cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

The purpose of this study is to acquire information on the usage, effectiveness, safety, and levels of health care resource utilization associated with Velcade therapy in recurrent and refractory multiple myeloma patients who are initiating Velcade and various combination therapies within the approved indication in a naturalistic setting.

This is a national, multi-center (study conducted in multiple sites), non-interventional (a scientific study where one or more investigators monitor one or more patients being treated with the same medication), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients treated with Velcade. The study consists of 3 phases, including, screening phase, treatment phase, and follow up phase. In the screening phase, data will be collected on the basis of patient's demographic status, components of disease severity assessment, and potential prognostic factors. Data on prior cancer treatments will be collected retrospectively at baseline for patients receiving cancer treatment prior to receiving Velcade. In the treatment phase, Velcade is administered intravenously for a 2-week treatment period followed by a 10-day rest period. Each treatment cycle consists of 21 days. Prospective (in which the participants are first identified and then followed forward as time passes) observational data will be collected during treatment with Velcade. In the follow up phase, patients will be followed for up to three years to document long-term survival data. For patients who reinitiate Velcade, data collection should follow Velcade treatment period documentation process. Safety evaluations will be based on the incidence, intensity, and types of adverse events. The total duration of the study is set prospectively for three years from the date of the patients' initiation of Velcade.

Eligibility Criteria:
Inclusion Criteria:

* Must give informed consent in agreement with local legislation
* Must not have any contraindication listed in package insert

Exclusion Criteria:

* Patients currently participating in another investigational study of Velcade or any other medication
* Patients with severe hepatic or renal impairment
* Patients with platelet count below 25000/μl
* Patients who are considered disqualified for the study by the investigators
CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Longitudinal Study

Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion (CSII) is an effective method of achieving this. Among the advantages of CSII is the opportunity for patients to potentially discard relatively inflexible mealtimes and carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI). There are also reported improvements in quality of life. Furthermore, in patients with good glycaemic control, such as those often assisted by CSII, various qualitative atherogenic lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile; potentially leading to increased cardiometabolic risks. Literature examining the eating behaviours, quality of life and cardiometabolic risks of CSII patients over time after commencement of the therapy is sparse, frequently dated and worthy of further research.

Continuous subcutaneous insulin infusion (CSII) is a therapy for patients with Type-1 diabetes mellitus involving insulin administration via electronic pump. CSII has been shown to reduce HbA1c levels and improve blood sugar control and the continuous, unobtrusive insulin delivery may potentially allow patients increased dietary flexibility and quality of life. However, despite these claims longitudinal investigatory literature is sparse. This study will clarify whether adult CSII patients experience eating behaviour and quality of life alterations over time after commencement of the therapy. This is important as changes may be associated with cardiometabolic risk variations; which will also be investigated.

Participants will comprise of a convenience sample of adults with Type-1 diabetes invited from diabetes clinics at the Royal Liverpool University Hospital who are due to commence CSII.

Following ethical consent the participants who are due to commence CSII will be observed at 5 time points (every three months) over a year. It should be noted that the recruitment period for the longitudinal arm of the study will be 9 months starting from the date the first participant is recruited. At each time point each participant will be asked to complete a 5 day food diary, a food intake questionnaire (FIQ), a quality of life (QOL) questionnaire, a semi-structured interview and give a 20ml sample of blood. This will be taken at the same time and in addition to their regular diagnostic sample, however where this is unfeasible extra occasional appointments may be needed. Results will be compared with existing patient medical records, which will also be analysed during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must reside in Liverpool or the surrounding areas.
* Patients must be ages over 18
* Patients must have Type 1 diabetes
* Patients must be using or pending the supply of an insulin pump.

Exclusion Criteria:

* Patients must not live outside of Liverpool and the surrounding areas.
* Patients must not be aged under 18
Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.

To elucidate the long-term protective effect of flavored Wenxin Decoction on heart failure after myocardial infarction.

To elucidate the effective components in the treatment of heart failure and the mechanism of metabolism regulation.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old；
* A history of acute myocardial infarction；
* Cardiac function Ⅱ - Ⅲ level；
* LVEF 50% or less;
* Nt-probnp level ≥ 450 pg/ mL；
* All men and women can sign the informed consent form.

Exclusion Criteria:

* Coronary artery bypass grafting was performed within 12 weeks；
* Undergo or possibly undergo cardiac resynchronization therapy;
* Primary valvular disease, left ventricular outflow tract obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina pectoris, or acute myocardial infarction;
* Having a serious primary liver, kidney or blood system disease or having a serious mental illness or a systemic disease that is out of control;
* Serum creatinine \> 194.5 mol/L or serum potassium \> 5.5mmol /L;
* The level of alanine aminotransferase or alkaline phosphatase is 1.5 times of the normal upper limit of \>;
* Abnormal blood pressure control, systolic blood pressure exceeding 180mmHg or diastolic blood pressure exceeding 110mmHg;
* Pregnancy or lactation; Known or suspected allergy to research drugs; To receive another investigational drug within 30 days of randomization or to be unwilling or unable to provide written consent.
Early Endoscopic Indicators for OACs After Lung Transplantation: Development of a Novel Mucosal Healing Score

Airway complications are a significant cause of morbidity after lung transplantation (LTx). Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.

The investigators evaluated lung transplant recipients prospectively. Adult patients surviving 90 day after LTx will be included. The investigators propose a classification of airway healing based on the endoscopic bronchial appearances at days 7, 14, 21, 90, 180 and 365 after LTx. A score system including mucosal healing, full tissue necrosis (=dehiscence), lose sutures, fibrin plugs, polyps and malacia will be developed (max. score 8 points/date). Endoscopic findings will be correlated with the development of obstructive airway complications (OAC, requiring \>1 intervention). Afterwards the new score system will be applied prospectively in the patients.

Eligibility Criteria:
Inclusion Criteria:

* 3 month survivor after LTx
* no OAC

Exclusion Criteria:

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Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.

Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life compared to healthy adults. This is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress.

It is known that physical education may improve course of disease and quality of life in a multitude of diseases. These include coronary heart disease, malignancies and also depression. The investigators believe that sport is as effective supportive tool in improving quality of life in IBD patients. But data is lacking with regard to controlled randomized clinical trials. Because of the small amount of data available the investigators considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The investigators further suspect that these patients improve their quality of life compared with patients in the control group.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* proven colitis ulcerosa (CU)
* proven crohns disease (CD)
* diagnosis \>= 1 year before start of the study
* low or moderate disease activity

Exclusion Criteria:

* \< 18 years
* high disease activity
* regular exercise \> 2 hours per week
* diagnosis of CU oder CD \< 1 year before start of the study
Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.

Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects.

K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system. This will be a single-center study. The study will consist of a 1-day visit for each study subject on which screening based on a questionnaire, blood draw and discharge will occur. For each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after blood collection. The data obtained will be used for determination of normal values of BNP in a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Philips for potential future analysis/ projects). Testing will be done according to a DRAFT Instructions for use (IFU) of the Minicare BNP.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Willing and able to sign the informed consent form (ICF)

Exclusion Criteria:

* Subjects suffering from cardiac and/or vascular disease, renal dysfunction, hypertension, cancer, Chronic Obstructive Pulmonary Disease (COPD), instable diabetes, pregnancy and extreme overweight are not allowed to donate blood.
* Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.
Performance Study of Newly Developed Ostomy Products

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent.
2. Be at least 18 years of age and have full legal capacity.
3. Have experienced leakage under the base plate at least once a week over the last two weeks.
4. Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
5. Have a colostomy with a diameter between 20 and 45 mm.
6. Have had their ostomy for at least three months.
7. Currently use a 1-piece flat product with closed bag.
8. Use minimum 1 product per day.
9. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects

Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal malalignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters .

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Group A group (n=20). All participants will receive only single session of neck mobilization. Grade IV unilateral posteroanterior pressure and sustained extension to be applied restricted joints and muscle energy technique.

- Group B (n=20) will receive single session of neck manipulation with high-velocity, low-amplitude thrust over restricted joints (one at a time) with the goal of restoring normal range of motion in the joint.

Eligibility Criteria:
Inclusion Criteria:

* SBP ranging from 135 to 159 mm Hg or DBP ranging from 85 to 99 mm Hg over 3 qualifying BP screening visits
* The age of participants will range from 27 to 60 years old.
* Body mass index of participants will range between \< 39 kg/m².

Exclusion Criteria:

* cardiovascular diseases or surgery, including second- or third-degree heart block, angina pectoris, defibrillator, valvular disease, recent myocardial infarction, cardiac surgery in the past 12 months.
* history of stroke.
* body mass index (BMI) greater than 39 kg/m2.
* pregnancy.
Treating COVID-19 With a Bidirectional Oxygenation Valve

This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.

Eligibility Criteria:
Inclusion Criteria:

* Oxygen saturation \<93%
* Able to provide informed consent
* Not currently requiring intubation
* Receiving oxygen by face mask

Exclusion Criteria:

* Unable or unwilling to provide informed consent, cognitive impairment
* Rapidly decompensating status requiring urgent or emergent higher level of care
Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.

OBJECTIVES:

* Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients.
* Evaluate the toxicity and overall survival of these patients.

OUTLINE: Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: This study will accrue 14 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS
* No systemic lymphoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-3

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3000/mm\^3
* Platelet count at least 80,000/mm\^3

Hepatic:

* No serious impairment of liver function

Renal:

* No serious impairment of renal function
* Creatinine clearance at least 40 mL/min

Cardiovascular:

* No serious impairment of cardiac function

Neurologic:

* Neurological functional status 0-3

Other:

* No prior or active CNS-opportunistic infections
* No AIDS dementia complex
* No active systemic infections

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects

Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive protein of a negative energy balance and a reduction in body fat stores. Secondly to compare CRP with fibrinogen and interleukin-6 (IL-6).

Background:

Previous epidemiological studies have associated elevated levels of acute phase proteins, mainly C-reactive protein, with cardiovascular diseases (CVD) and cardiac death. Levels of several cy-tokines and acute phase proteins as CRP, haptoglobin and fibrinogen have been found associated with elevated body fat and the risk of diseases associated to the metabolic syndrome.

Method:

Thirty-six otherwise healthy obese subjects (BMI: 34.23.2 kg/m2, age: 43.410.5 y) participated in a 20-week controlled dietary intervention divided into 4 periods. Weight reduction was induced by an 8-week low caloric diet (LCD) (3.4 MJ/d) followed by a 4-week weight stable maintenance program (M1). Subsequently, they underwent another 4-week LCD (4.2 MJ/d) followed by a final 4-week weight stable maintenance diet (M2). Blood samples and anthropometrical measures were assessed at baseline and after each of the four periods (8, 12, 16 and 20 weeks).

Eligibility Criteria:
Inclusion Criteria:

* 41 participants (20 men, 21 women) were included in the study. They were between 24-62y, healthy, non-athletic, weight stabile (\< 3 kg in last 2 mo) but overweight to obese (BMI: 28-40 kg/m2).

Exclusion Criteria:

* evidence of metabolic or systemic diseases other than obesity. Frequent use of medication, a systolic blood pressure \>165 mmHg and diastolic blood pressure \>95 mmHg.
Walk With Ease Program For Patients With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook. The book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. Participants will complete questionnaires assessing their symptoms before and after completing the six-week program.

The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook, a publication of the Arthritis Foundation. Participants will complete self-reported outcomes questionnaires prior to beginning the program and six weeks later at completion of the program. The questionnaires will include visual analog scales for pain, stiffness, and fatigue as well as a FACIT-Fatigue form. Participants will also complete a satisfaction survey at the end of the program.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of systemic lupus erythematosus
* Age \>/= 18

Exclusion Criteria:

* Age \<18
* Engagement in \>150 minutes of moderate-intensity activity at baseline
* Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score \>8
* Pregnancy
Korean Stroke Cohort for Functioning and Rehabilitation-II

Korean Stroke Cohort for functioning and rehabilitation (KOSCO)-II is a large, multi-centre prospective cohort study for all acute first-ever stroke patients admitted to participating hospitals in nine distinct areas of Korea. This study is designed as a 10-year, longitudinal follow-up investigating the residual disabilities, activity limitations, and quality of life issues arising in patients suffering from first-ever stroke as previous similar stroke cohort with KOSCO. The main objectives of this study are to identify and compare the factors that influence residual disability and long-term quality of life in first-ever acute stroke patients with KOSCO. The secondary objectives of this study are to determine and compare the risk of mortality and recurrent vascular events in first-ever acute stroke patients with KOSCO. Investigators will investigate longitudinal health behaviors and patterns of healthcare utilization, including stroke rehabilitation care. Investigators will also investigate the long-term health status, mood, and quality of life in stroke patient caregivers. In addition, investigators will identify baseline and ongoing characteristics that are associated with secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* First-ever acute stroke (ischemic stroke or intracerebral hemorrhage) with corresponding lesion and/or evidence of acute arterial occlusion on CT (A)- or MRI/A-scan.
* Age ≥ 19 years at onset of stroke.
* Onset of symptoms within seven days prior to inclusion.

Exclusion Criteria:

* Transient ischemic attack.
* History of stroke.
* Traumatic intracerebral hemorrhage.
* Not Korean.
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
* has chronic pain, \>3 months;
* is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion Criteria:

* currently adjusting oral pain medications for their PLP;
* has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
* has a pacemaker, or other metal and/or implanted devices;
* has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
* has amputation in multiple limbs;
* have asthma or other pulmonary diseases;
* are not medically stable;
* have preexisting psychiatric disorders;
* alcohol or drug abuse;
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.