cyrilzakka/clinical-trials huggingface dataset:
Project humAn dieTary daTa rEtuRN

This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation.


Eligibility Criteria:
Inclusion Criteria:

* Participant's parent/legal guardian is over age 18 and able to understand English
* Plans to remain in the area for the next two years
* Primary caregiver for infant less than 12 months old
* Able to collect and ship the requested infant stool samples

Exclusion Criteria:

There will be no specific exclusions for this study. However, the following biospecimens will not be collected for research purposes from individuals who have a condition that, in the opinion of the site investigators and/or providers, would place the subject at unacceptable risk of injury or confound data interpretation; including but not limited to:

* Health conditions that impact the infant feeding in a way that may confound interpretation of study results.
Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.

Trigeminal neuralgia(TN) is a recurrent severe shooting neuropathic pain. Treatment of this pain continues to be a challenge in clinical pain management. Hyperbaric oxygen (HBO) has been used of neuropathic diseases, which can improve blood partial pressure of oxygen, reduce edema, relieve neural oppression and attenuate inflammatory response. The hypothesis of this protocol is that hyperbaric oxygen treatment could relieve neuropathic pain and improve the quality of life in TN patients. Visual analogue scale (VAS) and the mcgill pain questionnaire (MGPQ) will be assessed before the initiation of the study, after hyperbaric oxygen (HBO) treatment and at monthly intervals for the subsequent 3 months. Titration of dosage and pain frequency will be recorded throughout the study. Clinical global impression (CGI) by the individual patient will be evaluated at monthly intervals after HBO treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70
2. Primary TN patient (MRI examination support diagnosis)
3. Suffering from this pain for at least 3 months
4. VAS﹥40mm
5. Patient can assess pain intensity correctly

Exclusion Criteria:

1. Undergone surgery for TN(including nerve injections) within the last year
2. Oral medicine change within the last week
3. With other diseases of nervous system
Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics

The overall goal of this study is to assess the effectiveness of screening for undiagnosed atrial fibrillation (AF) using simple, efficient, and portable electronic health and mobile technologies in a healthcare system. The investigators propose to perform population-based screening for undiagnosed AF as part of usual care in patients ≥ 65 years when their vital signs are checked (spot-check) at scheduled outpatient visits in adult Massachusetts General Hospital (MGH) primary care clinics. Patients will receive routine care by their primary care provider (PCP) based upon the results of the screening during the visit.

The investigators hypothesize that rates of AF detection among individuals ≥ 65 years in the MGH primary care network will be greater among patients in clinics assigned to the spot-check arm compared to patients in clinics assigned to the usual care arm of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years or older
* Presenting for an outpatient clinic appointment at a participating clinic
* Visit with a physician, nurse practitioner, or physician's assistant

Exclusion Criteria:

* Have a primary care physician outside of the network
* Do not visit their primary care practice during the study period
High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)

This study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. Patients aged 4-25 years of age will be recruited.

In this study, the Investigator hopes to also learn how this directed steroid delivery during an active flare will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging or biopsy (i.e. at the time of endoscopy). Additional data will determine how the blood vessels in the bowel affect, and potentially even drive the mechanisms, of inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosis of inflammatory bowel disease (IBD) or patients who have an established diagnosis of IBD and are experiencing an acute flare which is not being controlled with first line therapy
* Patients present with typical IBD symptoms which will include, but are not limited to, abdominal pain, loss of appetite, rectal bleeding, diarrhea, obstruction, or passage of mucus.
* Patients referred by the GI team.
* Patients (or guardians/parents) must be able and willing to give consent (or assent where applicable) and be able to attend all study visits.

Exclusion Criteria:

* Patients with MR unsafe metallic implants that will not be able to undergo the MRI portion of the study.
* Patients with renal function impairment (GFR \&lt; 45 mL/min) preventing contrast administration.
* Patients with contrast allergy.
Acute Dyspnea After Use of Non-invasive Ventilation in COPD and Emphysema (Deventilation Syndrome)

Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients with COPD and emphysema. This trial aims to document incidence and severity of augmented dyspnea in patients with long term NIV therapy. These findings may help in understanding the pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.

Non-invasive ventilation (NIV) is a widespread therapy option for patients with hypercapnic failure due to COPD and emphysema. Augmented dyspnea after use of NIV is commonly found and leads not only to high patient discomfort, but can also be associated with acute respiratory failure. This monocentric obervation trial includes patients with COPD III°-IV° (GOLD) and emphysema and an established long term NIV therapy. During their routine inpatient follow-up, we will extend the routine examinations, focussing on the vulnerable first hour after the nocturnal use of NIV. This includes monitoring of breath rate, heart rate, pulsoxymetry, trancutaneous CO2, blood pressure and capillary blood gas analysis. Sonographic measurement of diaphragm movement and thickness will be complemented. Subjective dyspnea will be documented by use of the BORG scale.

By collecting this data, we hope to understand the pathomechanisms causing augmented dyspnea after NIV and thus provide information for therapeutical concepts to prevent it.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with stabile COPD, last exacerbation over one month,
* GOLD III to IV
* Regular use of noninvasive ventilation, more than four hours per day for more than one year
* Signed declaration of consent
* Sufficient language capabilities, german

Exclusion Criteria:

* Acute exacerbation in the past four weeks
* Acute pulmonary embolus
* Haemoptysis
* Severe neurological disease
* Severe cardiological disease
* Haemodynamic instability
* New hypoxia or worsening of hypercapnia more than twenty percent of usual rate
* Acute pneumothorax
* Other instable Situation, for example intraabdominal bleedings
* Drug or alcohol dependency
* Regular intake of morphium
* Adiposity BMI over 35
Body Position and Ultrasound Examination of the Gastric Antrum

Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. In particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. This score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. However, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. This study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old or older
* Last consumption of solids at least 6 hours before the start of the study, last consumption of clear fluids at least 2 hours before the start of the study
* Informed consent must have been signed.
* No significant medical history (American Society of Anesthesiologists (ASA) class 1)

Exclusion Criteria:

* Adult unable to give informed consent
* Previous gastrointestinal surgery
* Medication affecting gastric motility
* Digestive diseases, gastroparesis, diabetes mellitus with insulin
* Pregnancy or breastfeeding
* Obesity (Body Mass Index (BMI) ≥ 30 kilograms/meter² (kg/m²))
Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.

The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.


Eligibility Criteria:
inclusion criteria :

* Patients with a COVID-19 confirmed infection.
* Admission in intensive care unit for an acute respiratory failure requiring oxygen flow above 6l/min by facial mask.
* Presence of an arterial catheter for blood sampling.

exclusion criteria :

* Patients on mechanical ventilation on admission to the ICU.
* Patients requiring immediate intubation on admission.
* Patients admitted to the ICU for more than 48 hours at the time of inclusion.
* Pulmonary embolism diagnosed before admission to the ICU.
* Minor patients
* Pregnant women
* Patients under curatorship or guardianship
* Persons deprived of liberty by a judicial or administrative decision
Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants

The objective of the SIMCA study was to analyse the impact of structured medication counselling by community pharmacists on medication adherence, economic, clinical and humanistic outcomes of depressed primary care patients who started a new treatment with antidepressants.

A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At the time of the start of the study, the Surplus Network included 97 pharmacies, in all five Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were informed about the SIMCA-study and instructed how to approach eligible patients.

Randomisation was obtained at the pharmacy level by a computerized random-number generator, following a permuted block design (1:1). The Surplus Network contains a number of local pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy chains.

Pharmacists in the intervention group were trained in communication skills related to depression treatment counselling in groups of no more than 10 participants over a single day. In total, 10 training days were scheduled between November and December, 2010.

Patients were eligible for inclusion in the study if they started using at least one antidepressant drug, if they were at least 18 years old, if they were able to understand and complete Dutch questionnaires and if they could be reached by telephone for follow-up. "Starting" was defined as not having been prescribed antidepressants over the last six months, which was checked in the pharmacy records. If the patient gave verbal consent to the pharmacist, to be contacted by the research team, the patient was provided with written and oral information about the SIMCA project and a consent form. At the same time an automatic e-mail was generated from the pharmacy software to inform the research team about the patient's willingness to be contacted about the study. The patient was contacted by the research team, as soon as possible to give more information about the study, to ask for informed consent and to schedule a first telephone survey interview. If the patient wished to participate, he/she completed the consent form, and sent it back with the included postage-paid envelope addressed to the research team. Upon receipt of the consent form, the recruited patient's prescribing doctor was contacted and asked to complete and return a brief questionnaire to provide the diagnosis and its severity related to prescribing antidepressants.

Telephone survey interviews based on validated scales were used to collect data at the start of treatment (as close as possible to the time of recruitment), after one month, three months and six months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* able to understand and complete Dutch questionnaires
* could be reached by telephone for follow-up

Exclusion Criteria:

* used antidepressants over the last six months
Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial

This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 45 primary care sites are randomized to three groups, with 15 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 15 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 15 sites to the control group.


Eligibility Criteria:
Inclusion Criteria:

1. 35 ≤ Age \< 80 years.
2. Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
3. Diagnosed with hypertension, with SBP ≥140mmHg at screening.
4. Currently taking 0 or 1 class of antihypertensive medication (A/B/C/D).
5. Willing to participate in the trial and capable of providing written informed consent.

Exclusion Criteria:

1. Physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug-induced, or rare monogenic genetic disease).
2. SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
3. Suspected or diagnosed white coat hypertension.
4. History of coronary heart disease a, heart failure.
5. Intolerance to 2 or more classes of antihypertensive medications(A/B/C/D).
6. Currently taking 2 or more antihypertensive medications.
7. Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)\< 60 ml/min·1.73m2, or receiving dialysis.
8. Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
9. Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
10. Cognitive or communicative disorders.
11. Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
12. Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
13. Participating in other clinical trials.
Effects of scFOS on Stool Frequency in People With Functionnal Constipation

The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation


Eligibility Criteria:
Inclusion Criteria:

* subjects with functional constipation

Exclusion Criteria:

* subjects treated with laxative treatments
* subjects consuming more than 25g/day of dietary fibres
* pregnant women
Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics

To quantify the incremental cost of infections in patients treated with etanercept, adalimumab or infliximab versus abatacept.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older;
* Have a diagnosis of of rheumatoid arthritis (ICD-9:714x.xx);
* Have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment;
* are enrolled in a health plan between February 2006 and June 2009
* have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for teh 6 months assessment and 12 months for the 12 months assessment

Exclusion Criteria:

* Patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded
* Patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period).
* Patients on biologics 6 months prior to the biologic index date will also be excluded
* Patients with diagnosis for other non-RA conditions commonly treated with biologics (ex. Crohn's disease) during the 6 month pre-index period.
Canakinumab MAP in COVID-19 Pneumonia With CRS

This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending);
* Hospitalized with COVID-19-induced pneumonia;
* Elevated CRP or ferritin levels;
* Body weight ≥ 40kg.

Exclusion Criteria:

* Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab;
* On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day);
* Use of tocilizumab within 3 weeks prior to dosing with canakinumab;
* Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19);
* Patients with significant neutropenia (ANC \<1000/mm3);
* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.
Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness

currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals. The project aims to examine trends in patient-reported outcomes (PROMs), including symptoms, quality of life, and distress, in multimorbid hospitalized patients from admission to 30 days post-discharge. It will also investigate whether PROMs at discharge are linked to the risk of readmission or emergency visits and explore how these outcomes differ in patients who receive low-value care. Additionally, the project will assess the relationship between patient-reported experiences (PREMs) and the provision of low-value care during the hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* eligible for the LUCID registry (CER-VD AO_2023-00029) \[Age ≥ 18 years, hospitalized in one of the five participating university hospitals (Geneva, Lausanne, Bern, Zürich, Basel), after 01.01.2014, and admitted to general internal medicine wards
* Multimorbid patients (2 or more chronic diseases, defined as chronic conditions defined by international classification of diseases, 10th revision, codes with an estimated expected duration of at least 6 months or based on a clinical decision.
* Acute illness
* Signature of study specific informed consent

Exclusion Criteria:

* Not able to speak French, German or English
* Foreseen length of stay of less than 4 days (estimated by study collaborators)
* Prior inclusion in the TRADUCE study
* Incapacity of discernment, i.e. cognitive impairment which could interfere with the ability to fill in PROMs tools
Long-term Pacemaker Arrhythmia Analysis

Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.


Eligibility Criteria:
Inclusion Criteria:

* Pre-existing dual chamber permanent pacemaker

Exclusion Criteria:

* Nil