cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring of Interstitial Lung Disease

As in-clinic pulmonary function testing is greatly restricted due to Coronavirus Disease 2019 (COVID19), alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. This project will evaluate the feasibility of a remote monitoring programme designed for interstitial lung disease (ILD) \[including idiopathic pulmonary fibrosis (IPF)\] patients which includes patient-reported spirometry \& pulse oximetry (to estimate lung airflow and oxygen levels in the blood).

Patients with a confirmed diagnosis of ILD will be asked to measure spirometry \& pulse oximetry once/day for approximately three months. Each patient will be supplied with a spirometer \& pulse oximeter for home use. There will be no other changes to patients' care. The clinical teams responsible for care of the patients will be able to view all patient-recorded data immediately after data are recorded by the patient. Feasibility of remote monitoring will be assessed by determining the proportion of patients who provide measurements at least 3 times/week and on at least 70% of days in the observation period. Patient engagement (Patient Activation Measure), changes in spirometry measurements over time and healthcare resource utilisation (e.g. number of in-clinic visits) will also be assessed. Other outcomes assessed will include estimation of the proportion of patients with significant decreases in lung function, number of occasions where critical alert values of physiological parameters are reported and number of interventions by healthcare professionals in response to observations or alerts from remote monitoring. Feedback from patients and healthcare providers on user experience will also be sought.

Learnings from this project will be used to assess the wider application of delivery of digitally-based remote monitoring in management of long-term respiratory conditions.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of interstitial lung disease
* Forced Vital Capacity ≥50% predicted (at most recent in-clinic spirometry test)
* owns a smartphone or tablet device
* has a mobile telephone number, email address and access to internet at home
* willing to allow home monitoring of their health including spirometry and pulse oximetry data
* understands how to use mobile technology (e.g. has downloaded and used other "apps" on their mobile device; uses email)
* demonstrates willingness to measure spirometry and pulse oximetry daily for the duration of the study
* fluent in English language
* Written informed consent.

Exclusion Criteria:

* serious concomitant conditions which place the patient at high risk of respiratory distress, making them unsuitable to be managed at home
* confusion which would limit the patient's understanding of the project or the measurement procedures
* current or recent (within last 6 weeks before baseline) participation in another clinical research project.
Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst

The purpose of this study is to determine whether regional implementation of shared care with respect to type 2 diabetes is feasible, effective and cost-effective.

Background Diabetes is an important chronic condition with significant associated morbidity and mortality, which can be reduced by effective care. An interdisciplinary approach, sharing responsibility and involvement and education of patients are of major importance in diabetes care.

In Belgium a research project aimed at creating regional diabetes shared care was set up.

Research questions

* Is regional implementation of shared care feasible?
* Does it increases quality of care (evidence based care) and patient satisfaction with care?
* Does it have a positive effect on health status (emotional distress, overall quality of life, Hba1c)?

Methods Controlled trial (July 2004 - June 2006) with a regional complex intervention comprising introduction of a care-manager and 2 community based diabetes educators, development and implementation of a shared care protocol (with a central role for the GP), regional feedback on the quality of diabetes care and patient education. Practitioners and patients participate on a voluntary basis. In the control region usual care continues.

Biophysical, psychosocial and process outcomes were collected thru GP registration of patients records and self-administered patient questionnaires (PAID, QUOTE).

Eligibility Criteria:
Inclusion Criteria:

* All type 2 diabetes patients living in the defined intervention region
* All caregivers involved in type 2 diabetes care in the defined intervention region

Exclusion Criteria:

* None
Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Irritable Bowel Syndrome and Healthy Subjects

In this observational case-control study investigators aimed to assess the serum levels of adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome (IBS), and compare it with healthy controls. Furthermore, investigators evaluated the possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical and psychological disorders.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18, and 80 years.
* IBS patients diagnosed according to the Rome III Diagnostic Criteria for Functional GI Disorders.

Exclusion Criteria:

* Any evidence of abdominal surgery or radiation
* celiac disease, or other primary GI illnesses
* GI infection obscuring IBS symptoms,
* using total parenteral nutrition therapy in the last 6 months
* pregnancy and lactation
* alcohol consumption
* concurrent chronic diseases such as diabetes, renal failure
* diagnosed and/or treated malignancy in the past 5 years
* anti-inflammatory drugs usage
* intake of vitamin D, omega-3, vitamin E, and calcium supplements
* being on a special diet or medication regimen during the last 6 months
Replacement of Saturated Fat in Dairy on Total Cholesterol

The consumption of milk and dairy products is recognised as an essential part of a healthy diet as it represents an important source of key micro- and macronutrients. Nevertheless, there is still a widespread conviction that the overall high energy density and concentration of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects, contributing to the progression of cardiovascular disease, obesity and diabetes.

Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an achievable strategy in order to reduce the amount of SFA present in dairy products.

The aim of this project is to observe the effects of three types of dairy products (UHT milk, cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products will affect vascular function and CVD biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Mildly hypercholesterolemic: TC \<5.2 and \<8mmol/L
* Age: 25-70
* BMI: 19-32 kg/m2
* Haemoglobin: \>125g/L for women and 135g/L for men
* Normal liver and kidney function

Exclusion Criteria:

* Milk, cheese, butter, lactose allergy
* Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation
* Suffered myocardial infarction/stroke in the past 12months
* Diabetic (diagnosed or fasting glucose \> 7 mmol/l) or suffer from other endocrine disorders
* Surgery in the previous 6 months
* Excessive alcohol consumption (\>28 unit/wk man; \>21 unit/wk women)
* Taking vitamin, mineral or fatty acid supplements (e.g. fish oil, calcium)
* Pregnant, lactating, planning a pregnancy or not using effective contraceptive precautions
* Smokers
* Vegans
* Anaemic
* Planning or on a weight reduction scheme
* Parallel participation in another intervention study
* Participating in intensive aerobic activity for \> 20 minutes 3 times per week
* Use of anti-inflammatory medication
CD19 Redirected Autologous T Cells for Hodgkin Lymphoma

Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as RNA CART19) in Hodgkin Lymphoma (HL) patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with HL with no available curative treatment options (such as autologous SCT) who have a limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.

  i. HL with biopsy-proven relapse or refractory disease who are unresponsive to or intolerant of at least one line of standard salvage therapy ii. Patients must have evaluable disease by radiologic imaging (FDG PET/CT or PET/MRI) within 42 days of enrollment; evaluable includes both assessable and/or measurable disease as defined by Cheson et al., 2007.
* Age ≥ 18 years of age
* Creatinine \< 1.6 mg/dl.
* ALT/AST \< 3x upper limit of normal
* Bilirubin \< 2.0 mg/dl, unless subject has Gilbert's syndrome (≤3.0 mg/dL)
* Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and

  1. Have no active GVHD and require no immunosuppression
  2. Are more than 6 months from transplant
* Performance status (ECOG) 0 or 1.
* Left Ventricular Ejection Fraction (LVEF) ≥ 40% as confirmed by ECHO/MUGA
* Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
* Written informed consent is given.
* Successful T cell test expansion (to be performed as part of inclusion criteria until 3 subjects meet all enrollment criteria)

Exclusion Criteria:

* Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum pregnancy test at enrollment. A urine or serum pregnancy test will be performed within 72 hours before the first RNA CART19 infusion.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* HIV infection.
* Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
* Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment
* Patients in complete remission with no evidence of evaluable disease by radiologic imaging.
* History of allergy to murine proteins.
* History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
* Anti-CD20 monoclonal antibody therapy within the last 3 months, or absence of circulating B cells.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD

The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 6 years of age and not yet be 18 years of age at the completion of visit 6
* Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
* Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
* Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on a IQ test)
* Patients must be able to swallow capsules

Exclusion Criteria:

* Patients who weigh less than 22 kg or more than 70 kg at study entry
* Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder
* Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, or patients who have taken (or are currently taking) anticonvulsants for seizure control
* Patients with a history of severe allergies to more than one class of medication, or multiple adverse drug reactions
* Patients who have glaucoma
Trimodality Therapy for Malignant Pleural Mesothelioma

The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.

Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.

The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of MPM (all subtypes)
* Clinical T1-3, N0-2, M0 disease.
* No prior treatment for MPM.
* Adequate renal and liver function
* Adequate cardio-pulmonary reserves

Exclusion Criteria:

* Patients with unresectable disease
* Patients with an active infection that require systemic treatments
* Patients with a concurrent active malignancy.
* Patients with serious medical illness.
Pilot Study on Evaluating the Geroprotective Effect of Metformin

The objective of this research is to assess the efficacy of oral metformin in mitigating the aging process in middle-aged and elderly males, to pinpoint sensitive indicators of human senescence, and to offer innovative frameworks and scientific insights for pharmaceutical interventions in aging.

Subjects in both the metformin hydrochloride extended-release tablets treatment group and the placebo group received two tablets (500 mg each) once daily after dinner, continuing for a one-year period of drug intervention.

Eligibility Criteria:
Inclusion Criteria：

1. Male
2. Age 55-65; 18-28;
3. Able to understand and execute instructions;
4. After reading the consent form, be able to answer questions about the study and demonstrate understanding of the protocol;
5. Be able to participate in regular follow-up visits.

Exclusion Criteria

1. Severe chronic or acute disease: cancer, clinically significant congestive heart failure, chronic obstructive pulmonary disease (COPD), previous or new-onset diabetes, inflammatory state, serum creatinine \>1.5 mg/dl , active liver disease, History of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) cardiovascular events (MI, PTCA, CABG, stroke), severe renal insufficiency, inflammatory bowel disease, persistent glucocorticoids Treatment; neurological diseases such as dementia, AD, PD, etc.; infectious diseases such as HIV, hepatitis, tuberculosis, etc.; severe autoimmune diseases;
2. BMI\<18.5 or BMI\>30;
3. Persistent alcohol or drug abuse;
4. Treatment with drugs known to affect glucose metabolism (other diabetes drugs, systemic glucocorticoids, niacin);
5. Hypersensitivity to metformin or any component of the preparation;
6. Have taken metformin, low-dose aspirin, acarbose, vitamin C in the recent (3 months);
7. Unable to provide informed consent;
8. Other circumstances in which the researcher believes that the physical factors of the participants may adversely affect the research process or results.
Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea

This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18yrs at the time of recruitment)
* Body mass index (BMI) ≥ 30
* Symptoms suggestive of sleep apnea
* Epworth Sleepiness Score (ESS) within range
* Positive sleep study for sleep apnea

Exclusion Criteria:

* Tobacco use within the last 3 months.
* Presence of other significant comorbid heart or lung disease
* Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
* Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
* Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
* Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
* History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
* Night shift workers, or other subjects with significantly altered sleep-wake cycles.
* Baseline post-bronchodilator FEV1 \< 70% predicted.
* Severe gastroesophageal reflux disease.
Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).

In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals, ages 18 and above, meeting current diagnostic and statistical manual (DSM-IV) criteria for opioid dependence.
* Subject has voluntarily given informed consent and signed the informed consent document.
* Able to read English and complete study evaluations.

Exclusion Criteria:

* Regular use of benzodiazepines.
* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
* Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
* Abstinent from opiates for more than four weeks prior to naltrexone initiation.
* Medical problems that would preclude naltrexone treatment, such as laboratory evidence of significant hepato-cellular injury as evidenced by abnormal liver enzyme tests including SGOT and SGPT (\> three times normal) or elevated bilirubin levels), and a history of cirrhosis.
* Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial evaluation for naltrexone, and every two weeks during the course of the study).
Vest Prevention of Early Sudden Death Trial and VEST Registry

This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.

In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)
* LV ejection fraction ≤35% determined at the following time point:

  1. If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
  2. If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
  3. If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG
* Age ≥ 18 years

Exclusion Criteria:

* Existing ICD or indication for an ICD at the time of screening
* Existing unipolar pacemakers/leads
* Chronic renal failure requiring hemodialysis after hospital discharge
* Chest circumference too small or too large for LifeVest garment\*
* Participants discharged to an institutional setting with an anticipated stay \> 7 days
* Pregnancy
* Inability to consent
* Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.
Immediate Post-operative Recovery After Regional vs. General Anesthesia

Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. This investigation intends to compare the rate of postoperative complications in the 2 groups from pair matched patient records after regional anesthesia with otherwise similar patients after general anesthesia.

It is still unclear whether the immediate post-operative condition of patients after surgery and anesthesia is dependent on the basic anesthesia technique (General vs. regional anesthesia). The patients' post-anesthesia presentation encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. By pair matching of patient records after regional anesthesia with otherwise similar patients after general anesthesia (control group), the rate of postoperative complications in the 2 groups will be compared. The results of this investigation will help to answer what is the difference in complication rates and wellbeing of patients depending on their previous anesthesia. The results of this study will Show which basic anesthesia technique has more or less early complications.

Eligibility Criteria:
Inclusion Criteria:

* Records from regional anesthesia cases on adults which have quality control assessment data, plus the same number of matched pairs who had general anesthesia.

Exclusion Criteria:

* Cases with incomplete quality control assessment data.