's disease, Charcot's disease, severe osteoporosis compromising bone stock (Dorr type C bone).
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
* Patients with a "fused" hip.
* Patients who have had a total hip arthroplasty on the contralateral hip within the last year.
Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 24 months
* BMI between 18 and 30 kg/m2
* Insulin naive subjects
* OAD treatment with max two OADs alone or combined with other therapy
* HbA1c between 7-12%

Exclusion Criteria:

* Type 1 diabetes
* Receipt of any investigational drug within the last three months prior to this trial
* Current or previous treatment with thiazolidiones within the last 6 months
* OAD treatment with three or more OADs within the last 4 months
Tacrolimus for Thrombocytopenia in SS

This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.

This study evaluates the efficacy and safety of Tacrolimus for the treatment of thrombocytopenia in Sjogren's syndrome patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
* Baseline platelet counts within 30-80×109/L.

Exclusion Criteria:

* Concomitant other systemic autoimmune diseases.
* Severe complications of Sjogren's syndrome.
* Abnormal laboratory tests such as: white blood cell count \<2.5x10\^9/L, hemoglobin \<80 g/L, AST/ALT \>1.5 ULN, serum creatine \> 1.5 mg/dL.
* Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
* Active acute or chronic infections.
* History of malignancy.
* Pregnancy or breastfeeding.
MitraClip® Registry

Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.


Eligibility Criteria:
Inclusion Criteria:

* severe mitral regurgitation
* percutaneous mitral valve repair (PMVR) with the MitraClip® system

Exclusion Criteria:

* \< 18 years
* Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure